		ISSN 1977-091X
Official Journal of the European Union		C 356

English edition	Information and Notices	Volume 57 9 October 2014

Notice No	Contents	page
	II Information
	INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2014/C 356/01	Initiation of proceedings (Case M.7265 — Zimmer / Biomet) ( 1 )	1

	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	Council
2014/C 356/02	Notice for the attention of the persons subject to restrictive measures provided for in Council Decision 2011/486/CFSP, as implemented by Council Implementing Decision 2014/701/CFSP, and Council Regulation (EU) No 753/2011, as implemented by Council Implementing Regulation (EU) No 1057/2014 concerning restrictive measures in view of the situation in Afghanistan	2

2014/C 356/03	Notice for the attention of the persons and entities subject to restrictive measures provided for in Council Decision 2013/183/CFSP, as amended by Council Decision 2014/700/CFSP, concerning restrictive measures against the Democratic People’s Republic of Korea	4

	European Commission
2014/C 356/04	Euro exchange rates	5

	Court of Auditors
2014/C 356/05	Special Report No 15/2014 The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value	6

	NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA
	Standing Committee of the EFTA States
2014/C 356/06	Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2011	7

2014/C 356/07	Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2012	22

2014/C 356/08	Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012	37

	V Announcements
	PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY
	European Commission
2014/C 356/09	Prior notification of a concentration (Case M.7359 — PCCR USA/Total's CCP Composite Business) ( 1 )	52

2014/C 356/10	Prior notification of a concentration (Case M.7095 — SOCAR/DESFA) ( 1 )	53

	OTHER ACTS
	European Commission
2014/C 356/11	Publication of an amendment application pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs	54

2014/C 356/12	Notice for the attention of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) which were added to the list referred to in Articles 2, 3 and 7 of Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, by virtue of Commission Implementing Regulation (EU) No 1058/2014	63


	(1) Text with EEA relevance

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

9.10.2014

Official Journal of the European Union

C 356/1

Initiation of proceedings

(Case M.7265 — Zimmer / Biomet)

(Text with EEA relevance)

2014/C 356/01

On 3 October 2014, the Commission decided to initiate proceedings in the abovementioned case after finding that the notified concentration raises serious doubts as to its compatibility with the internal market. The initiation of proceedings opens a second phase investigation with regard to the notified concentration, and is without prejudice to the final decision on the case. The decision is based on Article 6(1)(c) of Council Regulation (EC) No 139/2004 (1).

The Commission invites interested third parties to submit their observations on the proposed concentration to the Commission.

In order to be fully taken into account in the procedure, observations should reach the Commission not later than 15 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301) or by post, under reference M.7265 — Zimmer / Biomet, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

9.10.2014

Official Journal of the European Union

C 356/2

Notice for the attention of the persons subject to restrictive measures provided for in Council Decision 2011/486/CFSP, as implemented by Council Implementing Decision 2014/701/CFSP, and Council Regulation (EU) No 753/2011, as implemented by Council Implementing Regulation (EU) No 1057/2014 concerning restrictive measures in view of the situation in Afghanistan

2014/C 356/02

The following information is brought to the attention of the persons that appear in the Annex to Council Decision 2011/486/CFSP (1), as implemented by Council Implementing Decision 2014/701/CFSP (2), and in Annex I to Council Regulation (EU) No 753/2011 (3), as implemented by Council Implementing Regulation (EU) No 1057/2014 (4) concerning restrictive measures in view of the situation in Afghanistan.

The United Nations Security Council adopted Resolution 1988 (2011), imposing restrictive measures with respect to individuals and entities designated, prior to the date of adoption of that Resolution, as the Taliban, and other individuals, groups, undertakings and entities associated with them, as specified in Section A (‘Individuals associated with the Taliban’) and Section B (‘Entities and other groups and undertakings associated with the Taliban’) of the Consolidated List of the Committee established pursuant to Resolutions 1267 (1999) and 1333 (2000), as well as other individuals, groups, undertakings and entities associated with the Taliban.

On 11 February, 18 March, 16 May, 30 July and 20 August 2014, the Committee established pursuant to paragraph 30 of United Nations Security Council Resolution 1988 (2011) amended and updated the list of individuals, groups, undertakings and entities subject to restrictive measures.

The persons concerned may submit at any time a request to the UN Committee established pursuant to paragraph 30 of UNSCR 1988 (2011), together with any supporting documentation, for the decisions to include them in the UN list to be reconsidered. Such request should be sent to the following address:

United Nations — Focal point for delisting

Security Council Subsidiary Organs Branch

Room TB-08045D

United Nations

New York, N.Y. 10017

UNITED STATES OF AMERICA

Tel. +1 9173679448

Fax +1 2129631300/3778

E-mail: delisting@un.org

For more information see: http://www.un.org/sc/committees/1988/index.shtml

Further to the UN decision, the Council of the European Union has determined that the persons designated by the UN should be included in the lists of persons, groups, undertakings and entities which are subject to the restrictive measures provided for in Decision 2011/486/CFSP and Regulation (EU) No 753/2011. The grounds for listing of the persons concerned appear in the relevant entries in the Annex to the Decision and in Annex I to the Regulation.

The attention of the persons concerned is drawn to the possibility of making an application to the competent authorities of the relevant Member State(s) as indicated in the websites in Annex II to Regulation (EU) No 753/2011, in order to obtain an authorisation to use frozen funds for basic needs or specific payments (cf. Article 5 of the Regulation).

The persons concerned may submit a request to the Council, together with supporting documentation, that the decision to include them on the abovementioned lists should be reconsidered, to the following address:

Council of the European Union

General Secretariat

DG C 1C

Rue de la Loi/Wetstraat 175

1048 Bruxelles/Brussel

BELGIQUE/BELGIË

E-mail: sanctions@consilium.europa.eu

The attention of the persons concerned is also drawn to the possibility of challenging the Council’s decision before the General Court of the European Union, in accordance with the conditions laid down in Article 275, 2nd paragraph, and Article 263, 4th and 6th paragraphs, of the Treaty on the Functioning of the European Union.

(1) OJ L 199, 2.8.2011, p. 57.

(2) OJ L 293, 9.10.2014, p. 37.

(3) OJ L 199, 2.8.2011, p. 1.

(4) OJ L 293, 9.10.2014, p. 1.

9.10.2014

Official Journal of the European Union

C 356/4

Notice for the attention of the persons and entities subject to restrictive measures provided for in Council Decision 2013/183/CFSP, as amended by Council Decision 2014/700/CFSP, concerning restrictive measures against the Democratic People’s Republic of Korea

2014/C 356/03

The following information is brought to the attention of the persons and entities that appear in Annex I to Council Decision 2013/183/CFSP (1), as amended by Council Decision 2014/700/CFSP (2), concerning restrictive measures against the Democratic People’s Republic of Korea.

The United Nations Security Council decided to include those persons on the list of persons and entities subject to the measures imposed by UNSCR 1718 (2006), 1874 (2009), 2087 (2013) and 2094 (2013).

Those concerned may submit at any time a request to the United Nations Security Council Committee established pursuant to resolution 1718 (2006), together with any supporting documentation, for the decisions to include them in the UN list to be reconsidered. Such request should be sent to the following address:

The Focal Point may be contacted at this address:

Focal Point for De-listing

Security Council Subsidiary Organs Branch

Room DC2 2034

United Nations

New York, NY 10017

UNITED STATES OF AMERICA

Tel. +1 9173679448

Fax +1 2129631300

E-mail: delisting@un.org

For more information see: http://www.un.org/sc/committees/index.shtml

Further to the UN decision, the Council of the European Union has decided that those persons and entities should be included in the list of persons and entities subject to restrictive measures in Annex I to Decision 2013/183/CFSP concerning restrictive measures against the Democratic People’s Republic of Korea. The grounds for designations of those persons and entities appear in the relevant entries in that Annex.

The attention of the persons and entities concerned is drawn to the possibility of making an application to the competent authorities of the relevant Member State(s) as indicated in the web-sites in Annex II to Council Regulation (EC) No 329/2007 (3), in order to obtain an authorisation to use frozen funds for basic needs or specific payments (cf. Article 7 of the Regulation).

The persons and entities concerned may submit a request to the Council, together with supporting documentation, that the decision to include them on the above-mentioned list should be reconsidered, to the following address:

Council of the European Union

General Secretariat

DG C 1C

Rue de la Loi/Wetstraat 175

1048 Bruxelles/Brussel

BELGIQUE/BELGIË

E-mail: sanctions@consilium.europa.eu

The attention of the persons and entities concerned is also drawn to the possibility of challenging the Council’s decision before the General Court of the European Union, in accordance with the conditions laid down in Article 275, 2nd paragraph, and Article 263, 4th and 6th paragraphs, of the Treaty on the Functioning of the European Union.

(1) OJ L 111, 23.4.2013, p. 52.

(2) OJ L 293, 9.10.2014, p. 34.

(3) OJ L 88, 29.3.2007, p. 1.

European Commission

9.10.2014

Official Journal of the European Union

C 356/5

Euro exchange rates (1)

8 October 2014

2014/C 356/04

1 euro =

	Currency	Exchange rate
USD	US dollar	1,2645
JPY	Japanese yen	136,97
DKK	Danish krone	7,4442
GBP	Pound sterling	0,78700
SEK	Swedish krona	9,1322
CHF	Swiss franc	1,2132
ISK	Iceland króna
NOK	Norwegian krone	8,1945
BGN	Bulgarian lev	1,9558
CZK	Czech koruna	27,480
HUF	Hungarian forint	307,92
LTL	Lithuanian litas	3,4528
PLN	Polish zloty	4,1919
RON	Romanian leu	4,4108
TRY	Turkish lira	2,8992
AUD	Australian dollar	1,4416
CAD	Canadian dollar	1,4131
HKD	Hong Kong dollar	9,8080
NZD	New Zealand dollar	1,6210
SGD	Singapore dollar	1,6173
KRW	South Korean won	1 360,58
ZAR	South African rand	14,1770
CNY	Chinese yuan renminbi	7,7624
HRK	Croatian kuna	7,6440
IDR	Indonesian rupiah	15 490,74
MYR	Malaysian ringgit	4,1388
PHP	Philippine peso	56,673
RUB	Russian rouble	50,5925
THB	Thai baht	41,238
BRL	Brazilian real	3,0246
MXN	Mexican peso	17,0353
INR	Indian rupee	77,6300

(1) Source: reference exchange rate published by the ECB.

Court of Auditors

9.10.2014

Official Journal of the European Union

C 356/6

Special Report No 15/2014 ‘The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value’

2014/C 356/05

The European Court of Auditors hereby informs you that Special Report No 15/2014 ‘The External Borders Fund has fostered financial solidarity but requires better measurement of results and needs to provide further EU added value’ has just been published.

The report can be accessed for consultation or downloading on the European Court of Auditors' website: http://eca.europa.eu

A hard copy version of the report may be obtained free of charge on request to the Court of Auditors:

European Court of Auditors

Publications (PUB)

12, rue Alcide De Gasperi

1615 Luxembourg

LUXEMBOURG

Tel. +352 4398-1

e-mail: eca-info@eca.europa.eu

or by filling in an electronic order form on EU-Bookshop.

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

9.10.2014

Official Journal of the European Union

C 356/7

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2011

2014/C 356/06

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July - 31 December 2011, at their meeting on 15 June 2012:

Annex I	List of new marketing authorisations
Annex II	List of renewed marketing authorisations
Annex III	List of extended marketing authorisations
Annex IV	List of withdrawn marketing authorisations
Annex V	List of suspended marketing authorisations

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July- 31 December 2011:

EU-Number	Product	Country	Date of authorisation
EU/1/09/543/001-002	Cayston (1)	Liechtenstein	31.10.2011
EU/1/10/642/001-004	Ibandronic Acid Teva	Norway	23.8.2011
EU/1/10/649/001-016	Clopidogrel Teva Pharma B.V	Norway	19.7.2011
EU/1/10/649/001-016	Clopidogrel Teva Pharma B.V.	Liechtenstein	31.8.2011
EU/1/10/652/001-003	TOBI Podhaler	Liechtenstein	31.8.2011
EU/1/10/652/001-003	TOBI Podhaler	Norway	17.8.2011
EU/1/10/652/001-003	TOBI Podhaler	Iceland	9.8.2011
EU/1/10/654/001-004	Leflunomide ratiopharm	Norway	25.8.2011
EU/1/10/660/001-002	Potactasol	Norway	24.8.2011
EU/1/10/661/001-002	Fluenz	Norway	23.8.2011
EU/1/11/672/001-006	Xeplion	Liechtenstein	31.10.2011
EU/1/11/683/001-080	Sprimeo HCT	Liechtenstein	31.8.2011
EU/1/11/683/001-080	Sprimeo HCT	Norway	22.8.2011
EU/1/11/683/001-080	Sprimeo HCT	Iceland	10.8.2011
EU/1/11/685/001-005	Ibandronic acid Sandoz	Liechtenstein	31.8.2011
EU/1/11/685/001-005	Ibandronic acid Sandoz	Iceland	18.8.2011
EU/1/11/689/001-002	IOA	Liechtenstein	31.12.2011
EU/1/11/689/001-002	IOA	Norway	6.12.2011
EU/1/11/689/001-002	Ioa	Iceland	25.11.2011
EU/1/11/690/001-002	Zoely	Liechtenstein	31.8.2011
EU/1/11/690/001-002	Zoely	Norway	18.8.2011
EU/1/11/690/001-002	Zoely	Iceland	9.8.2011
EU/1/11/691/001-005	Eliquis	Iceland	8.8.2011
EU/1/11/693/001-016	Rivastigmin Actavis	Norway	19.8.2011
EU/1/11/694/001-002	Nulojix	Liechtenstein	31.8.2011
EU/1/11/694/001-002	Nulojix	Norway	1.8.2011
EU/1/11/694/001-002	Nulojix	Iceland	6.7.2011
EU/1/11/695/001-055	Leganto	Liechtenstein	31.8.2011
EU/1/11/695/001-055	Leganto	Norway	23.8.2011
EU/1/11/695/001-055	Leganto	Iceland	6.7.2011
EU/1/11/696/001-002	Bydureon	Norway	5.7.2011
EU/1/11/696/001-002	Bydureon	Iceland	6.7.2011
EU/1/11/696/001-002	Bydureon	Liechtenstein	31.8.2011
EU/1/11/697/001-012	Temozolomide Sun	Liechtenstein	31.8.2011
EU/1/11/697/001-012	Temozolomide SUN	Norway	22.8.2011
EU/1/11/697/001-012	Temozolomide SUN	Iceland	9.8.2011
EU/1/11/698/001-002	Yervoy	Liechtenstein	31.8.2011
EU/1/11/698/001-002	Yervoy	Norway	18.8.2011
EU/1/11/698/001-002	Yervoy	Iceland	21.7.2011
EU/1/11/699/001-002	Fampyra	Liechtenstein	31.8.2011
EU/1/11/699/001-002	Fampyra	Norway	23.8.2011
EU/1/11/699/001-002	Fampyra	Iceland	9.8.2011
EU/1/11/700/001-002	Benlysta	Liechtenstein	31.8.2011
EU/1/11/700/001-002	Benlysta	Norway	27.7.2011
EU/1/11/700/001-002	Benlysta	Iceland	21.7.2011
EU/1/11/701/001-028	Levetiracetam Teva	Liechtenstein	31.10.2011
EU/1/11/701/001-028	Levetiracetam Teva	Norway	26.9.2011
EU/1/11/701/001-028	Levetiracetam Teva	Iceland	16.9.2011
EU/1/11/702/001-031	Levetiracetam Ratiopharm	Liechtenstein	31.10.2011
EU/1/11/702/001-031	Levetiracetam ratiopharm	Norway	26.9.2011
EU/1/11/702/001-031	Levetiracetam ratiopharm	Iceland	16.9.2011
EU/1/11/703/001-002	Xgeva	Liechtenstein	31.8.2011
EU/1/11/703/001-002	Xgeva	Norway	15.8.2011
EU/1/11/703/001-002	XGEVA	Iceland	21.7.2011
EU/1/11/704/001	Victrelis	Liechtenstein	31.8.2011
EU/1/11/704/001	Victrelis	Norway	16.8.2011
EU/1/11/704/001	Victrelis	Iceland	10.8.2011
EU/1/11/705/001-002	Vibativ	Liechtenstein	31.10.2011
EU/1/11/705/001-002	Vibativ	Norway	19.9.2011
EU/1/11/705/001-002	Vibativ	Iceland	16.9.2011
EU/1/11/706/001-033	Levodopa/Cardidopa/Entacapone Orion	Liechtenstein	31.10.2011
EU/1/11/706/001-033	Levodopa/Carbidopa/Entacapone Orion	Norway	23.9.2011
EU/1/11/706/001-033	Levodopa/Carbidopa/Entacapone Orion	Iceland	14.9.2011
EU/1/11/707/001-011	Trajenta	Liechtenstein	31.10.2011
EU/1/11/707/001-011	Trajenta	Norway	12.9.2011
EU/1/11/707/001-011	Trajenta	Iceland	14.9.2011
EU/1/11/708/001-004	Entacapone Orion	Liechtenstein	31.8.2011
EU/1/11/708/001-004	Entacapone Orion	Norway	22.9.2011
EU/1/11/708/001-004	Entacapone Orion	Iceland	26.8.2011
EU/1/11/709/001-004	Buccolam	Norway	27.9.2011
EU/1/11/709/001-03	Buccolam	Iceland	1.11.2011
EU/1/11/710/001-007	Votubia	Liechtenstein	31.10.2011
EU/1/11/710/001-007	Votubia	Norway	15.9.2011
EU/1/11/710/001-007	Votubia	Iceland	16.9.2011
EU/1/11/711/001-030	Matever	Liechtenstein	31.10.2011
EU/1/11/711/001-030	Matever	Iceland	13.10.2011
EU/1/11/712/001-028	Levetiracetam Accord	Liechtenstein	31.10.2011
EU/1/11/712/001-028	Levetiracetam Accord	Iceland	6.11.2011
EU/1/11/713/001-040	Levetiracetam Actavis	Liechtenstein	31.10.2011
EU/1/11/713/001-040	Levetiracetam Actavis	Iceland	13.10.2011
EU/1/11/714/001	Zytiga	Liechtenstein	31.10.2011
EU/1/11/714/001	Zytiga	Norway	26.9.2011
EU/1/11/714/001	Zytiga 250 mg Tafla	Iceland	19.9.2011
EU/1/11/715/001-002	Plenadren	Liechtenstein	31.12.2011
EU/1/11/715/001-002	Plenadren	Norway	25.11.2011
EU/1/11/716/001-005	Eurartesim	Liechtenstein	31.12.2011
EU/1/11/716/001-005	Eurartesim	Norway	21.12.2011
EU/1/11/716/001-005	Eurartesim	Iceland	10.11.2011
EU/1/11/717/001	Vyndaqel	Liechtenstein	31.12.2011
EU/1/11/717/001	Vyndaqel	Norway	6.12.2011
EU/1/11/717/001	Vyndaqel	Iceland	25.11.2011
EU/1/11/718/001-006	Dexdor	Liechtenstein	31.10.2011
EU/1/11/718/001-006	Dexdor	Norway	11.10.2011
EU/1/11/718/001-006	Dexdor	Iceland	30.9.2011
EU/1/11/719/001-060	Telmisartan Teva Pharma	Norway	18.10.2011
EU/1/11/719/001-060	Telmisartan Teva Pharma	Iceland	6.11.2011
EU/1/11/720/001	Incivo	Liechtenstein	31.10.2011
EU/1/11/720/001	Incivo	Norway	6.10.2011
EU/1/11/720/001	Incivo 375 mg Filmuhúðuð tafla	Iceland	8.10.2011
EU/1/11/728/001-010	Pramipexole Accord	Liechtenstein	31.10.2011
EU/1/11/728/001-010	Pramipexole Accord	Norway	18.10.2011
EU/1/11/728/001-010	Pramipexole Accord	Iceland	10.10.2011
EU/1/11/729/001-006	Onduarp	Liechtenstein	31.12.2011
EU/1/11/729/001-006	Onduarp	Iceland	14.12.2011
EU/1/11/730/001-060	Rasitrio	Norway	7.12.2011
EU/1/11/731/001-012	Komboglyze	Liechtenstein	31.12.2011
EU/1/11/731/001-012	Komboglyze	Norway	15.12.2011
EU/1/11/731/001-012	Komboglyze	Iceland	8.12.2011
EU/1/11/732/001-013	Desloratadine Teva	Liechtenstein	31.12.2011
EU/1/11/732/001-013	Desloratadine Teva	Norway	20.12.2011
EU/1/11/732/001-013	Desloratadine Teva	Iceland	8.12.2011
EU/1/11/733/001-004	Dificlir	Liechtenstein	31.12.2011
EU/1/11/733/001-004	Dificlir	Norway	20.12.2011
EU/1/11/733/001-004	Dificlir	Iceland	14.12.2011
EU/1/11/734/001-011	Edarbi	Liechtenstein	31.12.2011
EU/1/11/734/001-011	Edarbi	Norway	21.12.2011
EU/1/11/734/001-011	Edarbi	Iceland	17.12.2011
EU/1/11/735/001-011	Ipreziv	Liechtenstein	31.12.2011
EU/1/11/735/001-011	Ipreziv	Norway	21.12.2011
EU/1/11/735/001-011	Ipreziv	Iceland	17.12.2011
EU/1/11/736/001	Edurant	Liechtenstein	31.12.2011
EU/1/11/736/001	Edurant	Norway	6.12.2011
EU/1/11/736/001	EDURANT	Iceland	14.12.2011
EU/1/11/737/001-002	Eviplera	Liechtenstein	31.12.2011
EU/1/11/737/001-002	Eviplera	Norway	6.12.2011
EU/1/11/737/001-002	Eviplera	Iceland	14.12.2011
EU/1/11/738/001-003	Levetiracetam Actavis Group	Liechtenstein	31.12.2011
EU/1/11/738/001-003	Levetiracetam Actavis Group	Iceland	14.12.2011
EU/1/11/739/001-008	Dasselta	Liechtenstein	31.12.2011
EU/1/11/739/001-008	Dasselta	Iceland	8.12.2011
EU/1/11/740/001	Ameluz	Liechtenstein	31.12.2011
EU/2/07/078/011-014	Rheumocam	Norway	6.7.2011
EU/2/10/110/001-002	Coxevac	Norway	22.8.2011
EU/2/10/112/001-005	BTVPUR AlSap 1	Norway	22.8.2011
EU/2/10/113/001-005	BTVPUR AlSap 1-8	Norway	23.8.2011
EU/2/11/122/001-003	Bluevac BTV8	Iceland	12.7.2011
EU/2/11/124/001-008	Zuprevo	Norway	6.7.2011
EU/2/11/125/001-008	Certifect	Norway	1.9.2011
EU/2/11/126/001	MS-H-vaksine – Mycoplasma synoviae	Norway	5.7.2011
EU/2/11/127/001	Recuvyra	Norway	6.12.2011
EU/2/11/127/001	RECUVYRA	Iceland	11.11.2011
EU/2/11/128/001-003	Emdocam	Norway	14.9.2011
EU/2/11/128/001-003	Emdocam	Iceland	8.9.2011
EU/2/11/129/001-004	Proteq West Nile	Norway	19.8.2011
EU/2/11/129/001-004	Proteq West Nile	Iceland	12.8.2011
EU/2/11/130/001-003	Zulvac 1 Bovis	Norway	17.8.2011
EU/2/11/130/001-003	Zulvac 1 Bovis	Iceland	18.8.2011
EU/2/11/131/001-006	Zulvac 1 Ovis	Norway	17.8.2011
EU/2/11/131/001-006	Zulvac 1 Ovis	Iceland	12.8.2011
EU/2/11/132/001-004	Nobivac Myxo-RHD	Norway	19.9.2011
EU/2/11/132/001-004	Nobivac Myxo-RHD	Iceland	20.9.2011
EU/2/11/133/001-003	Recocam	Norway	6.10.2011
EU/2/11/133/001-003	Recocam 20 mg/ml	Iceland	23.9.2011
EU/2/11/134/001-014	Inflacam	Iceland	19.12.2011
EU/2/11/135/001-003	Panacur AquaSol	Iceland	19.12.2011

(1) From the conditional marketing authorisation with a marketing authorisation not subject to specific obligations.

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July- 31 December 2011:

EU-Number	Product	Country	Date of authorisation
EU/1/01/196/001 EU/1/01/196/003	Cancidas	Norway	20.9.2011
EU/1/01/196/001, 003	Cancidas	Iceland	20.9.2011
EU/1/01/196/001, 003	Cancidas	Liechtenstein	31.10.2011
EU/1/01/200/001-002	Viread	Liechtenstein	31.12.2011
EU/1/06/336/001	Tygacil	Iceland	13.7.2011
EU/1/06/340/001-002	Ganfort	Liechtenstein	31.8.2011
EU/1/06/340/001-002	Ganfort	Norway	1.9.2011
EU/1/06/340/001-002	Ganfort	Iceland	8.7.2011
EU/1/06/342/001	Nexavar	Liechtenstein	31.8.2011
EU/1/06/342/001	Nexavar	Norway	20.9.2011
EU/1/06/342/001	Nexavar	Iceland	9.8.2011
EU/1/06/343/001-007	Baraclude	Norway	6.7.2011
EU/1/06/346/001	Tysabri	Liechtenstein	31.8.2011
EU/1/06/346/001	Tysabri	Norway	19.7.2011
EU/1/06/35/001-003	Livensa	Liechtenstein	31.8.2011
EU/1/06/350/001	Savene	Liechtenstein	31.8.2011
EU/1/06/350/001	Savene	Norway	18.8.2011
EU/1/06/350/001	Savene	Iceland	9.8.2011
EU/1/06/351/001-003	Livensa	Norway	12.8.2011
EU/1/06/351/001-003	Livensa	Iceland	9.8.2011
EU/1/06/352/001-003	Intrinsa	Liechtenstein	31.8.2011
EU/1/06/352/001-003	Intrinsa	Norway	12.8.2011
EU/1/06/352/001-003	Intrinsa	Iceland	10.8.2011
EU/1/06/355/001-003	ATryn	Liechtenstein	31.8.2011
EU/1/06/355/001-003	ATryn	Norway	1.9.2011
EU/1/06/355/001-003	ATryn	Iceland	18.8.2011
EU/1/06/356/001-009	Exjade	Liechtenstein	31.8.2011
EU/1/06/356/001-009	Exjade	Norway	17.8.2011
EU/1/06/356/001-009	Exjade	Iceland	9.8.2011
EU/1/06/357/001-008, 018-021	Gardasil	Iceland	11.8.2011
EU/1/06/357/001-008 EU/1/06/357/018-021	Gardasil	Norway	19.8.2011
EU/1/06/358/001-008, 018-021	Silgard	Iceland	10.8.2011
EU/1/06/358/001-021	Silgard	Liechtenstein	31.8.2011
EU/1/06/358/001-021	Silgard	Norway	12.8.2011
EU/1/06/359/001-004	Suboxone	Liechtenstein	31.10.2011
EU/1/06/359/001-004	Suboxone	Norway	14.10.2011
EU/1/06/359/001-004	Suboxone	Iceland	4.10.2011
EU/1/06/360/001-013	Champix	Norway	3.8.2011
EU/1/06/360/001-013	Champix	Iceland	7.7.2011
EU/1/06/361/001-002	Luminity	Liechtenstein	31.10.2011
EU/1/06/361/001-002	Luminity	Norway	21.9.2011
EU/1/06/361/001-002	Luminity	Iceland	21.9.2011
EU/1/06/362/001-004	Byetta	Liechtenstein	31.10.2011
EU/1/06/362/001-004	Byetta	Norway	6.10.2011
EU/1/06/362/001-004	Byetta	Iceland	8.10.2011
EU/1/06/363/001-015	Sprycel	Liechtenstein	31.10.2011
EU/1/06/363/001-015	Sprycel	Norway	14.10.2011
EU/1/06/363/001-015	Sprycel	Iceland	7.11.2011
EU/1/06/364/001-004 EU/1/06/364/006-008	Adrovance	Norway	23.12.2011
EU/1/06/364/001-004, 006-008	Adrovance	Iceland	7.12.2011
EU/1/06/364/006-008	Adrovance	Liechtenstein	31.12.2011
EU/1/06/365/001-003	Elaprase	Liechtenstein	31.10.2011
EU/1/06/365/001-003	Elaprase	Norway	14.10.2011
EU/1/06/365/001-003	Elaprase	Iceland	6.11.2011
EU/1/06/368/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088-102, 113-150, 163-168	Insulin Human Winthrop	Liechtenstein	31.12.2011
EU/1/06/368/001-168	Insulin Human Winthrop	Iceland	6.12.2011
EU/1/06/370/001-039	Exforge	Liechtenstein	31.12.2011
EU/1/06/372/001-039	Copalia	Liechtenstein	31.12.2011
EU/1/06/372/001-039	Copalia	Iceland	7.12.2011
EU/1/06/373/001-039	Imprida	Liechtenstein	31.12.2011
EU/1/07/440/001-006	Tyverb	Iceland	22.8.2011
EU/1/08/468/001	Intelence	Liechtenstein	31.8.2011
EU/1/08/468/001	Intelence	Norway	17.8.2011
EU/1/08/468/001	INTELENCE	Iceland	11.8.2011
EU/1/09/543/001-002	Cayston	Norway	19.9.2011
EU/1/09/543/001-002	Cayston	Iceland	19.9.2011
EU/1/10/628/001-004	Votrient	Norway	21.10.2011
EU/1/96/024/001-005	Crixivan	Liechtenstein	31.8.2011
EU/1/96/024/001-005 EU/1/96/024/010	Crixivan	Norway	18.8.2011
EU/1/96/024/001-010	Crixivan	Iceland	10.8.2011
EU/2/06/059/001	Convenia	Norway	6.7.2011
EU/2/06/060/001-002	Poulvac Flufend H5N3 RG	Iceland	11.8.2011
EU/2/06/061/001-004	Nobilis Influenza H5N2	Norway	14.9.2011
EU/2/06/061/001-004	Nobilis Influenza H5N2	Iceland	8.9.2011
EU/2/06/062/001-005	Cerenia	Norway	18.8.2011
EU/2/06/062/001-005	Cerenia	Iceland	12.8.2011
EU/2/06/064/001-004	ProMeris	Norway	8.12.2011
EU/2/06/064/001-004	ProMeris	Iceland	21.11.2011
EU/2/06/065/001-010	ProMeris Duo	Iceland	4.12.2011
EU/2/06/065/001-010	ProMeris Duo	Norway	8.12.2011
EU/2/06/066/001-012	Prac-Tic	Norway	8.12.2011
EU/2/06/066/001-012	Prac-tic	Iceland	25.11.2011
EU/2/06/069/001	Cortavance	Norway	27.9.2011
EU/2/06/069/001	Cortavance	Iceland	23.9.2011
EU/2/99/016/001-006	Porcilis Pesti	Norway	6.10.2011
EU/2/99/016/001-006	Porcilis Pesti	Iceland	7.10.2011

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July- 31 December 2011:

EU-Number	Product	Country	Date of authorisation
EU/1/00/165/008	Ovitrelle	Liechtenstein	31.8.2011
EU/1/00/165/008	Ovitrelle	Norway	6.7.2011
EU/1/01/176/007-009	Zometa	Liechtenstein	31.10.2011
EU/1/01/176/007-009	Zometa	Norway	12.9.2011
EU/1/01/176/007-009	Zometa	Iceland	12.11.2011
EU/1/02/221/011-016	Pegasys	Liechtenstein	31.8.2011
EU/1/03/248/013-023	Levitra	Liechtenstein	31.12.2011
EU/1/03/249/013-015	Vivanza	Liechtenstein	31.12.2011
EU/1/03/260/034-038	Stalevo	Norway	23.9.2011
EU/1/03/260/034-038	Stalevo	Liechtenstein	31.10.2011
EU/1/03/260/034-038	Stalevo	Iceland	13.9.2011
EU/1/03/262/009-010	Emend	Liechtenstein	31.12.2011
EU/1/03/270/004-005	Kentera	Liechtenstein	31.8.2011
EU/1/03/270/004-005	Kentera	Norway	7.9.2011
EU/1/03/270/004-005	Kentera	Iceland	9.9.2011
EU/1/03/271/007-010	Advate	Liechtenstein	31.12.2011
EU/1/05/322/002	Yttriga	Liechtenstein	31.8.2011
EU/1/06/332/010-012	Omnitrope	Norway	25.8.2011
EU/1/06/378/017	Inovelon	Liechtenstein	31.12.2011
EU/1/06/378/017	Inovelon	Norway	20.12.2011
EU/1/07/392/003	Circadin	Liechtenstein	31.10.2011
EU/1/07/401/016	Alli	Liechtenstein	31.8.2011
EU/1/07/422/007-008	Tasigna	Liechtenstein	31.8.2011
EU/1/07/422/009-012	Tasigna	Liechtenstein	31.12.2011
EU/1/08/442/009-013	Pradaxa	Iceland	10.8.2011
EU/1/08/442/009-014	Pradaxa	Liechtenstein	31.8.2011
EU/1/08/442/009-014	Pradaxa	Norway	17.8.2011
EU/1/08/468/002	Intelence	Liechtenstein	31.12.2011
EU/1/08/468/002	Intelence	Norway	15.12.2011
EU/1/08/470/014-015	Vimpat	Iceland	8.12.2011
EU/1/08/472/011-021	Xarelto	Liechtenstein	31.12.2011
EU/1/08/472/011-021	Xarelto	Iceland	20.12.2011
EU/1/09/508/011	Synflorix	Liechtenstein	31.8.2011
EU/1/09/531/010-021	Instanyl	Liechtenstein	31.8.2011
EU/1/09/531/010-021	Instanyl	Norway	1.8.2011
EU/1/09/531/010-021	Instanyl	Iceland	13.7.2011
EU/1/09/564/003	Ilaris	Liechtenstein	31.10.2011
EU/1/09/564/003	Ilaris	Iceland	5.10.2011
EU/1/09/564/003	Ilaris	Norway	27.9.2011
EU/1/09/610/031-060	Telmisartan Teva	Liechtenstein	31.8.2011
EU/1/10/614/003	Menveo	Liechtenstein	31.8.2011
EU/1/10/636/004-007	Daxas	Liechtenstein	31.12.2011
EU/1/10/646/003-006	VPRIV	Liechtenstein	31.8.2011
EU/1/10/647/003-004	Myclausen	Norway	27.9.2011
EU/1/10/647/003-004	Myclausen	Iceland	3.10.2011
EU/1/95/003/011-012	Betaferon	Liechtenstein	31.8.2011
EU/1/97/055/005-009	Viramune	Norway	14.10.2011
EU/1/97/055/005-009	Viramune	Iceland	5.10.2011
EU/1/98/090/021-022	Micardis	Liechtenstein	31.8.2011
EU/1/99/119/019-023	NovoRapid	Liechtenstein	31.8.2011
EU/1/99/126/022	Enbrel	Iceland	13.7.2011
EU/2/08/090/010-018	Loxicom	Norway	15.8.2011
EU/2/08/090/010-026	Loxicom	Iceland	22.7.2011
EU/2/08/090/019-026	Loxicom	Norway	27.9.2011

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July- 31 December 2011:

EU-Number	Product	Country	Date of withdrawal
EU/1/02/225/001-002	Xigris	Liechtenstein	31.12.2011
EU/1/03/259/001-006	Onsenal	Norway	5.8.2011
EU/1/05/313/001-009	Ablavar	Liechtenstein	31.10.2011
EU/1/05/313/001-009	Ablavar	Norway	29.11.2011
EU/1/05/313/001-009	Ablavar	Iceland	6.11.2011
EU/1/08/470/014-015	Vimpat	Iceland	8.12.2011
EU/1/08/478/001	Prepandemic influenza vaccine (H5N1)	Liechtenstein	31.10.2011
EU/1/08/478/001	Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals	Iceland	6.11.2011
EU/1/09/547/001-007	Clopidogrel Sandoz	Norway	5.8.2011
EU/1/09/547/001-007	Clopidogrel Sandoz	Iceland	23.8.2011
EU/1/10/629/001	Humenza	Norway	5.8.2011
EU/2/06/063/001-003	Yarvitan	Norway	22.9.2011
EU/2/06/063/001-003	Yarvitan	Iceland	26.8.2011
EU/1/06/349/001-010	Avaglim	Norway	18.8.2011

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July- 31 December 2011:

EU-Number	Product	Country	Date of suspension
EU/1/06/361/001-002	Luminity	Liechtenstein	31.12.2011
EU/2/08/088/001-003	Acticam	Iceland	23.8.2011

9.10.2014

Official Journal of the European Union

C 356/22

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2012

2014/C 356/07

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2012, at their meeting on 15 July 2013:

Annex I	List of new marketing authorisations
Annex II	List of renewed marketing authorisations
Annex III	List of extended marketing authorisations
Annex IV	List of withdrawn marketing authorisations
Annex V	List of suspended marketing authorisations

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January-30 June 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/11/711/001-030	Matever	Norway	1.6.2012
EU/1/11/712/001-028	Levetiracetam Accord	Norway	13.4.2012
EU/1/11/713/001-040	Levetiracetam Actavis	Norway	16.4.2012
EU/1/11/715/001-002	Plenadren	Iceland	23.4.2012
EU/1/11/721/001-021	Paglitaz	Norway	13.4.2012
EU/1/11/721/001-021	Paglitaz	Iceland	17.4.2012
EU/1/11/722/001-030	Pioglitazone Accord	Norway	11.4.2012
EU/1/11/722/001-030	Pioglitazon Accord	Liechtenstein	30.4.2012
EU/1/11/722/001-030	Pioglitazone Accord	Iceland	20.4.2012
EU/1/11/723/001-021	Pioglitazone Krka	Norway	23.5.2012
EU/1/11/723/001-021	Pioglitazone Krka	Iceland	20.4.2012
EU/1/11/727/001	Mercatopurine Nova lab.	Norway	19.4.2012
EU/1/11/727/001	Mercaptopurine Nova Laboratories	Iceland	3.4.2012
EU/1/11/727/001	Mercatopurine Nova Laboratories	Liechtenstein	30.4.2012
EU/1/11/729/001-006	Onduarp	Norway	8.5.2012
EU/1/11/730/001-060	Rasitrio	Iceland	3.2.2012
EU/1/11/738/001-003	Levetiracetam Actavis Gr.	Norway	1.3.2012
EU/1/11/739/001-008	Dasselta	Norway	16.1.2012
EU/1/11/740/001	Ameluz	Iceland	5.1.2012
EU/1/11/740/001	Ameluz	Norway	16.1.2012
EU/1/11/741/001	Levetiracetam SUN	Norway	27.1.2012
EU/1/11/741/001	Levetiracetam Sun	Iceland	9.1.2012
EU/1/11/742/001-010	Efavirenz Teva	Norway	13.2.2012
EU/1/11/742/001-010	Efavirenz Teva	Iceland	24.1.2012
EU/1/11/742/001-010	Efavirenz Teva	Liechtenstein	29.2.2012
EU/1/11/743/001-015	Repaglinide Accord	Norway	13.2.2012
EU/1/11/743/001-015	Repaglinide Accord	Iceland	19.1.2012
EU/1/11/743/001-015	Repaglinide Accord	Liechtenstein	29.2.2012
EU/1/11/744/001-002	Topotecan Eagle	Iceland	22.1.2012
EU/1/11/744/001-002	Topotecan Eagle	Liechtenstein	29.2.2012
EU/1/11/745/001-009	Desloratadine Actavis	Iceland	3.2.2012
EU/1/11/745/001-009	Desloratadine Actavis	Norway	13.2.2012
EU/1/11/746/001-012	Desloratadine ratiopharm	Norway	13.2.2012
EU/1/11/746/001-012	Desloratadine ratiopharm	Iceland	3.2.2012
EU/1/11/746/001-012	Desloratadine ratiopharm	Liechtenstein	29.2.2012
EU/1/11/747/001	Colobreathe	Iceland	29.2.2012
EU/1/11/747/001	Colobreathe	Liechtenstein	29.2.2012
EU/1/11/748/001-006	Docetaxel Mylan	Iceland	7.2.2012
EU/1/11/748/001-006	Docetaxel Mylan	Liechtenstein	29.2.2012
EU/1/11/749/001-002	Caprelsa	Liechtenstein	30.4.2012
EU/1/11/749/001-003	Caprelsa	Iceland	9.3.2012
EU/1/11/749/001-002	Caprelsa	Norway	13.3.2012
EU/1/12/750/001	Esmya	Norway	30.3.2012
EU/1/12/750/001	Esmya	Iceland	14.3.2012
EU/1/12/750/001	Esmya	Liechtenstein	30.4.2012
EU/1/12/751/001	Zelboraf	Norway	14.3.2012
EU/1/12/751/001	Zelboraf	Iceland	7.3.2012
EU/1/12/751/001	Zelboraf	Liechtenstein	29.2.2012
EU/1/12/752/001	Vepacel	Norway	1.3.2012
EU/1/12/752/001	Vepacel	Iceland	9.3.2012
EU/1/12/752/001	Vepacel	Liechtenstein	29.2.2012
EU/1/12/753/001-012	Signifor	Norway	10.5.2012
EU/1/12/753/001-012	Signifor	Iceland	24.5.2012
EU/1/12/753/001-012	Signifor	Liechtenstein	30.6.2012
EU/1/12/754/001-021	Sepioglin	Norway	10.4.2012
EU/1/12/754/001-021	Sepioglin	Iceland	3.4.2012
EU/1/12/754/001-021	Sepioglin	Liechtenstein	30.4.2012
EU/1/12/755/001-027	Pioglitazone Actavis	Norway	13.4.2012
EU/1/12/755/001-027	Pioglitazone Actavis	Iceland	30.4.2012
EU/1/12/756/001-027	Glidipion (ex Ogliton)	Norway	13.4.2012
EU/1/12/756/001-027	Pioglitazone Actavis Group	Iceland	13.4.2012
EU/1/12/756/001-027	Pioglitazone Actavis Group	Liechtenstein	30.4.2012
EU/1/12/757/001-030	Pioglitazone Teva	Norway	11.4.2012
EU/1/12/757/001-030	Pioglitazone Teva	Iceland	23.4.2012
EU/1/12/758/001-030	Pioglitazone Teva Pharma	Norway	17.4.2012
EU/1/12/758/001-030	Pioglitazone Teva Pharma	Iceland	25.4.2012
EU/1/12/759/001-003	Zoledronic acid Actavis	Norway	8.5.2012
EU/1/12/759/001-003	Zoledronic acid Actavis	Iceland	16.5.2012
EU/1/12/759/001-003	Zoledronsäure Actavis	Liechtenstein	30.4.2012
EU/1/12/760/001-002	Bronchitol	Norway	18.5.2012
EU/1/12/760/001-002	Bronchitol	Iceland	9.5.2012
EU/1/12/761/001-002	Capecitabine Teva	Norway	30.5.2012
EU/1/12/761/001-002	Capecitabine Teva	Iceland	20.5.2012
EU/1/12/761/001-002	Capecitabin Teva	Liechtenstein	30.4.2012
EU/1/12/762/001-018	Capecitabine Accord	Iceland	20.5.2012
EU/1/12/762/001-018	Capecitabin Accord	Liechtenstein	30.4.2012
EU/1/12/763/001-018	Capecitabine Krka	Iceland	16.5.2012
EU/1/12/763/001-018	Capecitabin Krka	Liechtenstein	30.4.2012
EU/1/12/763/001-018	Capecitabine Krka	Norway	14.6.2012
EU/1/12/764/001	Pixuvri	Norway	14.6.2012
EU/1/12/764/001	Pixuvri	Iceland	29.5.2012
EU/1/12/764/001	Pixuvri	Liechtenstein	30.6.2012
EU/1/12/765/001-004	Sabervel	Iceland	9.5.2012
EU/1/12/765/001-006	Sabervel	Norway	8.5.2012
EU/1/12/765/001-006	Sabervel	Liechtenstein	30.4.2012
EU/1/12/766/001	Sancuso	Norway	10.5.2012
EU/1/12/766/001	Sancuso	Iceland	20.5.2012
EU/1/12/766/001	Sancuso	Liechtenstein	30.6.2012
EU/1/12/767/001-007	Nimenrix	Norway	1.5.2012
EU/1/12/767/001-007	Nimenrix	Iceland	16.5.2012
EU/1/12/768/001	Riluzole Zentiva	Iceland	25.5.2012
EU/1/12/768/001	Riluzol Zentiva	Liechtenstein	30.6.2012
EU/1/12/769/001-003	Docetaxel Accord	Iceland	12.6.2012
EU/1/12/769/001-003	Docetaxel Accord	Liechtenstein	30.6.2012
EU/1/12/770/001-004	Docetaxel Kabi	Norway	19.6.2012
EU/1/12/770/001-004	Docetaxel Kabi	Iceland	13.6.2012
EU/1/12/770/001-004	Docetaxel Kabi	Liechtenstein	30.6.2012
EU/2/11/134/001-014	Inflacam	Norway	6.1.2012
EU/2/11/135/001-003	Panacur AquaSol	Norway	10.2.2012
EU/2/11/136/001	Truscient	Norway	6.1.2012
EU/2/11/136/001	TruScient	Iceland	12.1.2012
EU/2/11/137/001-015	Activyl Tick Plus	Norway	13.2.2012
EU/2/11/137/001-015	Activyl Tick Plus	Iceland	25.1.2012
EU/2/11/137/001-015	Activyl Tick Plus	Liechtenstein	29.2.2012
EU/2/12/138/001-003	RevitaCAM	Iceland	14.3.2012
EU/2/12/139/001-003	Zulvac 1 + 8 Bovis	Norway	3.4.2012
EU/2/12/139/001-003	Zulvac 1 + 8 Bovis	Iceland	4.4.2012
EU/2/12/139/001-003	Zulvac 1 + 8 Bovis	Liechtenstein	30.4.2012

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January-30 June 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/01/197/001-005	Foscan	Iceland	14.5.2012
EU/1/01/200/001-002	Viread	Norway	6.1.2012
EU/1/01/200/001-002	Viread	Iceland	5.1.2012
EU/1/02/209/001-008	Dynastat	Norway	8.3.2012
EU/1/02/209/001-008	Dynastat	Iceland	7.2.2012
EU/1/02/209/001-008	Dynastat	Liechtenstein	29.2.2012
EU/1/02/212/001-026	Vfend	Norway	6.3.2012
EU/1/02/212/001-026	Vfend	Iceland	14.3.2012
EU/1/02/212/001-026	Vfend	Liechtenstein	30.4.2012
EU/1/02/216/001-002	Invanz	Norway	19.1.2012
EU/1/02/216/001-002	Invanz	Iceland	20.1.2012
EU/1/02/216/001-002	Invanz	Liechtenstein	29.2.2012
EU/1/02/220/001-006	Tracleer	Norway	8.5.2012
EU/1/02/220/001-006	Tracleer	Iceland	20.5.2012
EU/1/02/220/001-006	Tracleer	Liechtenstein	30.4.2012
EU/1/02/222/001-005	Tamiflu	Norway	8.3.2012
EU/1/02/222/001-005	Tamiflu	Iceland	19.6.2012
EU/1/02/222/001-005	Tamiflu	Liechtenstein	30.6.2012
EU/1/06/334/001-005	Evoltra	Liechtenstein	30.4.2012
EU/1/06/347/001-008	Sutent	Liechtenstein	29.2.2012
EU/1/06/366/005-022	Tandemact	Norway	11.4.2012
EU/1/06/366/005-022	Tandemact	Iceland	22.3.2012
EU/1/06/366/005-022	Tandemact	Liechtenstein	30.4.2012
EU/1/06/367/001-012	Diacomit	Norway	6.3.2012
EU/1/06/367/001-012	Diacomit	Iceland	7.2.2012
EU/1/06/367/001-012	Diacomit	Liechtenstein	29.2.2012
EU/1/06/370/001-039	Exforge	Norway	16.1.2012
EU/1/06/370/001-039	EXFORGE	Iceland	3.2.2012
EU/1/06/371/001-039	Dafiro	Iceland	8.2.2012
EU/1/06/371/001-039	Dafiro	Liechtenstein	29.2.2012
EU/1/06/372/001-039	Copalia	Norway	11.1.2012
EU/1/06/373/001-039	Imprida	Norway	16.1.2012
EU/1/06/373/001-039	Imprida	Iceland	6.2.2012
EU/1/06/374/001	Lucentis	Norway	17.1.2012
EU/1/06/374/001	Lucentis	Iceland	12.1.2012
EU/1/06/376/001-033	Irbesartan Zentiva (ex-Winthrop)	Norway	14.2.2012
EU/1/06/376/001-033	Irbesartan Zentiva	Iceland	7.2.2012
EU/1/06/376/001-033	Irbesartan Winthrop	Liechtenstein	29.2.2012
EU/1/06/377/001-028	Irbesartan HCT Zentiva (ex-Winthrop)	Norway	16.4.2012
EU/1/06/377/001-028	Irbesartan HCT Zentiva	Iceland	22.3.2012
EU/1/06/377/001-028	Irbesartan HCT	Liechtenstein	30.4.2012
EU/1/06/378/001-017	Inovelon	Norway	6.3.2012
EU/1/06/378/001-017	Inovelon	Iceland	24.1.2012
EU/1/06/378/001-017	Inovelon	Liechtenstein	29.2.2012
EU/1/06/379/001	Cystadane	Iceland	9.3.2012
EU/1/06/379/001	Cystadane	Liechtenstein	29.2.2012
EU/1/06/386/001-015, 020-024, 029-033, 038-042, 047-051, 056-057, 088102, 113-150, 163-168	Insulin Human Winthrop	Norway	6.1.2012
EU/1/07/382/001-018	Xelevia	Norway	14.2.2012
EU/1/07/382/001-018	Xelevia	Iceland	6.2.2012
EU/1/07/382/001-018	Xelevia	Liechtenstein	29.2.2012
EU/1/07/383/001-018	Januvia	Norway	26.3.2012
EU/1/07/383/001-018	Januvia	Iceland	11.5.2012
EU/1/07/383/001-018	Januvia	Liechtenstein	30.4.2012
EU/1/07/384/003-005	Docetaxel Winthrop	Norway	10.4.2012
EU/1/07/384/003-005	Docetaxel Winthrop	Iceland	23.3.2012
EU/1/07/384/003-005	Docetaxel Winthrop	Liechtenstein	30.4.2012
EU/1/07/386/001-018	Toviaz	Norway	11.4.2012
EU/1/07/386/001-018	Toviaz	Iceland	10.4.2012
EU/1/07/386/001-018	Toviaz	Liechtenstein	30.4.2012
EU/1/07/387/001-026	Advagraf	Norway	2.5.2012
EU/1/07/387/001-026	Advagraf	Iceland	9.5.2012
EU/1/07/387/001-026	Advagraf	Liechtenstein	30.4.2012
EU/1/07/388/001-003	Sebivo	Norway	8.5.2012
EU/1/07/388/001-003	Sebivo	Iceland	16.5.2012
EU/1/07/388/001-003	Sebivo	Liechtenstein	30.4.2012
EU/1/07/389/001-003	Orencia	Norway	10.4.2012
EU/1/07/389/001-003	Orencia	Iceland	10.4.2012
EU/1/07/389/001-003	Orencia	Liechtenstein	30.4.2012
EU/1/07/390/001-004	Altargo	Norway	8.5.2012
EU/1/07/390/001-004	Altargo	Iceland	16.5.2012
EU/1/07/390/001-004	Altargo	Liechtenstein	30.4.2012
EU/1/07/391/001-004	Revlimid	Norway	3.5.2012
EU/1/07/391/001-004	Revlimid	Iceland	9.5.2012
EU/1/07/391/001-004	Revlimid	Liechtenstein	30.4.2012
EU/1/07/392/001-003	Circadin	Norway	16.5.2012
EU/1/07/392/001-003	Circadin	Iceland	10.5.2012
EU/1/07/392/001-003	Circadin	Liechtenstein	30.6.2012
EU/1/07/394/001-009	Optaflu	Norway	20.6.2012
EU/1/07/395/001-095	Invega	Liechtenstein	30.6.2012
EU/1/07/396/001-003	Pergoveris	Iceland	20.6.2012
EU/1/07/396/001-003	Pergoveris	Liechtenstein	30.6.2012
EU/1/07/398/001-014	Optimark	Norway	27.6.2012
EU/1/07/399/001-006	Aerinaze	Norway	18.6.2012
EU/1/07/399/001-006	Aerinaze	Liechtenstein	30.6.2012
EU/1/07/399/001-006	Aerinaze	Iceland	20.6.2012
EU/1/07/400/008-013, 017-024	Mircera	Iceland	7.6.2012
EU/1/07/400/008-013, 017-024	Mircera	Norway	14.6.2012
EU/1/07/400/017-024	Mircera	Liechtenstein	30.6.2012
EU/1/07/401/007-016	alli	Norway	29.6.2012
EU/1/07/412/001-052	Abseamed	Liechtenstein	30.6.2012
EU/1/07/423/001-003	Vectibix	Norway	19.3.2012
EU/1/07/423/001-003	Vectibix	Iceland	9.3.2012
EU/1/07/440/001-003	Tyverb	Liechtenstein	30.4.2012
EU/1/07/440/001-006	Tyverb	Norway	2.5.2012
EU/1/07/440/001-006	Tyverb	Iceland	11.5.2012
EU/1/10/625/001&003	Arzerra	Iceland	17.2.2012
EU/1/10/625/001&003	Arzerra	Norway	18.5.2012
EU/1/10/628/001-004	Votrient	Norway	19.6.2012
EU/1/10/628/001-004	Votrient	Iceland	13.6.2012
EU/1/11/699/001-004	Fampyra	Norway	19.6.2012
EU/1/11/699/001-004	Fampyra	Iceland	13.6.2012
EU/1/11/699/001-004	Fampyra	Liechtenstein	30.6.2012
EU/2/05/053/001-003	Naxcel	Norway	14.2.2012
EU/2/06/068/001-004	Ypozane	Norway	13.2.2012
EU/2/06/068/001-004	Ypozane	Iceland	18.1.2012
EU/2/06/068/001-004	Ypozane	Liechtenstein	30.4.2012
EU/2/06/070/001-008	Meloxidyl	Iceland	13.1.2012
EU/2/07/071/001-003	SLENTROL	Iceland	7.5.2012
EU/2/07/071/001-003	Slentrol	Liechtenstein	30.4.2012
EU/2/07/072/001-004	Suprelorin	Iceland	21.6.2012
EU/2/07/074/001-006	Prilactone	Iceland	13.6.2012
EU/2/07/075/001-004	Circovac	Liechtenstein	30.6.2012
EU/2/07/075/001-004	Circovac	Iceland	4.6.2012

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January-30 June 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/00/141/002	Myocet	Liechtenstein	30.4.2012
EU/1/02/222/05	Tamiflu	Iceland	6.2.2012
EU/1/03/262/009-010	Emend	Norway	5.1.2012
EU/1/03/262/009-010	Emend	Iceland	3.2.2012
EU/1/03/271/007-010	Advate	Norway	23.1.2012
EU/1/03/271/007-010	Advate	Iceland	17.1.2012
EU/1/05/318/003	Revatio	Norway	13.4.2012
EU/1/05/318/003	Revatio	Iceland	17.4.2012
EU/1/05/318/003	Revatio	Liechtenstein	30.4.2012
EU/1/06/339/003	Preotact	Liechtenstein	30.6.2012
EU/1/08/465/021	Clopidogrel Zentiva	Liechtenstein	30.6.2012
EU/1/08/468/002	INTELENCE	Iceland	3.1.2012
EU/1/08/470/018-019	Vimpat	Norway	14.3.2012
EU/1/08/470/018-019	Vimpat	Iceland	14.3.2012
EU/1/08/470/018-019	Vimpat	Liechtenstein	30.4.2012
EU/1/08/472/011-021	Xarelto	Norway	4.1.2012
EU/1/08/475/035-060	Olanzapin Mylan	Liechtenstein	29.2.2012
EU/1/09/536/003-004	Topotecan Actavis	Liechtenstein	30.4.2012
EU/1/09/551/013-027	Vizarsin	Iceland	7.6.2012
EU/1/09/551/013-027	Vizarsin	Liechtenstein	30.6.2012
EU/1/09/571/002	Pandemic influenza vaccine H5N1 Baxter	Liechtenstein	30.4.2012
EU/1/11/667/004	Esbriet	Liechtenstein	30.4.2012
EU/1/11/699/003-004	Fampyra	Liechtenstein	30.4.2012
EU/1/11/701/029-032	Levetiracetam Teva	Liechtenstein	30.6.2012
EU/1/11/703/003	Xgeva	Liechtenstein	29.2.2012
EU/1/11/704/002	Victrelis	Liechtenstein	30.4.2012
EU/1/11/720/002	Incivo	Liechtenstein	30.6.2012
EU/1/97/044/009	Tasmar	Liechtenstein	30.4.2012
EU/2/07/078/015-017	Rheumocam	Norway	13.2.2012
EU/2/07/078/015-017	Rheumocam	Iceland	7.2.2012
EU/2/07/078/015-017	Rheumocam	Liechtenstein	29.2.2012
EU/2/08/085/002-006	Easotic	Liechtenstein	30.4.2012
EU/2/08/090/027	Loxicom	Liechtenstein	30.6.2012
EU/2/10/114/003	Hiprabovis IBR Marker Live	Liechtenstein	29.2.2012
EU/2/97/004/049	Metacam	Liechtenstein	29.2.2012

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January-30 June 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/02/255/001-002	Xigris	Iceland	25.6.2012
EU/1/04/272/001-002	PhotoBarr	Norway	24.5.2012
EU/1/04/272/001-002	Photobarr	Iceland	20.5.2012
EU/1/04/272/001-002	PhotoBarr	Liechtenstein	30.6.2012
EU/1/06/335/001	Valtropin	Iceland	5.6.2012
EU/1/06/335/001	Valtropin	Liechtenstein	30.6.2012
EU/1/06/351/001-003	Livensa	Iceland	11.4.2012
EU/1/06/351/001-003	Livensa	Liechtenstein	30.4.2012
EU/1/06/352/001-003	Intrinsa	Liechtenstein	30.6.2012
EU/1/06/352/001-003	Intrinsa	Iceland	23.6.2012
EU/1/09/534/001-007	Clopidogrel Hexal	Iceland	2.3.2012
EU/1/09/534/001-007	Clopidgrel Hexal	Liechtenstein	29.2.2012
EU/1/09/548/001-007	Clopidogrel Acino Pharma GmbH	Iceland	2.3.2012
EU/1/09/548/001-007	Clopidgrel Acino Pharma GmbH	Liechtenstein	29.2.2012
EU/1/09/549/001-007	Clopidogrel Acino Pharma	Iceland	2.3.2012
EU/1/09/549/001-007	Clopidogrel Acino Pharma	Liechtenstein	29.2.2012
EU/1/10/630/001-002	Docefrez	Iceland	20.6.2012
EU/1/10/630/001-002	Docefrez	Liechtenstein	30.6.2012
EU/1/97/035/003-004	Refludan	Iceland	24.5.2012
EU/1/97/035/001-004	Refludan	Norway	6.6.2012
EU/1/97/035/001-004	Refludan	Liechtenstein	30.6.2012
EU/2/00/028/002-008	Zubrin	Iceland	17.4.2012
EU/2/00/028/002-008	Zubrin	Liechtenstein	30.4.2012
EU/2/03/040/001-002	Gonazon	Norway	2.4.2012
EU/2/03/040/001-002	Gonazon	Iceland	17.4.2012
EU/2/03/040/001-002	Gonazon	Liechtenstein	30.4.2012
EU/2/06/060/001-002	Poulvac FluFend H5N3 RG	Liechtenstein	30.6.2012

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January-30 June 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/06/361/001-002	Luminity	Iceland	20.6.2012
EU/1/06/361/001-002	Luminity	Liechtenstein	30.6.2012
EU/1/97/037/001	Vistide	Liechtenstein	29.2.2012
EU/1/11/705/001	Vibativ	Iceland	27.6.2012

9.10.2014

Official Journal of the European Union

C 356/37

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2012

2014/C 356/08

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 July-31 December 2012, at their meeting on 8 November 2013:

Annex I	List of new marketing authorisations
Annex II	List of renewed marketing authorisations
Annex III	List of extended marketing authorisations
Annex IV	List of withdrawn marketing authorisations
Annex V	List of suspended marketing authorisations

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July- 31 December 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/11/685/001-005	Ibandronic acid Sandoz	Norway	31.7.2012
EU/1/11/719/001-062	Telmisartan Teva Pharma	Liechtenstein	31.12.2012
EU/1/11/744/001-002	Topotecan Eagle	Norway	30.8.2012
EU/1/11/747/001	Colobreathe	Norway	11.7.2012
EU/1/11/748/001-006	Docetaxel Mylan	Norway	17.12.2012
EU/1/12/762/001-018	Capecitabine Accord	Norway	13.8.2012
EU/1/12/768/001	Riluzole Zentiva	Norway	16.8.2012
EU/1/12/769/001-003	Docetaxel Accord	Norway	13.8.2012
EU/1/12/771/001-006	Zoledronic Acid Teva	Iceland	10.9.2012
EU/1/12/771/001-006	Zoledronic acid Teva	Norway	12.10.2012
EU/1/12/772/001-004	Zoledronic acid Teva Pharma	Iceland	10.9.2012
EU/1/12/772/001-004	Zoledronic acid Teva Pharma	Norway	10.10.2012
EU/1/12/773/001-003	Jakavi	Liechtenstein	31.8.2012
EU/1/12/773/001-003	Jakavi	Norway	5.9.2012
EU/1/12/773/001-003	Jakavi	Iceland	19.9.2012
EU/1/12/774/001-002	Rienso	Norway	14.8.2012
EU/1/12/774/001-002	Rienso	Iceland	20.7.2012
EU/1/12/774/001-002	Rienso	Liechtenstein	31.12.2012
EU/1/12/775/001	NovoThirteen	Iceland	17.9.2012
EU/1/12/775/001	Novo Thirteen	Norway	19.9.2012
EU/1/12/775/001	Novo Thirteen	Liechtenstein	31.10.2012
EU/1/12/776/001-016	Fycompa	Norway	27.8.2012
EU/1/12/776/001-016	Fycompa	Liechtenstein	31.8.2012
EU/1/12/776/001-016	Fycompa	Iceland	11.9.2012
EU/1/12/777/001-006	Inlyta	Iceland	14.9.2012
EU/1/12/777/001-006	Inlyta	Norway	21.9.2012
EU/1/12/777/001-006	Inlyta	Liechtenstein	31.10.2012
EU/1/12/778/001-003	Eklira Genuair	Iceland	13.8.2012
EU/1/12/778/001-003	Eklira Genuair	Norway	15.8.2012
EU/1/12/778/001-003	Eklira Genuair	Liechtenstein	31.8.2012
EU/1/12/779/001-006	Zoledronic acid medac	Norway	15.8.2012
EU/1/12/779/001-006	Zoledronic acid medac	Iceland	27.8.2012
EU/1/12/779/001-006	Zoledronic acid medac	Liechtenstein	31.8.2012
EU/1/12/780/001-028	Jentadueto	Norway	31.7.2012
EU/1/12/780/001-028	Jentadueto	Liechtenstein	31.8.2012
EU/1/12/780/001-028	Jentadueto	Iceland	17.8.2012
EU/1/12/781/001-003	Bretaris Genuair	Iceland	13.8.2012
EU/1/12/781/001-003	Bretaris Genuair	Norway	15.8.2012
EU/1/12/781/001-003	Bretaris Genuair	Liechtenstein	31.8.2012
EU/1/12/782/001-002	Kalydeco	Norway	6.8.2012
EU/1/12/782/001-002	Kalydeco	Iceland	21.8.2012
EU/1/12/782/001-002	Kalydeco	Liechtenstein	31.8.2012
EU/1/12/783/001-003	Zyclara	Liechtenstein	31.8.2012
EU/1/12/783/001-003	Zyclara	Iceland	12.9.2012
EU/1/12/783/001-003	Zyclara	Norway	10.10.2012
EU/1/12/784/001	Cuprymina	Iceland	7.9.2012
EU/1/12/784/001	Cuprymina	Norway	25.9.2012
EU/1/12/784/001	Cuprymina	Liechtenstein	31.10.2012
EU/1/12/785/001	Zinforo	Liechtenstein	31.8.2012
EU/1/12/785/001	Zinforo	Iceland	6.9.2012
EU/1/12/785/001	Zinforo	Norway	17.9.2012
EU/1/12/786/001-003	Zoledronic acid Mylan	Liechtenstein	31.8.2012
EU/1/12/786/001-003	Zoledronic acid Mylan	Iceland	4.9.2012
EU/1/12/786/001-003	Zoledronic acid Mylan	Norway	12.10.2012
EU/1/12/787/001	Revestive	Iceland	14.9.2012
EU/1/12/787/001	Revestive	Norway	26.9.2012
EU/1/12/787/001	Revestive	Liechtenstein	31.10.2012
EU/1/12/788/001-006	Seebri Breezhaler	Iceland	16.10.2012
EU/1/12/788/001-006	Seebri Breezhaler	Norway	17.10.2012
EU/1/12/789/001-006	Enurev Breezhaler	Iceland	17.10.2012
EU/1/12/789/001-006	Enurev Breezhaler	Norway	29.10.2012
EU/1/12/790/001-006	Tovanor Breezhaler	Iceland	17.10.2012
EU/1/12/790/001-006	Tovanor Breezhaler	Norway	29.10.2012
EU/1/12/791/001	Glybera	Iceland	15.11.2012
EU/1/12/791/001	Glybera	Norway	6.12.2012
EU/1/12/792/001	Dacogen	Iceland	15.10.2012
EU/1/12/792/001	Dacogen	Norway	17.10.2012
EU/1/12/792/001	Dacogen	Liechtenstein	31.10.2012
EU/1/12/793/001-004	Xalkori	Iceland	8.11.2012
EU/1/12/793/001-004	Xalkori	Norway	14.11.2012
EU/1/12/793/001-004	Xalkori	Liechtenstein	31.12.2012
EU/1/12/794/001	Adcetris	Norway	10.12.2012
EU/1/12/794/001	Adectris	Liechtenstein	31.12.2012
EU/1/12/795/001-010	Forxiga	Norway	6.12.2012
EU/1/12/795/001-010	Forxiga	Iceland	7.12.2012
EU/1/12/796/001-002	Picato	Norway	27.11.2012
EU/1/12/796/001-002	Picato	Iceland	7.12.2012
EU/1/12/796/001-002	Picato	Liechtenstein	31.12.2012
EU/1/12/797/001-002	Eylea	Norway	6.12.2012
EU/1/12/797/001-002	Eylea	Iceland	13.12.2012
EU/1/12/798/001-004	Ibandronic acid Accord	Norway	12.12.2012
EU/1/12/798/001-004	Ibandronic acid Accord	Iceland	10.12.2012
EU/1/12/798/001-004	Ibandronic acid Accord	Liechtenstein	31.12.2012
EU/1/12/799/001-029	Memantine Merz	Iceland	12.12.2012
EU/1/12/799/001-029	Memantine Merz	Liechtenstein	31.12.2012
EU/1/12/800/001-004	Zoledronic Acid Hospira	Iceland	7.12.2012
EU/1/12/800/001-004	Zoledronic acid Hospira	Norway	17.12.2012
EU/1/12/800/001-004	Zoledronic acid Hospira	Liechtenstein	31.12.2012
EU/1/12/801/001-004	Constella	Iceland	13.12.2012
EU/1/12/801/001-004	Constella	Liechtenstein	31.12.2012
EU/1/12/801/001-004	Constella	Norway	17.12.2012
EU/1/12/802/001-042	Capecitabine medac	Norway	13.12.2012
EU/1/12/802/001-042	Capecitabine medac	Iceland	18.12.2012
EU/1/12/802/001-042	Capecitabine medac	Liechtenstein	31.12.2012
EU/2/09/099/001-006	Suvaxyn PCV	Iceland	8.11.2012
EU/2/11/122/001-003	Bluevac BTV8	Norway	18.7.2012
EU/2/12/138/001-003	RevitaCAM	Norway	19.9.2012
EU/2/12/140/001-008	Poulvac E. Coli	Iceland	23.7.2012
EU/2/12/141/001-009	Porcilis ColiClos	Iceland	5.7.2012
EU/2/12/141/001-009	Porcilis ColiClos	Norway	31.7.2012
EU/2/12/141/001-009	Porcilis ColiClos	Liechtenstein	31.8.2012
EU/2/12/142/001-006	Cardalis 2,5/20 mg	Iceland	20.8.2012
EU/2/12/143/001-005	Nobivac L4	Iceland	20.8.2012
EU/2/12/143/001-005	Nobivac L4	Norway	28.8.2012
EU/2/12/143/001-005	Nobivac L4	Liechtenstein	31.8.2012

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July- 31 December 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/01/187/001	DepoCyte	Norway	13.8.2012
EU/1/01/197/001-005	Foscan	Norway	7.9.2012
EU/1/02/222/001-005	Tamiflu	Norway	21.8.2012
EU/1/02/223/001-003	Evra	Iceland	5.7.2012
EU/1/02/223/001-003	Evra	Norway	27.8.2012
EU/1/02/223/001-003	Evra	Liechtenstein	31.8.2012
EU/1/02/224/001-005	Ambirix	Iceland	21.8.2012
EU/1/02/224/001-005	Ambirix	Norway	27.8.2012
EU/1/02/224/001-005	Ambirix	Liechtenstein	31.8.2012
EU/1/02/226/001	InductOs	Norway	2.8.2012
EU/1/02/226/001	InductOs	Iceland	14.8.2012
EU/1/02/237/001-009	Cialis	Norway	11.10.2012
EU/1/02/237/001-009	Cialis	Iceland	17.10.2012
EU/1/02/237/001-009	Cialis	Liechtenstein	31.10.2012
EU/1/02/238/001	Zavesca	Iceland	22.10.2012
EU/1/02/238/001	Zavesca	Norway	29.10.2012
EU/1/02/238/001	Zavesca	Liechtenstein	31.10.2012
EU/1/05/314/001	Kepivance	Norway	11.9.2012
EU/1/06/339/001-002	Preotact	Norway	28.8.2012
EU/1/06/367/001-012	Diacomit	Norway	12.12.2012
EU/1/06/367/001-012	Diacomit	Iceland	13.12.2012
EU/1/06/367/001-012	Diacomit	Liechtenstein	31.12.2012
EU/1/06/371/001-039	Dafiro	Norway	26.9.2012
EU/1/06/376/001-039	Irbesartan Zentiva	Iceland	28.9.2012
EU/1/07/393/001	Soliris	Iceland	5.7.2012
EU/1/07/393/001	Soliris	Norway	13.8.2012
EU/1/07/394/001-009	Optaflu	Iceland	8.11.2012
EU/1/07/395/001-095	Invega	Iceland	31.8.2012
EU/1/07/395/001-095	Invega	Norway	11.9.2012
EU/1/07/397/001-004	Siklos	Iceland	23.7.2012
EU/1/07/397/001-004	Siklos	Norway	9.8.2012
EU/1/07/398/001-014	Optimark	Iceland	5.7.2012
EU/1/07/398/001-014	Optimark	Liechtenstein	31.8.2012
EU/1/07/401/007-016	alli	Iceland	20.7.2012
EU/1/07/401/007-016	alli	Liechtenstein	31.8.2012
EU/1/07/402/001	Increlex	Iceland	29.8.2012
EU/1/07/402/001	Increlex	Liechtenstein	31.8.2012
EU/1/07/402/001	Increlex	Norway	3.9.2012
EU/1/07/403/001	Atriance	Iceland	20.7.2012
EU/1/07/403/001	Atriance	Norway	7.8.2012
EU/1/07/403/001	Atriance	Liechtenstein	31.8.2012
EU/1/07/404/001-008	Flebogamma DIF	Iceland	11.9.2012
EU/1/07/404/001-008	Flebogamma DIF	Norway	12.10.2012
EU/1/07/405/001-040	Rasilez	Liechtenstein	31.8.2012
EU/1/07/405/001-040	Rasilez	Iceland	19.9.2012
EU/1/07/405/001-040	Rasilez	Norway	10.10.2012
EU/1/07/409/001-040	Riprazo	Iceland	12.9.2012
EU/1/07/409/001-040	Riprazo	Norway	10.10.2012
EU/1/07/409/001-040	Riprazo	Liechtenstein	31.8.2012
EU/1/07/410/001-052	Binocrit	Norway	27.8.2012
EU/1/07/410/001-052	Binocrit	Iceland	20.7.2012
EU/1/07/410/001-052	Binocrit	Liechtenstein	31.8.2012
EU/1/07/411/001-052	Epoetin alfa Hexal	Iceland	19.7.2012
EU/1/07/411/001-052	Epoetin alfa Hexal	Norway	27.8.2012
EU/1/07/411/001-052	Epoetin alfa Hexal	Liechtenstein	31.8.2012
EU/1/07/412/001-052	Abseamed	Iceland	20.7.2012
EU/1/07/412/001-052	Abseamed	Norway	27.8.2012
EU/1/07/413/001-003	Gliolan	Iceland	7.9.2012
EU/1/07/413/001-003	Gliolan	Norway	15.10.2012
EU/1/07/413/001-003	Gliolan	Liechtenstein	31.10.2012
EU/1/07/414/001-010, 018	Galvus	Iceland	17.8.2012
EU/1/07/414/001-010, 018	Galvus	Norway	31.7.2012
EU/1/07/415/001-056	Zalasta	Norway	24.8.2012
EU/1/07/415/001-056	Zalasta	Iceland	25.8.2012
EU/1/07/415/001-056	Zalasta	Liechtenstein	31.8.2012
EU/1/07/416/002	Ecalta	Iceland	3.9.2012
EU/1/07/416/002	Ecalta	Liechtenstein	31.8.2012
EU/1/07/416/002	Ecalta	Norway	26.9.2012
EU/1/07/417/001-002	Yondelis	Iceland	28.8.2012
EU/1/07/417/001-002	Yondelis	Liechtenstein	31.8.2012
EU/1/07/417/001-002	Yondelis	Norway	17.9.2012
EU/1/07/418/001-010	Celsentri	Liechtenstein	31.8.2012
EU/1/07/418/001-010	Celsentri	Iceland	12.9.2012
EU/1/07/418/001-010	Celsentri	Norway	18.9.2012
EU/1/07/419/001-012	Cervarix	Iceland	12.10.2012
EU/1/07/419/001-012	Cervarix	Norway	12.10.2012
EU/1/07/419/001-012	Cervarix	Liechtenstein	31.10.2012
EU/1/07/420/001-002	Cyanokit	Iceland	14.8.2012
EU/1/07/420/001-002	Cyanokit	Norway	17.8.2012
EU/1/07/420/001-002	Cyanokit	Liechtenstein	31.8.2012
EU/1/07/421/001-009	Glubrava	Iceland	12.10.2012
EU/1/07/421/001-009	Glubrava	Norway	12.10.2012
EU/1/07/421/001-009	Glubrava	Liechtenstein	31.10.2012
EU/1/07/422/001-012	Tasigna	Norway	24.10.2012
EU/1/07/422/001-012	Tasigna	Liechtenstein	31.10.2012
EU/1/07/422/001-012	Tasigna	Iceland	6.12.2012
EU/1/07/424/001	Torisel	Iceland	12.10.2012
EU/1/07/424/001	Torisel	Norway	22.10.2012
EU/1/07/424/001	Torisel	Liechtenstein	31.10.2012
EU/1/07/425/001-018	Eucreas	Norway	31.7.2012
EU/1/07/425/001-018	Eucreas	Iceland	21.8.2012
EU/1/07/425/001-018	Eucreas	Liechtenstein	31.8.2012
EU/1/07/426/001-011	Olanzapine Neopharma	Iceland	17.10.2012
EU/1/07/426/001-011	Olanzapine Neopharma	Norway	24.10.2012
EU/1/07/426/001-011	Olanzapine Neopharma	Liechtenstein	31.10.2012
EU/1/07/427/001-057	Olanzapine Teva	Norway	6.12.2012
EU/1/07/427/001-057	Olanzapine Teva	Iceland	7.12.2012
EU/1/07/427/001-057	Olanzapine Teva	Liechtenstein	31.12.2012
EU/1/07/430/001-002	Atripla	Norway	26.9.2012
EU/1/07/430/001-002	Atripla	Iceland	12.10.2012
EU/1/07/431/001-025	Retacrit	Iceland	7.12.2012
EU/1/07/431/001-025	Retacrit	Norway	17.12.2012
EU/1/07/431/001-025	Retacrit	Liechtenstein	31.12.2012
EU/1/07/432/001-022	Silapo	Iceland	22.8.2012
EU/1/07/432/001-022	Silapo	Norway	24.8.2012
EU/1/07/432/001-022	Silapo	Liechtenstein	31.8.2012
EU/1/07/433/001	Nevanac	Norway	15.10.2012
EU/1/07/433/001	Nevanac	Liechtenstein	31.10.2012
EU/1/07/435/001-018	Tesavel	Iceland	15.10.2012
EU/1/07/435/001-018	Tesavel	Norway	15.10.2012
EU/1/07/437/001-004	IVEMEND	Iceland	7.12.2012
EU/1/07/437/003-004	IVEMEND	Norway	6.12.2012
EU/1/07/437/003-004	IVEMEND	Liechtenstein	31.12.2012
EU/1/07/438/001-006	Myfenax	Iceland	12.12.2012
EU/1/07/438/006	Myfenax	Norway	13.12.2012
EU/1/07/439/001-006	Mycophenolate mofetil Teva	Iceland	12.12.2012
EU/1/07/439/001-006	Mycophenolate mofetil Teva	Norway	17.12.2012
EU/1/08/468/001-002	INTELENCE	Iceland	16.8.2012
EU/1/08/468/001-002	INTELENCE	Norway	27.8.2012
EU/1/08/468/001-002	INTELENCE	Liechtenstein	31.8.2012
EU/1/11/710/001-007	Votubia	Norway	16.8.2012
EU/1/11/710/001-007	Votubia	Iceland	25.8.2012
EU/1/11/710/001-007	Votubia	Liechtenstein	31.8.2012
EU/1/97/047/004-007	BeneFIX	Iceland	16.8.2012
EU/1/97/047/004-007	BeneFIX	Norway	24.8.2012
EU/1/97/047/004-007	BeneFIX	Liechtenstein	31.8.2012
EU/2/02/032/001-002	Vaxxitek HVT + IBD	Iceland	23.7.2012
EU/2/02/032/001-002	Vaxxitek HVT + IBD	Liechtenstein	31.8.2012
EU/2/02/034/001	Nobivac Bb	Iceland	18.9.2012
EU/2/02/034/001	Nobivac Bb	Norway	23.10.2012
EU/2/02/034/001	Nobivac Bb	Liechtenstein	31.10.2012
EU/2/07/072/001-004	Suprelorin	Norway	31.7.2012
EU/2/07/072/001-004	Suprelorin	Liechtenstein	31.8.2012
EU/2/07/074/001-006	Prilactone	Liechtenstein	31.8.2012
EU/2/07/077/001-005	Meloxivet	Iceland	6.12.2012
EU/2/07/077/001-005	Meloxivet	Liechtenstein	31.10.2012

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July- 31 December 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/01/200/003-009	Viread	Iceland	18.12.2012
EU/1/04/274/001-002	Velcade	Norway	18.10.2012
EU/1/04/306/002-003	Aloxi	Norway	19.11.2012
EU/1/06/368/169-174	Insulin Human Winthrop	Liechtenstein	31.8.2012
EU/1/06/376/034, 036-039	Irbesartan Zentiva	Liechtenstein	31.10.2012
EU/1/06/376/034, 036-039	Irbesartan Zentiva	Norway	30.8.2012
EU/1/06/377/029-034	Irbesartan HCT Zentiva	Liechtenstein	31.8.2012
EU/1/06/377/029-034	Irbesartan HCT Zentiva	Norway	12.11.2012
EU/1/06/380/006	Prezista	Iceland	14.11.2012
EU/1/06/380/006	Prezista	Norway	24.10.2012
EU/1/07/389/004-009	Orencia	Liechtenstein	31.10.2012
EU/1/07/389/004-009	Orencia	Norway	13.11.2012
EU/1/07/389/004-009	Orencia	Iceland	19.10.2012
EU/1/07/391/005-006	Revlimid	Norway	25.9.2012
EU/1/07/391/005-006	Revlimid	Iceland	11.10.2012
EU/1/07/440/007	Tyverb	Liechtenstein	31.8.2012
EU/1/07/440/007	Tyverb	Norway	31.7.2012
EU/1/09/514/021-023	Zebinix	Liechtenstein	31.8.2012
EU/1/09/514/021-023	Zebinix	Iceland	3.9.2012
EU/1/09/514/021-023	Zebinix	Norway	25.9.2012
EU/1/10/616/025-036	Temozolomide HEXAL	Liechtenstein	31.8.2012
EU/1/10/617/025-036	Temozolomide Sandoz	Liechtenstein	31.8.2012
EU/1/11/691/006-013	Eliquis	Iceland	11.12.2012
EU/1/11/691/006-013	Eliquis	Norway	19.12.2012
EU/1/11/712/029-040	Levetiracetam Accord	Liechtenstein	31.10.2012
EU/1/11/731/013-014	Komboglyze	Liechtenstein	31.10.2012
EU/1/11/731/013-014	Komboglyze	Norway	24.9.2012
EU/1/11/734/012-018	Edarbi	Liechtenstein	31.8.2012
EU/1/11/735/012-018	Ipreziv	Liechtenstein	31.8.2012
EU/1/12/752/002	Vepacel	Liechtenstein	31.10.2012
EU/1/12/765/007-009	Sabervel	Liechtenstein	31.12.2012
EU/1/97/030/196-201	Insuman	Liechtenstein	31.8.2012
EU/1/97/047/008	BeneFIX	Liechtenstein	31.8.2012
EU/1/97/047/008	BeneFIX	Iceland	4.9.2012
EU/1/97/047/008	BeneFIX	Norway	10.10.2012
EU/2/02/033/003-004	Dexdomitor	Iceland	13.9.2012
EU/2/02/033/003-004	Dexdomitor	Norway	30.8.2012
EU/2/02/033/003-004	Dexdomitor	Liechtenstein	31.10.2012
EU/2/07/074/007-009	Prilactone	Liechtenstein	31.12.2012
EU/2/07/078/018-020	Rheumocam	Norway	6.12.2012
EU/2/07/078/018-020	Rheumocam	Liechtenstein	31.12.2012
EU/2/08/090/028	Loxicom	Liechtenstein	31.12.2012
EU/2/10/118/015-021	Activyl	Liechtenstein	31.8.2012
EU/2/11/134/015-017	Inflacam	Iceland	5.9.2012
EU/2/11/134/015-017	Inflacam	Norway	1.11.2012
EU/2/11/134/015-017	Inflacam	Liechtenstein	31.8.2012
EU/2/11/134/018-020	Inflacam	Iceland	6.12.2012
EU/2/11/134/018-020	Inflacam	Liechtenstein	31.12.2012
EU/2/99/015/003-004	Oxyglobin	Liechtenstein	31.12.2012

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July- 31 December 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/00/147/001-012	Hexavac	Iceland	23.7.2012
EU/1/00/147/001-012	Hexavac	Liechtenstein	31.8.2012
EU/1/01/193/001-002	MabCampath	Norway	8.8.2012
EU/1/01/193/001-002	MabCampath	Iceland	30.8.2012
EU/1/01/193/001-002	MabCampath	Liechtenstein	31.8.2012
EU/1/02/205/005-006	Lumigan	Liechtenstein	31.12.2012
EU/1/02/209/001-004	Dynastat	Norway	18.7.2012
EU/1/04/281/001-002, 004	Erbitux	Norway	30.8.2012
EU/1/07/407/001-040	Sprimeo	Iceland	23.7.2012
EU/1/07/407/001-040	Sprimeo	Norway	4.7.2012
EU/1/07/407/001-040	Sprimeo	Liechtenstein	31.8.2012
EU/1/09/513/001-020	Rivastigmine Teva	Norway	10.9.2012
EU/1/09/513/001-020	Rivastigmine Teva	Iceland	20.9.2012
EU/1/09/513/001-020	Rivastigmine Teva	Liechtenstein	31.10.2012
EU/1/09/520/001-020	Exalief	Iceland	6.12.2012
EU/1/09/520/001-020	Exalief	Norway	30.7.2012
EU/1/09/570/001-060	Imprida HCT	Iceland	7.12.2012
EU/1/09/576/040	Irbesartan Teva	Liechtenstein	31.12.2012
EU/1/09/582/001	Rilonacept Regeneron	Iceland	14.11.2012
EU/1/09/582/001	Rilonacept Regeneron	Norway	24.10.2012
EU/1/10/634/005-011	Ribavirin Mylan	Liechtenstein	31.12.2012
EU/1/11/638/001-080	Sprimeo HCT	Liechtenstein	31.8.2012
EU/1/11/669/005	Teysuno	Liechtenstein	31.12.2012
EU/1/11/679/007	Pravafenix	Liechtenstein	31.12.2012
EU/1/11/680/001-080	Riprazo HCT	Norway	30.8.2012
EU/1/11/680/001-080	Riprazo HCT	Iceland	12.9.2012
EU/1/11/683/001-080	Sprimeo HCT	Norway	6.7.2012
EU/1/11/683/001-080	Sprimeo HCT	Iceland	23.7.2012
EU/1/11/691/006-013	Eliquis	Liechtenstein	31.12.2012
EU/1/11/697/013-024	Temozolomide SUN	Liechtenstein	31.12.2012
EU/1/12/765/007-009	Sabervel	Liechtenstein	31.12.2012
EU/1/12/776/017-023	Fycompa	Liechtenstein	31.12.2012
EU/1/12/780/029-034	Jentadueto	Liechtenstein	31.12.2012
EU/1/96/006/008-011	NovoSeven	Liechtenstein	31.12.2012
EU/1/97/040/001-002	Teslascan	Iceland	14.9.2012
EU/1/99/099/001-006	Zerene	Norway	23.8.2012
EU/1/99/099/001-006	Zerene	Iceland	7.9.2012
EU/1/99/099/001-006	Zerene	Liechtenstein	31.10.2012
EU/1/99/101/001	Regranex	Norway	16.7.2012
EU/1/99/101/001	Regranex	Liechtenstein	31.8.2012
EU/1/99/101/001	Regranex	Iceland	14.8.2012
EU/1/99/103/009	Refacto AF	Liechtenstein	31.12.2012

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July- 31 December 2012:

EU-Number	Product	Country	Date of authorisation
EU/1/09/509/001-004	Ribavirin Teva	Iceland	14.12.2012
EU/1/09/509/001-004	Ribavirin Teva	Norway	6.12.2012
EU/1/09/527/001-016	Ribavirin Teva Pharma BV	Iceland	14.12.2012
EU/1/09/527/001-016	Ribavirin Teva Pharma BV	Norway	6.12.2012

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

9.10.2014

Official Journal of the European Union

C 356/52

Prior notification of a concentration

(Case M.7359 — PCCR USA/Total's CCP Composite Business)

(Text with EEA relevance)

2014/C 356/09

On 30 September 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1) by which the undertaking PCCR USA, Inc (‘PCCR’, the United States), a fully owned subsidiary of Polynt Group SàRL (‘Polynt Group’, Luxembourg) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of CCP Composites SA (France), CCP Composites UK Limited (the United Kingdom), CCP Composites Canada, Inc. (Canada), CCP Composites US LLC (the United States), CCP Composites Korea Co., Ltd (South Corea), CCP Composites Resins España, SLU (Spain), CCP Composites e Resinas do Brazil Ltda (Brazil), CCP Australia Pty Ltd (Australia), CCP Composites Resins Malaysia Sdn Bhd (Malaysia), CCP Composites Guangzhou Co., Ltd (China) (altogether referred to as ‘CCP Composite Business’) by way of purchase of shares.

The business activities of the undertakings concerned are:

— for PCCR: PCCR is active in the production and the sale of resins for the coating and composite industry in North America (both in the US and Canada),

— for CCP Composite Business: is active in the production and the sale of unsaturated polyester resins and gel coats worldwide.

3.	On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number M.7359 — PCCR USA/Total's CCP Composite Business, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

9.10.2014

Official Journal of the European Union

C 356/53

Prior notification of a concentration

(Case M.7095 — SOCAR/DESFA)

(Text with EEA relevance)

2014/C 356/10

On 1 October 2014, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the State Oil Company of the Azerbaijan Republic (‘SOCAR’ of Azerbaijan) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of the Hellenic Gas Transmission System Operator (‘DESFA’ of Greece) by way of purchase of shares.

The business activities of the undertakings concerned are:

— for SOCAR: wholly-owned by the Republic of Azerbaijan and involved in exploring oil and gas fields, producing, processing, and transporting oil, gas and gas condensate, marketing petroleum and petrochemical products in domestic and international markets, and supplying natural gas to industry and the public in Azerbaijan;

— for DESFA: established in 2007 with the objective of operating, maintaining, managing, exploiting and developing the Hellenic Gas Transmission System. The activities of the company, which are governed by a special law, are a public utility and are subject to government supervision.

3.	On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

(1) OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

OTHER ACTS

European Commission

9.10.2014

Official Journal of the European Union

C 356/54

Publication of an amendment application pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

2014/C 356/11

This publication confers the right to oppose the application pursuant to Article 51 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council (1).

AMENDMENT APPLICATION

COUNCIL REGULATION (EC) No 510/2006

on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2)

AMENDMENT APPLICATION ACCORDING TO ARTICLE 9

‘COMTÉ’

EC No: FR-PDO-0217-0116-30.6.2009

PGI ( ) PDO ( X )

1. Heading in the product specification affected by the amendment

—

☐ Name of product

—

☒ Description of product

—

☐ Geographical area

—

☐ Proof of origin

—

☒ Method of production

—

☒ Link

—

☒ Labelling

—

☐ National requirements

—

☐ Other [to be specified]

2. Type of amendments

—

☐ Amendment to the Single Document or Summary Sheet

—

☒ Amendment to the Specification of the registered PDO or PGI for which neither the Single Document nor the Summary Sheet has been published

—

☐ Amendment to the Specification that requires no amendment to the published Single Document (Article 9(3) of Regulation (EC) No 510/2006)

—

☐ Temporary amendment to the Specification resulting from the imposition of obligatory sanitary or phytosanitary measures by the public authorities (Article 9(4) of Regulation (EC) No 510/2006)

3. Amendment(s)

3.1. Amendment to point (2) Description of product

The stage corresponding to the description of the product has been clarified. The term ‘renneted’ has been deleted (the addition of rennet is described under the heading ‘Method of production’), as has the term ‘firm’, which is not very precise.

The maximum fat content has been defined in order to avoid an excess of non-traditional fat.

Stricter criteria have been laid down for the sizes and weights of the cheese in order to better characterise the product.

A new type of packaging (grated) has been included in the specification.

The organoleptic characteristics have been added in order to better describe the product.

The minimum maturing period is reiterated in this chapter.

3.2. Amendment to point (5) Method of production

5.1. Milk production

The addition of the breed types (46 and 35) helps facilitate checks. Replacing the former name of the breed, ‘Pie-Rouge de l’Est’, with its new name, ‘Simmental française’, does not change the list of authorised traditional breeds. The authorisation of products obtained by crossing the two breeds (Montbéliarde and Simmental française), which used to be implicit, is now explicit.

Clarifications regarding the seeding of grassland in order to promote a more diverse flora have been added: ‘Grassland that has been seeded with one type of legume, either alone or in combination with one type of grass, for less than five years is authorised on at most 15 % of the forage area of the farm. For the re-seeding of other grassland, it is obligatory to use long-duration mixtures combining at least three types of complementary species: hay grass, pasture grass and legumes.’

Clarifications regarding the fertilisation conditions make it possible to strengthen the link with the region by maintaining a diverse natural flora and avoiding the addition of artificial agents.

‘The amount of nitrogenous mineral manure may not exceed an average of 50 units per hectare of forage area per farm. Any use of the forage area (grazing or mowing) is prohibited for one month after the date of spreading the organic manure and for three weeks after the spreading of any mineral manure. The only organic fertilising substances authorised in the forage areas of the farm come from the geographical area and include compost, manure, slurry and liquid manure. They must meet certain conditions.

3.2.1.

The following are forbidden: organic fertilising substances from animals fed silage, unless the substances have first been composted to destroy any butyric spores, composts of green waste unless they are from the farm, co-composts of green waste except agricultural co-composts of the “manure with green waste” type.

The spreading of organic manure of non-agricultural origin on the farm land is authorised, but it must be ploughed in immediately.

Only co-composts where at least one-third of the co-compost is manure from the farm may be spread on the forage areas of the farm.’

With a view to maintaining the grazing tradition, provisions on feeding (‘Feeding systems with no grazing are forbidden. Supplementary green feed is limited to one meal a day during the growing season, so that grazing provides at least half of the minimum daily ration of roughage.’) have been added, as well as grazing requirement applicable as soon as the soils’ bearing capacity allows and for as long as the weather conditions, the soil’s bearing capacity and the presence of grass allow.

The provisions banning GMOs make it possible to maintain the link to the region.

Provisions on milk productivity per hectare of forage area have been added. Productivity is limited in order to maintain the special characteristics of the region in the cheese. ‘In order to preserve the quality and specificity of “Comté”, milk productivity in forage areas and potential forage areas reserved for the feeding of dairy herds is limited for each farm to the level reached during the best marketing year between 2008/09 and 2012/13, plus 10 %. This productivity may under no circumstances exceed 4 600 litres of milk per year and per hectare of forage area or potential forage area.’ The farm’s stocking density is limited to 1,3 LU/ha in order to preserve the link to the region.

A provision on fermented feed (a farm that switches over to the production of ‘Comté’ must have ceased feeding its dairy herd with fermented feed at least a year earlier) makes it possible to limit the risk of contamination by butyric bacteria. The conditions for the cohabitation of herds (the dairy herd used in the production of ‘Comté’ must be separated from the other herds) are clarified in order to facilitate checks.

By banning the supply of concentrate mixtures with the chopped roughage feed given to the dairy herd, it is possible to limit the risk of contamination by butyric bacteria.

Compliance with the different provisions on feeding means that at least 70 % of the herd’s feed comes from the geographical area. Provisions on the quality of the feed supplied have been added, including a list of forbidden feeds, the conditions applied to supplementary green feed and the conditions for the distribution of beetroot, because of either an adverse effect on the smell or taste of the milk or the risks of contamination by butyric bacteria.

These clarifications make it possible to avoid the use of any supplementary feed that might radically change or alter the characteristics of the milk and consequently of the cheese.

In order to facilitate checks, the conditions for supplying supplementary feed have been clarified: ‘The supply of supplementary feed (grains, flours, oilmeals, dried plants produced outside the farm, etc.) is limited to an average per herd of 1 800 kg/dairy cow/year. The annual consumption of supplementary feed by the heifer herd is calculated on the basis of 500 kg per heifer LU.’ The milking conditions are clarified, as these affect the milk’s flora. ‘Prior to attaching the milking cluster, it is forbidden to use milking grease or to disinfect the teats using impregnated wipes, a spray or any other procedure. The first streams must be eliminated. After calving, the milk may not be used for production for at least eight days.’ A qualified technician must regularly inspect the functioning of the milking installations and of the refrigeration and cooling equipment for the milk. Furthermore, ‘the use of disinfectants for cleaning, disinfection and rinsing is authorised only if necessary’

5.2. Milk transport

The milk storage conditions are clarified, as they affect the milk’s flora: ‘the milk is stored either at the farm, at the processing plant or at a place to which producers take the milk themselves. There may be no other intermediate storage centres.’ The storage temperatures for milk are laid down in detail. ‘it must be stored at a temperature of 10 °C to 18 °C.,’ Experience shows that by not cooling the milk to less than 10 °C the specific organoleptic qualities of the cheese are brought out more fully.

It is reiterated that ‘Comté’ may only be produced from a mixture of milk from several farms. The aim is to uphold the tradition of a ‘collective product’. The conditions for keeping the milk intended for the production of ‘Comté’ separate from other milk have been clarified.

5.3. Processing of the milk into cheese

The production plant and its equipment are defined in detail. The time limit for renneting has been redefined in order to facilitate checks. Instead of ‘renneting takes place at the latest within 24 hours of the first milking’ the following wording is proposed: ‘Milking takes place at the latest: — before noon, when the first milking is that of the morning of the previous day; — before midnight, when the first milking is that of the evening of the previous day.’ The provision on heating equipment for milk has been clarified by adding that, in order to facilitate checks, the heating appliance may not have a chambering section.

The authorised leavens and the type of rennet that may be used have been defined in more detail in order to preserve the specificities of the product.

‘Heating and pressing are the only production stages that may be programmed beforehand’ and ‘Production in closed vats is forbidden.’ Indeed, the production method must remain manual, so as to allow cheesemakers to demonstrate their know-how.

‘The maximum capacity of the vats is limited to a maximum of 12 cheeses per vat’ in order to preserve the quality of the cheeses.

‘Over a period of 24 hours not more than three production rounds may be carried out in the same vat. The vat must be scrubbed, washed and rinsed between each production round,’ in order to allow a sufficient release of copper ions, which is indispensable for the selection of the cheese’s microflora. As regards the pressure during pressing, ‘150 g/cm2’ is replaced with ‘100 g/cm2’. This is changed in order to correct a mistake in the previous specification.

5.4. Maturation

The provision on the frequency of turning over the cheeses during pre-maturation is removed, because it is not applicable to all lots. The characteristics of the wheels vary greatly, in particular depending on the season. Maturers must be able to demonstrate their know-how by adjusting the frequency of treatment to the drying capacity of the cheese. While this treatment is necessary in most cases, that is not the case for the most moist wheels, especially those on the periphery. In such situations, the treatment may impair the quality (risk of a sticky rind); it is then better to postpone the treatment until the wheel is less moist. The practices of dry salting and brining, both of which are traditional methods, have been defined in detail, as they are essential to revealing the special character of ‘Comté’. ‘Dry salting may be replaced with brining, which must be carried out within 24 hours of removal from the mould, and the cheese must be treated within 48 hours of removal from the brine.’ The use of an international measuring method is specified for the maturity index. ‘Proteolysis measured using a minimum maturity index such as the non-protein nitrogenous content must make up at least 15,5 % of the total nitrogenous content, on the basis of the nitrogen content measured with the Kjeldahl method. For cheeses where the fat content in dry matter exceeds 52 %, this ratio must be 17,5 % or more.’ The addition of provisions on the necessity to measure and register the humidity facilitates checks.

5.5. Portioning and packaging

The term ‘pre-packaging’ is defined.

The grating conditions are laid down. When packaging small portions of ‘Comté’, especially when it is grated, there is a risk that the quality of the product will be impaired and therefore specific know-how is required. By identifying these operators as packers, it is possible to impose inspection obligations on them and consequently to guarantee good traceability in order to protect consumers. ‘The rind may be removed from portions weighing less than 40 grams each or intended to be grated. If the rind is very moist or if it has deteriorated, it must be removed immediately after the cheese has been cut into portions. If the rind is in good condition, it must be removed within 8 hours of the first cutting. Pieces whose rind has been removed may not be stored in the open air for more than 72 hours; after that, they must be vacuum-packed. Vacuum-packing must take place within 15 days.’

5.6. Technological innovations

A paragraph on technological innovations has been added.

3.3. Amendment to point (6) Elements justifying the link with the geographical area

The heading ‘Link to the origin’ has been divided into three parts: ‘specificity of the geographical area’, ‘specificity of the product’ and ‘causal link between the geographical area and the quality or characteristics of the product’ in order to ensure consistency with the single document. This chapter has been rewritten for the sake of clarity.

3.4. Amendment to point (8) Specific rules on labelling

—	Abolition of the INAO logo, which is replaced with the European Union’s AOP (PDO) symbol.

—	Obligation to affix clearly the name and address of the producer, maturer or prepacker in order to provide consumers with better information.

—	Size of the name ‘Comté’ (at least two thirds of the other characters), prohibition on the use of additional wording, description of the identification marks, etc.

SINGLE DOCUMENT

COUNCIL REGULATION (EC) No 510/2006

on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (3)

‘COMTÉ’

EC No: FR-PDO-0217-0116-30.6.2009

PGI ( ) PDO ( X )

1. Name

‘Comté’

2. Member State or Third Country

France

3. Description of the agricultural product or foodstuff

3.1. Type of product

Class 1.3. Cheeses

3.2. Description of the product to which the name in point 1 applies

‘Comté’ is made entirely of whole cow’s milk used in raw condition. It is a cheese with pressed, cooked paste that is salted on the surface or in brine. At the time of marketing, which takes place after a minimum maturation period of 120 days, the cheese’s paste has an ivory to yellow colour and an ‘opening’ that may reach the size of a small cherry.

‘Comté’ contains a minimum of 45 g and a maximum of 54 g of fat per 100 g of cheese after total desiccation and the dry matter must not weigh less than 62 g per 100 g of cheese. The salt content is not less than 0,6 g of sodium chloride per 100 g of cheese. The water content of the defatted cheese does not exceed 54 %.

‘Comté’ is presented to consumers in the form of a wheel that weighs 32 to 45 kg and has a diameter of 55 to 75 centimetres and a straight or slightly convex heel 8-13 cm in height. It has a scrubbed, solid and grainy rind that is golden yellow to brown in colour. The cheese must not be more than 1,4 times higher at the centre than at the outer rim.

‘Comté’ may also be presented in packaged portions or grated.

‘Comté’ has a complex taste. While the general sensorial features of all the wheels are the same, no two wheels of Comté are identical. Six main groups of aromas can be distinguished in ‘Comté’ (fruity, milky, roasted, plant-like, animal-like, spicy) and they include more than 90 nuances.

3.3. Raw materials (for processed products only)

The milk used to produce ‘Comté’ must come solely from a dairy herd of Montbéliarde cows of breed type 46, or from French Simmental cows of breed type 35, or from crosses of these two breeds of certified descent.

The milk must be collected from within a circular area measuring no more than 25 km in diameter. This rule limits the duration of transport and therefore protects the milk from structural degradation. This ensures that the milk is processed in the conditions laid down in the specification (raw milk). These conditions favour the development of endogenous lactic flora.

In order to maintain the quality and specificity of the product, milk productivity is limited per hectare of potential forage areas.

As regards the use of the milk, the capacity of the vats is limited to a maximum of 12 cheeses per vat in order to guarantee the quality of the product. Over a period of 24 hours not more than three production rounds may be carried out in the same vat.

3.4. Feed (for products of animal origin only)

In order to guarantee a close link between the region and the product by using specific feed from the geographical area, supplementary feed is limited to 1 800 kg per dairy cow per year. On the farm, the grazing area actually used must be at least equal to 1 hectare per dairy cow. Grazing is obligatory for as long as the weather conditions, the soils’ bearing capacity and the presence of grass allow. Compliance with these provisions means that at least 70 % of the herd’s feed comes from the geographical area. The dairy cows’ basic intake comes entirely from the geographical area.

In order to maintain the traditional practice of grazing, farm production systems where all the feed is supplied in troughs during the growing season are forbidden and grazing should remain the main practice.

Fermented fodder, whether silage products or other, are not to be used in the feed of the dairy herd at any time of the year owing to the technological risks related to these practices during the production and maturing of cheeses.

Only raw materials and supplementary feed derived from non-transgenic products are authorised for the dairy herd so as to preserve the traditional nature of the feed.

3.5. Specific steps in production that must take place in the defined geographical area

The milk is produced and the cheese manufactured and matured in the geographical area.

3.6. Specific rules on slicing, grating, packaging, etc.

The procedure of cutting and packaging pieces of ‘Comté’ is part of an extended maturation process. It requires particular know-how and has a direct and definite effect on the quality of the product, because it is necessary to sort the wheels to remove those that may not be fit for prepacking. These conditions make it possible to comply fully with the conditions for preserving the cheese after it has been formed into wheels and to guarantee the physical and organoleptic integrity of ‘Comté’ until it reaches the consumer.

If the cheese is prepacked, these are the reasons for cutting or grating it in the geographical area.

If the cheese is prepacked,

—	the wheels may be cut within not more than 15 days of leaving the maturing cellar. During this time they must be kept at a temperature of 4 °C to 8 °C with a humidity level at least equal to 85 %.

—

the rind may be removed from portions weighing less than 40 grams each or intended to be grated. If the rind is very moist or if it has deteriorated, it must be removed immediately after the cheese has been cut into portions. If the rind is in good condition, it must be removed within 8 hours of the first cutting. Pieces whose rind has been removed may not be stored in the open air for more than 72 hours; after that, they must be vacuum-packed. Vacuum-packing must take place within 15 days.

—	no simultaneous operations involving a product other than ‘Comté’ may take place on the cutting and packaging line.

The cheese may be cut and grated outside the geographical area if this is done in front of the consumer.

3.7. Specific rules on labelling

All cheeses with the registered designation of origin ‘Comté’ must bear a label showing the designation in a font at least two thirds as large as the largest font shown on the label.

The labelling must include the European Union’s PDO symbol. It may also include the words ‘appellation d’origine protégée’ [‘protected designation of origin’].

The producer, maturer or prepacker must affix its name and address clearly, and the address must be located in the geographical area.

The use of any term or other reference accompanying the designation is prohibited on the labelling and in advertising, invoices or commercial documents, with the exception of specific trademarks.

Cheeses sold under the designation of origin ‘Comté’ must bear the required identifying marks. Prior to the cheese leaving the maturing cellar, a green or brick-brown band must be affixed to the side of each wheel. Each packaged portion must bear the ‘Comté clochettes vertes’ logo. For consumer portions, it is obligatory to affix the ‘Comté clochettes vertes’ logo and the name ‘Comté’ on the front in a font at least two thirds as large as the largest font using the Pantone 349C green colour code.

If the wheel is sold whole, it must bear on the side under the band an oval-shaped green casein plate bearing the following words printed in black: France, Comté, the number of the production plant and the production month. The production day must be indicated using a casein plate placed near the green casein plate.

4. Concise definition of the geographical area

Definition of the geographical area

The geographical area extends over the territory of the following municipalities:

The department of Ain:

The cantons of Bellegarde-sur-Valserine, Brénod, Ceyzériat, Champagne-en-Valromey, Hauteville-Lompnes, Izernore, Lhuis, Nantua, Oyonnax, Poncin, Saint-Rambert-en-Bugey, Seyssel and Treffort-Cuisiat: all municipalities;

The canton of Ambérieu-en-Bugey: the municipalities of L’Abergement-de-Varey, Ambérieu-en-Bugey, Ambronay, Bettant and Douvres;

The canton of Coligny: the municipalities of Bény, Coligny, Domsure, Pirajoux, Salavre, Verjon and Villemotier;

The canton of Collonges: the municipalities of Chézery-Forens, Collonges, Confort, Farges, Lancrans, Léaz, Péron and Saint-Jean-de-Gonville;

The canton of Ferney-Voltaire: the municipalities of Sergy and Thoiry;

The canton of Gex: the municipalities of Cessy, Crozet, Divonne-les-Bains, Echenevex, Gex, Grilly, Lélex, Mijoux and Vesancy;

The canton of Lagnieu: the municipalities of Ambutrix, Lagnieu, Saint-Sorlin-en-Bugey, Sault-Brénaz, Souclin, Vaux-en-Bugey and Villebois;

The canton of Pont-d’Ain: the municipalities of Druillat, Journans, Neuville-sur-Ain, Pont-d’Ain, Saint-Martin-du-Mont and Tossiat.

The department of Doubs:

The cantons of Amancey, Audeux, Baume-les-Dames, Besançon, Boussières, Clerval, Levier, Maîche, Marchaux, Montbenoît, Morteau, Mouthe, Ornans, Pierrefontaine-les-Varans, Pontarlier, Quingey, Roulans, Le Russey, Saint-Hippolyte and Vercel-Villedieu-le-Camp: all the municipalities;

The canton of Hérimoncourt: the municipalities of Autechaux-Roide, Blamont, Dannemarie, Ecurcey, Glay, Pierrefontaine-lès-Blamont, Roches-lès-Blamont and Villars-lès-Blamont;

The canton of L’Isle-sur-le-Doubs: the municipalities of Hyémondans and Lanthenans;

The canton of Pont-de-Roide: the municipalities of Dambelin, Feule, Goux-lès-Dambelin, Neuchâtel-Urtière, Noirefontaine, Péseux, Pont-de-Roide, Remondans-Vaivre, Rosière-sur-Barbèche, Solemont, Valonne, Villars-sous-Dampjoux and Vernois-lès-Belvoir;

The canton of Rougemont: the municipality of Rillans.

The department of Jura:

All the municipalities, with the exception of the municipalities of the canton of Chemin.

The department of Saône-et-Loire:

The canton of Beaurepaire-en-Bresse: the municipalities of Beaurepaire-en-Bresse, Sagy, Saillenard and Savigny-en-Revermont;

The canton of Cuiseaux: the municipalities of Champagnat, Cuiseaux, Flacey-en-Bresse and Joudes;

The canton of Pierre-de-Bresse: the municipalities of Beauvernois, Bellevesvre, Fretterans, Mouthiers-en-Bresse and Torpes;

The department of Haute-Savoie:

The canton of Seyssel: the municipalities of Challonges solely for parcels No 562 (a) and 563 (a) of section A, sixth leaf.

5. Link with the geographical area

5.1. Specificity of the geographical area

5.1.1. Natural factors

The geographical area comprises the arc of the Jura mountains, a set of limestone plateaux, and its extension into a small part of the adjoining plain.

The agricultural areas in question are characterised by their poor soils and significant contours and by the calcareous and molassic nature of the geological substratum.

The climate of the area tends towards both continental and northern with a big difference between winter and summer temperatures and rainfall that, although it is even throughout the year, is heavy in the summer, with a low annual average temperature, despite summer heatwaves, and a large number of days of frost.

It is a very wet mountain or sub-mountain environment with annual rainfall always in excess of 900 mm and generally in excess of 1 000 mm. This rainfall is already considerable at low altitude and increases towards the interior of the mountain range. Seasonal distribution is characterised by the lack of a dry season.

This area is divided between woodland, half of which is composed of spruce, and grassland. The area’s particular geo-climatic conditions (heavy rainfall, no summer drought, limestone substrate) contribute very favourably to high-quality grass production. Indeed, they allow the development of natural grassland that has a very rich flora (especially as regards dicotyledons) and a specific limestone flora.

5.1.2. Human factors

In this area which is well-suited to grazing, dairy cows feed in this manner for as long as the weather conditions, the soils’ bearing capacity and the presence of grass allow. Breeders have selected the Montbéliarde breed, which is well adapted to the conditions in the area and makes up nearly all of the dairy herds in the geographical area. The extensive farming of grassland has been maintained (stocking density, the use of nitrogen and concentrates etc. are limited). In addition, the geographical area has a particular cheese-making tradition. This tradition, based on the pooling of milk for the purpose of making a large cheese, has led to a strong sense of solidarity and common rules.

Since the 11th century farmers in this region have worked together to pool every day the milk produced by their various herds in order to make a large wheel. Still today the great majority of milk producers belong to cooperatives and pool their milk in a processing plant called ‘fruitière’, the local cheese dairy.

The traditional methods of making this cheese live on and are maintained, on the one hand, in the way the animals are bred using a specific system for the management of pastures and the drying of mowed grass and, on the other, in the way the cheese is made by carefully timing the cutting of the curd, its stirring and heating, the extraction and pressing and then the salting, prematuring and maturing.

5.2. Specificity of the product

‘Comté’ is a cheese made from raw cow’s milk. It has a cooked pressed paste and is in the shape of a large wheel 55 to 75 cm in diameter. It is matured for a long time and is therefore a long-keeping cheese.

‘Comté’ has a limited fat content and this distinguishes it from other cheeses with a cooked pressed paste.

It contains at least 62 grams of dry matter per 100 grams of cheese and the water content of the defatted cheese does not exceed 54 %.

The salt content is not less than 0,6 g of sodium chloride per 100 g of cheese.

‘Comté’ has a complex taste. While the general sensorial features of all the wheels are the same, no two wheels of Comté are identical. Six main groups of aromas can be distinguished (fruity, milky, roasted, plant-like, animal-like, spicy) and they include more than 90 nuances.

5.3. Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI)

It is in this difficult environment, where the landscape is divided between woodland and grassland and where it was impossible to develop other resources, that large hard cheeses became the product of choice. For the people living on this land, a long-keeping cheese was the only preserved food that could be made from the abundant supply of summer milk and that would keep through the long winter. Therefore local breeders selected a cow breed that was particularly well suited to the local conditions and to the making of this particular cheese. The milk was pooled in the ‘fruitières’ for the purpose of producing a large, long-keeping cheese that would allow the breeders to make the best use of the richness of this land outside the geographical area. The choice of a cheese with a cooked paste was based on the abundance of firewood in the area.

The distinctive characteristics of the grassland are expressed in the cheese with the help of specific expertise applied at every production stage.

First of all, the great floral richness of the natural environment of the geographical area contributes strongly to the development of the cheese’s aromatic components. This diversity is preserved through the extensive farming of the grassland. The close link between floral diversity and the rich aroma of ‘Comté’ has been demonstrated by two scientific studies in 1994. By limiting the fat content during cheese-making it is possible to avoid off-tastes due to lipolysis and reinforce the typical aromas of ‘Comté’. By laying down a minimum dry matter content and a maximum water content for the defatted cheese, it is possible to avoid excess water in the cheese and help bring out all the aromas. The aromas are enhanced also by the minimum salt content of the cheese. The obligation to use open vats allows the cheesemakers to maintain their skills, such as the correct timing of the cutting and extraction of the curd. Finally, the maturers use their know-how to carefully adjust the maturing conditions of each lot. The cheese’s aroma, which is the result of natural factors such as the grass and the microbe ecosystem, is fully developed only after a long period of maturation on spruce boards, which are particularly well suited to the maturation of ‘Comté’. The production of ‘Comté’ allows the maintenance of traditional agricultural activities and contributes greatly to achieving a balanced local economy.

Reference to publication of the specification

(Article 5(7) of Regulation (EC) No 510/2006 (4))

https://www.inao.gouv.fr/fichier/CDCComte.pdf

(1) OJ L 343, 14.12.2012, p. 1.

(2) OJ L 93, 31.3.2006, p. 12. Replaced by Regulation (EU) No 1151/2012.

(3) Replaced by Regulation (EU) No 1151/2012.

(4) See footnote 3.

9.10.2014

Official Journal of the European Union

C 356/63

Notice for the attention of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) which were added to the list referred to in Articles 2, 3 and 7 of Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, by virtue of Commission Implementing Regulation (EU) No 1058/2014

2014/C 356/12

Common Position 2002/402/CFSP (1) calls upon the Union to freeze the funds and economic resources of the members of the Al-Qaida organisation and other individuals, groups, undertakings and entities associated with them, as referred to in the list drawn up pursuant to UNSCR 1267(1999) and 1333(2000) to be updated regularly by the UN Committee established pursuant to UNSCR 1267(1999).

The list drawn up by this UN Committee comprises:

—

Al Qaida,

—	natural or legal persons, entities, bodies and groups associated with Al Qaida, and

—	legal persons, entities and bodies owned or controlled by, or otherwise supporting, any of these associated persons, entities, bodies and groups.

Acts or activities indicating that an individual, group, undertaking, or entity is ‘associated with’ Al-Qaida include:

(a)	participating in the financing, planning, facilitating, preparing, or perpetrating of acts or activities by, in conjunction with, under the name of, on behalf of, or in support of Al Qaida, or any cell, affiliate, splinter group or derivative thereof;

(b)	supplying, selling or transferring arms and related materiel to any of them;

(c)	recruiting for any of them; or

(d)	otherwise supporting acts or activities of any of them.

The UN Security Council approved on 23 September 2014 the addition of Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) to the Al-Qaida Sanctions Committee’s list.

They may submit at any time a request to the UN Ombudsperson, together with any supporting documentation, for the decision to include them in the UN list referred to above, to be reconsidered. Such request should be sent to the following address:

United Nations — Office of the Ombudsperson

Room TB-08041D

New York, NY 10017

UNITED STATES OF AMERICA

Tel. +1 2129632671

Fax +1 2129631300/3778

E-mail: ombudsperson@un.org

See for more information at: http://www.un.org/sc/committees/1267/delisting.shtml

Further to the UN decision referred to in paragraph 2, the Commission has adopted Implementing Regulation (EU) No 1058/2014 (2), which amends Annex I to Council Regulation (EC) No 881/2002 (3) imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network. The amendment, made pursuant to Article 7(1)(a) and 7a(1) of Regulation (EC) No 881/2002, adds Ahmed Abdullah Saleh Al-Khazmari Al-Zahrani, Azzam Abdullah Zureik Al-Maulid Al-Subhi, Anders Cameroon Ostensvig Dale, Ibrahim Suleiman Hamad Al-Hablain, Seifallah Ben Hassine, ‘Abd Al-Rahman Bin ‘Umayr Al-Nu’aymi, ‘Abd Al-Rahman Khalaf ‘Ubayd Juday’ Al-‘Anizi, Anas Hasan Khattab, Maysar Ali Musa Abdallah Al-Juburi, Shafi Sultan Mohammed Al-Ajmi, ‘Abd Al-Rahman Muhammad Mustafa Al-Qaduli, Emilie Konig, Kevin Guiavarch, Oumar Diaby, Ansar Al-Shari’a in Tunisia (ASS-T) and Abdallah Azzam Brigades (AAB) to the list in Annex I of that Regulation (‘Annex I’).

The following measures of Regulation (EC) No 881/2002 apply to the individuals and entities included in Annex I:

(1)

the freezing of all funds and economic resources belonging to the individuals and entities concerned, or owned or held by them, and the prohibition (on everyone) on making funds and economic resources available to any of the individuals and entities concerned or for their benefit, whether directly or indirectly (Articles 2 and 2a); and

(2)	the prohibition on granting, selling, supplying or transferring technical advice, assistance or training related to military activities to any of the individuals and entities concerned, whether directly or indirectly (Article 3).

Article 7a of Regulation (EC) No 881/2002 provides for a review process where observations on the grounds for listing are submitted by those listed. Individuals and entities added to Annex I by Implementing Regulation (EU) No 1058/2014 may make a request for the grounds for their listing to the Commission. This request should be sent to:

European Commission

‘Restrictive measures’

Rue de la Loi/Wetstraat 200

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

The attention of the individuals and entities concerned is also drawn to the possibility of challenging Implementing Regulation (EU) No 1058/2014 before the General Court of the European Union, in accordance with the conditions laid down in the fourth and sixth paragraphs of Article 263 of the Treaty on the Functioning of the European Union.

For good order, the attention of the individuals and entities included in Annex I is drawn to the possibility of making an application to the competent authorities in the relevant Member State(s), as listed in Annex II to Regulation (EC) No 881/2002, in order to obtain an authorisation to use frozen funds and economic resources for essential needs or specific payments in accordance with Article 2a of that Regulation.

(1) OJ L 139, 29.5.2002, p. 4.

(2) OJ L 293, 9.10.2014, p. 12.

(3) OJ L 139, 29.5.2002, p 9.