ISSN 1725-2423
Official Journal
of the European Union
C 266
English edition
Information and Notices
Volume 50
8 November 2007
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ISSN 1725-2423 |
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Official Journal of the European Union |
C 266 |
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English edition |
Information and Notices |
Volume 50 |
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Notice No |
Contents |
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II Information |
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INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
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Commission |
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2007/C 266/01 |
Non-opposition to a notified concentration (Case COMP/M.4838 — SLP/TPG V/Avaya) ( 1 ) |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
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Commission |
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2007/C 266/02 |
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NOTICES FROM MEMBER STATES |
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2007/C 266/03 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises ( 1 ) |
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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
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EFTA Surveillance Authority |
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2007/C 266/04 |
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2007/C 266/05 |
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2007/C 266/06 |
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V Announcements |
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OTHER ACTS |
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Commission |
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2007/C 266/07 |
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Corrigenda |
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2007/C 266/08 |
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(1) Text with EEA relevance |
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EN |
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II Information
INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
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8.11.2007 |
EN |
Official Journal of the European Union |
C 266/1 |
Non-opposition to a notified concentration
(Case COMP/M.4838 — SLP/TPG V/Avaya)
(Text with EEA relevance)
(2007/C 266/01)
On 26 September 2007, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
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— |
from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
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in electronic form on the EUR-Lex website under document number 32007M4838. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
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8.11.2007 |
EN |
Official Journal of the European Union |
C 266/2 |
Euro exchange rates (1)
7 November 2007
(2007/C 266/02)
1 euro=
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Currency |
Exchange rate |
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USD |
US dollar |
1,4722 |
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JPY |
Japanese yen |
166,07 |
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DKK |
Danish krone |
7,4540 |
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GBP |
Pound sterling |
0,69960 |
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SEK |
Swedish krona |
9,2535 |
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CHF |
Swiss franc |
1,6589 |
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ISK |
Iceland króna |
86,40 |
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NOK |
Norwegian krone |
7,7660 |
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BGN |
Bulgarian lev |
1,9558 |
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CYP |
Cyprus pound |
0,5842 |
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CZK |
Czech koruna |
26,934 |
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EEK |
Estonian kroon |
15,6466 |
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HUF |
Hungarian forint |
253,64 |
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LTL |
Lithuanian litas |
3,4528 |
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LVL |
Latvian lats |
0,7021 |
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MTL |
Maltese lira |
0,4293 |
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PLN |
Polish zloty |
3,6435 |
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RON |
Romanian leu |
3,4001 |
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SKK |
Slovak koruna |
33,183 |
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TRY |
Turkish lira |
1,7345 |
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AUD |
Australian dollar |
1,5703 |
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CAD |
Canadian dollar |
1,3354 |
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HKD |
Hong Kong dollar |
11,4372 |
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NZD |
New Zealand dollar |
1,8767 |
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SGD |
Singapore dollar |
2,1180 |
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KRW |
South Korean won |
1 333,89 |
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ZAR |
South African rand |
9,5611 |
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CNY |
Chinese yuan renminbi |
10,9563 |
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HRK |
Croatian kuna |
7,3315 |
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IDR |
Indonesian rupiah |
13 426,46 |
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MYR |
Malaysian ringgit |
4,9032 |
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PHP |
Philippine peso |
63,709 |
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RUB |
Russian rouble |
35,9600 |
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THB |
Thai baht |
46,571 |
Source: reference exchange rate published by the ECB.
NOTICES FROM MEMBER STATES
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8.11.2007 |
EN |
Official Journal of the European Union |
C 266/3 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises
(Text with EEA relevance)
(2007/C 266/03)
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Aid No |
XS 268/07 |
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Member State |
Malta |
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Region |
— |
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Title of aid scheme or name of company receiving individual aid |
Skema ghall-Promozzjoni ta' l-Innovazzjoni |
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Legal basis |
Att dwar il-Korporazzjoni Maltija ghall-Intrapriza (KAP 463) |
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Type of measure |
Aid scheme |
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Budget |
Annual budget: MTL 0,3 million; overall budget: — |
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Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
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Date of implementation |
1.9.2007 |
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Duration |
31.12.2013 |
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Objective |
Small and medium-sized enterprises |
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Economic sectors |
All sectors eligible for aid to SMEs |
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Name and address of the granting authority |
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Aid No |
XS 269/07 |
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Member State |
Denmark |
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Region |
— |
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Title of aid scheme or name of company receiving individual aid |
Program for brugerdreven innovation støtter udvikling og afprøvning af den brugerdrevne tilgang til innovation til SMV'ere |
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Legal basis |
Lov om erhvervsfremme § 2, stk. 2 og 3, stk. 2, § 4 stk. 1 og § 22 stk. 1,3 og 4 i lov nr. 602 af 24. juni 2005. Bekendtgørelse nr. 241 af 20. marts 2007 |
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Type of measure |
Aid scheme |
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Budget |
Annual budget: DKK 94 million; overall budget: — |
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Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
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Date of implementation |
15.6.2007 |
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Duration |
31.12.2011 |
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Objective |
Small and medium-sized enterprises |
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Economic sectors |
All sectors eligible for aid to SMEs |
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Name and address of the granting authority |
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Aid No |
XS 270/07 |
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Member State |
Spain |
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Region |
Islas Canarias |
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Title of aid scheme or name of company receiving individual aid |
Fomento de la creación y expansión de empresas innovadoras de base tecnológica |
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Legal basis |
Orden de la Consejería de Empleo, Industria y Comercio del Gobierno de Canarias, de 20 de septiembre de 2007, por la que se aprueban las bases reguladoras para el período 2007-2013, que han de regir en la concesión de subvenciones, mediante concurso, para fomentar la creación y expansión de empresas innovadoras de base tecnológica, y se efectúa convocatoria para 2007 (BOC no 197, de 2 de octubre de 2007) www.gobiernodecanarias.org/boc/anexos/2007/197/00023-00063.pdf |
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Type of measure |
Aid scheme |
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Budget |
Annual budget: EUR 0,9 million; overall budget: — |
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Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
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Date of implementation |
2.10.2007 |
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Duration |
31.12.2013 |
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Objective |
Small and medium-sized enterprises |
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Economic sectors |
All sectors eligible for aid to SMEs |
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Name and address of the granting authority |
Consejería de Empleo, Industria y Comercio del Gobierno de Canarias
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Aid No |
XS 271/07 |
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Member State |
Spain |
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Region |
Islas Canarias |
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Title of aid scheme or name of company receiving individual aid |
Innovación y desarrollo tecnológico de empresas industriales y de base tecnológica |
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Legal basis |
Orden de la Consejería de Industria, Comercio y Nuevas Tecnologías del Gobierno de Canarias, de 13 de julio de 2007, por la que se convoca mediante concurso la concesión de subvenciones para la innovación y desarrollo tecnológico de empresas industriales y de base tecnológica (BOC no 150, de 26 de julio de 2007) www.gobiernodecanarias.org/boc/anexos/2007/150/00015-00056.pdf |
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Type of measure |
Aid scheme |
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Budget |
Annual budget: EUR 2,98 million; overall budget: — |
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Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
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Date of implementation |
26.7.2007 |
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Duration |
31.12.2007 |
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Objective |
Small and medium-sized enterprises |
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Economic sectors |
All manufacturing |
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Name and address of the granting authority |
Consejería de Empleo, Industria y Comercio del Gobierno de Canarias
o
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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA
EFTA Surveillance Authority
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8.11.2007 |
EN |
Official Journal of the European Union |
C 266/6 |
Authorisation of State aid pursuant to Article 61 of the EEA Agreement and Article 1(3) in Part I of Protocol 3 to the Surveillance and Court Agreement
EFTA Surveillance Authority decision not to raise objections
(2007/C 266/04)
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Date of adoption |
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24 April 2007 |
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EFTA State |
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Norway |
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Aid No |
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61274 |
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Title |
: |
Regional direct transport aid scheme |
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Objective |
: |
The objective of the scheme is to offset competitive disadvantages resulting from extra transport costs for firms located in peripheral areas and within sparsely populated regions and thus situated long distances away from their markets. |
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Legal basis |
: |
The legal basis for the scheme can be found in the State aid guidelines on National regional aid 2007-2013, National guidelines for regional transport aid (‘Nasjonale retningslinjer for regional transportstøtte (Ytre rammeverk)’) and in the State budget for 2007 (St.prp. nr. 1 (2006-2007) Kommunal- og regionaldepartementet). |
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Budget/Duration |
: |
The annual budget of the scheme will not exceed NOK 70 million (approximately EUR 9 million). The duration of the scheme is from 1 January 2007 until 31 December 2013. |
The authentic text of the decision, from which all confidential information has been removed, can be found at:
http://www.eftasurv.int/fieldsofwork/fieldstateaid/stateaidregistry
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8.11.2007 |
EN |
Official Journal of the European Union |
C 266/7 |
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2006
(2007/C 266/05)
Subcommittee I — On the free movement of goods
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 8 December 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2006:
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ANNEX I |
List of new marketing authorisations |
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ANNEX II |
List of renewed marketing authorisations |
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ANNEX III |
List of extended marketing authorisations |
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ANNEX IV |
List of withdrawn marketing authorisations |
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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 2006:
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EU-Number |
Product |
Country |
Date of authorisation |
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EU/1/01/183/020-029 |
HBVAXPRO |
Liechtenstein |
28.2.2006 |
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EU/1/01/187/001 |
DepoCyte |
Liechtenstein |
31.1.2006 |
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EU/1/03/258/015-022 |
Avandamet |
Liechtenstein |
28.2.2006 |
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EU/1/03/262/001-006 |
Emend |
Liechtenstein |
31.1.2006 |
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EU/1/03/265/003-004 |
Bonviva |
Liechtenstein |
31.1.2006 |
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EU/1/03/266/001-002 |
Bondenza |
Liechtenstein |
28.2.2006 |
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EU/1/04/307/005-010 |
Zonegran |
Liechtenstein |
31.1.2006 |
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EU/1/05/322/001 |
Yttriga |
Liechtenstein |
31.1.2006 |
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EU/1/05/322/001/IS |
Yttriga |
Iceland |
17.2.2006 |
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EU/1/05/322/001/NO |
Yttriga |
Norway |
10.2.2006 |
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EU/1/05/323/001/NO-011/NO |
ProQuad |
Norway |
24.4.2006 |
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EU/1/05/323/001-011 |
ProQuad |
Liechtenstein |
30.4.2006 |
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EU/1/05/323/001-011/IS |
ProQuad |
Iceland |
25.4.2006 |
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EU/1/05/324/001 |
Naglazyme |
Liechtenstein |
31.1.2006 |
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EU/1/05/324/001/IS |
Naglazyme |
Iceland |
22.6.2006 |
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EU/1/05/324/01/NO |
Naglazyme |
Norway |
23.2.2006 |
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EU/1/05/325/001 |
Macugen |
Liechtenstein |
28.2.2006 |
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EU/1/05/325/001/IS |
Macugen |
Iceland |
10.3.2006 |
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EU/1/05/325/001/NO |
Macugen |
Norway |
2.3.2006 |
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EU/1/05/326/001 |
Ionsys |
Liechtenstein |
31.1.2006 |
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EU/1/05/326/001/IS |
Ionsys |
Iceland |
22.2.2006 |
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EU/1/05/326/001/NO |
Ionsys |
Norway |
16.2.2006 |
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EU/1/05/327/001/NO-017/NO |
Exubera |
Norway |
16.2.2006 |
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EU/1/05/327/001-017 |
Exubera |
Liechtenstein |
31.1.2006 |
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EU/1/05/327/001-017/IS |
Exubera |
Iceland |
22.3.2006 |
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EU/1/05/328/001/NO-002/NO |
Cubicin |
Norway |
16.2.2006 |
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EU/1/05/328/001-002 |
Cubicin |
Liechtenstein |
28.2.2006 |
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EU/1/05/328/001-002/IS |
Cubicin |
Iceland |
13.2.2006 |
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EU/1/05/329/001/NO-005/NO |
Kiovig |
Norway |
27.1.2006 |
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EU/1/05/329/001-005 |
Kiovig |
Liechtenstein |
31.1.2006 |
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EU/1/05/329/001-005/IS |
Kiovig |
Iceland |
10.2.2006 |
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EU/1/05/330/001/NO-004/NO |
Rotarix |
Norway |
8.3.2006 |
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EU/1/05/330/001-004 |
Rotarix |
Liechtenstein |
28.2.2006 |
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EU/1/05/330/001-004/IS |
Rotarix |
Iceland |
27.4.2006 |
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EU/1/05/331/001/NO-013/NO |
Neupro |
Norway |
17.3.2006 |
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EU/1/05/331/001-013 |
Neupro |
Liechtenstein |
28.2.2006 |
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EU/1/05/331/001-013/IS |
Neupro |
Iceland |
10.4.2006 |
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EU/1/06/332/001/NO-003/NO |
Omnitrope |
Norway |
5.5.2006 |
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EU/1/06/332/001-003 |
Omnitrope |
Liechtenstein |
30.4.2006 |
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EU/1/06/332/001-003/IS |
Omnitrope |
Iceland |
11.5.2006 |
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EU/1/06/333/001/NO-003/NO |
Myozyme |
Norway |
8.5.2006 |
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EU/1/06/333/001-003 |
Myozyme |
Liechtenstein |
30.4.2006 |
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EU/1/06/334/001/NO-004/NO |
Evoltra |
Norway |
27.6.2006 |
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EU/1/06/334/001-004/IS |
Evoltra |
Iceland |
26.6.2006 |
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EU/1/06/335/001 |
Valtropin |
Liechtenstein |
30.6.2006 |
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EU/1/06/335/001/IS |
Valtropin |
Iceland |
12.5.2006 |
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EU/1/06/335/001/NO |
Valtropin |
Norway |
24.5.2006 |
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EU/1/06/336/001 |
Tygacil |
Liechtenstein |
30.6.2006 |
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EU/1/06/336/001/IS |
Tygacil |
Iceland |
1.6.2006 |
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EU/1/06/336/001/NO |
Tygacil |
Norway |
24.5.2006 |
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EU/1/06/337/001/NO-013/NO |
M-M-Rvaxpro |
Norway |
19.5.2006 |
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EU/1/06/337/001-013 |
M-M-Rvaxpro |
Liechtenstein |
30.6.2006 |
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EU/1/06/337/001-013/IS |
M-M-Rvaxpro |
Iceland |
13.6.2006 |
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EU/1/06/338/001/NO-003/NO |
DuoTrav |
Norway |
10.5.2006 |
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EU/1/06/338/001-003 |
DuoTrav |
Liechtenstein |
30.6.2006 |
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EU/1/06/338/001-003/IS |
DuoTrav |
Iceland |
12.5.2006 |
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EU/1/06/339/001/NO-002/NO |
Preotact |
Norway |
19.5.2006 |
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EU/1/06/339/001-002 |
Preotact |
Liechtenstein |
30.6.2006 |
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EU/1/06/339/001-002/IS |
Preotact |
Iceland |
18.5.2006 |
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EU/1/06/340/001/NO-002/NO |
Ganfort |
Norway |
1.6.2006 |
|
EU/1/06/340/001-002 |
Ganfort |
Liechtenstein |
30.6.2006 |
|
EU/1/06/340/001-002/IS |
Ganfort |
Iceland |
15.6.2006 |
|
EU/1/06/341/001/NO-013/NO |
Zostavax |
Norway |
6.6.2006 |
|
EU/1/06/341/001-013 |
Zostavax |
Liechtenstein |
30.6.2006 |
|
EU/1/06/341/001-013/IS |
Zostavax |
Iceland |
19.6.2006 |
|
EU/1/06/344/001/NO-009/NO |
Acomplia |
Norway |
30.6.2006 |
|
EU/1/06/344/001-009 |
Acomplia |
Liechtenstein |
30.6.2006 |
|
EU/1/06/345/001/NO-009/NO |
Zimulti |
Norway |
30.6.2006 |
|
EU/1/06/345/001-009 |
Zimulti |
Liechtenstein |
30.6.2006 |
|
EU/1/96/022/019-022 |
Zyprexa |
Liechtenstein |
31.1.2006 |
|
EU/1/97/043/003 |
Revasc |
Liechtenstein |
31.1.2006 |
|
EU/1/97/044/007-008 |
Tasmar |
Liechtenstein |
28.2.2006 |
|
EU/1/97/046/031-033 |
Aprovel |
Liechtenstein |
31.1.2006 |
|
EU/1/97/049/031-033 |
Karvea |
Liechtenstein |
31.1.2006 |
|
EU/1/97/055/003 |
Viramune |
Liechtenstein |
31.1.2006 |
|
EU/1/98/063/007 |
Rebif |
Liechtenstein |
31.1.2006 |
|
EU/2/00/025/001-004 |
Advasure |
Liechtenstein |
28.2.2006 |
|
EU/2/03/037/005 |
ProteqFlu |
Liechtenstein |
28.2.2006 |
|
EU/2/03/038/005 |
ProteqFlu Te |
Liechtenstein |
28.2.2006 |
|
EU/2/04/043/001 |
Equilis StrepE |
Liechtenstein |
31.1.2006 |
|
EU/2/04/044/001 |
Aivlosin |
Liechtenstein |
31.1.2006 |
|
EU/2/04/044/002-005 |
Aivlosin |
Liechtenstein |
28.2.2006 |
|
EU/2/06/058/001/NO-003/NO |
Flexicam |
Norway |
3.5.2006 |
|
EU/2/06/058/001-003 |
Flexicam |
Liechtenstein |
30.4.2006 |
|
EU/2/06/058/001-003/IS |
Flexicam |
Iceland |
22.4.2006 |
|
EU/2/06/059/001 |
Convenia |
Liechtenstein |
30.6.2006 |
|
EU/2/97/004/014-015 |
Metacam |
Liechtenstein |
28.2.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of renewal |
|
EU/1/00/154/001/NO-002/NO |
Neospect |
Norway |
27.2.2006 |
|
EU/1/00/154/001-002 |
NeoSpect |
Liechtenstein |
28.2.2006 |
|
EU/1/00/154/001-002/IS |
NeoSpect |
Iceland |
22.2.2006 |
|
EU/1/00/155/001/NO-006/NO |
Luveris |
Norway |
27.2.2006 |
|
EU/1/00/155/001-006 |
Luveris |
Liechtenstein |
31.1.2006 |
|
EU/1/00/155/001-006/IS |
Luveris |
Iceland |
25.4.2006 |
|
EU/1/00/156/002/NO-003/NO |
Trizivir |
Norway |
27.4.2006 |
|
EU/1/00/156/002-003 |
Trizivir |
Liechtenstein |
30.4.2006 |
|
EU/1/00/157/001-034 |
Azomyr |
Liechtenstein |
28.2.2006 |
|
EU/1/00/160/001-034 |
Aerius |
Liechtenstein |
28.2.2006 |
|
EU/1/00/161/001-034 |
Neoclarityn |
Liechtenstein |
28.2.2006 |
|
EU/1/00/163/001/NO |
Xeloda |
Norway |
3.3.2006 |
|
EU/1/00/163/001-002 |
Xeloda |
Liechtenstein |
28.2.2006 |
|
EU/1/00/163/001-002/IS |
Xeloda |
Iceland |
7.3.2006 |
|
EU/1/00/163/002/NO |
Xeloda |
Norway |
3.3.2006 |
|
EU/1/00/164/003/NO-006/NO |
NutropinAq |
Norway |
20.4.2006 |
|
EU/1/00/164/003-005 |
NutropinAq |
Liechtenstein |
30.4.2006 |
|
EU/1/00/164/003-005/IS |
NutropinAq |
Iceland |
18.5.2006 |
|
EU/1/00/165/001/NO-007/NO |
Ovitrelle |
Norway |
2.3.2006 |
|
EU/1/00/165/001-007 |
Ovitrelle |
Liechtenstein |
28.2.2006 |
|
EU/1/00/165/007/IS |
Ovitrelle |
Iceland |
11.4.2006 |
|
EU/1/00/166/001/NO-003/NO |
NeuroBloc |
Norway |
3.5.2006 |
|
EU/1/00/166/001-003 |
NeuroBloc |
Liechtenstein |
30.4.2006 |
|
EU/1/00/166/001-003/IS |
NeuroBloc |
Iceland |
9.6.2006 |
|
EU/1/00/167/001/NO-007/NO |
Prevenar |
Norway |
3.5.2006 |
|
EU/1/00/167/001-007 |
Prevenar |
Liechtenstein |
30.4.2006 |
|
EU/1/00/167/001-007/IS |
Prevenar |
Iceland |
30.5.2006 |
|
EU/1/00/169/002/NO-004/NO |
Metalyse |
Norway |
14.3.2006 |
|
EU/1/00/169/004-006 |
Metalyse |
Liechtenstein |
30.4.2006 |
|
EU/1/00/169/004-006/IS |
Metalyse |
Iceland |
11.4.2006 |
|
EU/1/00/170/001/NO-002/NO |
Fasturtec |
Norway |
27.2.2006 |
|
EU/1/00/170/001-002 |
Fasturtec |
Liechtenstein |
28.2.2006 |
|
EU/1/00/170/001-002(IS |
Fasturtec |
Iceland |
7.3.2006 |
|
EU/1/01/171/001,007-012/IS |
Rapamune |
Iceland |
8.6.2006 |
|
EU/1/01/171/001/NO, 007/NO-012/NO |
Rapamune |
Norway |
5.5.2006 |
|
EU/1/01/172/001/NO-003/NO |
Kaletra |
Norway |
26.4.2006 |
|
EU/1/01/172/001-003 |
Kaletra |
Liechtenstein |
30.4.2006 |
|
EU/1/01/172/001-003/IS |
Kaletra |
Iceland |
23.5.2006 |
|
EU/1/01/173/001/NO-003/NO |
Vaniqa |
Norway |
9.5.2006 |
|
EU/1/01/173/001-003 |
Vaniqa |
Liechtenstein |
30.4.2006 |
|
EU/1/01/173/001-003/IS |
Vaniqa |
Iceland |
7.6.2006 |
|
EU/1/01/174/001/NO-007/NO |
Starlix |
Norway |
23.5.2006 |
|
EU/1/01/174/001-021 |
Starlix |
Liechtenstein |
30.6.2006 |
|
EU/1/01/174/001-021/IS |
Starlix |
Iceland |
7.6.2006 |
|
EU/1/01/175/001, 004-007, 008, 011-014, 015, 018-021/IS |
Trazec |
Iceland |
7.6.2006 |
|
EU/1/01/175/001, 004-008, 011-015, 018-021 |
Trazec |
Liechtenstein |
30.6.2006 |
|
EU/1/01/175/001/NO, 004/NO-007/NO, 008/NO, 011/NO-014/NO, 015/NO, 018/NO-021/NO |
Trazec |
Norway |
23.5.2006 |
|
EU/1/01/176/001/NO-003/NO |
Zometa |
Norway |
2.5.2006 |
|
EU/1/01/176/001-006 |
Zometa |
Liechtenstein |
30.6.2006 |
|
EU/1/01/176/001-006/IS |
Zometa |
Iceland |
22.5.2006 |
|
EU/1/01/177/001/NO-002/NO |
SonoVue |
Norway |
4.5.2006 |
|
EU/1/01/177/001-002 |
SonoVue |
Liechtenstein |
30.4.2006 |
|
EU/1/01/177/002/IS |
SonoVue |
Iceland |
8.6.2006 |
|
EU/1/01/178/001/IS |
Targretin |
Iceland |
9.6.2006 |
|
EU/1/01/178/001/NO |
Targretin |
Norway |
16.5.2006 |
|
EU/1/01/179/001 |
Osigraft |
Liechtenstein |
30.6.2006 |
|
EU/1/01/179/001/NO |
Osigraft |
Norway |
30.5.2006 |
|
EU/1/01/184/001/NO-056/NO |
Nespo |
Norway |
26.6.2006 |
|
EU/1/01/184/001-056 |
Nespo |
Liechtenstein |
30.6.2006 |
|
EU/1/01/185/001/NO-056/NO |
Aranesp |
Norway |
26.6.2006 |
|
EU/1/01/185/001-056 |
Aranesp |
Liechtenstein |
30.6.2006 |
|
EU/1/01/187/001 |
DepoCyte |
Liechtenstein |
30.6.2006 |
|
EU/1/01/195/001/NO-015 /NO |
Liprolog |
Norway |
14.3.2006 |
|
EU/1/01/195/001-015 |
Liprolog |
Liechtenstein |
28.2.2006 |
|
EU/1/01/195/001-015/IS |
Liprolog |
Iceland |
13.3.2006 |
|
EU/1/03/262/007-008/IS |
Emend |
Iceland |
19.6.2006 |
|
EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035 |
Gonal-f |
Liechtenstein |
31.1.2006 |
|
EU/1/95/002/001/NO-002/NO |
Taxotere |
Norway |
23.2.2006 |
|
EU/1/95/002/001-002 |
Taxotere |
Liechtenstein |
31.1.2006 |
|
EU/1/95/002/001-002/IS |
Taxotere |
Iceland |
23.2.2006 |
|
EU/1/95/003/003/NO-004/NO |
Betaferon |
Norway |
2.3.2006 |
|
EU/1/95/003/003-004 |
Betaferon |
Liechtenstein |
28.2.2006 |
|
EU/1/95/003/003-004/IS |
Betaferon |
Iceland |
10.4.2006 |
|
EU/1/96/004/001/NO-002/NO |
Fareston |
Norway |
1.3.2006 |
|
EU/1/96/004/001-002 |
Fareston |
Liechtenstein |
28.2.2006 |
|
EU/1/96/005/001/NO-006/NO |
CellCept |
Norway |
6.4.2006 |
|
EU/1/96/005/001-006 |
CellCept |
Liechtenstein |
30.4.2006 |
|
EU/1/96/005/001-006/IS |
CellCept |
Iceland |
5.5.2006 |
|
EU/1/96/006/001/NO-003/NO |
Novoseven |
Norway |
3.3.2006 |
|
EU/1/96/006/001-003 |
NovoSeven |
Liechtenstein |
28.2.2006 |
|
EU/1/96/006/001-003/IS |
NovoSeven |
Iceland |
10.4.2006 |
|
EU/1/96/007/002, 004-006, 008, 010-011, 015-021, 023-030 |
Humalog |
Liechtenstein |
30.4.2006 |
|
EU/1/96/007/002, 004-006, 008, 010-011, 015-021, 023-030/IS |
Humalog |
Iceland |
13.3.2006 |
|
EU/1/96/007/002/NO, 004/NO-006/NO, 008/NO, 010/NO-011/NO, 015/NO-021/NO, 023/NO-030/NO |
Humalog |
Norway |
3.3.2006 |
|
EU/1/96/008/001/NO-040/NO |
Puregon |
Norway |
26.6.2006 |
|
EU/1/96/008/001-041 |
Puregon |
Liechtenstein |
30.6.2006 |
|
EU/1/96/009/001/NO-002/NO |
Zerit |
Norway |
2.5.2006 |
|
EU/1/96/009/001-009 |
Zerit |
Liechtenstein |
30.4.2006 |
|
EU/1/96/009/001-009/IS |
Zerit |
Iceland |
24.5.2006 |
|
EU/1/96/011/001/NO-004/NO |
Caelyx |
Norway |
26.5.2006 |
|
EU/1/96/011/001-004 |
Caelyx |
Liechtenstein |
30.6.2006 |
|
EU/1/96/011/001-004/IS |
Caelyx |
Iceland |
16.6.2006 |
|
EU/1/98/093/002/IS |
Forcaltonin |
Iceland |
31.5.2006 |
|
EU/1/98/093/002/NO |
Forcaltonin |
Norway |
21.6.2006 |
|
EU/2/00/019/001-003/IS |
Purevax FeLV |
Iceland |
9.3.2006 |
|
EU/2/00/025/001/NO-004/NO |
Advasure |
Norway |
15.3.2006 |
|
EU/2/00/026/001/NO-004/NO |
Porcilis AR-T DF |
Norway |
10.3.2006 |
|
EU/2/00/026/001-004 |
Porcilis AR-T DF |
Liechtenstein |
28.2.2006 |
|
EU/2/00/026/001-004/IS |
Porcilis AR-T DF |
Iceland |
8.3.2006 |
|
EU/2/00/027/001/NO-003/NO |
Pirsue |
Norway |
10.3.2006 |
|
EU/2/00/027/001-003 |
Pirsue |
Liechtenstein |
28.2.2006 |
|
EU/2/00/028/002/NO-008 /NO |
Zubrin |
Norway |
7.4.2006 |
|
EU/2/00/028/002-008 |
Zubrin |
Liechtenstein |
30.4.2006 |
|
EU/2/00/028/002-008/IS |
Zubrin |
Iceland |
11.4.2006 |
|
EU/2/01/029/001/NO-003/NO |
Eurican Herpes |
Norway |
18.5.2006 |
|
EU/2/01/029/001-003 |
Eurican Herpes |
Liechtenstein |
30.4.2006 |
|
EU/2/01/029/001-003/IS |
Eurican Herpes |
Iceland |
8.6.2006 |
|
EU/2/96/001/001-010 |
Porcilis Porcoli |
Liechtenstein |
30.4.2006 |
|
EU/2/96/001/NO-010/NO |
Porcilis Porcoli |
Norway |
5.5.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/1/00/137/013-018 |
Avandia |
Liechtenstein |
30.6.2006 |
|
EU/1/00/146/030 |
Keppra |
Liechtenstein |
30.4.2006 |
|
EU/1/00/146/030/IS |
Keppra |
Iceland |
7.4.2006 |
|
EU/1/00/146/030/NO |
Keppra |
Norway |
28.4.2006 |
|
EU/1/00/150/016-024 |
Actos |
Liechtenstein |
30.4.2006 |
|
EU/1/00/151/014-022 |
Glustin |
Liechtenstein |
30.4.2006 |
|
EU/1/00/162/019-021 |
Prandin |
Liechtenstein |
30.6.2006 |
|
EU/1/03/255/004-005 |
Ventavis |
Liechtenstein |
30.6.2006 |
|
EU/1/03/262/007/NO-008/NO |
Emend |
Norway |
28.6.2006 |
|
EU/1/03/262/007-008 |
Emend |
Liechtenstein |
30.6.2006 |
|
EU/1/03/262/007-008/IS |
Emend |
Iceland |
19.6.2006 |
|
EU/1/03/265/005/NO-006/NO |
Bonviva |
Norway |
2.5.2006 |
|
EU/1/03/265/005-006/IS |
Bonviva |
Iceland |
12.6.2006 |
|
EU/1/03/266/005/NO-006/NO |
Bondenza |
Norway |
8.5.2006 |
|
EU/1/04/279/033/NO-035/NO |
Lyrica |
Norway |
19.6.2006 |
|
EU/1/04/279/033-035 |
Lyrica |
Liechtenstein |
30.6.2006 |
|
EU/1/04/296/007 |
Cymbalta |
Liechtenstein |
30.4.2006 |
|
EU/1/04/296/008 |
Cymbalta |
Liechtenstein |
30.6.2006 |
|
EU/1/04/297/007 |
Xeristar |
Liechtenstein |
30.4.2006 |
|
EU/1/04/297/008 |
Xeristar |
Liechtenstein |
30.6.2006 |
|
EU/1/04/302/004 |
Prialt |
Liechtenstein |
30.4.2006 |
|
EU/1/04/302/004/IS |
Prialt |
Iceland |
22.4.2006 |
|
EU/1/04/302/004/NO |
Prialt |
Norway |
29.3.2006 |
|
EU/1/05/319/003-004 |
Xolair |
Liechtenstein |
30.6.2006 |
|
EU/1/96/007/029-030 |
Humalog |
Liechtenstein |
30.4.2006 |
|
EU/1/98/063/007/IS |
Rebif |
Iceland |
30.5.2006 |
|
EU/1/98/063/007/NO |
Rebif |
Norway |
16.2.2006 |
|
EU/1/98/076/022-024 |
NovoNorm |
Liechtenstein |
30.6.2006 |
|
EU/1/98/089/017-019 |
Pritor |
Liechtenstein |
30.4.2006 |
|
EU/1/99/107/005 |
Rebetol |
Liechtenstein |
30.4.2006 |
|
EU/2/00/019/005-007/IS |
Purevax FeL V |
Iceland |
9.3.2006 |
|
EU/2/02/035/007 |
SevoFlo |
Liechtenstein |
30.4.2006 |
|
EU/2/03/037/005/NO |
Proteqflu |
Norway |
15.3.2006 |
|
EU/2/03/038/005/NO |
Proteqflu-Te |
Norway |
15.3.2006 |
|
EU/2/04/044/002/NO |
Aivlosin |
Norway |
4.3.2006 |
|
EU/2/04/044/003-005/IS |
Aivlosin |
Iceland |
22.3.2006 |
|
EU/2/97/004/016/NO-023/NO |
Metacam |
Norway |
22.4.2006 |
|
EU/2/97/004/016-023 |
Metacam |
Liechtenstein |
30.4.2006 |
|
EU/2/97/004/016-023/IS |
Metacam |
Iceland |
7.4.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/00/137/001 |
Avandia |
Liechtenstein |
30.6.2006 |
|
EU/1/01/183/002-003, 006, 009-010, 012, 014, 016-17 |
HBVAXPRO |
Liechtenstein |
28.2.2006 |
|
EU/1/02/245/001 |
Theryttrex |
Liechtenstein |
28.2.2006 |
|
EU/1/02/245/001/IS |
Theryttrex |
Iceland |
10.2.2006 |
|
EU/1/06/024/006, 009 |
Crixivan |
Liechstenstein |
31.1.2006 |
|
EU/1/96/022/001, 003, 005, 007, 013, 015 |
Zyprexa |
Liechstenstein |
31.1.2006 |
|
EU/1/97/052/001/NO-006/NO, 009/NO-010/NO |
Daquiran |
Norway |
22.2.2006 |
|
EU/1/97/052/001-006, 009-010 |
Daquiran |
Liechtenstein |
28.2.2006 |
|
EU/1/97/052/001-010/IS |
Daquiran |
Iceland |
10.2.2006 |
|
EU/1/98/075/001-002 |
Fortovase |
Liechtenstein |
30.6.2006 |
|
EU/1/98/075/001-002/IS |
Fortovase- Saquinavir |
Iceland |
26.6.2006 |
|
EU/1/98/087/001/NO-003/NO |
Infergen |
Norway |
30.5.2006 |
|
EU/1/98/087/001-003 |
Infergen |
Liechtenstein |
30.6.2006 |
|
EU/1/98/087/001-003/IS |
Infergen |
Iceland |
16.6.2006 |
|
EU/2/00/028/001 |
Zubrin |
Liechtenstein |
28.2.2006 |
|
EU/2/98/010/001-003, 015-016, 019-020 |
Econor |
Liechtenstein |
31.1.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of suspention |
|
EU/1/02/239/001-030 |
Bextra |
Liechtenstein |
31.1.2006 |
|
8.11.2007 |
EN |
Official Journal of the European Union |
C 266/18 |
Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2006
(2007/C 266/06)
Subcommittee I — On the free movement of goods
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 8 December 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 July-31 December 2006:
|
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 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 2006:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/06/333/001-003/IS |
Myozyme |
Iceland |
10.8.2006 |
|
EU/1/06/342/001 |
Nexavar |
Liechtenstein |
31.8.2006 |
|
EU/1/06/342/001/IS |
Nexavar |
Iceland |
4.8.2006 |
|
EU/1/06/342/001/NO |
Nexavar |
Norway |
28.7.2006 |
|
EU/1/06/343/001/NO-005/NO |
Baraclude |
Norway |
25.7.2006 |
|
EU/1/06/343/001-006/IS |
Baraclude |
Iceland |
24.7.2006 |
|
EU/1/06/344/001-009/IS |
Acomplia |
Iceland |
19.7.2006 |
|
EU/1/06/345/001-009/IS |
Zimulti |
Iceland |
19.7.2006 |
|
EU/1/06/346/001 |
Tysabri |
Liechtenstein |
31.8.2006 |
|
EU/1/06/346/001/IS |
Tysabri |
Iceland |
24.7.2006 |
|
EU/1/06/346/001/NO |
Tysabri |
Norway |
13.7.2006 |
|
EU/1/06/347/001/NO-003/NO |
Sutent |
Norway |
27.7.2006 |
|
EU/1/06/347/001-003 |
Sutent |
Liechtenstein |
31.8.2006 |
|
EU/1/06/347/001-003/IS |
Sutent |
Iceland |
3.8.2006 |
|
EU/1/06/348/001/NO-002/NO |
RotaTeq |
Norway |
12.7.2006 |
|
EU/1/06/348/001-002 |
RotaTeq |
Liechtenstein |
31.8.2006 |
|
EU/1/06/348/001-002/IS |
RotaTeq |
Iceland |
26.7.2006 |
|
EU/1/06/349/001/NO-008/NO |
Avaglim |
Norway |
13.7.2006 |
|
EU/1/06/349/001-008 |
Avaglim |
Liechtenstein |
31.8.2006 |
|
EU/1/06/349/001-008/IS |
Avaglim |
Iceland |
25.7.2006 |
|
EU/1/06/350/001 |
Savene |
Liechtenstein |
31.8.2006 |
|
EU/1/06/350/001/IS |
Savene |
Iceland |
18.8.2006 |
|
EU/1/06/350/001/NO |
Savene |
Norway |
16.8.2006 |
|
EU/1/06/351/001/NO-003/NO |
Livensa |
Norway |
6.9.2006 |
|
EU/1/06/351/001-003 |
Livensa |
Liechtenstein |
31.8.2006 |
|
EU/1/06/351/001-003/IS |
Livensa |
Iceland |
28.8.2006 |
|
EU/1/06/352/001/NO-003/NO |
Intrinsa |
Norway |
25.8.2006 |
|
EU/1/06/352/001-003 |
Intrinsa |
Liechtenstein |
31.8.2006 |
|
EU/1/06/352/001-003/IS |
Intrinsa |
Iceland |
18.8.2006 |
|
EU/1/06/353/001/NO-005/NO |
Thelin |
Norway |
1.9.2006 |
|
EU/1/06/353/001-005 |
Thelin |
Liechtenstein |
31.10.2006 |
|
EU/1/06/353/001-005/IS |
Thelin |
Iceland |
8.9.2006 |
|
EU/1/06/354/001/NO-009/NO |
Competact |
Norway |
22.8.2006 |
|
EU/1/06/354/001-009 |
Competact |
Liechtenstein |
31.8.2006 |
|
EU/1/06/354/001-009/IS |
Competact |
Iceland |
28.8.2006 |
|
EU/1/06/355/001/NO-003/NO |
Atryn |
Norway |
21.8.2006 |
|
EU/1/06/355/001-003 |
Atryn |
Liechtenstein |
31.8.2006 |
|
EU/1/06/355/001-003/IS |
Atryn |
Iceland |
17.8.2006 |
|
EU/1/06/356/001/NO-006/NO |
Exjade |
Norway |
20.9.2006 |
|
EU/1/06/356/001-006 |
Exjade |
Liechtenstein |
31.10.2006 |
|
EU/1/06/356/001-006/IS |
Exjade |
Iceland |
21.9.2006 |
|
EU/1/06/357/001/NO-017/NO |
Gardasil |
Norway |
28.9.2006 |
|
EU/1/06/357/001-017 |
Gardasil |
Liechtenstein |
31.10.2006 |
|
EU/1/06/357/001-017/IS |
Gardasil |
Iceland |
17.10.2006 |
|
EU/1/06/358/001/NO-017/NO |
Silgard |
Norway |
29.9.2006 |
|
EU/1/06/358/001-017 |
Silgard |
Liechtenstein |
31.10.2006 |
|
EU/1/06/358/001-017/IS |
Silgard |
Iceland |
19.10.2006 |
|
EU/1/06/359/001/NO-004/NO |
Suboxone |
Norway |
26.10.2006 |
|
EU/1/06/359/001-004 |
Suboxone |
Liechtenstein |
31.10.2006 |
|
EU/1/06/359/001-004/IS |
Suboxone |
Iceland |
24.10.2006 |
|
EU/1/06/360/001/NO-010/NO |
Champix |
Norway |
20.10.2006 |
|
EU/1/06/360/001-010/IS |
Champix |
Iceland |
24.10.2006 |
|
EU/1/06/361/001/IS |
Luminity |
Iceland |
20.10.2006 |
|
EU/1/06/362/001/NO-004/NO |
Byetta |
Norway |
13.12.2006 |
|
EU/1/06/362/001-004 |
Byetta |
Liechtenstein |
31.12.2006 |
|
EU/1/06/362/001-004/IS |
Byetta |
Iceland |
19.12.2006 |
|
EU/1/06/363/001/NO-009/NO |
Sprycel |
Norway |
20.12.2006 |
|
EU/1/06/363/001-009/IS |
Sprycel |
Iceland |
15.12.2006 |
|
EU/2/02/036/001-002/IS |
Nobilis OR inac |
Iceland |
3.8.2006 |
|
EU/2/06/059/001/IS |
Convenia |
Iceland |
19.7.2006 |
|
EU/2/06/059/001/NO |
Convenia |
Norway |
6.7.2006 |
|
EU/2/06/060/001/NO-002/NO |
Poulvac FluFend H5N3 |
Norway |
2.10.2006 |
|
EU/2/06/060/001-002 |
Poulvac Flufend H5N3 RG |
Liechtenstein |
31.10.2006 |
|
EU/2/06/060/001-002/IS |
Poulvac Flufend H5N3 RG |
Iceland |
18.10.2006 |
|
EU/2/06/061/001/NO-004/NO |
Nobilis Influenza H5N2 |
Norway |
2.10.2006 |
|
EU/2/06/061/001-004 |
Nobilis Influenza H5N2 |
Liechtenstein |
31.10.2006 |
|
EU/2/06/061/001-004/IS |
Nobilis Influenza |
Iceland |
19.9.2006 |
|
EU/2/06/062/001/NO-005/NO |
Cerenia |
Norway |
31.10.2006 |
|
EU/2/06/062/001-005 |
Cerenia |
Liechtenstein |
31.10.2006 |
|
EU/2/06/062/001-005/IS |
Cerenia |
Iceland |
19.10.2006 |
|
EU/2/06/063/001/NO-003/NO |
Yarvitan |
Norway |
14.12.2006 |
|
EU/2/06/063/001-003 |
Yarvitan |
Liechtenstein |
31.12.2006 |
|
EU/2/06/063/001-003/IS |
Yarvitan |
Iceland |
7.12.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of renewal |
|
EU/1/00/156/002-003/IS |
Trizivir |
Iceland |
17.7.2006 |
|
EU/1/01/171/001, 007-012 |
Rapamune |
Liechtenstein |
31.8.2006 |
|
EU/1/01/179/001/IS |
Osigraft |
Iceland |
4.9.2006 |
|
EU/1/01/183/001, 004-005, 007-008, 011, 013, 015, 018-029 |
HBVAXPRO |
Liechtenstein |
31.8.2006 |
|
EU/1/01/183/001/NO, 004/NO-005/NO, 007/NO-008/NO, 011/NO, 013/NO, 015/NO, 018/NO-029/NO |
HBVAXPRO |
Norway |
1.9.2006 |
|
EU/1/01/184/001-056/IS |
Nespo |
Iceland |
17.7.2006 |
|
EU/1/01/185/001-056/IS |
Aranesp |
Iceland |
13.7.2006 |
|
EU/1/01/186/001/NO-002/NO |
Nonafact |
Norway |
21.8.2006 |
|
EU/1/01/186/001-002 |
Nonafact |
Liechtenstein |
31.8.2006 |
|
EU/1/01/186/001-002/IS |
Nonafact |
Iceland |
29.8.2006 |
|
EU/1/01/187/001/IS |
Depocyte |
Iceland |
1.9.2006 |
|
EU/1/01/188/001/NO-006/NO |
Fabrazyme |
Norway |
28.8.2006 |
|
EU/1/01/188/001-003/IS |
Fabrazyme |
Iceland |
28.8.2006 |
|
EU/1/01/188/004-006 |
Fabrazyme |
Liechtenstein |
31.8.2006 |
|
EU/1/01/189/001-006 |
Replagal |
Liechtenstein |
31.8.2006 |
|
EU/1/01/189/001/IS |
Replagal |
Iceland |
28.8.2006 |
|
EU/1/01/189/001/NO-006/NO |
Replagal |
Norway |
28.8.2006 |
|
EU/1/01/190/001/NO-002/NO |
Ceprotin |
Norway |
22.8.2006 |
|
EU/1/01/190/001-002 |
Ceprotin |
Liechtenstein |
31.8.2006 |
|
EU/1/01/190/001-002/IS |
Ceprotin |
Iceland |
21.9.2006 |
|
EU/1/01/191/001/NO-005/NO |
Ketek |
Norway |
16.10.2006 |
|
EU/1/01/191/001-005 |
Ketek |
Liechtenstein |
31.10.2006 |
|
EU/1/01/191/001-005/IS |
Ketek |
Iceland |
18.9.2006 |
|
EU/1/01/192/001/NO-005/NO |
Levviax |
Norway |
16.10.2006 |
|
EU/1/01/192/001-005 |
Levviax |
Liechtenstein |
31.10.2006 |
|
EU/1/01/192/001-005/IS |
Levviax |
Iceland |
18.9.2006 |
|
EU/1/01/193/001/NO-002/NO |
MabCampath |
Norway |
10.8.2006 |
|
EU/1/01/193/001-002 |
MabCampath |
Liechtenstein |
31.8.2006 |
|
EU/1/01/193/001-002/IS |
MabCampath |
Iceland |
28.8.2006 |
|
EU/1/01/194/001/NO-002/NO |
INOmax |
Norway |
28.8.2006 |
|
EU/1/01/194/001-002 |
INOmax |
Liechtenstein |
31.8.2006 |
|
EU/1/01/194/001-002/IS |
INOmax |
Iceland |
8.11.2006 |
|
EU/1/01/196/001/NO-003/NO |
Cancidas |
Norway |
1.12.2006 |
|
EU/1/01/196/001-003 |
Cancidas |
Liechtenstein |
31.10.2006 |
|
EU/1/01/196/001-003/IS |
Cancidas |
Iceland |
13.10.2006 |
|
EU/1/01/197/001/NO-002/NO |
Foscan |
Norway |
11.12.2006 |
|
EU/1/01/197/001-002 |
Foscan |
Liechtenstein |
31.12.2006 |
|
EU/1/01/197/001-002/IS |
Foscan |
Iceland |
1.12.2006 |
|
EU/1/01/198/001/NO-013/NO |
Glivec |
Norway |
16.10.2006 |
|
EU/1/01/198/001-013 |
Glivec |
Liechtenstein |
31.10.2006 |
|
EU/1/01/198/001-013/IS |
Glivec |
Iceland |
16.10.2006 |
|
EU/1/01/199/001/NO-002/NO |
Travatan |
Norway |
30.10.2006 |
|
EU/1/01/199/001-002 |
Travatan |
Liechtenstein |
31.10.2006 |
|
EU/1/01/199/001-002/IS |
Travatan |
Iceland |
9.11.2006 |
|
EU/1/02/201/001/NO-006/NO |
Protopic |
Norway |
5.12.2006 |
|
EU/1/02/201/001-006 |
Protopic |
Liechtenstein |
31.12.2006 |
|
EU/1/02/202/001/NO-006/NO |
Protopy |
Norway |
5.12.2006 |
|
EU/1/02/202/001-006 |
Protopy |
Liechtenstein |
31.12.2006 |
|
EU/1/06/015/001/NO-005/NO |
Epivir |
Norway |
17.8.2006 |
|
EU/1/96/004/001-002/IS |
Fareston |
Iceland |
18.9.2006 |
|
EU/1/96/008/001-041/IS |
Puregon |
Iceland |
30.8.2006 |
|
EU/1/96/010/001 |
Rilutek |
Liechtenstein |
31.8.2006 |
|
EU/1/96/010/001/IS |
Rilutek |
Iceland |
4.9.2006 |
|
EU/1/96/010/001/NO |
Rilutek |
Norway |
4.9.2006 |
|
EU/1/96/012/001-013/IS |
Bondronat |
Iceland |
28.8.2006 |
|
EU/1/96/012/004, 009-013 |
Bondronat |
Liechtenstein |
31.8.2006 |
|
EU/1/96/012/004/NO, 009/NO-010/NO, 011/NO-013/NO |
Bondronat |
Norway |
24.7.2006 |
|
EU/1/96/014/001/NO-003/NO |
Tritanrix HepB |
Norway |
21.8.2006 |
|
EU/1/96/014/001-003 |
Tritanrix HepB |
Liechtenstein |
31.8.2006 |
|
EU/1/96/015/001-005 |
Epivir |
Liechtenstein |
31.8.2006 |
|
EU/1/96/015/001-005/IS |
Epivir |
Iceland |
22.9.2006 |
|
EU/1/96/016/001, 003 |
Norvir |
Liechtenstein |
31.12.2006 |
|
EU/1/96/016/001, 003/IS |
Norvir |
Iceland |
29.11.2006 |
|
EU/1/96/016/001/NO, 003/NO |
Norvir |
Norway |
6.12.2006 |
|
EU/1/96/018/001 |
Rapilysin |
Liechtenstein |
31.8.2006 |
|
EU/1/96/018/001/IS |
Rapilysin |
Iceland |
4.9.2006 |
|
EU/1/96/018/001/NO |
Rapilysin |
Norway |
6.9.2006 |
|
EU/1/96/020/001/NO-009/NO |
Twinrix Adult |
Norway |
25.9.2006 |
|
EU/1/96/020/001-009 |
Twinrix Adult |
Liechtenstein |
31.10.2006 |
|
EU/1/96/020/001-009/IS |
Twinrix Adult |
Iceland |
16.10.2006 |
|
EU/1/96/022/002, 004, 006, 008-012, 014, 016-017, 019-022 |
Zyprexa |
Liechtenstein |
31.10.2006 |
|
EU/1/96/022/002, 004, 006, 008-012, 014, 016-017, 019-022/IS |
Zyprexa |
Iceland |
29.9.2006 |
|
EU/1/96/022/002/NO, 004/NO, 006/NO, 008/NO-012/NO, 014/NO, 016/NO-017/NO, 019/NO-022/NO |
Zyprexa |
Norway |
26.10.2006 |
|
EU/1/96/024/001/NO-005/NO, 007/NO-008/NO, 010/NO |
Crixivan |
Norway |
7.12.2006 |
|
EU/1/96/024/001-005, 007-008, 010 |
Crixivan |
Liechtenstein |
31.12.2006 |
|
EU/1/96/024/001-005, 007-008, 010/IS |
Crixivan |
Iceland |
1.12.2006 |
|
EU/1/96/026/001/NO-002/NO |
Invirase |
Norway |
12.12.2006 |
|
EU/1/96/026/001-002 |
Invirase |
Liechtenstein |
31.12.2006 |
|
EU/1/96/026/001-002/IS |
Invirase |
Iceland |
19.12.2006 |
|
EU/1/96/027/001, 003-005 |
Hycamtin |
Liechtenstein |
31.12.2006 |
|
EU/1/96/027/001/NO-005/NO |
Hycamtin |
Norway |
4.12.2006 |
|
EU/1/97/029/001/NO-010/NO |
Twinrix Paediatric |
Norway |
25.9.2006 |
|
EU/1/97/029/001-0010/IS |
Twinrix Paediatric |
Iceland |
16.10.2006 |
|
EU/1/97/029/001-010 |
Twinrix Paediatric |
Liechtenstein |
31.10.2006 |
|
EU/1/99/125/001/NO-008/NO |
Zyprexa Velotab |
Norway |
26.10.2006 |
|
EU/1/99/125/001-008 |
Zyprexa Velotab |
Liechtenstein |
31.10.2006 |
|
EU/1/99/125/001-008/IS |
Zyprexa Velotab |
Iceland |
29.9.2006 |
|
EU/2/00/023/001-004/IS |
Advasure |
Iceland |
7.11.2006 |
|
EU/2/00/027/001-003/IS |
Pirsue |
Iceland |
7.11.2006 |
|
EU/2/01/030/001-004 |
Virbagen Omega |
Liechtenstein |
31.12.2006 |
|
EU/2/01/030/001-004/IS |
Virbagen Omega |
Iceland |
4.12.2006 |
|
EU/2/96/001/001-002, 009-010/IS |
Porcilis Porcoli |
Iceland |
3.10.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/02/215/011-012 |
PritorPlus |
Liechtenstein |
31.12.2006 |
|
EU/1/00/143/007-009 |
Kogenate |
Liechtenstein |
31.8.2006 |
|
EU/1/00/160/035-036 |
Aerius |
Liechtenstein |
31.10.2006 |
|
EU/1/01/172/004/NO-005/NO |
Kaletra |
Norway |
11.7.2006 |
|
EU/1/01/172/004-005 |
Kaletra |
Liechtenstein |
31.8.2006 |
|
EU/1/01/172/004-005/IS |
Kaletra |
Iceland |
12.7.2006 |
|
EU/1/01/184/057-068 |
Nespo |
Liechtenstein |
31.12.2006 |
|
EU/1/01/185/057-068 |
Aranesp |
Liechtenstein |
31.12.2006 |
|
EU/1/01/188/001-003 |
Fabrazyme |
Liechtenstein |
31.8.2006 |
|
EU/1/02/206/018-020 |
Arixtra |
Liechtenstein |
31.10.2006 |
|
EU/1/02/207/018-020 |
Quixidar |
Liechtenstein |
31.10.2006 |
|
EU/1/02/213/011-012 |
MicardisPlus |
Liechtenstein |
31.8.2006 |
|
EU/1/02/219/014-015 |
Ebixa |
Liechtenstein |
31.12.2006 |
|
EU/1/03/256/007-010 |
Humira |
Liechtenstein |
31.12.2006 |
|
EU/1/03/257/007-010 |
Trudexa |
Liechtenstein |
31.12.2006 |
|
EU/1/03/260/013-015 |
Stalevo |
Liechtenstein |
31.8.2006 |
|
EU/1/03/266/005-006/IS |
Bondenza |
Iceland |
25.8.2006 |
|
EU/1/04/276/036 |
Abilify |
Liechtenstein |
31.10.2006 |
|
EU/1/04/276/036/NO |
Abilify |
Norway |
21.12.2006 |
|
EU/1/04/279/033-035/IS |
LYRICA |
Iceland |
21.7.2006 |
|
EU/1/04/285/029-036 |
Apidra |
Liechtenstein |
31.10.2006 |
|
EU/1/05/308/002 |
Aclasta |
Liechtenstein |
31.10.2006 |
|
EU/1/05/323/012-013 |
ProQuad |
Liechtenstein |
31.10.2006 |
|
EU/1/95/003/005-006 |
Betaferon |
Liechtenstein |
31.10.2006 |
|
EU/1/98/082/005 |
Comtess |
Liechtenstein |
31.8.2006 |
|
EU/1/98/085/023/NO-028/NO |
Karvezide |
Norway |
22.9.2006 |
|
EU/1/98/085/023-028 |
Karvezide |
Liechtenstein |
31.10.2006 |
|
EU/1/98/085/023-028/IS |
Karvezide |
Iceland |
18.9.2006 |
|
EU/1/98/086/023/NO-028/NO |
CoAprovel |
Norway |
22.9.2006 |
|
EU/1/98/086/023-028 |
CoAprovel |
Liechtenstein |
31.10.2006 |
|
EU/1/98/086/023-028/IS |
CoAprovel |
Iceland |
18.9.2006 |
|
EU/1/98/090/015-016 |
Micardis |
Liechtenstein |
31.8.2006 |
|
EU/1/99/111/010-011 |
Stocrin |
Liechtenstein |
31.12.2006 |
|
EU/1/99/111/010-011/IS |
Stocrin |
Iceland |
15.12.2006 |
|
EU/1/99/126/012 |
Enbrel |
Liechtenstein |
31.8.2006 |
|
EU/1/99/126/012/NO |
Enbrel |
Norway |
23.8.2006 |
|
EU/1/99/126/012-18/IS |
Enbrel |
Iceland |
11.10.2006 |
|
EU/1/99/126/013/NO-018/NO |
Enbrel |
Norway |
23.10.2006 |
|
EU/1/99/126/013-018 |
Enbrel |
Liechtenstein |
31.10.2006 |
|
EU/2/05/053/002 |
Naxcel |
Liechtenstein |
31.10.2006 |
|
EU/2/05/056/003-004 |
Equilis Prequenza |
Liechtenstein |
31.8.2006 |
|
EU/2/05/057/003-004 |
Equilis Prequenza Te |
Liechtenstein |
31.8.2006 |
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 2006:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/02/235/001-004 |
Monotard |
Liechtenstein |
31.12.2006 |
|
EU/1/02/235/001-004/IS |
Monotard |
Iceland |
16.11.2006 |
|
EU/1/02/235/001-004/NO |
Monotard |
Norway |
20.12.2006 |
|
EU/1/02/236/001-004 |
Ultratard |
Liechtenstein |
31.12.2006 |
|
EU/1/02/236/001-004/IS |
Ultratard |
Iceland |
20.11.2006 |
|
EU/1/02/236/001-004/NO |
Ultratard |
Norway |
13.12.2006 |
|
EU/1/98/075/001/NO-002/NO |
Fortovase |
Norway |
6.7.2006 |
|
EU/1/98/075/001-002/IS |
Fortovase |
Iceland |
4.7.2006 |
V Announcements
OTHER ACTS
Commission
|
8.11.2007 |
EN |
Official Journal of the European Union |
C 266/27 |
Publication of an application pursuant to Article 8(2) of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed
(2007/C 266/07)
This publication confers the right to object to the application pursuant to Article 9 of Council Regulation (EC) No 509/2006 (1). Statements of objection must reach the Commission within six months from the date of this publication.
APPLICATION FOR REGISTRATION OF A TSG
COUNCIL REGULATION (EC) No 509/2006
‘CZWÓRNIAK’
EC No PL/TSG/007/0035/06.09.2006
1. Name and address of the applicant group
|
Name: |
Krajowa Rada Winiarstwa i Miodosytnictwa przy Stowarzyszeniu Naukowo — Technicznym Inżynierów i Techników Przemysłu Spożywczego |
||
|
Address: |
|
||
|
Tel. |
(48) 22 828 27 21 |
||
|
E-mail: |
krwim@sitspoz.pl |
2. Member State or Third Country
Poland
3. Product specification
3.1. Name to be registered
‘Czwórniak’
When the product is placed on the market, the label may contain the following information: ‘miód pitny wytworzony zgodnie ze staropolską tradycją’ (mead produced in accordance with an old Polish tradition). This information should be translated into other official languages.
3.2. Whether the name
|
|
is specific in itself |
|
|
expresses the specific character of the agricultural product or foodstuff |
The name ‘czwórniak’ derives from the numeral ‘4’ (PL: ‘cztery’) and relates directly to the historically established composition and method of production of ‘czwórniak’ — the proportions of honey and water in the mead wort being one part honey to three parts water. The name therefore expresses the specific character of the product. Since the term ‘czwórniak’ is a word that is used solely to denote a specific type of mead, the name should also be considered to be specific in itself.
3.3. Whether reservation of the name is sought under Article 13(2) of Regulation (EC) No 509/200
|
|
Registration with reservation of the name |
|
|
Registration without reservation of the name |
3.4. Type of product
Class 1.8 — Other products of Annex I
3.5. Description of the agricultural product or foodstuff to which the name under point 3.1 applies
‘Czwórniak’ is a mead, a clear beverage fermented from mead wort, distinguished by its characteristic honey aroma and the taste of the raw material used.
The flavour of ‘czwórniak’ may be enriched by the taste of spices that are used. The colour of ‘czwórniak’ ranges from golden to dark amber and depends on the type of honey used for production.
The physico-chemical indicators typical for ‘czwórniak’ mead are:
|
— |
alcohol content: 9-12 % vol., |
|
— |
reducing sugars after inversion: 35-90 g/l, |
|
— |
total acidity expressed as malic acid: 3,5-8 g/l, |
|
— |
volatile acidity expressed as acetic acid: max. 1,4 g/l, |
|
— |
total sugar (g) plus actual alcohol content (% vol.) multiplied by 18: min. 240 g, |
|
— |
non-sugar extract: not less than:
|
|
— |
ash: min. 1,3 g/l — in the case of fruit mead. |
The use of preservatives, stabilisers and artificial colourings and flavourings is prohibited in the production of ‘czwórniak’.
3.6. Description of the production method of the agricultural product or foodstuff to which the name under point 3.1 applies
Raw materials
|
— |
Natural honey with the following parameters:
|
|
— |
High-attenuation mead yeast — suitable for attenuation of high extracts in pitched wort. |
|
— |
Herbs and spices: cloves, cinnamon, nutmeg or ginger. |
|
— |
Natural fruit juices or fresh fruit. |
Production method
Stage 1
Brewing (boiling) of the mead wort at a temperature of 95-105 °C. The required proportions of honey and water for ‘czwórniak’ are one part honey to three parts water (or water mixed with fruit juice), to which herbs or spices may be added. In the case of fruit meads, at least 30 % of the water is replaced with fruit juice.
Strict adherence to the proportions of water and honey and obtaining the required extract in a wort kettle fitted with a steam jacket. This method of brewing prevents caramelisation of the sugars.
Stage 2
Cooling of the wort to 20-22 °C, the optimum temperature for yeast to propagate. The wort must be cooled on the day of production, and the cooling time depends on the efficiency of the cooler. Cooling guarantees the microbiological safety of the wort.
Stage 3
Pitching — addition of a yeast solution to the wort in a fermentation tank.
Stage 4
|
A. |
Violent fermentation: 6-10 days. Keeping the temperature at a maximum level of 28 °C ensures that the fermentation process runs properly. |
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B. |
Still fermentation: 3-6 weeks. The still fermentation period ensures that the proper physico-chemical parameters are attained. |
Stage 5
Racking of the attenuated pitched wort.
After obtaining an alcohol content of at least 9 % vol., racking prior to ageing should be carried out. This guarantees that the ‘czwórniak’ has the appropriate physico-chemical and organoleptic properties. Leaving the pitched wort on the lees beyond the still fermentation period adversely affects the organoleptic properties, owing to yeast autolysis.
Stage 6
Ageing (maturing) and siphoning (decanting) — this is repeated as necessary to prevent unwanted processes from taking place in the lees (yeast autolysis). During ageing it is possible to carry out operations such as pasteurisation and filtration.
This stage is essential for ensuring that the product has the right organoleptic properties.
The minimum ageing time for ‘czwórniak’ is nine months.
Stage 7
Flavour-adjustment (composition) — this stage concerns the preparation of a final product having the organoleptic and physico-chemical properties appropriate to ‘czwórniak’, as specified in point 3.5 — Description of the agricultural product or foodstuff. In order to ensure that the required parameters are attained, it is possible to correct the organoleptic and physico-chemical properties by:
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adding honey to sweeten the mead, |
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adding herbs and spices. |
The aim of this stage is to obtain a product with the characteristic ‘czwórniak’ bouquet.
Stage 8
Pouring into unit containers at a temperature of 55-60 °C. It is recommended that ‘czwórniak’ be presented in traditional packaging, such as: carboys, ceramic containers or oak barrels.
3.7. Specific character of the agricultural product or foodstuff
The specific character of ‘czwórniak’ results from:
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the preparation of the wort (composition and proportion of raw materials), |
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ageing and maturing, |
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its physico-chemical and organoleptic properties. |
Preparation of the wort (composition and proportion of raw materials)
The specific character of ‘czwórniak’ results in particular from the use of, and strict adherence to, the established proportions of honey and water — one part honey to three parts water — in the mead wort. This proportion is the determining factor in all further stages in the production of ‘czwórniak’ that impart its unique properties.
Ageing and maturing
According to the traditional old Polish recipe, the character of the product depends on its being aged and matured for a specified period of time. In the case of ‘czwórniak’ this period is at least nine months.
Physico-chemical and organoleptic properties
Observance of all the stages of production included in the specification ensures that a product of unique taste and aroma is obtained. The unique taste and odour of ‘czwórniak’ is the result of appropriate sugar and alcohol content:
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reducing sugars after inversion: > 35-90 g/l, |
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total sugar (g) plus actual alcohol content (% vol.) multiplied by 18: min. 240 g, |
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alcohol: 9-12 % vol. |
Owing to strictly defined proportions of the ingredients used in its production, ‘czwórniak’ possesses a typically viscous and runny consistency which distinguishes it from other types of mead.
3.8. Traditional character of the agricultural product or foodstuff
Traditional production method
Mead production in Poland is a tradition which dates back over a thousand years and is characterised by great diversity. The development and improvement of the production method over the centuries has given rise to many types of mead. The history of mead production dates back to the beginnings of Poland's statehood. In 966 the Spanish diplomat, merchant and traveller, Ibrahim ibn Yaqub, wrote: ‘Besides food, meat and land for ploughing, the country of Mieszko I abounds in mead, which is what the Slavic wines and intoxicating drinks are called’ (Mieszko I was the first historic king of Poland). The Chronicles of Gallus Anonymus, who recorded Polish history at the turn of the 11th and 12th centuries, also contain numerous references to the production of mead.
The Polish national epic poem ‘Pan Tadeusz’ by Adam Mickiewicz, which tells the story of the nobility between 1811 and 1812, contains a good deal of information on the production, consumption and different types of mead. Mentions of mead can also be found in the poems of Tomasz Zan (1796-1855) and in Henryk Sienkiewicz's trilogy describing events in Poland in the 17th century (‘Ogniem i mieczem’, published in 1884; ‘Potop’, published in 1886 and ‘Pan Wołodyjowski’, published in 1887 and 1888).
Source materials describing Polish culinary traditions of the 17th and 18th centuries contain not only general references to mead, but also references to different types of mead. Depending on the production method, they were called ‘półtorak’, ‘dwójniak’, ‘trójniak’ and ‘czwórniak’. Each of these names relates to a different type of mead, produced on the basis of different proportions of honey and water or juice, and different ageing times. The ‘czwórniak’ production technique has been used, with minor modifications, for centuries.
Traditional composition
The traditional division of mead into ‘półtorak’, ‘dwójniak’, ‘trójniak’ and ‘czwórniak’ has existed in Poland for centuries and still exists in consumers' consciousness to this day. After the Second World War attempts were made to regulate the traditional division of mead into four categories. This division was finally enshrined in Polish law in 1948 by means of the Act on the production of wines, wine musts, meads and trade in such products (Journal of Laws of the Republic of Poland of 18 November 1948). This Act contains rules on the production of meads, specifying the proportions of honey and water and the technological requirements. The proportion of water and honey for ‘czwórniak’ is given as follows: ‘Only mead produced from one part natural honey and three parts water may be called “czwórniak”’.
3.9. Minimum requirements and procedures to check the specific character
Mandatory checking encompasses:
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adherence to the established proportions of ingredients in the mead wort, |
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adherence to the length of the ageing time, |
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organoleptic properties of the finished product (taste, odour, colour, clarity), |
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physico-chemical indicators of the finished product: alcohol content, total sugar, reducing sugar after inversion, total acidity, volatile acidity, non-sugar extract, and ash in the case of fruit meads — the values should correspond to the values specified at point 3.5 of the specification. |
Mandatory checks are carried out at least once a year.
It is recommended that checks also be carried out during the production stages listed below. Checks at the production stages listed below are not mandatory, but are advisable, because they help eliminate possible errors occurring at different stages of production:
Stage 4
During the fermentation process, regular laboratory tests should be carried out on organoleptic properties (taste and odour) and physico-chemical parameters such as alcohol content and content of sugars that are subject to change during the alcoholic fermentation process.
Stage 6
During ageing, regular checks should be carried out on the basic organoleptic properties of the product and physico-chemical indicators such as alcohol content, total sugar, total acidity and volatile acidity.
Stage 8
Before bottling, checks are carried out on the various physico-chemical and organoleptic parameters specified at 3.5 — Description of the agricultural product or foodstuff.
4. Authorities or bodies verifying compliance with the product specification
4.1. Name and address
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Name: |
Główny Inspektorat Jakości Handlowej Artykułów Rolno — Spożywczych |
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Address: |
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Tel. |
(48) 22 623 29 00 |
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Fax |
(48) 22 623 29 98 |
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E-mail: |
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4.2. Specific tasks of the authority or body
The inspection authority above is responsible for the verification of the entirety of the specification.
Corrigenda
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8.11.2007 |
EN |
Official Journal of the European Union |
C 266/33 |
Corrigendum to the Communication from the EFTA Surveillance Authority under Article 7 of the Act referred to at point 18 of Annex VII to the EEA Agreement (Council Directive 85/384/EEC of 10 June 1985 on the mutual recognition of diplomas, certificates and other evidence of formal qualifications in architecture, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services)
( Official Journal of the European Union C 38 of 22 February 2007 and EEA Supplement No 8 of 22 February 2007)
(2007/C 266/08)
On page 17, in the third paragraph, second sentence, and fourth paragraph:
for:
‘This new title is to be recognised by the contracting parties to the EEA Agreement in respect of those students who began their studies in architecture in the academic year 2001/2002.
The following designation is to be deleted from the list of titles of diplomas and the bodies awarding such diplomas for Norway:
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“Sivilarkitekt” |
and replaced by the designation:
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“Master i arkitektur”.’, |
read:
‘This new title is to be recognised by the contracting parties to the EEA Agreement in respect of those students who began their studies in architecture in the academic year 1999/2000 at the Norges teknisk-naturvitenskaplige universitet (NTNU), in the academic year 1998/1999 at the Arkitektur- og designhøgskolen i Oslo (AHO) (before 29 October 2004Arkitekthøgskolen i Oslo) and in the academic year 2001/2002 at the Bergen Arkitekt Skole (BAS).
The following designation is to be added to the list of titles of diplomas and the bodies awarding such diplomas for Norway:
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“Master i arkitektur”.’ |
