ISSN 1725-2423

Official Journal

of the European Union

C 259
European flag  

English edition

Information and Notices

Volume 49
27 October 2006

Notice No

Contents

page

 

I   Information

 

Council

2006/C 259/1

Letter to the Council Presidency and the Commission from the Department of Homeland Security (DHS) of the United States of America, concerning the interpretation of certain provisions of the undertakings issued by DHS on 11 MAY 2004 in connection with the transfer by air carriers of passenger name record (PNR) data

1

2006/C 259/2

Reply by the Council Presidency and the Commission to the letter from the USA's Department of Homeland Security

4

 

Commission

2006/C 259/3

Euro exchange rates

5

2006/C 259/4

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2006 to 30 September 2006(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )

6

2006/C 259/5

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections ( 1 )

13

2006/C 259/6

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections

17

2006/C 259/7

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections

19

 

 

(1)   Text with EEA relevance

EN

 

I Information

Council

27.10.2006   

EN

Official Journal of the European Union

C 259/1

Letter to the Council Presidency and the Commission from the Department of Homeland Security (DHS) of the United States of America, concerning the interpretation of certain provisions of the undertakings issued by DHS on 11 MAY 2004 in connection with the transfer by air carriers of passenger name record (PNR) data (1)

(2006/C 259/01)

‘This letter is intended to set forth our understandings with regard to the interpretation of a number of provisions of the Passenger Name Record (PNR) Undertakings issued on May 11, 2004 by the Department of Homeland Security (DHS). For the purposes of this letter, DHS means the Bureau of Customs and Border Protection, U.S. Immigration and Customs Enforcement and the Office of the Secretary and the entities that directly support it, but does not include other components of DHS such as the Citizenship and Immigration Services, Transportation Security Administration, United States Secret Service, the United States Coast Guard, and the Federal Emergency Management Agency. We look forward to further reviewing these and other issues in the context of future discussions toward a comprehensive, reciprocal agreement based on common principles.

Sharing and Disclosure of PNR

The Intelligence Reform and Terrorism Prevention Act of 2004 required the President to establish an Information Sharing Environment “that facilitates the sharing of terrorism information.” Following this enactment, on October 25, 2005 the President issued Executive Order 13388, directing that DHS and other agencies “promptly give access to … terrorism information to the head of each other agency that has counterterrorism functions” and establishing a mechanism for implementing the Information Sharing Environment.

Pursuant to Paragraph 35 of the Undertakings (which states that “No statement in these Undertakings shall impede the use or disclosure of PNR data in any criminal judicial proceedings or as otherwise required by law” and allows DHS to “advise the European Commission regarding the passage of any U.S. legislation which materially affects the statements made in these Undertakings”), the U.S. has now advised the EU that the implementation of the Information Sharing Environment required by the Act and the Executive Order described above may be impeded by certain provisions of the Undertakings that restrict information sharing among U.S. agencies, particularly all or portions of paragraphs 17, 28, 29, 30, 31, and 32.

In light of these developments and in accordance with what follows, the Undertakings should be interpreted and applied so as to not impede the sharing of PNR data by DHS with other authorities of the U.S. government responsible for preventing or combating of terrorism and related crimes as set forth in Paragraph 3 of the Undertakings.

DHS will therefore facilitate the disclosure (without providing unconditional direct electronic access) of PNR data to U.S. government authorities exercising a counter-terrorism function that need PNR for the purpose of preventing or combating terrorism and related crimes in cases (including threats, flights, individuals, and routes of concern) that they are examining or investigating. DHS will ensure that such authorities respect comparable standards of data protection to that applicable to DHS, in particular in relation to purpose limitation, data retention, further disclosure, awareness and training, security standards and sanctions for abuse, and procedures for information, complaints and rectification. Prior to commencing facilitated disclosure, each receiving authority will confirm in writing to DHS that it respects those standards. DHS will inform the EU in writing of the implementation of such facilitated disclosure and respect for the applicable standards before the expiration of the Agreement.

Early Access Period for PNR

While Paragraph 14 limits the number of times PNR can be pulled, the provision puts no such restriction on the “pushing” of data to DHS. The push system is considered by the EU to be less intrusive from a data privacy perspective. The push system does not confer on airlines any discretion to decide when, how or what data to push, however. That decision is conferred on DHS by U.S. law. Therefore, it is understood that DHS will utilize a method of pushing the necessary PNR data that meets the agency's needs for effective risk assessment, taking into account the economic impact upon air carriers.

In determining when the initial push of data is to occur, DHS has discretion to obtain PNR more than 72 hours prior to the departure of a flight so long as action is essential to combat an offense enumerated in Paragraph 3. Additionally, while there are instances in which the U.S. government may have specific information regarding a particular threat, in most instances the available intelligence is less definitive and may require the casting of a broader net to try and uncover both the nature of the threat and the persons involved. Paragraph 14 is therefore understood to permit access to PNR outside of the 72 hour mark when there is an indication that early access is likely to assist in responding to a specific threat to a flight, set of flights, route, or other circumstances associated with offenses described in Paragraph 3 of the Undertakings. In exercising this discretion, DHS will act judiciously and with proportionality.

DHS will move as soon as practicable to a push system for the transfer of PNR data in accordance with the Undertakings and will carry out no later than the end of 2006 the necessary tests for at least one system currently in development if DHS's technical requirements are satisfied by the design to be tested. Without derogating from the Undertakings and in order to avoid prejudging the possible future needs of the system any filters employed in a push system, and the design of the system itself must permit any PNR data in the airline reservation or departure control systems to be pushed to DHS in exceptional circumstances where augmented disclosure is strictly necessary to address a threat to the vital interests of the data subject or other persons.

Data Retention

Several important uses for PNR data help to identify potential terrorists; even data that is more than 3.5 years old can be crucial in identifying links among terrorism suspects. The Agreement will have expired before Paragraph 15 of the Undertakings requires the destruction of any data, and questions of whether and when to destroy PNR data collected in accordance with the Undertakings will be addressed by the United States and the European Union as part of future discussions.

The Joint Review

Given the extensive joint analysis of the Undertakings conducted in September 2005 and the expiration of the agreement prior to the next Joint Review, the question of how and whether to conduct a joint review in 2007 will be addressed during the discussions regarding a future agreement.

Data Elements

The frequent flyer field may offer addresses, telephone numbers, email addresses; all of these, as well as the frequent flyer number itself, may provide crucial evidence of links to terrorism. Similarly, information about the number of bags carried by a passenger may have value in a counterterrorism context. The Undertakings authorize DHS to add data elements to the 34 previously set forth in Attachment “A” of the Undertakings, if such data is necessary to fulfill the purposes set forth in paragraph 3.

With this letter the U.S. has consulted under Paragraph 7 with the EU in connection with item 11 of Attachment A regarding DHS's need to obtain the frequent flier number and any data element listed in Attachment A to the Undertakings wherever that element may be found.

Vital Interests of the Data Subject or Others

Recognizing the potential importance of PNR data in the context of infectious disease and other risks to passengers, DHS reconfirms that access to such information is authorized by paragraph 34, which provides that the Undertakings must not impede the use of PNR for the protection of the vital interests of the data subject or of other persons or inhibit the direct availability of PNR to relevant authorities for the purposes set forth in Paragraph 3 of the Undertakings. “Vital interests” encompasses circumstances in which the lives of the data subject or of others could be at stake and includes access to information necessary to ensure that those who may carry or may have been exposed to a dangerous communicable disease can be readily identified, located, and informed without delay. Such data will be protected in a manner commensurate with its nature and used strictly for the purposes for which it was accessed.

Sincerely yours,

Stewart BAKER

Assistant Secretary for Policy’

(1)  For Council Decision and the PNR Agreement, see OJ L 298, 27.10.2006.

27.10.2006   

EN

Official Journal of the European Union

C 259/4

Reply by the Council Presidency and the Commission to the letter from the USA's Department of Homeland Security

(2006/C 259/02)

‘Stewart Baker

Assistant Secretary for Policy

U.S. Department for Homeland Security

Washington DC 20528

Dear Stewart,

On 11 October 2006 we received, by electronic transmission, your letter to the Council Presidency and the Commission, concerning the interpretation of certain provisions of the Undertakings issued by DHS on 11 May 2004 in connection with the transfer by air carriers of passenger name record (PNR) data.

While taking note of the content of your letter, we wish to reaffirm the importance that the EU and its Member States attach to respect for fundamental rights, in particular to the protection of personal data.

The commitments of DHS to continue to implement the Undertakings allow the EU to deem that, for purposes of the implementation of the Agreement, it ensures an adequate level of data protection.

Yours sincerely,

Irma ERTMAN

Jonathan FAULL’

Commission

27.10.2006   

EN

Official Journal of the European Union

C 259/5

Euro exchange rates (1)

26 October 2006

(2006/C 259/03)

1 euro=

 

Currency

Exchange rate

USD

US dollar

1,2653

JPY

Japanese yen

150,40

DKK

Danish krone

7,4546

GBP

Pound sterling

0,67155

SEK

Swedish krona

9,2265

CHF

Swiss franc

1,5924

ISK

Iceland króna

86,03

NOK

Norwegian krone

8,2875

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5765

CZK

Czech koruna

28,299

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

261,09

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6961

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,8793

RON

Romanian leu

3,5137

SIT

Slovenian tolar

239,60

SKK

Slovak koruna

36,381

TRY

Turkish lira

1,8345

AUD

Australian dollar

1,6600

CAD

Canadian dollar

1,4259

HKD

Hong Kong dollar

9,8456

NZD

New Zealand dollar

1,9332

SGD

Singapore dollar

1,9850

KRW

South Korean won

1 201,78

ZAR

South African rand

9,5042

CNY

Chinese yuan renminbi

9,9907

HRK

Croatian kuna

7,3750

IDR

Indonesian rupiah

11 526,88

MYR

Malaysian ringgit

4,6418

PHP

Philippine peso

63,101

RUB

Russian rouble

33,9300

THB

Thai baht

46,835

(1)  

Source: reference exchange rate published by the ECB.

27.10.2006   

EN

Official Journal of the European Union

C 259/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2006 to 30 September 2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2006/C 259/04)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

20.9.2006

Gardasil

Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/357/001-017

Suspension for injection

J07BM1

22.9.2006

20.9.2006

Silgard

Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/06/358/001-017

Suspension for injection

J07BM1

22.9.2006

20.9.2006

Luminity

Perflutren

Bristol-Myers Squibb Pharma

Belgium Sprl

Chaussée de la Hulpe 185

B-1170 Brussels

EU/1/06/361/001

Solution for dispersion for injection or infusion

V08D A04

22.9.2006

26.9.2006

Suboxone

buprenorphine/ naloxone

Schering Plough Europ

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-180 Brussel

EU/1/06/359/001-004

Sublingual tablet

N07B C51

28.9.2006

26.9.2006

Champix

varenicline tartrate

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-010

Film-coated tablet

N07BA03

28.9.2006

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

5.9.2006

Alpheon

BioPartners GmbH

Eisenstrasse 3

D-65428 Rüsselsheim

Non applicable

7.9.2006

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.9.2006

Aldara

Laboratoires 3M Santé

Boulevard de l'Oise

F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

5.9.2006

1.9.2006

Angiox

The Medicines Company UK Ltd

Suite B

Park House, 11

Milton Park

Abingdon

Oxfordshire OX14 4RS

United Kingdom

EU/1/04/289/001-002

7.9.2006

1.9.2006

Rebif

Serono Europe Ltd.

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/98/063/001-007

7.9.2006

1.9.2006

Iscover

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/98/070/001a-001b

EU/1/98/070/002a-002b

EU/1/98/070/003a-003b

EU/1/98/070/004a-004b

11.9.2006

1.9.2006

Fasturtec

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/00/170/001-002

7.9.2006

1.9.2006

Neoclarityn

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/00/161/001-034

7.9.2006

1.9.2006

Replagal

TKT Europe AB

Rinkebyvägen 11B

S-182 36 Danderyd

EU/1/01/189/001-006

7.9.2006

1.9.2006

Liprolog

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/01/195/003

EU/1/01/195/006

EU/1/01/195/011

EU/1/01/195/014

7.9.2006

1.9.2006

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/01/188/001-006

7.9.2006

1.9.2006

Azomyr

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/00/157/001-034

7.9.2006

1.9.2006

Aerius

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/00/160/001-035

6.9.2006

1.9.2006

Remicade

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

6.9.2006

1.9.2006

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

6.9.2006

1.9.2006

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/134/030-037

6.9.2006

1.9.2006

Viramune

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

6.9.2006

1.9.2006

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/99/110/001-009

6.9.2006

1.9.2006

Betaferon

Schering Aktiengesellschaft

D-13342 Berlin

EU/1/95/003/003-006

6.9.2006

1.9.2006

Viread

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/01/200/001

7.9.2006

1.9.2006

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/001-009

6.9.2006

1.9.2006

Rebetol

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/99/107/001-005

7.9.2006

1.9.2006

Humalog

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/007/005

EU/1/96/007/008

EU/1/96/007/016

EU/1/96/007/024

EU/1/96/007/027

7.9.2006

1.9.2006

Apidra

Sanofi-Aventis Deutschland GmbH

Brueningstrasse 50

D-65926 Frankfurt am Main

EU/1/04/285/001-036

7.9.2006

1.9.2006

ViraferonPeg

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/00/132/001-050

7.9.2006

1.9.2006

IntronA

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/99/127/001-044

8.9.2006

1.9.2006

Viraferon

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/99/128/001-037

8.9.2006

1.9.2006

PegIntron

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles/

Stallestraat, 73

B-1180 Brussel

EU/1/00/131/001-050

8.9.2006

1.9.2006

Invanz

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/02/216/001-002

8.9.2006

7.9.2006

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/001-035

12.9.2006

7.9.2006

Lyrica

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/04/279/001-035

12.9.2006

7.9.2006

Rapamune

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/01/171/001

EU/1/01/171/007-012

12.9.2006

7.9.2006

Avonex

Biogen Idec Ltd

5 Roxborough Way

Foundation Park, Maidenhead

Berkshire SL6 3UD

United Kindgom

EU/1/97/033/001-003

12.9.2006

7.9.2006

Levviax

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

12.9.2006

7.9.2006

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

12.9.2006

7.9.2006

Zonegran

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

EU/1/04/307/001-010

12.9.2006

12.9.2006

Arixtra

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/018-020

15.9.2006

12.9.2006

ProQuad

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/05/323/001-013

14.9.2006

12.9.2006

Tamiflu

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/02/222/001-002

14.9.2006

12.9.2006

Quixidar

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/207/018-020

15.9.2006

12.9.2006

Zyprexa Velotab

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/99/125/001-008

14.9.2006

12.9.2006

Zyprexa

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/008-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-022

14.9.2006

13.9.2006

Zyprexa Velotab

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/99/125/001-008

15.9.2006

13.9.2006

Zyprexa

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/008-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-022

15.9.2006

14.9.2006

Glivec

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

18.9.2006

14.9.2006

Prialt

Elan Pharma International Ltd

WIL House

Shannon Business Park

Shannon

County Clare

Ireland

EU/1/04/302/001-004

18.9.2006

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

18.9.2006

18.9.2006

DaTSCAN

GE Healthcare Limited

Little Chalfont

Bucks HP7 9NA

United Kingdom

EU/1/00/135/001-002

20.9.2006

21.9.2006

Fuzeon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/03/252/001-003

25.9.2006

21.9.2006

Glivec

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/198/001-013

25.9.2006

26.9.2006

Aclasta

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/05/308/001-002

28.9.2006

26.9.2006

Enbrel

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/013-018

28.9.2006

29.9.2006

Cancidas

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/01/196/001-003

3.10.2006

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

1.9.2006

Poulvac FluFend H5N3 RG

Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) 256 — 4046 HA Units

Fort Dodge Animal Health Ltd

Flanders Road

Hedge End

Southampton SO30 4QH

United Kingdom

EU/2/06/060/001-002

Emulsion for injection

QI01AA23

7.9.2006

1.9.2006

Nobilis Influenza H5N2

Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/06/061/001-004

Emulsion for injection

QI01AA23

7.9.2006

29.9.2006

Cerenia

Maropitant

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/06/062/001-004

Tablet

QA04AD90

3.10.2006

EU/2/06/062/005

Solution for injection

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency

7, Westferry Circus, Canary Wharf

LONDON E14 4HB

United Kingdom

(1)  OJ L 136 of 30 April 2004, page 1.

27.10.2006   

EN

Official Journal of the European Union

C 259/13

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2006/C 259/05)

(Text with EEA relevance)

Date of adoption of the decision

10.2.2006

Reference number of the aid

N 13/06

Member State

Poland

Region

Dolnośląski

Title

Program pomocy regionalnej dla przedsiębiorców inwestujących na terenie gminy Kobierzyce

Legal basis

Ustawa o samorządzie gminnym z dnia 8 marca 1990 r., Dz.U. z 2001 r. nr 142 poz. 1591 z późn. zm.

Ustawa o podatkach i opłatach lokalnych z dnia 12 stycznia 1991 r., Dz.U. z 2002 r. nr 9, poz. 84 z późn. zm.

Ustawa o podatkach i opłatach lokalnych z dnia 12 stycznia 1991 r., Dz.U. z 2002 r. nr 9, poz. 84 z późn. zm.

Type of measure

Aid scheme

Objective

Regional development

Form of aid

Tax advantage

Budget

PLN 50 000 000

Intensity

50 %

Duration

31.12.2006

Economic sectors

All sectors

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

26.4.2006

Reference number of the aid

N 16/06 & N 17/06

Member State

Germany

Region

Brandenburg

Title

First Solar (MSF 2002 — SME bonus)

Legal basis

Massnahmen N 642/2002, N 142a/2004, N 297/91

Type of measure

Individual aid

Objective

Regional development — Small and medium-sized enterprises

Form of aid

Tax advantage — Direct grant — Guarantee

Budget

EUR 45,48 million

Intensity

39,3 %

Duration

2006-2008

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

16.5.2006

Reference number of the aid

N 35/06

Member State

France

Title

Notification d'un régime de garantie dans le secteur de la construction navale

Legal basis

Loi no 2005-1720 du 30 décembre 2005 de finances rectificative pour 2005 — Article 119

Type of measure

Aid scheme

Objective

Sectoral development

Form of aid

Guarantee

Budget

Annual budget: —

Overall budget: —

Duration

4 years

Economic sectors

Shipbuilding

Name and address of the granting authority

Caisse française de développement industriel

45, rue Saint Dominique

F-75007 Paris

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

3.7.2006

Reference number of the aid

N 166/06

Member State

Spain

Region

Asturias

Title

Ayudas a Temper Phoenix Ibérica, S.L.

Legal basis

—

Propuesta de resolución provisional del Instituto de Desarrollo Económico del Principado de Asturias por la que se concede subvención a la empresa Temper Phoenix Ibérica, S.L. para la puesta en marcha de un proyecto de inversión empresarial localizado en Llanera.

—

Ley 38/2003, de 17 de noviembre, General de Subvenciones.

—

Ley del Principado de Asturias 2/2002, de 12 de abril, del Instituto de Desarrollo Económico del Principado de Asturias.

—

Decreto 14/2000, de 10 de febrero, primera modificación del Decreto 79/92, de 29 de octubre, por el que se regula el régimen general de concesión de subvenciones del principado de Asturias

Type of measure

Individual aid

Objective

Regional development

Form of aid

Direct grant

Budget

EUR 1,95 million

Intensity

16,81 % NGE

Duration

31.12.2006

Economic sectors

Limited to electrical and optical equipment

Name and address of the granting authority

Gobierno del Principado de Asturias

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

7.6.2006

Reference number of the aid

N 422/05

Member State

Germany

Region

Sachsen-Anhalt

Title

Neckermann Renewables Wittneberg GmbH

Legal basis

Gemeinschaftsaufgabe Verbesserung der regionalen Wirtschaftsstruktur (N 642/2002), Investitionszulagengesetz 2005 (N 142a/2005)

Type of measure

Individual aid

Objective

Regional development

Form of aid

Direct grant

Budget

EUR 30,04 million

Intensity

45,28 %

Duration

October 2004-October 2007

Economic sectors

Chemical and pharmaceutical industry

Other information

Investment premium

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

13.9.2006

Reference number of the aid

N 513/05

Member State

Germany

Title

KMU-Förderprogramm des Landes Sachsen zur Unterstützung von Unternehmen nach Insolvenz

Legal basis

§§ 23 und 44 der Haushaltsordnung des Freistaates Sachsen

Type of measure

Aid scheme

Objective

Small and medium-sized enterprises

Budget

Annual budget: —

Overall budget: EUR 14,6 million

Economic sectors

All sectors

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

14.8.2006

Reference number of the aid

NN 39/06

Member State

Belgium

Region

Région wallonne

Title

Aide au sauvetage en faveur de l'entreprise De Poortere Frères SA

Legal basis

Décision du gouvernement wallon en date du 11 mai 2006 fondée sur le décret du 6 mai 1999 portant modification du chapitre V de la loi du 2 avril 1962 créant une Société Nationale et des Sociétés Régionales d'Investissement

Type of measure

Individual aid

Objective

Rescue of firms in difficulty

Form of aid

Soft loan

Budget

Annual budget: —

Overall budget: EUR 1,25 million

Duration

23 May 2006-23 November 2006

Economic sectors

Textiles

Name and address of the granting authority

Région wallone, SOGEPA

Boulevard d'Avroy 39

B-4000 Liège

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

27.10.2006   

EN

Official Journal of the European Union

C 259/17

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2006/C 259/06)

Date of adoption of the decision:

Member State: France

Aid No: NN 36/06 (ex N 255/06)

Title: Rescue aid for the undertaking, DUC

Objective: To rescue an undertaking in difficulty

Legal basis: Circulaire du ministre de l'agriculture et de la pêche DPEI/SDEPA/C 2006-4019 du 15 mars 2006

Budget: EUR 6,5 million

Aid intensity or amount: EUR 2,1 million in the form of a deferment of tax and social security liabilities and EUR 4,4 million in the form of a repayable advance subject to an interest rate of 3,7 %

Duration: Six months

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision:

Member State: Italy (Veneto)

Aid No: N 301/04

Title: Specific investments in agricultural holdings

Objective: Investments in the purchase of plants, the creation of energy-saving or energy-generation systems and the introduction of quality systems

Legal basis: Legge regionale 12 dicembre 2003, n. 40 ‘Nuove norme per gli interventi in agricoltura’, articolo 17bis, e legge regionale n. 8 del 9 aprile 2004.

Legge regionale 25 febbraio 2005, n. 5, articolo 13

Budget: EUR 300 000 for the first year, then amount to be fixed annually

Aid intensity or amount: Between 40 and 55 %

Duration: Six years

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision:

Member State: The Republic of Estonia

Aid No: N 338/05

Title: Aid to implement the national programme for the eradication and control of outbreaks of harmful plant diseases and pests

Objective: Combating plant diseases

Legal basis:

—

Taimekaitseseadus, vastu võetud 21. aprillil 2004, jõustunud 1. mail 2004 (RT I, 28.4.2004, 32, 226), § 4, 9, 15.

—

Ministeeriumi määrus “Ohtlike taimekahjustajate nimekiri” (RT L, 15.7.2004, 96, 1503)

—

Ministeeriumi määrus “Ohtliku taimekahjustajaga saastunud, saastumisohus või saastumiskahtlasel taimel, taimsel saadusel või muul objektil leiduva ohtliku taimekahjustaja liigile kohased tõrjeabinõud” (RT L, 24.3.2005, 33, 469)

—

Ministeeriumi määruse eelnõu “Tõrjeabinõude rakendamisega seotud kulude osaline hüvitamine”

Budget: 3 million EEK per annum (approximately EUR 191 000)

Aid intensity or amount: Up to 100 %

Duration: Unlimited

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision:

Member State: United Kingdom (Northern Ireland)

Aid No: NN 2/06 (ex N 660/B/2000)

Title: Climate change levy rebate — Annex I-products (Northern Ireland)

Objective: A 100 % rebate on the applicable climate change levy rate is proposed for gas in Northern Ireland

Legal basis: Schedule 6 of the Finance Act 2000

Budget: 2001: GBP 260 000

2002: GBP 270 000

2003: GBP 330 000

2004: GBP 290 000

2005: GBP 310 000

Total: GBP 1 460 000 (EUR 2 146 000)

Aid intensity or amount: 100 % rebate on the applicable levy rates

Duration: 1 April 2001 to 31 March 2006

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

27.10.2006   

EN

Official Journal of the European Union

C 259/19

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2006/C 259/07)

Date of adoption of the decision

12.7.2006

Aid No

N 337/06

Member State

Italy

Region

Veneto

Title

Assistance in farming areas affected by natural disasters (excessive snow from 26 to 27 January 2006 in the province of Belluno, Veneto)

Legal basis

Decreto legislativo n. 102/2004

Type of measure

Aid scheme

Objectives

To compensate for damage to agricultural production and farming structures as a result of bad weather

Budget

See the approved scheme (NN 54/A/04)

Intensity

Up to 80 % for damage to agricultural production, up to 100 % for damage to farming structures

Duration

Until the final payment is made

Economic sectors

Agriculture

Name and address of the granting authority

Ministero delle politiche agricole e forestali

Via XX settembre 20

I-00187 Roma

Other information

Measure applying the scheme approved by the Commission under State aid NN 54/A/04 (Commission letter C(2005)1622 final, dated 7 June 2005)

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

13.9.2006

Reference number of the aid

N 462/06

Member State

Belgium

Region

Flanders

Title

Promotion of the bakery and frozen and canned vegetables sectors

Legal basis

Besluit van de Vlaamse regering van 4 februari 1997 betreffende de verplichte bijdragen bestemd voor de promotie en afzetbevordering van de Vlaamse producten van de sectoren landbouw, tuinbouw en visserij

Decreet van 7 mei 2004 betreffende het privaatrechterlijk vormgeven van het extern verzelfstandigd agentschap Vlaams Centrum voor Agro- en Visserijmarketing

Type of measure

Aid scheme

Objective

The aim of this measure is to promote products of the bakery and frozen and canned vegetables sectors

Form of aid

Annual payments

Budget

EUR 1 380 000 per year

Intensity

Bakery sector: 100 %

Frozen and canned vegetables: 60 %

Duration

Bakery sector: indefinite

Frozen and canned vegetables: 2006-08

Economic sectors

Bakery and frozen and canned vegetables sectors

Name and address of the granting authority

Vlaamse overheid, Departement Landbouw en Visserij

Treurenberg 16

B-1000 Brussel

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

31.8.2006

Reference number of the aid

N 499/06

Member State

The Netherlands

Title

Wijziging van de steunmaatregel overname van de steunmaatregelen van het Landbouwschap door het Productschap voor Vee en Vlees, steunmaatregel N 413/1998

Boeren die rosé kalveren fokken

Legal basis

Wet op de bedrijfsorganisaties (artikel 126), Instellingsbesluit Productschap Vee en Vlees (artikelen 10 en 12), Verordening algemene bepalingen heffingen (PVV) 2006, Verordening bestemmingsheffingen runderen en kalveren (PVV) 2006

Type of measure

Aid Scheme; adjustment of the aid scheme N 413/98, N 213/97, N 995/95 and 613/91/A concerning research and development in the rose veal calf sector

Objective

The measure changes the levy that is imposed on calfs in a separate levy for rose veal calfs and white veal cal's. The maximum amount of the levy concerning white veal calfs remains the same. The maximum amount of the levy for rose veal calf's is raised, because of the planned higher cost in research for these specific calf's

Form of aid

Para fiscal levy

Budget

Planned expectation approximately: EUR 60 000

Intensity

EUR 100 per farmer

Duration

Indefinite

Economic sectors

Veal calf's, sub sector rose veal calf's

Name and address of the granting authority

Het Productschap voor Vee en Vlees

Postbus 4600

2700 AL Zoetermeer

Nederland

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

31.8.2006

Reference number of the aid

N 519/05

Member State

Hungary

Title

Állati eredetű hulladékok ártalmatlanításának támogatása

Legal basis

A földművelésügyi és vidékfejlesztési miniszter …/2006. ( ) FVM rendelete az állati eredetű hulladékok ártalmatlanításának támogatásáról

Type of measure

Aid scheme

Objective

Contribution to the costs of destruction of fallen stock

Form of aid

Direct grant

Budget

Annual expenditure planned for 2006: HUF 280 million

Intensity

40 % of the eligible costs

Duration

The scheme will be in force until 31 December 2010.

Economic sectors

Agriculture

Name and address of the granting authority

Földművelésügyi és Vidékfejlesztési Minisztérium

Kossuth tér 11

H-1055 Budapest

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/