# Official Journal C 44/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.044.eng |
| --- | --- |
| Official Journal
  of the European Union | C 44 |
| | |
| English edition | Information and Notices | Volume 5516 February 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.044.eng

Official Journal

of the European Union

C 44

English edition

Information and Notices

Volume 5516 February 2012

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| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 044/01 | Non-opposition to a notified concentration (Case COMP/M.6456 — EDF/Kogeneracja) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 044/01

Non-opposition to a notified concentration (Case COMP/M.6456 — EDF/Kogeneracja) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 044/02 | Euro exchange rates | 2 |
| | NOTICES FROM MEMBER STATES |
| 2012/C 044/03 | Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 | 3 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2012/C 044/04 | Publication of Sogn og Fjordane County Council’s notification of tender procedure pursuant to Article 7.2 of Regulation (EC) No 1370/2007 of the European Parliament and of the Council on public passenger transport services by rail and by road and repealing Council Regulations (EEC) No 1191/69 and (EEC) No 1107/70 | 5 |
| | Standing Committee of the EFTA States |
| 2012/C 044/05 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the first half of 2011 | 6 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 044/02

Euro exchange rates

2

NOTICES FROM MEMBER STATES

2012/C 044/03

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001

3

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2012/C 044/04

Publication of Sogn og Fjordane County Council’s notification of tender procedure pursuant to Article 7.2 of Regulation (EC) No 1370/2007 of the European Parliament and of the Council on public passenger transport services by rail and by road and repealing Council Regulations (EEC) No 1191/69 and (EEC) No 1107/70

5

Standing Committee of the EFTA States

2012/C 044/05

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

6

| | V   Announcements |
| --- | --- |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2012/C 044/06 | Action brought on 15 December 2011 by the EFTA Surveillance Authority against Iceland (Case E-16/11) | 21 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY |
| | European Commission |
| 2012/C 044/07 | Notice of initiation of an anti-dumping proceeding concerning imports of ceramic tableware and kitchenware originating in the People's Republic of China | 22 |
| 2012/C 044/08 | Notice of initiation of an anti-dumping proceeding concerning imports of threaded tube or pipe cast fittings, of malleable cast iron originating in the People's Republic of China, Thailand and Indonesia | 33 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2012/C 044/09 | Prior notification of a concentration (Case COMP/M.6520 — Cinven/George Topco) (
  1
  ) | 44 |
| | OTHER ACTS |
| | European Commission |
| 2012/C 044/10 | Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs | 45 |

V   Announcements

COURT PROCEEDINGS

EFTA Court

2012/C 044/06

Action brought on 15 December 2011 by the EFTA Surveillance Authority against Iceland (Case E-16/11)

21

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

European Commission

2012/C 044/07

Notice of initiation of an anti-dumping proceeding concerning imports of ceramic tableware and kitchenware originating in the People's Republic of China

22

2012/C 044/08

Notice of initiation of an anti-dumping proceeding concerning imports of threaded tube or pipe cast fittings, of malleable cast iron originating in the People's Republic of China, Thailand and Indonesia

33

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2012/C 044/09

Prior notification of a concentration (Case COMP/M.6520 — Cinven/George Topco) (
  1
  )

1

44

OTHER ACTS

European Commission

2012/C 044/10

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

45

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 16.2.2012 | EN | Official Journal of the European Union | C 44/1 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/1

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Non-opposition to a notified concentration

(Case COMP/M.6456 — EDF/Kogeneracja)

(Text with EEA relevance)

2012/C 44/01

On 8 February 2012, 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:

| — | in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

| — | in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32012M6456. EUR-Lex is the on-line access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32012M6456. EUR-Lex is the on-line access to the European law.

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 16.2.2012 | EN | Official Journal of the European Union | C 44/2 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/2

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Euro exchange rates (1)

15 February 2012

2012/C 44/02

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3092 |
| JPY | Japanese yen | 102,73 |
| DKK | Danish krone | 7,4324 |
| GBP | Pound sterling | 0,83480 |
| SEK | Swedish krona | 8,7861 |
| CHF | Swiss franc | 1,2073 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 7,5285 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,170 |
| HUF | Hungarian forint | 289,63 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6987 |
| PLN | Polish zloty | 4,1875 |
| RON | Romanian leu | 4,3470 |
| TRY | Turkish lira | 2,3101 |
| AUD | Australian dollar | 1,2195 |
| CAD | Canadian dollar | 1,3053 |
| HKD | Hong Kong dollar | 10,1514 |
| NZD | New Zealand dollar | 1,5626 |
| SGD | Singapore dollar | 1,6513 |
| KRW | South Korean won | 1 470,35 |
| ZAR | South African rand | 10,1010 |
| CNY | Chinese yuan renminbi | 8,2412 |
| HRK | Croatian kuna | 7,5830 |
| IDR | Indonesian rupiah | 11 779,18 |
| MYR | Malaysian ringgit | 3,9756 |
| PHP | Philippine peso | 55,931 |
| RUB | Russian rouble | 39,3175 |
| THB | Thai baht | 40,297 |
| BRL | Brazilian real | 2,2475 |
| MXN | Mexican peso | 16,6897 |
| INR | Indian rupee | 64,6420 |

Currency

Exchange rate

USD

US dollar

1,3092

JPY

Japanese yen

102,73

DKK

Danish krone

7,4324

GBP

Pound sterling

0,83480

SEK

Swedish krona

8,7861

CHF

Swiss franc

1,2073

ISK

Iceland króna

NOK

Norwegian krone

7,5285

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,170

HUF

Hungarian forint

289,63

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6987

PLN

Polish zloty

4,1875

RON

Romanian leu

4,3470

TRY

Turkish lira

2,3101

AUD

Australian dollar

1,2195

CAD

Canadian dollar

1,3053

HKD

Hong Kong dollar

10,1514

NZD

New Zealand dollar

1,5626

SGD

Singapore dollar

1,6513

KRW

South Korean won

1 470,35

ZAR

South African rand

10,1010

CNY

Chinese yuan renminbi

8,2412

HRK

Croatian kuna

7,5830

IDR

Indonesian rupiah

11 779,18

MYR

Malaysian ringgit

3,9756

PHP

Philippine peso

55,931

RUB

Russian rouble

39,3175

THB

Thai baht

40,297

BRL

Brazilian real

2,2475

MXN

Mexican peso

16,6897

INR

Indian rupee

64,6420

---

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

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NOTICES FROM MEMBER STATES

| 16.2.2012 | EN | Official Journal of the European Union | C 44/3 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/3

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Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001

2012/C 44/03

Aid No: SA.33986 (11/XA)

Member State: Italy

Region: Lazio

Title of aid scheme or name of company receiving an individual aid: Interventi di divulgazione e comunicazione in ambito agricolo, agroalimentare e forestale per l’innovazione e lo sviluppo integrato delle zone rurali del Lazio (legge regionale 4 agosto 2009, n. 19) — Regime di esenzione a norma del regolamento (CE) n. 1857/2006 — Avviso pubblico ARSIAL: interventi sub lettere A, C, D, E, F, H, I.

Legal basis:

| 1) | LR 4 agosto 2009, n. 19 «Divulgazione e comunicazione in ambito agricolo, agroalimentare e forestale per l'innovazione e lo sviluppo integrato delle zone rurali della Regione»; |
| --- | --- |

1)

LR 4 agosto 2009, n. 19 «Divulgazione e comunicazione in ambito agricolo, agroalimentare e forestale per l'innovazione e lo sviluppo integrato delle zone rurali della Regione»;

| 2) | deliberazione Giunta regionale del 17 dicembre 2010, n. 591 concernente «Approvazione del Piano annuale degli interventi di divulgazione e comunicazione nell'ambito agricolo ...»; |
| --- | --- |

2)

deliberazione Giunta regionale del 17 dicembre 2010, n. 591 concernente «Approvazione del Piano annuale degli interventi di divulgazione e comunicazione nell'ambito agricolo ...»;

| 3) | avviso pubblico Arsial: «Incentivazione agli interventi di divulgazione e comunicazione in ambito agricolo ...». |
| --- | --- |

3)

avviso pubblico Arsial: «Incentivazione agli interventi di divulgazione e comunicazione in ambito agricolo ...».

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: Annual overall amount of the budget planned under the scheme: EUR 0,90 million

Maximum aid intensity: 100 %

Date of implementation: —

Duration of scheme or individual aid award: 15 February 2012-31 December 2013

Objective of aid: Technical support (Article 15 of Regulation (EC) No 1857/2006)

Sector(s) concerned: Crop and animal production, hunting and related service activities

Name and address of the granting authority:

| ARSIAL — Agenzia Regionale per lo Sviluppo e l'Innovazione dell'Agricoltura del Lazio |
| --- |
| Via Rodolfo Lanciani 38 |
| 00162 Roma RM |
| ITALIA |

ARSIAL — Agenzia Regionale per lo Sviluppo e l'Innovazione dell'Agricoltura del Lazio

Via Rodolfo Lanciani 38

00162 Roma RM

ITALIA

Website: http://www.arsial.it

Other information: —

Aid No: SA.34310 (12/XA)

Member State: Belgium

Region: Vlaams Gewest

Title of aid scheme or name of company receiving an individual aid: Facultatieve subsidie aan het Steunpunt Hoeveproducten

Legal basis: Ministerieel besluit houdende de toekenning van een facultatieve subsidie aan KVLV vzw betreffende het Steunpunt Hoeveproducten

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: Annual overall amount of the budget planned under the scheme: EUR 0,07 million

Maximum aid intensity: 100 %

Date of implementation: —

Duration of scheme or individual aid award: 8 February 2012-31 December 2012

Objective of aid: Technical support (Article 15 of Regulation (EC) No 1857/2006)

Sector(s) concerned: Crop and animal production, hunting and related service activities

Name and address of the granting authority:

| Vlaamse Overheid |
| --- |
| Departement Landbouw en Visserij |
| Koning Albert II-laan 35, bus 40 |
| 1030 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Vlaamse Overheid

Departement Landbouw en Visserij

Koning Albert II-laan 35, bus 40

1030 Bruxelles/Brussel

BELGIQUE/BELGIË

Website: http://lv.vlaanderen.be/nlapps/docs/default.asp?id=2357

Other information: —

Aid No: SA.34311 (12/XA)

Member State: Germany

Region: Hamburg

Title of aid scheme or name of company receiving an individual aid: Richtlinie für die Gewährung von Beihilfen für Maßnahmen zum Schutz der Rinder vor einer Infektion mit dem Bovinen Herpesvirus Typ 1 (BHV1-Beihilfe-Richtlinie)

Legal basis: § 7 Absatz 1 Nummer 3 des Hamburgischen Ausführungsgesetzes zum Tierseuchengesetz vom 6. Februar 2007 (HmbGVBl. S. 68), zuletzt geändert am 6. April 2010 (HmbGVBl. S. 260)

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: Annual overall amount of the budget planned under the scheme: EUR 0,02 million

Maximum aid intensity: 100 %

Date of implementation: —

Duration of scheme or individual aid award: 8 February 2012-31 December 2013

Objective of aid: Animal diseases (Article 10 of Regulation (EC) No 1857/2006)

Sector(s) concerned: Agriculture, forestry and fishing

Name and address of the granting authority:

| Behörde für Gesundheit und Verbraucherschutz |
| --- |
| Fachabteilung Lebensmittelsicherheit und Veterinärwesen |
| Billstraße 80 |
| 20539 Hamburg |
| DEUTSCHLAND |

Behörde für Gesundheit und Verbraucherschutz

Fachabteilung Lebensmittelsicherheit und Veterinärwesen

Billstraße 80

20539 Hamburg

DEUTSCHLAND

Website: http://www.hamburg.de/contentblob/2926426/data/bhv1-beihilfe-richtlinie.pdf

http://www.landesrecht.hamburg.de/jportal/portal/page/bshaprod.psml?showdoccase=1&doc.id=jlr-TierSGAGHArahmen&doc.part=X&doc.origin=bs&st=lr

Other information: —

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 16.2.2012 | EN | Official Journal of the European Union | C 44/5 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/5

---

Publication of Sogn og Fjordane County Council’s notification of tender procedure pursuant to Article 7.2 of Regulation (EC) No 1370/2007 of the European Parliament and of the Council on public passenger transport services by rail and by road and repealing Council Regulations (EEC) No 1191/69 and (EEC) No 1107/70

2012/C 44/04

| 1. | Name and address of the competent authority:





  Sogn og Fjordane County Council |
| --- | --- |
| Department of transport services |
| Askedalen 2 |
| 6863 Leikanger |
| NORWAY |

1.

Name and address of the competent authority:

Sogn og Fjordane County Council

Department of transport services

Askedalen 2

6863 Leikanger

NORWAY

| 2. | Type of award envisaged:
  Open tender procedure |
| --- | --- |

2.

Type of award envisaged:

Open tender procedure

| 3. | Services and areas potentially covered by the award:
  Local/regional passenger services by bus, covering the areas of Stryn, Hornindal, Eid, Vågsøy and Selje municipalities in Sogn og Fjordane county. |
| --- | --- |

3.

Services and areas potentially covered by the award:

Local/regional passenger services by bus, covering the areas of Stryn, Hornindal, Eid, Vågsøy and Selje municipalities in Sogn og Fjordane county.

---

Standing Committee of the EFTA States

| 16.2.2012 | EN | Official Journal of the European Union | C 44/6 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/6

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

2012/C 44/05

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note the following lists concerning marketing authorisations for medicinal products for the period 1 January-30 June 2011, at their meeting on 30 September 2011:

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

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations

Annex V

List of suspended marketing authorisations

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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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/578/001 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Iceland | 29.4.2011 |
| EU/1/10/635/001-014 | Olanzapin Apotex | Norway | 14.2.2011 |
| EU/1/10/639/001-030 | Telmisartan Actavis | Norway | 17.3.2011 |
| EU/1/10/641/001 | Ruconest | Iceland | 24.1.2011 |
| EU/1/10/642/001-004 | Ibandronic Acid Teva | Iceland | 17.1.2011 |
| EU/1/10/647/001-002 | Myclausen | Iceland | 21.1.2011 |
| EU/1/10/647/001-028 | Twynsta | Iceland | 21.1.2011 |
| EU/1/10/650/001-015 | Clopidogrel Teva Generics BV | Iceland | 1.2.2011 |
| EU/1/10/651/001-015 | Clopidogrel HCS | Iceland | 1.2.2011 |
| EU/1/10/654/001-004 | Leflunomide ratiopharm | Iceland | 14.3.2011 |
| EU/1/10/656/001-006 | Possia | Iceland | 13.1.2011 |
| EU/1/10/656/001-006 | Possia | Norway | 25.1.2011 |
| EU/1/10/657/001-002 | Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia | Iceland | 14.3.2011 |
| EU/1/10/657/001-002 | Prepandemic Influenza Vaccine | Norway | 3.1.2011 |
| EU/1/10/658/001-002 | Aflunov | Iceland | 14.3.2011 |
| EU/1/10/658/001-002 | Aflunov | Norway | 3.1.2011 |
| EU/1/10/659/001-010 | Iasibon | Iceland | 14.2.2011 |
| EU/1/10/659/001-010 | Iasibon | Norway | 17.2.2011 |
| EU/1/10/659/001-010 | Iasibon | Liechtenstein | 28.2.2011 |
| EU/1/10/660/001-002 | Potactasol | Iceland | 16.3.2011 |
| EU/1/10/660/001-002 | Potactasol | Liechtenstein | 28.2.2011 |
| EU/1/10/661/001-002 | Fluenz | Iceland | 16.3.2011 |
| EU/1/10/661/001-002 | Fluenz | Liechtenstein | 28.2.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Iceland | 17.2.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Liechtenstein | 28.2.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Norway | 17.3.2011 |
| EU/1/10/662/001-002 | Docetaxel Teva Pharma | Norway | 17.3.2011 |
| EU/1/10/663/001-002 | Lamivudine/Zidovudine Teva | Norway | 31.3.2011 |
| EU/1/10/663/001-002 | Lamivudine/Zidovudine Teva | Liechtenstein | 30.4.2011 |
| EU/1/10/664/001 | Pumarix | Iceland | 8.4.2011 |
| EU/1/10/664/001 | Pumarix | Norway | 13.4.2011 |
| EU/1/10/664/001 | Pumarix | Liechtenstein | 30.4.2011 |
| EU/1/10/665/001-004 | Entacapone Teva | Iceland | 21.3.2011 |
| EU/1/10/665/001-004 | Entacapone Teva | Norway | 4.4.2011 |
| EU/1/10/665/001-004 | Entacapone Teva | Liechtenstein | 30.4.2011 |
| EU/1/11/666/001-003 | Libertek | Iceland | 24.3.2011 |
| EU/1/11/666/001-003 | Libertek | Norway | 15.3.2011 |
| EU/1/11/666/001-003 | Libertek | Liechtenstein | 30.4.2011 |
| EU/1/11/667/001-003 | Esbriet | Liechtenstein | 30.4.2011 |
| EU/1/11/667/001-003 | Esbriet | Iceland | 25.3.2011 |
| EU/1/11/667/001-003 | Esbriet | Norway | 15.3.2011 |
| EU/1/11/667/001-003 | Esbriet | Norway | 15.3.2011 |
| EU/1/11/668/001-003 | Daliresp | Iceland | 12.4.2011 |
| EU/1/11/668/001-003 | Daliresp | Norway | 15.3.2011 |
| EU/1/11/668/001-003 | Daliresp | Liechtenstein | 30.4.2011 |
| EU/1/11/669/001-004 | Teysuno | Iceland | 12.4.2011 |
| EU/1/11/669/001-004 | Teysuno | Norway | 24.5.2011 |
| EU/1/11/669/001-004 | Teysuno | Liechtenstein | 30.4.2011 |
| EU/1/11/671/001 | Xiapex | Iceland | 28.3.2011 |
| EU/1/11/671/001 | Xiapex | Norway | 31.3.2011 |
| EU/1/11/671/001 | Xiapex | Liechtenstein | 30.4.2011 |
| EU/1/11/672/001-006 | Xeplion | Iceland | 8.4.2011 |
| EU/1/11/672/001-006 | Xeplion | Norway | 5.4.2011 |
| EU/1/11/672/001-006 | Xeplion | Liechtenstein | 30.4.2011 |
| EU/1/11/673/001-024 | Ifirmacombi | Iceland | 4.4.2011 |
| EU/1/11/673/001-024 | Ifirmacombi | Norway | 6.4.2011 |
| EU/1/11/673/001-024 | Ifirmacombi | Liechtenstein | 30.4.2011 |
| EU/1/11/674/001-010 | Repso | Iceland | 13.4.2011 |
| EU/1/11/674/001-010 | Repso | Norway | 26.4.2011 |
| EU/1/11/674/001-010 | Repso | Liechtenstein | 30.4.2011 |
| EU/1/11/675/001-0010 | Leflunomide Teva | Iceland | 8.4.2011 |
| EU/1/11/675/001-010 | Lefluomide Teva | Norway | 11.4.2011 |
| EU/1/11/675/001-010 | Leflunomid Teva | Liechtenstein | 30.4.2011 |
| EU/1/11/676/001 | Jevtana | Iceland | 12.4.2011 |
| EU/1/11/676/001 | Jevtana | Norway | 6.4.2011 |
| EU/1/11/676/001 | Jevtana | Liechtenstein | 30.4.2011 |
| EU/1/11/677/001-004 | Gilenya | Iceland | 13.4.2011 |
| EU/1/11/677/001-004 | Gilenya | Norway | 28.3.2011 |
| EU/1/11/677/001-004 | Gilenya | Liechtenstein | 30.4.2011 |
| EU/1/11/678/001-002 | Halaven | Iceland | 14.4.2011 |
| EU/1/11/678/001-002 | Halaven | Norway | 6.4.2011 |
| EU/1/11/678/001-002 | Halaven | Liechtenstein | 30.4.2011 |
| EU/1/11/679/001-006 | Pravafenix | Iceland | 10.5.2011 |
| EU/1/11/679/001-006 | Pravafenix | Norway | 11.5.2011 |
| EU/1/11/679/001-006 | Pravafenix | Liechtenstein | 30.4.2011 |
| EU/1/11/680/001-080 | Riprazo HCT | Iceland | 29.4.2011 |
| EU/1/11/680/001-080 | Riprazo HCT | Norway | 24.5.2011 |
| EU/1/11/680/001-080 | Riprazo HCT | Liechtenstein | 30.4.2011 |
| EU/1/11/681/001-013 | Trobalt | Iceland | 19.4.2011 |
| EU/1/11/681/001-013 | Trobalt | Norway | 4.4.2011 |
| EU/1/11/681/001-013 | Trobalt | Liechtenstein | 30.6.2011 |
| EU/1/11/681/001-013 | Trobalt | Liechtenstein | 30.4.2011 |
| EU/1/11/682/001 | Methylthioninium chloride Proveblue | Iceland | 6.6.2011 |
| EU/1/11/682/001 | Methylhionininium chloride Proveblue | Norway | 27.6.2011 |
| EU/1/11/682/001 | Methylthioninchlorid Proveblue | Liechtenstein | 30.6.2011 |
| EU/1/11/686/001-056 | Rasilamlo | Iceland | 12.5.2011 |
| EU/1/11/686/001-056 | Rasilamlo | Norway | 24.5.2011 |
| EU/1/11/686/001-056 | Rasilamlo | Liechtenstein | 30.4.2011 |
| EU/1/11/687/001-012 | Hizentra | Iceland | 12.5.2011 |
| EU/1/11/687/001-012 | Hizentra | Norway | 9.5.2011 |
| EU/1/11/687/001-012 | Hizentra | Liechtenstein | 30.4.2011 |
| EU/1/11/688/001 | Cinryze | Iceland | 28.6.2011 |
| EU/1/11/688/001 | Cinryze | Norway | 27.6.2011 |
| EU/1/11/691/001-005 | Eliquis | Norway | 31.5.2011 |
| EU/1/11/691/001-005 | Eliquis | Liechtenstein | 30.6.2011 |
| EU/1/11/692/001 | Yellox | Iceland | 28.6.2011 |
| EU/1/11/692/001 | Yellox | Norway | 10.6.2011 |
| EU/1/11/692/001 | Yellox | Liechtenstein | 30.6.2011 |
| EU/1/11/693/001-016 | Rivastigmine Actavis | Iceland | 28.6.2011 |
| EU/1/11/693/001-016 | Rivastigmine Actavis | Liechtenstein | 30.6.2011 |
| EU/1/190/649/001-016 | Clopidogrel Teva Pharma BV | Iceland | 30.6.2011 |
| EU/1/98/058/001-002 | Lamivudine/Zidovudine Teva | Iceland | 12.4.2011 |
| EU/1/98/058/001-002 | Lamivudine | Norway | 31.3.2011 |
| EU/2/11/120/001-003 | Zulvac 1 + 8 Ovis | Liechtenstein | 30.4.2011 |
| EU/2/11/126/001 | MS-H Impfstoff | Liechtenstein | 30.6.2011 |
| EU/2/10/107/001-014 | Veraflox | Iceland | 10.5.2011 |
| EU/2/10/107/001-014 | Veraflox | Norway | 24.6.2011 |
| EU/2/10/107/001-014 | Veraflox | Liechtenstein | 30.4.2011 |
| EU/2/10/109/001-009 | RHINISENG | Norway | 3.1.2011 |
| EU/2/10/110/001-002 | Coxevac | Iceland | 26.1.2011 |
| EU/2/10/111/001-004 | Meloxoral | Iceland | 14.3.2011 |
| EU/2/10/111/001-004 | Meloxoral | Norway | 3.1.2011 |
| EU/2/10/112/001-005 | BTVPUR ALSap 1 | Iceland | 10.2.2011 |
| EU/2/10/112/001-005 | BTVPUR ALSap 1 | Liechtenstein | 28.2.2011 |
| EU/2/10/113/001-005 | BTVPUR ALSap 1-8 | Iceland | 10.2.2011 |
| EU/2/10/113/001-005 | BTVPUR ALSap 1-8 | Liechtenstein | 28.2.2011 |
| EU/2/10/114/001-002 | Hiprabovis IBR Marker Live | Iceland | 16.3.2011 |
| EU/2/10/114/001-002 | Hiprabovis IBR Marker Live | Norway | 9.2.2011 |
| EU/2/10/114/001-002 | Hiprabovis IBR Marker Live | Liechtenstein | 28.2.2011 |
| EU/2/10/115/001-010 | Comfortis | Iceland | 22.3.2011 |
| EU/2/10/115/001-010 | Comfortis | Norway | 22.2.2011 |
| EU/2/10/115/001-010 | Comfortis | Liechtenstein | 30.4.2011 |
| EU/2/10/115/001-010 | Comfortis | Norway | 22.2.2011 |
| EU/2/10/116/001-004 | Melosus | Iceland | 24.3.2011 |
| EU/2/10/116/001-004 | Melosus | Norway | 14.4.2011 |
| EU/2/10/116/001-004 | Melosus | Liechtenstein | 30.4.2011 |
| EU/2/10/117/001-002 | Purevax Rabies | Iceland | 21.3.2011 |
| EU/2/10/117/001-002 | Purevax Rabies | Norway | 4.4.2011 |
| EU/2/10/117/001-002 | Purevax Rabies | Liechtenstein | 30.4.2011 |
| EU/2/10/118/001-014 | Activyl | Iceland | 21.3.2011 |
| EU/2/10/118/001-014 | Activyl | Norway | 1.4.2011 |
| EU/2/10/118/001-014 | Activyl | Liechtenstein | 30.4.2011 |
| EU/2/10/119/001-012 | Cimalgex | Iceland | 21.3.2011 |
| EU/2/10/119/001-012 | Cimalgex | Norway | 1.4.2011 |
| EU/2/108/001-005 | BTVPUR ALSap 2-4 0.72 U.SN | Iceland | 10.2.2011 |
| EU/2/11/120/001-003 | Zulvac 1 + 8 Ovis | Iceland | 13.4.2011 |
| EU/2/11/120/001-003 | Zulvac 1 + 8 Ovis | Norway | 18.4.2011 |
| EU/2/11/121/001-009 | CaniLeish | Iceland | 13.4.2011 |
| EU/2/11/121/001-009 | CaniLeish | Norway | 11.4.2011 |
| EU/2/11/121/001-009 | CaniLeish | Liechtenstein | 30.4.2011 |
| EU/2/11/123/001-002 | Procox | Iceland | 28.6.2011 |
| EU/2/11/123/001-002 | Procox | Norway | 20.6.2011 |
| EU/2/11/123/001-002 | Procox | Liechtenstein | 30.6.2011 |
| EU/2/11/124/001-008 | Zuprevo | Iceland | 6.6.2011 |
| EU/2/11/124/001-008 | Zuprevo | Liechtenstein | 30.6.2011 |
| EU/2/11/125/001-008 | Certifect | Iceland | 6.6.2011 |
| EU/2/11/125/001-008 | Certificet | Liechtenstein | 30.6.2011 |
| EU/2/11/126/001 | MS-H-vaccine | Iceland | 28.6.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/578/001

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Iceland

29.4.2011

EU/1/10/635/001-014

Olanzapin Apotex

Norway

14.2.2011

EU/1/10/639/001-030

Telmisartan Actavis

Norway

17.3.2011

EU/1/10/641/001

Ruconest

Iceland

24.1.2011

EU/1/10/642/001-004

Ibandronic Acid Teva

Iceland

17.1.2011

EU/1/10/647/001-002

Myclausen

Iceland

21.1.2011

EU/1/10/647/001-028

Twynsta

Iceland

21.1.2011

EU/1/10/650/001-015

Clopidogrel Teva Generics BV

Iceland

1.2.2011

EU/1/10/651/001-015

Clopidogrel HCS

Iceland

1.2.2011

EU/1/10/654/001-004

Leflunomide ratiopharm

Iceland

14.3.2011

EU/1/10/656/001-006

Possia

Iceland

13.1.2011

EU/1/10/656/001-006

Possia

Norway

25.1.2011

EU/1/10/657/001-002

Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Dia

Iceland

14.3.2011

EU/1/10/657/001-002

Prepandemic Influenza Vaccine

Norway

3.1.2011

EU/1/10/658/001-002

Aflunov

Iceland

14.3.2011

EU/1/10/658/001-002

Aflunov

Norway

3.1.2011

EU/1/10/659/001-010

Iasibon

Iceland

14.2.2011

EU/1/10/659/001-010

Iasibon

Norway

17.2.2011

EU/1/10/659/001-010

Iasibon

Liechtenstein

28.2.2011

EU/1/10/660/001-002

Potactasol

Iceland

16.3.2011

EU/1/10/660/001-002

Potactasol

Liechtenstein

28.2.2011

EU/1/10/661/001-002

Fluenz

Iceland

16.3.2011

EU/1/10/661/001-002

Fluenz

Liechtenstein

28.2.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Iceland

17.2.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Liechtenstein

28.2.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Norway

17.3.2011

EU/1/10/662/001-002

Docetaxel Teva Pharma

Norway

17.3.2011

EU/1/10/663/001-002

Lamivudine/Zidovudine Teva

Norway

31.3.2011

EU/1/10/663/001-002

Lamivudine/Zidovudine Teva

Liechtenstein

30.4.2011

EU/1/10/664/001

Pumarix

Iceland

8.4.2011

EU/1/10/664/001

Pumarix

Norway

13.4.2011

EU/1/10/664/001

Pumarix

Liechtenstein

30.4.2011

EU/1/10/665/001-004

Entacapone Teva

Iceland

21.3.2011

EU/1/10/665/001-004

Entacapone Teva

Norway

4.4.2011

EU/1/10/665/001-004

Entacapone Teva

Liechtenstein

30.4.2011

EU/1/11/666/001-003

Libertek

Iceland

24.3.2011

EU/1/11/666/001-003

Libertek

Norway

15.3.2011

EU/1/11/666/001-003

Libertek

Liechtenstein

30.4.2011

EU/1/11/667/001-003

Esbriet

Liechtenstein

30.4.2011

EU/1/11/667/001-003

Esbriet

Iceland

25.3.2011

EU/1/11/667/001-003

Esbriet

Norway

15.3.2011

EU/1/11/667/001-003

Esbriet

Norway

15.3.2011

EU/1/11/668/001-003

Daliresp

Iceland

12.4.2011

EU/1/11/668/001-003

Daliresp

Norway

15.3.2011

EU/1/11/668/001-003

Daliresp

Liechtenstein

30.4.2011

EU/1/11/669/001-004

Teysuno

Iceland

12.4.2011

EU/1/11/669/001-004

Teysuno

Norway

24.5.2011

EU/1/11/669/001-004

Teysuno

Liechtenstein

30.4.2011

EU/1/11/671/001

Xiapex

Iceland

28.3.2011

EU/1/11/671/001

Xiapex

Norway

31.3.2011

EU/1/11/671/001

Xiapex

Liechtenstein

30.4.2011

EU/1/11/672/001-006

Xeplion

Iceland

8.4.2011

EU/1/11/672/001-006

Xeplion

Norway

5.4.2011

EU/1/11/672/001-006

Xeplion

Liechtenstein

30.4.2011

EU/1/11/673/001-024

Ifirmacombi

Iceland

4.4.2011

EU/1/11/673/001-024

Ifirmacombi

Norway

6.4.2011

EU/1/11/673/001-024

Ifirmacombi

Liechtenstein

30.4.2011

EU/1/11/674/001-010

Repso

Iceland

13.4.2011

EU/1/11/674/001-010

Repso

Norway

26.4.2011

EU/1/11/674/001-010

Repso

Liechtenstein

30.4.2011

EU/1/11/675/001-0010

Leflunomide Teva

Iceland

8.4.2011

EU/1/11/675/001-010

Lefluomide Teva

Norway

11.4.2011

EU/1/11/675/001-010

Leflunomid Teva

Liechtenstein

30.4.2011

EU/1/11/676/001

Jevtana

Iceland

12.4.2011

EU/1/11/676/001

Jevtana

Norway

6.4.2011

EU/1/11/676/001

Jevtana

Liechtenstein

30.4.2011

EU/1/11/677/001-004

Gilenya

Iceland

13.4.2011

EU/1/11/677/001-004

Gilenya

Norway

28.3.2011

EU/1/11/677/001-004

Gilenya

Liechtenstein

30.4.2011

EU/1/11/678/001-002

Halaven

Iceland

14.4.2011

EU/1/11/678/001-002

Halaven

Norway

6.4.2011

EU/1/11/678/001-002

Halaven

Liechtenstein

30.4.2011

EU/1/11/679/001-006

Pravafenix

Iceland

10.5.2011

EU/1/11/679/001-006

Pravafenix

Norway

11.5.2011

EU/1/11/679/001-006

Pravafenix

Liechtenstein

30.4.2011

EU/1/11/680/001-080

Riprazo HCT

Iceland

29.4.2011

EU/1/11/680/001-080

Riprazo HCT

Norway

24.5.2011

EU/1/11/680/001-080

Riprazo HCT

Liechtenstein

30.4.2011

EU/1/11/681/001-013

Trobalt

Iceland

19.4.2011

EU/1/11/681/001-013

Trobalt

Norway

4.4.2011

EU/1/11/681/001-013

Trobalt

Liechtenstein

30.6.2011

EU/1/11/681/001-013

Trobalt

Liechtenstein

30.4.2011

EU/1/11/682/001

Methylthioninium chloride Proveblue

Iceland

6.6.2011

EU/1/11/682/001

Methylhionininium chloride Proveblue

Norway

27.6.2011

EU/1/11/682/001

Methylthioninchlorid Proveblue

Liechtenstein

30.6.2011

EU/1/11/686/001-056

Rasilamlo

Iceland

12.5.2011

EU/1/11/686/001-056

Rasilamlo

Norway

24.5.2011

EU/1/11/686/001-056

Rasilamlo

Liechtenstein

30.4.2011

EU/1/11/687/001-012

Hizentra

Iceland

12.5.2011

EU/1/11/687/001-012

Hizentra

Norway

9.5.2011

EU/1/11/687/001-012

Hizentra

Liechtenstein

30.4.2011

EU/1/11/688/001

Cinryze

Iceland

28.6.2011

EU/1/11/688/001

Cinryze

Norway

27.6.2011

EU/1/11/691/001-005

Eliquis

Norway

31.5.2011

EU/1/11/691/001-005

Eliquis

Liechtenstein

30.6.2011

EU/1/11/692/001

Yellox

Iceland

28.6.2011

EU/1/11/692/001

Yellox

Norway

10.6.2011

EU/1/11/692/001

Yellox

Liechtenstein

30.6.2011

EU/1/11/693/001-016

Rivastigmine Actavis

Iceland

28.6.2011

EU/1/11/693/001-016

Rivastigmine Actavis

Liechtenstein

30.6.2011

EU/1/190/649/001-016

Clopidogrel Teva Pharma BV

Iceland

30.6.2011

EU/1/98/058/001-002

Lamivudine/Zidovudine Teva

Iceland

12.4.2011

EU/1/98/058/001-002

Lamivudine

Norway

31.3.2011

EU/2/11/120/001-003

Zulvac 1 + 8 Ovis

Liechtenstein

30.4.2011

EU/2/11/126/001

MS-H Impfstoff

Liechtenstein

30.6.2011

EU/2/10/107/001-014

Veraflox

Iceland

10.5.2011

EU/2/10/107/001-014

Veraflox

Norway

24.6.2011

EU/2/10/107/001-014

Veraflox

Liechtenstein

30.4.2011

EU/2/10/109/001-009

RHINISENG

Norway

3.1.2011

EU/2/10/110/001-002

Coxevac

Iceland

26.1.2011

EU/2/10/111/001-004

Meloxoral

Iceland

14.3.2011

EU/2/10/111/001-004

Meloxoral

Norway

3.1.2011

EU/2/10/112/001-005

BTVPUR ALSap 1

Iceland

10.2.2011

EU/2/10/112/001-005

BTVPUR ALSap 1

Liechtenstein

28.2.2011

EU/2/10/113/001-005

BTVPUR ALSap 1-8

Iceland

10.2.2011

EU/2/10/113/001-005

BTVPUR ALSap 1-8

Liechtenstein

28.2.2011

EU/2/10/114/001-002

Hiprabovis IBR Marker Live

Iceland

16.3.2011

EU/2/10/114/001-002

Hiprabovis IBR Marker Live

Norway

9.2.2011

EU/2/10/114/001-002

Hiprabovis IBR Marker Live

Liechtenstein

28.2.2011

EU/2/10/115/001-010

Comfortis

Iceland

22.3.2011

EU/2/10/115/001-010

Comfortis

Norway

22.2.2011

EU/2/10/115/001-010

Comfortis

Liechtenstein

30.4.2011

EU/2/10/115/001-010

Comfortis

Norway

22.2.2011

EU/2/10/116/001-004

Melosus

Iceland

24.3.2011

EU/2/10/116/001-004

Melosus

Norway

14.4.2011

EU/2/10/116/001-004

Melosus

Liechtenstein

30.4.2011

EU/2/10/117/001-002

Purevax Rabies

Iceland

21.3.2011

EU/2/10/117/001-002

Purevax Rabies

Norway

4.4.2011

EU/2/10/117/001-002

Purevax Rabies

Liechtenstein

30.4.2011

EU/2/10/118/001-014

Activyl

Iceland

21.3.2011

EU/2/10/118/001-014

Activyl

Norway

1.4.2011

EU/2/10/118/001-014

Activyl

Liechtenstein

30.4.2011

EU/2/10/119/001-012

Cimalgex

Iceland

21.3.2011

EU/2/10/119/001-012

Cimalgex

Norway

1.4.2011

EU/2/108/001-005

BTVPUR ALSap 2-4 0.72 U.SN

Iceland

10.2.2011

EU/2/11/120/001-003

Zulvac 1 + 8 Ovis

Iceland

13.4.2011

EU/2/11/120/001-003

Zulvac 1 + 8 Ovis

Norway

18.4.2011

EU/2/11/121/001-009

CaniLeish

Iceland

13.4.2011

EU/2/11/121/001-009

CaniLeish

Norway

11.4.2011

EU/2/11/121/001-009

CaniLeish

Liechtenstein

30.4.2011

EU/2/11/123/001-002

Procox

Iceland

28.6.2011

EU/2/11/123/001-002

Procox

Norway

20.6.2011

EU/2/11/123/001-002

Procox

Liechtenstein

30.6.2011

EU/2/11/124/001-008

Zuprevo

Iceland

6.6.2011

EU/2/11/124/001-008

Zuprevo

Liechtenstein

30.6.2011

EU/2/11/125/001-008

Certifect

Iceland

6.6.2011

EU/2/11/125/001-008

Certificet

Liechtenstein

30.6.2011

EU/2/11/126/001

MS-H-vaccine

Iceland

28.6.2011

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/135/001-002 | DaTSCAN | Iceland | 14.3.2011 |
| EU/1/00/149/001 | Panretin | Iceland | 18.1.2011 |
| EU/1/00/156/002-004 | Trizivir | Iceland | 14.2.2011 |
| EU/1/00/166/001-003 | NeuroBloc | Iceland | 15.2.2011 |
| EU/1/00/166/001-003 | NeuroBloc | Norway | 15.2.2011 |
| EU/1/00/167/001-008 | Prevenar | Iceland | 25.3.2011 |
| EU/1/00/167/001-008 | Prevenar | Norway | 3.3.2011 |
| EU/1/00/167/001-008 | Prevenar | Liechtenstein | 28.2.2011 |
| EU/1/00/173/001-003 | Vaniqa | Iceland | 15.4.2011 |
| EU/1/01/171/001, 007-010, 013-014 | Rapamune | Iceland | 21.2.2011 |
| EU/1/01/171/001, EU/1/01/171/007-010
  EU/1/01/171/013-014 | Rapamune | Norway | 2.2.2011 |
| EU/1/01/172/001-008 | Kaletra | Iceland | 21.3.2011 |
| EU/1/01/172/001-008 | Kaletra | Norway | 27.4.2011 |
| EU/1/01/172/001-008 | Kaletra | Liechtenstein | 30.4.2011 |
| EU/1/01/173/001-003 | Vaniqa | Norway | 3.5.2011 |
| EU/1/01/173/001-003 | Vaniqa | Liechtenstein | 30.4.2011 |
| EU/1/01/179/001 | Osigraft | Iceland | 17.5.2011 |
| EU/1/01/179/001 | Osigraft | Norway | 15.6.2011 |
| EU/1/01/179/001 | Osigraft | Liechtenstein | 30.6.2011 |
| EU/1/01/183/001&004-005, 007-008, 011, 013, 015, 018-032 | HBVAXPRO | Iceland | 18.4.2011 |
| EU/1/01/183/001, EU/1/01/183/004-005
  EU/1/01/183/007-008, EU/1/01/183/011
  EU/1/01/183/013, EU/1/01/183/015
  EU/1/01/183/018-032 | HBVAXPRO | Norway | 14.4.2011 |
| EU/1/01/187/001 | DepoCyte | Iceland | 23.6.2011 |
| EU/1/01/187/001 | DepoCyte | Liechtenstein | 30.6.2011 |
| EU/1/01/191/001-005 | Ketek 400 mg | Iceland | 9.6.2011 |
| EU/1/01/191/001-005 | Ketek | Norway | 31.5.2011 |
| EU/1/01/191/001-005 | Ketek | Liechtenstein | 30.6.2011 |
| EU/1/01/193/001-002 | MabCampath | Iceland | 23.6.2011 |
| EU/1/01/193/001-002 | MabCampath | Norway | 15.6.2011 |
| EU/1/05/312/001 | Xyrem | Iceland | 14.1.2011 |
| EU/1/05/313/001-009 | Ablavar | Iceland | 28.1.2011 |
| EU/1/05/314/001 | Kepivance | Iceland | 17.1.2011 |
| EU/1/05/315/001-002 | Aptivus | Iceland | 27.1.2011 |
| EU/1/05/320/001 | Noxafil | Iceland | 18.1.2011 |
| EU/1/05/322/001 | Yttriga | Iceland | 18.3.2011 |
| EU/1/05/322/001 | Yttriga | Norway | 20.1.2011 |
| EU/1/05/322/001 | Yttriga | Liechtenstein | 28.2.2011 |
| EU/1/05/323/001-013 | ProQuad | Iceland | 15.4.2011 |
| EU/1/05/323/001-013 | ProQuad | Norway | 6.4.2011 |
| EU/1/05/323/001-013 | ProQuad | Liechtenstein | 30.4.2011 |
| EU/1/05/324/001-002 | Naglazyme | Iceland | 23.3.2011 |
| EU/1/05/324/001-002 | Naglazyme | Norway | 7.2.2011 |
| EU/1/05/324/001-002 | Naglazyme | Liechtenstein | 28.2.2011 |
| EU/1/05/325/002 | Macugen | Iceland | 15.2.2011 |
| EU/1/05/325/002 | Macugen | Norway | 1.2.2011 |
| EU/1/05/325/002 | Macugen | Liechtenstein | 28.2.2011 |
| EU/1/05/328/001-004 | Cubicin | Iceland | 14.2.2011 |
| EU/1/05/328/001-004 | Cubicin | Norway | 11.1.2011 |
| EU/1/05/329/001-006 | Kiovig | Iceland | 24.2.2011 |
| EU/1/05/329/001-006 | Kiovig | Norway | 2.2.2011 |
| EU/1/05/329/001-006 | Kiovig | Liechtenstein | 28.2.2011 |
| EU/1/05/330/001-011 | Rotarix | Iceland | 22.3.2011 |
| EU/1/05/330/001-011 | Rotarix | Norway | 13.5.2011 |
| EU/1/05/331/001-055 | Neupro | Iceland | 15.2.2011 |
| EU/1/05/331/001-055 | Neupro | Norway | 10.1.2011 |
| EU/1/06/332/001-009 | Omnitrope | Iceland | 28.6.2011 |
| EU/1/06/332/001-009 | Omnitrope | Norway | 5.4.2011 |
| EU/1/06/332/001-009 | Omnitrope | Liechtenstein | 30.4.2011 |
| EU/1/06/333/001-003 | Myozyme | Iceland | 20.4.2011 |
| EU/1/06/333/001-003 | Myozyme | Norway | 22.3.2011 |
| EU/1/06/333/001-003 | Myozyme | Liechtenstein | 30.4.2011 |
| EU/1/06/334/001-005 | Evoltra | Iceland | 18.4.2011 |
| EU/1/06/334/001-005 | Evoltra | Norway | 25.5.2011 |
| EU/1/06/334/001-005 | Evoltra | Liechtenstein | 30.4.2011 |
| EU/1/06/335/001 | Valtropin | Iceland | 12.5.2011 |
| EU/1/06/335/001 | Valtropin | Norway | 3.6.2011 |
| EU/1/06/335/001 | Valtropin | Liechtenstein | 30.4.2011 |
| EU/1/06/336/001 | Tygacil | Norway | 31.5.2011 |
| EU/1/06/336/001 | Tygacil | Liechtenstein | 30.6.2011 |
| EU/1/06/337/001-013 | M-M-RVAXPRO | Iceland | 16.5.2011 |
| EU/1/06/337/001-013 | M-M-RVAXPRO | Norway | 31.5.2011 |
| EU/1/06/337/001-013 | M-M-RVAXPRO | Liechtenstein | 30.6.2011 |
| EU/1/06/338/001-003 | DuoTrav | Iceland | 21.1.2011 |
| EU/1/06/339/001-002 | Preotact | Iceland | 11.5.2011 |
| EU/1/06/339/001-002 | Preotact | Liechtenstein | 30.4.2011 |
| EU/1/06/341/001-013 | Zostavax | Iceland | 18.4.2011 |
| EU/1/06/341/001-013 | Zostavax | Liechtenstein | 30.4.2011 |
| EU/1/06/343/001-007 | Baraclude | Iceland | 23.6.2011 |
| EU/1/06/343/001-007 | Baraclude | Liechtenstein | 30.6.2011 |
| EU/1/06/346/001 | Tysabri | Iceland | 27.6.2011 |
| EU/1/06/348/001-002 | RotaTeq | Iceland | 23.6.2011 |
| EU/1/06/348/001-002 | RotaTeq | Norway | 17.6.2011 |
| EU/1/06/348/001-002 | RotaTeq | Liechtenstein | 28.2.2011 |
| EU/1/06/354/001-011 | Competact | Iceland | 24.6.2011 |
| EU/1/06/354/001-011 | Competact | Norway | 23.6.2011 |
| EU/1/06/354/001-011 | Competact | Liechtenstein | 30.6.2011 |
| EU/1/06/360/001-013 | Champix | Liechtenstein | 30.6.2011 |
| EU/1/06/367/001-012 | Diacomit | Iceland | 11.2.2011 |
| EU/1/06/367/001-012 | Diacomit | Norway | 15.2.2011 |
| EU/1/06/367/001-012 | Diacomit | Liechtenstein | 28.2.2011 |
| EU/1/07/423/001-003 | Vectibix | Iceland | 15.2.2011 |
| EU/1/07/423/001-003 | Vectibix | Norway | 25.1.2011 |
| EU/1/07/440/001-003 | Tyverb | Norway | 3.6.2011 |
| EU/1/10/625/001 | Arzerra | Iceland | 22.2.2011 |
| EU/1/10/625/001-002 | Arzerra | Norway | 17.2.2011 |
| EU/1/10/625/001-002 | Arzerra | Liechtenstein | 28.2.2011 |
| EU/1/10/628/001-004 | Votrient | Iceland | 6.6.2011 |
| EU/1/183/001, 004-005, 007-008, 011, 013, 015, 018-032 | HBVAXPRO | Liechtenstein | 30.4.2011 |
| EU/1/96/009/001-008 | Zerit | Iceland | 16.5.2011 |
| EU/1/96/009/001-009 | Zerit | Norway | 6.5.2011 |
| EU/1/96/009/001-009 | Zerit | Liechtenstein | 30.4.2011 |
| EU/2/00/026/001-004 | Porcilis AR-T DF | Norway | 3.1.2011 |
| EU/2/00/026/001-006 | Porcilis AR-T DF | Iceland | 17.1.2011 |
| EU/2/04/045/001-007 | Previcox | Norway | 18.4.2011 |
| EU/2/04/048/001-002 | Purevax RCP FeLV | Norway | 13.4.2011 |
| EU/2/04/049/001-002 | Purevax RCCh | Norway | 13.4.2011 |
| EU/2/04/050/001-002 | Purevax RCPCh | Norway | 13.4.2011 |
| EU/2/04/051/001-002 | Purevax RC | Norway | 13.4.2011 |
| EU/2/04/052/001-002 | Purevax RCP | Norway | 13.4.2011 |
| EU/2/06/058/004 | Flexicam | Iceland | 8.4.2011 |
| EU/2/06/058/004 | Flexicam | Norway | 26.4.2011 |
| EU/2/06/058/004 | Flexicam | Liechtenstein | 30.4.2011 |
| EU/2/06/059/001 | Convenia | Iceland | 27.6.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/135/001-002

DaTSCAN

Iceland

14.3.2011

EU/1/00/149/001

Panretin

Iceland

18.1.2011

EU/1/00/156/002-004

Trizivir

Iceland

14.2.2011

EU/1/00/166/001-003

NeuroBloc

Iceland

15.2.2011

EU/1/00/166/001-003

NeuroBloc

Norway

15.2.2011

EU/1/00/167/001-008

Prevenar

Iceland

25.3.2011

EU/1/00/167/001-008

Prevenar

Norway

3.3.2011

EU/1/00/167/001-008

Prevenar

Liechtenstein

28.2.2011

EU/1/00/173/001-003

Vaniqa

Iceland

15.4.2011

EU/1/01/171/001, 007-010, 013-014

Rapamune

Iceland

21.2.2011

EU/1/01/171/001, EU/1/01/171/007-010

EU/1/01/171/013-014

Rapamune

Norway

2.2.2011

EU/1/01/172/001-008

Kaletra

Iceland

21.3.2011

EU/1/01/172/001-008

Kaletra

Norway

27.4.2011

EU/1/01/172/001-008

Kaletra

Liechtenstein

30.4.2011

EU/1/01/173/001-003

Vaniqa

Norway

3.5.2011

EU/1/01/173/001-003

Vaniqa

Liechtenstein

30.4.2011

EU/1/01/179/001

Osigraft

Iceland

17.5.2011

EU/1/01/179/001

Osigraft

Norway

15.6.2011

EU/1/01/179/001

Osigraft

Liechtenstein

30.6.2011

EU/1/01/183/001&004-005, 007-008, 011, 013, 015, 018-032

HBVAXPRO

Iceland

18.4.2011

EU/1/01/183/001, EU/1/01/183/004-005

EU/1/01/183/007-008, EU/1/01/183/011

EU/1/01/183/013, EU/1/01/183/015

EU/1/01/183/018-032

HBVAXPRO

Norway

14.4.2011

EU/1/01/187/001

DepoCyte

Iceland

23.6.2011

EU/1/01/187/001

DepoCyte

Liechtenstein

30.6.2011

EU/1/01/191/001-005

Ketek 400 mg

Iceland

9.6.2011

EU/1/01/191/001-005

Ketek

Norway

31.5.2011

EU/1/01/191/001-005

Ketek

Liechtenstein

30.6.2011

EU/1/01/193/001-002

MabCampath

Iceland

23.6.2011

EU/1/01/193/001-002

MabCampath

Norway

15.6.2011

EU/1/05/312/001

Xyrem

Iceland

14.1.2011

EU/1/05/313/001-009

Ablavar

Iceland

28.1.2011

EU/1/05/314/001

Kepivance

Iceland

17.1.2011

EU/1/05/315/001-002

Aptivus

Iceland

27.1.2011

EU/1/05/320/001

Noxafil

Iceland

18.1.2011

EU/1/05/322/001

Yttriga

Iceland

18.3.2011

EU/1/05/322/001

Yttriga

Norway

20.1.2011

EU/1/05/322/001

Yttriga

Liechtenstein

28.2.2011

EU/1/05/323/001-013

ProQuad

Iceland

15.4.2011

EU/1/05/323/001-013

ProQuad

Norway

6.4.2011

EU/1/05/323/001-013

ProQuad

Liechtenstein

30.4.2011

EU/1/05/324/001-002

Naglazyme

Iceland

23.3.2011

EU/1/05/324/001-002

Naglazyme

Norway

7.2.2011

EU/1/05/324/001-002

Naglazyme

Liechtenstein

28.2.2011

EU/1/05/325/002

Macugen

Iceland

15.2.2011

EU/1/05/325/002

Macugen

Norway

1.2.2011

EU/1/05/325/002

Macugen

Liechtenstein

28.2.2011

EU/1/05/328/001-004

Cubicin

Iceland

14.2.2011

EU/1/05/328/001-004

Cubicin

Norway

11.1.2011

EU/1/05/329/001-006

Kiovig

Iceland

24.2.2011

EU/1/05/329/001-006

Kiovig

Norway

2.2.2011

EU/1/05/329/001-006

Kiovig

Liechtenstein

28.2.2011

EU/1/05/330/001-011

Rotarix

Iceland

22.3.2011

EU/1/05/330/001-011

Rotarix

Norway

13.5.2011

EU/1/05/331/001-055

Neupro

Iceland

15.2.2011

EU/1/05/331/001-055

Neupro

Norway

10.1.2011

EU/1/06/332/001-009

Omnitrope

Iceland

28.6.2011

EU/1/06/332/001-009

Omnitrope

Norway

5.4.2011

EU/1/06/332/001-009

Omnitrope

Liechtenstein

30.4.2011

EU/1/06/333/001-003

Myozyme

Iceland

20.4.2011

EU/1/06/333/001-003

Myozyme

Norway

22.3.2011

EU/1/06/333/001-003

Myozyme

Liechtenstein

30.4.2011

EU/1/06/334/001-005

Evoltra

Iceland

18.4.2011

EU/1/06/334/001-005

Evoltra

Norway

25.5.2011

EU/1/06/334/001-005

Evoltra

Liechtenstein

30.4.2011

EU/1/06/335/001

Valtropin

Iceland

12.5.2011

EU/1/06/335/001

Valtropin

Norway

3.6.2011

EU/1/06/335/001

Valtropin

Liechtenstein

30.4.2011

EU/1/06/336/001

Tygacil

Norway

31.5.2011

EU/1/06/336/001

Tygacil

Liechtenstein

30.6.2011

EU/1/06/337/001-013

M-M-RVAXPRO

Iceland

16.5.2011

EU/1/06/337/001-013

M-M-RVAXPRO

Norway

31.5.2011

EU/1/06/337/001-013

M-M-RVAXPRO

Liechtenstein

30.6.2011

EU/1/06/338/001-003

DuoTrav

Iceland

21.1.2011

EU/1/06/339/001-002

Preotact

Iceland

11.5.2011

EU/1/06/339/001-002

Preotact

Liechtenstein

30.4.2011

EU/1/06/341/001-013

Zostavax

Iceland

18.4.2011

EU/1/06/341/001-013

Zostavax

Liechtenstein

30.4.2011

EU/1/06/343/001-007

Baraclude

Iceland

23.6.2011

EU/1/06/343/001-007

Baraclude

Liechtenstein

30.6.2011

EU/1/06/346/001

Tysabri

Iceland

27.6.2011

EU/1/06/348/001-002

RotaTeq

Iceland

23.6.2011

EU/1/06/348/001-002

RotaTeq

Norway

17.6.2011

EU/1/06/348/001-002

RotaTeq

Liechtenstein

28.2.2011

EU/1/06/354/001-011

Competact

Iceland

24.6.2011

EU/1/06/354/001-011

Competact

Norway

23.6.2011

EU/1/06/354/001-011

Competact

Liechtenstein

30.6.2011

EU/1/06/360/001-013

Champix

Liechtenstein

30.6.2011

EU/1/06/367/001-012

Diacomit

Iceland

11.2.2011

EU/1/06/367/001-012

Diacomit

Norway

15.2.2011

EU/1/06/367/001-012

Diacomit

Liechtenstein

28.2.2011

EU/1/07/423/001-003

Vectibix

Iceland

15.2.2011

EU/1/07/423/001-003

Vectibix

Norway

25.1.2011

EU/1/07/440/001-003

Tyverb

Norway

3.6.2011

EU/1/10/625/001

Arzerra

Iceland

22.2.2011

EU/1/10/625/001-002

Arzerra

Norway

17.2.2011

EU/1/10/625/001-002

Arzerra

Liechtenstein

28.2.2011

EU/1/10/628/001-004

Votrient

Iceland

6.6.2011

EU/1/183/001, 004-005, 007-008, 011, 013, 015, 018-032

HBVAXPRO

Liechtenstein

30.4.2011

EU/1/96/009/001-008

Zerit

Iceland

16.5.2011

EU/1/96/009/001-009

Zerit

Norway

6.5.2011

EU/1/96/009/001-009

Zerit

Liechtenstein

30.4.2011

EU/2/00/026/001-004

Porcilis AR-T DF

Norway

3.1.2011

EU/2/00/026/001-006

Porcilis AR-T DF

Iceland

17.1.2011

EU/2/04/045/001-007

Previcox

Norway

18.4.2011

EU/2/04/048/001-002

Purevax RCP FeLV

Norway

13.4.2011

EU/2/04/049/001-002

Purevax RCCh

Norway

13.4.2011

EU/2/04/050/001-002

Purevax RCPCh

Norway

13.4.2011

EU/2/04/051/001-002

Purevax RC

Norway

13.4.2011

EU/2/04/052/001-002

Purevax RCP

Norway

13.4.2011

EU/2/06/058/004

Flexicam

Iceland

8.4.2011

EU/2/06/058/004

Flexicam

Norway

26.4.2011

EU/2/06/058/004

Flexicam

Liechtenstein

30.4.2011

EU/2/06/059/001

Convenia

Iceland

27.6.2011

---

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 2011:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/185/100-111 | Aranesp | Iceland | 15.4.2011 |
| EU/1/01/194/003-004 | INOmax | Iceland | 15.4.2011 |
| EU/1/02/227/003 | Neulasta | Liechtenstein | 30.4.2011 |
| EU/1/06/332/010-012 | Omnitrope | Iceland | 16.6.2011 |
| EU/1/06/332/010-012 | Omnitrope | Liechtenstein | 30.6.2011 |
| EU/1/06/354/010-011 | Competact | Liechtenstein | 28.2.2011 |
| EU/1/06/354/012 | Competact | Liechtenstein | 30.6.2011 |
| EU/1/06/370/037-039 | Exforge | Liechtenstein | 28.2.2011 |
| EU/1/06/371/037-039 | Dafiro | Liechtenstein | 28.2.2011 |
| EU/1/06/373/037-039 | Imprida | Liechtenstein | 28.2.2011 |
| EU/1/07/387/014-026 | Advagraf | Liechtenstein | 30.6.2011 |
| EU/1/07/397/002-004 | Siklos | Iceland | 25.3.2011 |
| EU/1/07/397/002-004 | Siklos | Norway | 5.4.2011 |
| EU/1/07/397/002-004 | Siklos | Liechtenstein | 30.4.2011 |
| EU/1/07/401/012-015 | Alli | Iceland | 16.2.2011 |
| EU/1/07/401/012-015 | Alli | Norway | 26.1.2011 |
| EU/1/07/404/006-008 | Flebogamma DIF | Iceland | 17.2.2011 |
| EU/1/07/404/006-008 | Flebogamma DIF | Norway | 14.1.2011 |
| EU/1/07/404/006-008 | Flebogamma DIF | Liechtenstein | 28.2.2011 |
| EU/1/07/407/021-040 | Sprimeo | Liechtenstein | 30.4.2011 |
| EU/1/07/410/027-052 | Binocrit | Liechtenstein | 30.4.2011 |
| EU/1/07/411/027-052 | Epoetin alfa Hexal | Liechtenstein | 30.4.2011 |
| EU/1/07/420/002 | Cyanokit | Iceland | 20.1.2011 |
| EU/1/07/420/002 | Cyanokit | Norway | 14.2.2011 |
| EU/1/07/422/005-006 | Tasigna | Iceland | 23.3.2011 |
| EU/1/07/422/005-006 | Tasigna | Norway | 21.1.2011 |
| EU/1/07/422/005-006 | Tasigna | Liechtenstein | 28.2.2011 |
| EU/1/07/438/005-006 | Myfenax | Liechtenstein | 30.6.2011 |
| EU/1/07/439/005-006 | Mycophenole mofetil Teva | Liechtenstein | 30.6.2011 |
| EU/1/08/461/002 | Firazyr | Liechtenstein | 30.4.2011 |
| EU/1/08/490/017-024 | Pramipexole Teva | Liechtenstein | 30.6.2011 |
| EU/1/09/511/005 | Conbriza | Liechtenstein | 30.4.2011 |
| EU/1/09/535/015-016 | Grepid | Liechtenstein | 28.2.2011 |
| EU/1/09/545/011-015 | Onglyza | Iceland | 14.4.2011 |
| EU/1/09/545/011-015 | Onglyza | Norway | 25.3.2011 |
| EU/1/09/545/011-015 | Onglyza | Liechtenstein | 30.4.2011 |
| EU/1/09/581/003-008 | Resolor | Liechtenstein | 28.2.2011 |
| EU/1/10/614/002 | Menveo | Liechtenstein | 30.4.2011 |
| EU/1/96/022/035-040 | Zyprexa | Liechtenstein | 28.2.2011 |
| EU/1/97/033/005-006 | Avonex | Liechtenstein | 30.6.2011 |
| EU/1/99/103/005 | ReFacto AF | Iceland | 6.6.2011 |
| EU/1/99/103/005-008 | ReFacto AF | Norway | 1.6.2011 |
| EU/1/99/103/005-008 | ReFacto AF | Liechtenstein | 30.6.2011 |
| EU/2/07/078/009-010 | Rheumocam | Iceland | 18.4.2011 |
| EU/2/07/078/009-010 | Rheumocam | Norway | 9.2.2011 |
| EU/2/07/078/009-010 | Rheumocam | Liechtenstein | 28.2.2011 |
| EU/2/07/078/011-014 | Rheumocam | Iceland | 28.6.2011 |
| EU/2/07/078/011-014 | Rheumocam | Liechtenstein | 30.6.2011 |
| EU/2/08/082/007 | Zactran | Liechtenstein | 30.6.2011 |
| EU/2/97/004/041-048 | Metacam | Liechtenstein | 28.2.2011 |
| EU/2/98/010/025 | Econor | Iceland | 18.2.2011 |
| EU/2/98/010/025 | Econor | Liechtenstein | 28.2.2011 |
| EU/99/119/017-018 | NovoRapid | Liechtenstein | 30.4.2011 |

EU-Number

Product

Country

Date of authorisation

EU/1/01/185/100-111

Aranesp

Iceland

15.4.2011

EU/1/01/194/003-004

INOmax

Iceland

15.4.2011

EU/1/02/227/003

Neulasta

Liechtenstein

30.4.2011

EU/1/06/332/010-012

Omnitrope

Iceland

16.6.2011

EU/1/06/332/010-012

Omnitrope

Liechtenstein

30.6.2011

EU/1/06/354/010-011

Competact

Liechtenstein

28.2.2011

EU/1/06/354/012

Competact

Liechtenstein

30.6.2011

EU/1/06/370/037-039

Exforge

Liechtenstein

28.2.2011

EU/1/06/371/037-039

Dafiro

Liechtenstein

28.2.2011

EU/1/06/373/037-039

Imprida

Liechtenstein

28.2.2011

EU/1/07/387/014-026

Advagraf

Liechtenstein

30.6.2011

EU/1/07/397/002-004

Siklos

Iceland

25.3.2011

EU/1/07/397/002-004

Siklos

Norway

5.4.2011

EU/1/07/397/002-004

Siklos

Liechtenstein

30.4.2011

EU/1/07/401/012-015

Alli

Iceland

16.2.2011

EU/1/07/401/012-015

Alli

Norway

26.1.2011

EU/1/07/404/006-008

Flebogamma DIF

Iceland

17.2.2011

EU/1/07/404/006-008

Flebogamma DIF

Norway

14.1.2011

EU/1/07/404/006-008

Flebogamma DIF

Liechtenstein

28.2.2011

EU/1/07/407/021-040

Sprimeo

Liechtenstein

30.4.2011

EU/1/07/410/027-052

Binocrit

Liechtenstein

30.4.2011

EU/1/07/411/027-052

Epoetin alfa Hexal

Liechtenstein

30.4.2011

EU/1/07/420/002

Cyanokit

Iceland

20.1.2011

EU/1/07/420/002

Cyanokit

Norway

14.2.2011

EU/1/07/422/005-006

Tasigna

Iceland

23.3.2011

EU/1/07/422/005-006

Tasigna

Norway

21.1.2011

EU/1/07/422/005-006

Tasigna

Liechtenstein

28.2.2011

EU/1/07/438/005-006

Myfenax

Liechtenstein

30.6.2011

EU/1/07/439/005-006

Mycophenole mofetil Teva

Liechtenstein

30.6.2011

EU/1/08/461/002

Firazyr

Liechtenstein

30.4.2011

EU/1/08/490/017-024

Pramipexole Teva

Liechtenstein

30.6.2011

EU/1/09/511/005

Conbriza

Liechtenstein

30.4.2011

EU/1/09/535/015-016

Grepid

Liechtenstein

28.2.2011

EU/1/09/545/011-015

Onglyza

Iceland

14.4.2011

EU/1/09/545/011-015

Onglyza

Norway

25.3.2011

EU/1/09/545/011-015

Onglyza

Liechtenstein

30.4.2011

EU/1/09/581/003-008

Resolor

Liechtenstein

28.2.2011

EU/1/10/614/002

Menveo

Liechtenstein

30.4.2011

EU/1/96/022/035-040

Zyprexa

Liechtenstein

28.2.2011

EU/1/97/033/005-006

Avonex

Liechtenstein

30.6.2011

EU/1/99/103/005

ReFacto AF

Iceland

6.6.2011

EU/1/99/103/005-008

ReFacto AF

Norway

1.6.2011

EU/1/99/103/005-008

ReFacto AF

Liechtenstein

30.6.2011

EU/2/07/078/009-010

Rheumocam

Iceland

18.4.2011

EU/2/07/078/009-010

Rheumocam

Norway

9.2.2011

EU/2/07/078/009-010

Rheumocam

Liechtenstein

28.2.2011

EU/2/07/078/011-014

Rheumocam

Iceland

28.6.2011

EU/2/07/078/011-014

Rheumocam

Liechtenstein

30.6.2011

EU/2/08/082/007

Zactran

Liechtenstein

30.6.2011

EU/2/97/004/041-048

Metacam

Liechtenstein

28.2.2011

EU/2/98/010/025

Econor

Iceland

18.2.2011

EU/2/98/010/025

Econor

Liechtenstein

28.2.2011

EU/99/119/017-018

NovoRapid

Liechtenstein

30.4.2011

---

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 2011:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/03/259/001-006 | Onsenal | Iceland | 20.4.2011 |
| EU/1/03/259/001-006 | Onsenal | Liechtenstein | 30.4.2011 |
| EU/1/05/326/001 | Ionsys | Iceland | 20.4.2011 |
| EU/1/06/353/001-005 | Thelin | Iceland | 15.3.2011 |
| EU/1/06/353/001-005 | Thelin | Liechtenstein | 28.2.2011 |
| EU/1/08/449/001-008 | Filgrastim ratiopharm | Liechtenstein | 30.4.2011 |
| EU/1/08/449/001-008 | Filgrastim ratiopharm | Iceland | 12.5.2011 |
| EU/1/09/542/001-007 | Clopidogrel 1A Pharma | Liechtenstein | 28.2.2011 |
| EU/1/09/542/001-007 | Clopidogrel 1A Pharma | Iceland | 16.3.2011 |
| EU/1/09/547/001-007 | Clopidogrel Sandoz | Liechtenstein | 30.4.2011 |
| EU/1/10/629/001 | Humenza | Iceland | 29.6.2011 |
| EU/1/10/629/001 | Humenza | Liechtenstein | 30.6.2011 |

EU-Number

Product

Country

Date of withdrawal

EU/1/03/259/001-006

Onsenal

Iceland

20.4.2011

EU/1/03/259/001-006

Onsenal

Liechtenstein

30.4.2011

EU/1/05/326/001

Ionsys

Iceland

20.4.2011

EU/1/06/353/001-005

Thelin

Iceland

15.3.2011

EU/1/06/353/001-005

Thelin

Liechtenstein

28.2.2011

EU/1/08/449/001-008

Filgrastim ratiopharm

Liechtenstein

30.4.2011

EU/1/08/449/001-008

Filgrastim ratiopharm

Iceland

12.5.2011

EU/1/09/542/001-007

Clopidogrel 1A Pharma

Liechtenstein

28.2.2011

EU/1/09/542/001-007

Clopidogrel 1A Pharma

Iceland

16.3.2011

EU/1/09/547/001-007

Clopidogrel Sandoz

Liechtenstein

30.4.2011

EU/1/10/629/001

Humenza

Iceland

29.6.2011

EU/1/10/629/001

Humenza

Liechtenstein

30.6.2011

---

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 2011:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/00/137/002-018 | Avandia | Iceland | 13.1.2011 |
| EU/1/03/258/001-022 | Avandamet | Iceland | 13.1.2011 |
| EU/1/06/349/001-010 | Avaglim | Iceland | 17.1.2011 |
| EU/2/06/058/001-003 | Flexicam | Iceland | 14.1.2011 |
| EU/2/08/088/001-003 | Acticam | Norway | 7.3.2011 |
| EU/2/09/099/001-006 | Suvaxyn PCV | Iceland | 22.3.2011 |

EU-Number

Product

Country

Date of suspension

EU/1/00/137/002-018

Avandia

Iceland

13.1.2011

EU/1/03/258/001-022

Avandamet

Iceland

13.1.2011

EU/1/06/349/001-010

Avaglim

Iceland

17.1.2011

EU/2/06/058/001-003

Flexicam

Iceland

14.1.2011

EU/2/08/088/001-003

Acticam

Norway

7.3.2011

EU/2/09/099/001-006

Suvaxyn PCV

Iceland

22.3.2011

---

V Announcements

COURT PROCEEDINGS

EFTA Court

| 16.2.2012 | EN | Official Journal of the European Union | C 44/21 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/21

---

Action brought on 15 December 2011 by the EFTA Surveillance Authority against Iceland

(Case E-16/11)

2012/C 44/06

An action against Iceland was brought before the EFTA Court on 15 December 2011 by the EFTA Surveillance Authority, represented by Xavier Lewis and Gjermund Mathisen, acting as Agents, 35, Rue Belliard, 1040 Brussels, Belgium.

The EFTA Surveillance Authority requests the EFTA Court to:

| 1. | declare that by failing to ensure payment of the minimum amount of compensation to Icesave depositors in the Netherlands and in the United Kingdom provided for in Article 7(1) of the Act referred to at point 19a of Annex IX to the Agreement on the European Economic Area (Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit-guarantee schemes) within the time limits laid down in Article 10 of the Act, Iceland has failed to comply with the obligations resulting from that Act, in particular its Articles 3, 4, 7 and 10, and/or Article 4 of the Agreement on the European Economic Area;
  and |
| --- | --- |

1.

declare that by failing to ensure payment of the minimum amount of compensation to Icesave depositors in the Netherlands and in the United Kingdom provided for in Article 7(1) of the Act referred to at point 19a of Annex IX to the Agreement on the European Economic Area (Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit-guarantee schemes) within the time limits laid down in Article 10 of the Act, Iceland has failed to comply with the obligations resulting from that Act, in particular its Articles 3, 4, 7 and 10, and/or Article 4 of the Agreement on the European Economic Area;

and

| 2. | order Iceland to bear the costs. |
| --- | --- |

2.

order Iceland to bear the costs.

Legal and factual background and pleas in law adduced in support:

| — | Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 referred to at point 19a of Annex IX to the EEA Agreement, as amended, provides for minimum harmonised rules as regards deposit guarantee schemes. At the material time, Directive 94/19/EC was implemented into Icelandic law by Act No 98/1999 on Deposit Guarantees and Investor-Compensation Schemes. Under Directive 94/19/EC, deposit-guarantee schemes must cover the aggregate deposits of each depositor up to ECU/EUR 20 000 in the event of deposits being unavailable. |
| --- | --- |

—

Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 referred to at point 19a of Annex IX to the EEA Agreement, as amended, provides for minimum harmonised rules as regards deposit guarantee schemes. At the material time, Directive 94/19/EC was implemented into Icelandic law by Act No 98/1999 on Deposit Guarantees and Investor-Compensation Schemes. Under Directive 94/19/EC, deposit-guarantee schemes must cover the aggregate deposits of each depositor up to ECU/EUR 20 000 in the event of deposits being unavailable.

| — | In early October 2008, the Icelandic bank Landsbanki Íslands hf. collapsed and was taken over by the Icelandic State. The depositors in the foreign branches of Landsbanki (‘Icesave’) in the United Kingdom and the Netherlands lost access to their deposits. |
| --- | --- |

—

In early October 2008, the Icelandic bank Landsbanki Íslands hf. collapsed and was taken over by the Icelandic State. The depositors in the foreign branches of Landsbanki (‘Icesave’) in the United Kingdom and the Netherlands lost access to their deposits.

| — | The EFTA Surveillance Authority submits that by failing to ensure payment of the minimum amount of compensation to Icesave depositors in the Netherlands and in the United Kingdom within the time limits laid down in Directive 94/19/EC, Iceland has failed to comply with its obligations arising under Articles 3(1), 4(1), 7(1) and 10(1) of Directive 94/19/EC. Additionally or in the alternative, the EFTA Surveillance Authority submits that Iceland has breached the prohibition on discrimination on grounds of nationality under Article 4 of the EEA. |
| --- | --- |

—

The EFTA Surveillance Authority submits that by failing to ensure payment of the minimum amount of compensation to Icesave depositors in the Netherlands and in the United Kingdom within the time limits laid down in Directive 94/19/EC, Iceland has failed to comply with its obligations arising under Articles 3(1), 4(1), 7(1) and 10(1) of Directive 94/19/EC. Additionally or in the alternative, the EFTA Surveillance Authority submits that Iceland has breached the prohibition on discrimination on grounds of nationality under Article 4 of the EEA.

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

European Commission

| 16.2.2012 | EN | Official Journal of the European Union | C 44/22 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/22

---

Notice of initiation of an anti-dumping proceeding concerning imports of ceramic tableware and kitchenware originating in the People's Republic of China

2012/C 44/07

The European Commission (‘the Commission’) has received a complaint pursuant to Article 5 of Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), alleging that imports of ceramic tableware and kitchenware, originating in the People's Republic of China, are being dumped and are thereby causing material injury to the Union industry.

1.   Complaint

The complaint was lodged on 3 January 2012 on behalf of EU producers (‘the complainants’) representing a major proportion, in this case more than 30 % of the total Union production of ceramic tableware and kitchenware.

2.   Product under investigation

The product subject to this investigation is ceramic tableware and kitchenware (‘the product under investigation’).

3.   Allegation of dumping
   (2)

The product allegedly being dumped is the product under investigation, originating in the People's Republic of China (‘the country concerned’), currently falling within CN codes 6911 10 00, ex 6912 00 10, ex 6912 00 30, ex 6912 00 50 and ex 6912 00 90. These CN codes are given for information only.

Since, in view of the provisions of Article 2(7) of the basic Regulation, the country concerned is considered to be a non-market economy country, the complainant established normal value for the imports from the People's Republic of China on the basis of the price in a market economy third country, namely Russia. The allegation of dumping is based on a comparison of the normal value thus established with the export price (at ex-works level) of the product under investigation when sold for export to the Union.

On this basis the dumping margins calculated are significant for the country concerned.

4.   Allegation of injury

The complainant have provided evidence that imports of the product under investigation from the country concerned have increased overall in terms of market share.

The prima facie evidence provided by the complainant shows that the volume and the prices of the imported product under investigation have, among other consequences, had a negative impact on the quantities sold, the level of prices charged and the market share held by the Union industry, resulting in substantial adverse effects on the overall performance of the Union industry.

5.   Procedure

Having determined, after consulting the Advisory Committee, that the complaint has been lodged by or on behalf of the Union industry and that there is sufficient evidence to justify the initiation of a proceeding, the Commission hereby initiates an investigation pursuant to Article 5 of the basic Regulation.

The investigation will determine whether the product under investigation originating in country concerned is being dumped and whether the dumped imports have caused injury to the Union industry. If the conclusions are affirmative, the investigation will examine whether the imposition of measures would not be against the Union interest.

5.1.   
  Procedure for the determination of dumping

Exporting producers (3) of the product under investigation from the country concerned are invited to participate in the Commission investigation.

5.1.1.   Investigating exporting producers

5.1.1.1.   Procedure for selecting exporting producers to be investigated in the country concerned

(a)   Sampling

In view of the potentially large number of exporting producers in the country concerned involved in this proceeding and in order to complete the investigation within the statutory time limits, the Commission may limit the exporting producers to be investigated to a reasonable number by selecting a sample (this process is also referred to as ‘sampling’). The sampling will be carried out in accordance with Article 17 of the basic Regulation.

In order to enable the Commission to decide whether sampling is necessary, and if so, to select a sample, all exporting producers, or representatives acting on their behalf, are hereby requested to make themselves known to the Commission. These parties have to do so within 15 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified, by providing the Commission with information on their company (ies) requested in Annex A to this notice.

In order to obtain the information it deems necessary for the selection of the sample of exporting producers, the Commission will also contact the authorities of the country concerned and may contact any known associations of exporting producers.

All interested parties wishing to submit any other relevant information regarding the selection of the sample, excluding the information requested above, must do so within 21 days of the publication of this notice in the Official Journal of the European Union, unless otherwise specified.

If a sample is necessary, the exporting producers may be selected based on the largest representative volume of exports to the Union which can reasonably be investigated within the time available. All known exporting producers, the authorities of the country concerned and associations of exporting producers will be notified by the Commission, via the authorities of the country concerned if appropriate, of the companies selected to be in the sample.

In order to obtain the information it deems necessary for its investigation with regard to exporting producers, the Commission will send questionnaires to the exporting producers selected to be in the sample, to any known association of exporting producers, and to the authorities of the People's Republic of China.

All exporting producers selected to be in the sample will have to submit a completed questionnaire within 37 days from the date of notification of the sample selection, unless otherwise specified.

The questionnaire will contain information on, inter alia, the structure of the exporting producer's company(ies), the activities of the company(ies) in relation to the product under investigation, the cost of production, the sales of the product under investigation on the domestic market of the country concerned and the sales of the product under investigation to the Union.

Companies that had agreed to their possible inclusion in the sample but were not selected to be in the sample shall be considered to be cooperating (‘non-sampled cooperating exporting producers’). Without prejudice to section (b) below, the anti-dumping duty that may be applied to imports from the non-sampled cooperating exporting producers will not exceed the weighted average margin of dumping established for the exporting producers in the sample (4).

(b)   Individual dumping margin for companies not included in the sample

Non-sampled cooperating exporting producers may request, pursuant to Article 17(3) of the basic Regulation, that the Commission establish their individual dumping margins (‘individual dumping margin’). The exporting producers wishing to claim an individual dumping margin must request a questionnaire and other applicable claim forms and return them duly completed within the deadlines specified in the following sentence and in section 5.1.2.2 below. The completed questionnaire reply must be submitted within 37 days of the date of the notification of the sample selection, unless otherwise specified. It must be underlined that, in order for the Commission to be able to establish individual dumping margins for those exporting producers in the non-market economy country, it must be proven that they fulfil the criteria for being granted market economy treatment (‘MET’) or at least individual treatment (‘IT’) as specified in section 5.1.2.2 below.

However, exporting producers claiming an individual dumping margin should be aware that the Commission may nonetheless decide not to determine their individual dumping margin if, for instance, the number of exporting producers is so large that such determination would be unduly burdensome and would prevent the timely completion of the investigation.

5.1.2.   Additional procedure with regard to exporting producers in the non-market economy country concerned

5.1.2.1.   Selection of a Market Economy Third Country

Subject to the provisions of section 5.1.2.2 below, in accordance with Article 2(7)(a) of the basic Regulation, in the case of imports from the country concerned normal value shall be determined on the basis of the price or constructed value in a market economy third country. For this purpose the Commission shall select an appropriate market economy third country. The Commission has provisionally chosen Russia. Interested parties are hereby invited to comment on the appropriateness of this choice within 10 days of the date of publication of this notice in the Official Journal of the European Union.

5.1.2.2.   Treatment of exporting producers in the non-market economy country concerned

In accordance with Article 2(7)(b) of the basic Regulation, individual exporting producers in the country concerned, which consider that market economy conditions prevail for them in respect of the manufacture and sale of the product under investigation, may submit a properly substantiated claim to this effect (‘MET claim’). Market economy treatment (‘MET’) will be granted if the assessment of the MET claim shows that the criteria laid down in Article 2(7)(c) of the basic Regulation (5) are fulfilled. The dumping margin of the exporting producers granted MET will be calculated, to the extent possible and without prejudice to the use of facts available pursuant to Article 18 of the basic Regulation, by using their own normal value and export prices in accordance with Article 2(7)(b) of the basic Regulation.

Individual exporting producers in the country concerned may also, or as an alternative, claim individual treatment (‘IT’). To be granted IT these exporting producers must provide evidence that they fulfil the criteria set out in Article 9(5) of the basic Regulation (6). The dumping margin of the exporting producers granted IT will be calculated on the basis of their own export prices. The normal value for exporting producers granted IT will be based on the values established for the market economy third country selected as outlined above.

Additional important information in relation to conditions for obtaining IT is providedin section 10 of this notice.

(a)   Market economy treatment (MET)

The Commission will send MET claim forms to all the exporting producers in the country concerned selected to be in the sample and to non-sampled cooperating exporting producers that wish to apply for an individual dumping margin, to any known association of exporting producers, as well as to the authorities of the country concerned.

All exporting producers claiming MET must submit a completed MET claim form within 21 days of the date of the notification of the sample selection or of the decision not to select a sample, unless otherwise specified.

(b)   Individual treatment (IT)

To apply for IT, exporting producers in the country concerned selected to be in the sample and non-sampled cooperating exporting producers that wish to apply for an individual dumping margin must submit the MET claim form with the sections relevant for IT duly completed within 21 days of the date of the notification of sample selection, unless otherwise specified.

5.1.3.   Investigating unrelated importers
   (7)
   (8)

Unrelated importers of the product under investigation from the country concerned to the Union are invited to participate in this investigation.

In view of the potentially large number of unrelated importers involved in this proceeding and in order to complete the investigation within the statutory time limits, the Commission may limit to a reasonable number the unrelated importers that will be investigated by selecting a sample (this process is also referred to as ‘sampling’). The sampling will be carried out in accordance with Article 17 of the basic Regulation.

In order to enable the Commission to decide whether sampling is necessary and, if so, to select a sample, all unrelated importers, or representatives acting on their behalf, are hereby requested to make themselves known to the Commission. These parties should do so within 15 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified, by providing the Commission with the information on their company(ies) requested in Annex B to this notice.

In order to obtain the information it deems necessary for the selection of the sample of unrelated importers, the Commission may also contact any known associations of importers.

All interested parties wishing to submit any other relevant information regarding the selection of the sample, excluding the information requested above, must do so within 21 days of the publication of this notice in the Official Journal of the European Union, unless otherwise specified.

If a sample is necessary, the importers may be selected based on the largest representative volume of sales of the product under investigation in the Union which can reasonably be investigated within the time available. All known unrelated importers and associations of importers will be notified by the Commission of the companies selected to be in the sample.

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the sampled unrelated importers and to any known association of importers. These parties must submit a completed questionnaire within 37 days from the date of the notification of the sample selection, unless otherwise specified. The completed questionnaire will contain information on, inter alia, the structure of their company(ies), the activities of the company(ies) in relation to the product under investigation and on the sales of the product under investigation.

5.2.   
  Procedure for the determination of injury

   (9)

  and investigating Union producers

A determination of injury is based on positive evidence and involves an objective examination of the volume of the dumped imports, their effect on prices on the Union market and the consequent impact of those imports on the Union industry. In order to establish whether the Union industry is materially injured, Union producers of the product under investigation are invited to participate in the Commission investigation.

In view of the large number of Union producers involved in this proceeding and in order to complete the investigation within the statutory time limits, the Commission has decided to limit to a reasonable number the Union producers that will be investigated by selecting a sample (this process is also referred to as ‘sampling’). The sampling is carried out in accordance with Article 17 of the basic Regulation.

The Commission has provisionally selected a sample of Union producers. Details can be found in the file for inspection by interested parties. Interested parties are hereby invited to consult the file (for this they should contact the Commission using the contact details provided in section 5.6 below). Other Union producers, or representatives acting on their behalf, that consider that there are reasons why they should be included in the sample should contact the Commission within 15 days of the date of publication of this notice in the Official Journal of the European Union.

All interested parties wishing to submit any other relevant information regarding the selection of the sample must do so within 21 days of the publication of this notice in the Official Journal of the European Union, unless otherwise specified.

All known Union producers and/or associations of Union producers will be notified by the Commission of the companies finally selected to be in the sample.

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the sampled Union producers and to any known association of Union producers. These parties must submit a completed questionnaire within 37 days from the date of the notification of the sample selection, unless otherwise specified. The completed questionnaire will contain information on, inter alia, the structure of their company(ies), the financial situation of the company(ies), the activities of the company(ies) in relation to the product under investigation, the cost of production and the sales of the product under investigation.

5.3.   
  Procedure for the assessment of Union interest

Should the existence of dumping and injury caused thereby be established, a decision will be reached, pursuant to Article 21 of the basic Regulation, as to whether the adoption of anti-dumping measures would be against the Union interest. Union producers, importers and their representative associations, users and their representative associations, and representative consumer organisations are invited to make themselves known within 15 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. In order to participate in the investigation, the representative consumer organisations have to demonstrate, within the same deadline, that there is an objective link between their activities and the product under investigation.

Parties that make themselves known within the above deadline may provide the Commission with information on the Union interest within 37 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. This information may be provided either in a free format or by completing a questionnaire prepared by the Commission. In any case, information submitted pursuant to Article 21 will only be taken into account if supported by factual evidence at the time of submission.

5.4.   
  Other written submissions

Subject to the provisions of this notice, all interested parties are hereby invited to make their views known, submit information and provide supporting evidence. Unless otherwise specified, this information and supporting evidence must reach the Commission within 37 days of the date of publication of this notice in the Official Journal of the European Union.

5.5.   
  Possibility to be heard by the Commission investigation services

All interested parties may request to be heard by the Commission investigation services. Any request to be heard should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the initial stage of the investigation the request must be submitted within 15 days of the date of publication of this notice in the Official Journal of the European Union. Thereafter, a request to be heard should be submitted within the specific deadlines set by the Commission in its communication with the parties.

5.6.   
  Instructions for making written submissions and sending completed questionnaires and correspondence

All written submissions, including the information requested in this notice, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested shall be labelled ‘Limited (10)’.

Interested parties providing ‘Limited’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of the basic Regulation, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If an interested party providing confidential information does not furnish a non-confidential summary of it in the requested format and quality, such confidential information may be disregarded.

Interested parties are required to make all submissions and requests in electronic format (the non-confidential submissions via e-mail, the confidential ones on CD-R/DVD), and must indicate the name, address, e-mail address, telephone and fax numbers of the interested party. However, any Powers of Attorney, signed certifications, and any updates thereof, accompanying MET and IT claim forms or questionnaire replies shall be submitted on paper, i.e. by post or by hand, at the address below. If an interested party cannot provide its submissions and requests in electronic format, it must immediately contact the Commission pursuant to Article 18(2) of the basic Regulation. For further information concerning correspondence with the Commission, interested parties may consult the relevant web page on the website of Directorate-General for Trade: http://ec.europa.eu/trade/tackling-unfair-trade/trade-defence

Commission address for correspondence:

| European Commission |
| --- |
| Directorate-General for Trade |
| Directorate H |
| Office: N105 04/092 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |
| Fax +32 22993704 |
| E-mail: TRADE-TABLEWARE-DUMPING@ec.europa.eu |
| TRADE-TABLEWARE-INJURY@ec.europa.eu |

European Commission

Directorate-General for Trade

Directorate H

Office: N105 04/092

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

Fax +32 22993704

E-mail: TRADE-TABLEWARE-DUMPING@ec.europa.eu

TRADE-TABLEWARE-INJURY@ec.europa.eu

6.   Non-cooperation

In cases where any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made on the basis of facts available, in accordance with Article 18 of the basic Regulation.

Where it is found that any interested party has supplied false or misleading information, the information may be disregarded and use may be made of facts available.

If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

7.   Hearing Officer

Interested parties may request the intervention of the Hearing Officer of Directorate-General for Trade. The Hearing Officer acts as an interface between the interested parties and the Commission investigation services. The Hearing Officer reviews requests for access to the file, disputes on the confidentiality of documents, requests for extension of time limits and requests by third parties to be heard. The Hearing Officer may organise a hearing with an individual interested party and mediate to ensure that the interested parties' rights of defence are being fully exercised.

A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the initial stage of the investigation the request must be submitted within 15 days of the date of publication of this notice in the Official Journal of the European Union. Thereafter, a request to be heard must be submitted within specific deadlines set by the Commission in its communication with the parties.

The Hearing Officer will also provide opportunities for a hearing involving parties to take place which would allow different views to be presented and rebuttal arguments offered on issues pertaining, among others, to dumping, injury, causal link and Union interest. Such a hearing would, as a rule, take place at the latest at the end of the fourth week following the disclosure of provisional findings.

For further information and contact details interested parties may consult the Hearing Officer's web pages on DG Trade's website: http://ec.europa.eu/trade/tackling-unfair-trade/hearing-officer/index_en.htm

8.   Schedule of the investigation

The investigation will be concluded, according to Article 6(9) of the basic Regulation within 15 months of the date of the publication of this notice in the Official Journal of the European Union. According to Article 7(1) of the basic Regulation, provisional measures may be imposed no later than nine months from the publication of this notice in the Official Journal of the European Union.

9.   Processing of personal data

Any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (11).

10.   Important information for exporting producers in the People's Republic of China: implications of the WTO Appellate Body Report EC-Antidumping measures on fasteners (WT/DS397) on the way in which the Commission will conduct this investigation

The Commission encourages all exporting producers from the country concerned which is considered to be a non-market economy country in view of the provisions of Article 2(7) of the basic Regulation, to make themselves known within 15 days of the date of publication of this notice in the Official Journal of the European Union, if they are interested in obtaining an individual anti-dumping duty, even if they consider that they do not comply with the criteria for obtaining IT. The Commission draws their attention to the following (12).

In EC-Certain Iron or Steel fasteners from China (WT/DS397), the WTO Appellate Body found, inter alia, that Article 9(5) of the basic Regulation is inconsistent with certain provisions of the WTO Anti-Dumping Agreement and with Article XVI:4 of the WTO Agreement.

Article 2 of Council Regulation (EC) No 1515/2001 of 23 July 2001 on the measures that may be taken by the Community following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters (13) (‘the enabling Regulation’) provides that the Council of the European Union may, inter alia, amend Union measures taken pursuant to the basic Regulation in order to take into account the legal interpretations made in a report adopted by the WTO Dispute Settlement Body with regard to a non-disputed measure, if it considers this appropriate.

Therefore, should the investigation which is initiated by the present notice result in the adoption of final anti-dumping measures, in the Commission's view the aforementioned Article 2 would constitute a legal basis for complying with the legal interpretations developed by the Appellate Body in the above mentioned dispute. This would imply, in more practical terms, that if an exporting producer came forward within the deadline set out above and fully cooperated by furnishing all relevant information but did not apply for IT, or applied but was found not to fulfil the criteria, the aforementioned Article 2 of the enabling Regulation could serve, in duly justified cases, as a legal basis for determining for that exporting producer an individual duty at the time of the imposition of definitive anti-dumping measures. In examining this question, the Commission will take account of the reasoning of the Appellate Body in the above-mentioned dispute, and in particular of the elements discussed in paragraphs 371-384 of its report.

Operators obtaining an individual duty on the basis of this part of this notice of initiation should be aware that the findings may result in an increase in the duty compared to the one that would apply if no individual duty had been determined.

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(1)  OJ L 343, 22.12.2009, p. 51.

(2)  Dumping is the practice of selling a product for export (‘the product concerned’) at a price below its ‘normal value’. The normal value is usually taken to be a comparable price for the ‘like’ product on the domestic market of the country concerned. The term ‘like product’ is interpreted to mean a product which is alike in all respects to the product concerned or, in the absence of such a product, a product which closely resembles the product.

(3)  An exporting producer is any company in the country concerned which produces and exports the product under investigation to the Union market, either directly or via third party, including any of its related companies involved in the production, domestic sales or exports of the product concerned.

(4)  Pursuant to Article 9(6) of the basic Regulation, any zero and de minimis margins, and margins established in accordance with the circumstances described in Article 18 of the basic Regulation shall be disregarded.

(5)  The exporting producers have to demonstrate in particular that: (i) business decisions and costs are made in response to market conditions and without significant State interference; (ii) firms have one clear set of basic accounting records which are independently audited in line with international accounting standards and are applied for all purposes; (iii) there are no significant distortions carried over from the former non-market economy system; (iv) bankruptcy and property laws guarantee legal certainty and stability and (v) exchange rate conversions are carried out at market rates.

(6)  The exporting producers have to demonstrate in particular that: (i) in the case of wholly or partly foreign owned firms or joint ventures, exporters are free to repatriate capital and profits; (ii) export prices and quantities and conditions and terms of sale are freely determined; (iii) the majority of the shares belong to private persons. State officials appearing on the Board of Directors or holding key management positions shall either be in a minority or it must be demonstrated that the company is nonetheless sufficiently independent from State interference; (iv) exchange rate conversions are carried out at the market rate and (v) State interference is not such as to permit circumvention of measures if individual exporters are given different rates of duty.

(7)  In accordance with Article 143 of Commission Regulation (EEC) No 2454/93 concerning the implementation of the Community Customs Code, persons shall be deemed to be related only if: (a) they are officers or directors of one another's businesses; (b) they are legally recognised partners in business; (c) they are employer and employee; (d) any person directly or indirectly owns, controls or holds 5 % or more of the outstanding voting stock or shares of both of them; (e) one of them directly or indirectly controls the other; (f) both of them are directly or indirectly controlled by a third person; (g) together they directly or indirectly control a third person; or (h) they are members of the same family. Persons shall be deemed to be members of the same family only if they stand in any of the following relationships to one another: (i) husband and wife, (ii) parent and child, (iii) brother and sister (whether by whole or half blood), (iv) grandparent and grandchild, (v) uncle or aunt and nephew or niece, (vi) parent-in-law and son-in-law or daughter-in-law, (vii) brother-in-law and sister-in-law. (OJ L 253, 11.10.1993, p. 1). In this context ‘person’ means any natural or legal person.

(8)  The data provided by unrelated importers may also be used in relation to aspects of this investigation other than the determination of dumping.

(9)  Injury means material injury to the Union industry, or threat of material injury to the industry, or material retardation of the establishment of such an industry.

(10)  A ‘Limited’ document is a document which is considered confidential pursuant to Article 19 of Council Regulation (EC) No 1225/2009 (OJ L 343, 22.12.2009, p. 51) and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-Dumping Agreement). It is also a document protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43).

(11)  OJ L 8, 12.1.2001, p. 1.

(12)  Should sampling for exporting producers be deemed necessary, an individual anti-dumping duty will only be determined for those exporting producers either (i) selected to be in the sample or (ii) for which an individual dumping margin has been determined pursuant to Article 17(3) of the basic Regulation.

(13)  OJ L 201, 26.7.2001, p. 10.

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ANNEX A

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ANNEX B

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| 16.2.2012 | EN | Official Journal of the European Union | C 44/33 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/33

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Notice of initiation of an anti-dumping proceeding concerning imports of threaded tube or pipe cast fittings, of malleable cast iron originating in the People's Republic of China, Thailand and Indonesia

2012/C 44/08

The European Commission (‘the Commission’) has received a complaint pursuant to Article 5 of Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), alleging that imports of threaded tube or pipe cast fittings, of malleable cast iron, originating in the People’s Republic of China, Thailand and Indonesia, are being dumped and are thereby causing material injury to the Union industry.

1.   Complaint

The complaint was lodged on 3 January 2012 by the Defence Committee of Tube or Pipe Cast Fittings, of Malleable Cast Iron of the European Union (‘the complainant’) on behalf of producers representing a major proportion, in this case more than 50 %, of the total Union production of threaded tube or pipe cast fittings, of malleable cast iron.

2.   Product under investigation

The product subject to this investigation is threaded tube or pipe cast fittings, of malleable cast iron (‘the product under investigation’).

3.   Allegation of dumping
   (2)

The product allegedly being dumped is the product under investigation, originating in the People’s Republic of China, Thailand and Indonesia (‘the countries concerned’), currently falling within CN code ex 7307 19 10. This CN code is given for information only.

Since, in view of the provisions of Article 2(7) of the basic Regulation, the People’s Republic of China is considered to be a non-market economy country, the complainant established normal value for the imports from the People’s Republic of China on the basis of the price in a market economy third country, in the present case Argentina. The allegation of dumping is based on a comparison of the normal value thus established with the export price (at ex-works level) of the product under investigation when sold for export to the Union.

The allegation of dumping for Thailand and Indonesia is based on a comparison of domestic price with the export price (at ex-works level) of the product under investigation when sold for export to the Union.

On this basis, the dumping margins calculated are significant for all the countries concerned.

4.   Allegation of injury

The complainant has provided evidence that imports of the product under investigation from the countries concerned have increased overall in absolute terms as well as in terms of market share.

The prima facie evidence provided by the complainant shows that the volume and the prices of the imported product under investigation have had, among other consequences, a negative impact on the quantities sold and the market share held by the Union industry, resulting in substantial adverse effects on the financial situation and the employment situation of the Union industry.

5.   Procedure

Having determined, after consulting the Advisory Committee, that the complaint has been lodged by or on behalf of the Union industry and that there is sufficient evidence to justify the initiation of a proceeding, the Commission hereby initiates an investigation pursuant to Article 5 of the basic Regulation.

The investigation will determine whether the product under investigation originating in countries concerned is being dumped and whether the dumped imports have caused injury to the Union industry. If the conclusions are affirmative, the investigation will examine whether the imposition of measures would not be against the Union interest.

5.1.   
  Procedure for the determination of dumping

Exporting producers (3) of the product under investigation from the countries concerned are invited to participate in the Commission investigation.

5.1.1.   Investigating exporting producers

5.1.1.1.   Procedure for selecting exporting producers to be investigated in the People’s Republic of China

(a)   Sampling

In view of the potentially large number of exporting producers in the People’s Republic of China involved in this proceeding and in order to complete the investigation within the statutory time limits, the Commission may limit the exporting producers to be investigated to a reasonable number by selecting a sample (this process is also referred to as ‘sampling’). The sampling will be carried out in accordance with Article 17 of the basic Regulation.

In order to enable the Commission to decide whether sampling is necessary, and if so, to select a sample, all exporting producers, or representatives acting on their behalf, are hereby requested to make themselves known to the Commission. These parties have to do so within 15 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified, by providing the Commission with information on their company(ies) as requested in Annex A to this notice.

In order to obtain the information it deems necessary for the selection of the sample of exporting producers, the Commission will also contact the authorities of the People’s Republic of China and may contact any known association of exporting producers.

All interested parties wishing to submit any other relevant information regarding the selection of the sample, excluding the information requested above, must do so within 21 days of the publication of this notice in the Official Journal of the European Union, unless otherwise specified.

If a sample is necessary, the exporting producers may be selected based on the largest representative volume of exports to the Union which can reasonably be investigated within the time available. All known exporting producers, the authorities of the country concerned and associations of exporting producers will be notified by the Commission, via the authorities of the country concerned if appropriate, of the companies selected to be in the sample.

In order to obtain the information it deems necessary for its investigation with regard to exporting producers, the Commission will send questionnaires to the exporting producers selected to be in the sample, to any known association of exporting producers and to the authorities of the country concerned. All exporting producers selected to be in the sample will have to submit a completed questionnaire within 37 days from the date of notification of the sample selection, unless otherwise specified.

The questionnaire will contain information on, inter alia, the structure of the exporting producer’s company(ies), the activities of the company(ies) in relation to the product under investigation, the cost of production, the sales of the product under investigation on the domestic market of the country concerned and the sales of the product under investigation to the Union.

The exporting producers that had agreed to their possible inclusion in the sample, but were not selected to be in the sample, shall be considered to be cooperating (‘non-sampled cooperating exporting producers’). Without prejudice to Section (b) below, the anti-dumping duty that may be applied to imports from the non-sampled cooperating exporting producers will not exceed the weighted average margin of dumping established for the exporting producers in the sample (4).

(b)   Individual dumping margin for exporting producers not included in the sample

Non-sampled cooperating exporting producers may request, pursuant to Article 17(3) of the basic Regulation, that the Commission establish their individual dumping margins. The exporting producers wishing to claim an individual dumping margin must request a questionnaire and other applicable claim forms and return them duly completed within the deadlines specified in the following sentence and in Section 5.1.2.2. below. The completed questionnaire reply must be submitted within 37 days of the date of the notification of the sample selection, unless otherwise specified. It must be underlined that, in order for the Commission to be able to establish individual dumping margins for those exporting producers in the non-market economy country, it must be proven that they fulfil the criteria for being granted market economy treatment (‘MET’) or at least individual treatment (‘IT’) as specified in Section 5.1.2.2. below.

However, exporting producers claiming an individual dumping margin should be aware that the Commission may nonetheless decide not to determine their individual dumping margin if, for instance, the number of exporting producers is so large that such determination would be unduly burdensome and would prevent the timely completion of the investigation.

5.1.1.2.   Procedure for exporting producers to be investigated in Thailand and Indonesia

All exporting producers and associations of exporting producers in Thailand and Indonesia are invited to contact the Commission, preferably by e-mail, immediately but no later than 15 days after the publication of this notice in the Official Journal of the European Union, unless otherwise specified, in order to make themselves known and to request a questionnaire. In order to obtain the information it deems necessary for its investigation with regard to exporting producers, the Commission will send questionnaires to the known exporting producers in Thailand and Indonesia, to any known association of exporting producers and to the authorities of Thailand and Indonesia.

The exporting producers and, where applicable, the associations of exporting producers, must submit the completed questionnaire within 37 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified.

The questionnaire will contain information on, inter alia, the structure of the exporting producer’s company(ies), the activities of the company(ies) in relation to the product under investigation, the cost of production, the sales of the product under investigation on the domestic market of the countries concerned and the sales of the product under investigation to the Union.

5.1.2.   Additional procedure with regard to exporting producers in the People’s Republic of China

5.1.2.1.   Selection of a market economy third country

Subject to the provisions of Section 5.1.2.2. below, in accordance with Article 2(7)(a) of the basic Regulation, in the case of imports from the People's Republic of China normal value shall be determined on the basis of the price or constructed value in a market economy third country. For this purpose the Commission shall select an appropriate market economy third country. The Commission has provisionally chosen Argentina. Interested parties are hereby invited to comment on the appropriateness of this choice within 10 days of the date of publication of this notice in the Official Journal of the European Union.

5.1.2.2.   Treatment of exporting producers in the People's Republic of China

In accordance with Article 2(7)(b) of the basic Regulation, individual exporting producers in the People's Republic of China, which consider that market economy conditions prevail for them in respect of the manufacture and sale of the product under investigation, may submit a properly substantiated claim to this effect (‘MET claim’). Market economy treatment (‘MET’) will be granted if the assessment of the MET claim shows that the criteria laid down in Article 2(7)(c) of the basic Regulation (5) are fulfilled. The dumping margin of the exporting producers granted MET will be calculated, to the extent possible and without prejudice to the use of facts available pursuant to Article 18 of the basic Regulation, by using their own normal value and export prices in accordance with Article 2(7)(b) of the basic Regulation.

Individual exporting producers in the People's Republic of China may also, or as an alternative, claim individual treatment (‘IT’). To be granted IT these exporting producers must provide evidence that they fulfil the criteria set out in Article 9(5) of the basic Regulation (6). The dumping margin of the exporting producers granted IT will be calculated on the basis of their own export prices. The normal value for exporting producers granted IT will be based on the values established for the market economy third country selected as outlined in Section 5.1.2.1. above.

Additional important information can be found in Section 10 of this notice.

(a)   Market economy treatment

The Commission will send MET claim forms to all the exporting producers in the People's Republic of China selected to be in the sample and to non-sampled cooperating exporting producers that wish to apply for an individual dumping margin, to any known association of exporting producers, as well as to the authorities of the country concerned.

All exporting producers claiming MET must submit a completed MET claim form within 21 days of the date of the notification of the sample selection, unless otherwise specified.

(b)   Individual treatment

To apply for IT, exporting producers in the People’s Republic of China selected to be in the sample and non-sampled cooperating exporting producers that wish to apply for an individual dumping margin must submit the MET claim form with the sections relevant for IT duly completed within 21 days of the date of the notification of sample selection, unless otherwise specified.

5.1.3.   Investigating unrelated importers
   (7)
   (8)

Unrelated importers of the product under investigation from the countries concerned to the Union are invited to participate in this investigation.

In view of the potentially large number of unrelated importers involved in this proceeding and in order to complete the investigation within the statutory time limits, the Commission may limit to a reasonable number the unrelated importers that will be investigated by selecting a sample (this process is also referred to as ‘sampling’). The sampling will be carried out in accordance with Article 17 of the basic Regulation.

In order to enable the Commission to decide whether sampling is necessary and, if so, to select a sample, all unrelated importers, or representatives acting on their behalf, are hereby requested to make themselves known to the Commission. These parties should do so within 15 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified, by providing the Commission with the information on their company(ies) as requested in Annex B to this notice.

In order to obtain the information it deems necessary for the selection of the sample of unrelated importers, the Commission may also contact any known association of importers.

All interested parties wishing to submit any other relevant information regarding the selection of the sample, excluding the information requested above, must do so within 21 days of the publication of this notice in the Official Journal of the European Union, unless otherwise specified.

If a sample is necessary, the unrelated importers may be selected based on the largest representative volume of sales of the product under investigation in the Union which can reasonably be investigated within the time available. All known unrelated importers and associations of importers will be notified by the Commission of the companies selected to be in the sample.

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the sampled unrelated importers and to any known association of importers. These parties must submit a completed questionnaire within 37 days from the date of the notification of the sample selection, unless otherwise specified. The completed questionnaire will contain information on, inter alia, the structure of their company(ies), the activities of the company(ies) in relation to the product under investigation and on the sales of the product under investigation.

5.2.   
  Procedure for the determination of injury

   (9)

  and for Union producers to be investigated

A determination of injury is based on positive evidence and involves an objective examination of the volume of the dumped imports, their effect on prices on the Union market and the consequent impact of those imports on the Union industry. In order to establish whether the Union industry is materially injured, Union producers of the product under investigation are invited to participate in the Commission investigation.

In view of the large number of Union producers involved in this proceeding and in order to complete the investigation within the statutory time limits, the Commission has decided to limit to a reasonable number the Union producers that will be investigated by selecting a sample (this process is also referred to as ‘sampling’). The sampling is carried out in accordance with Article 17 of the basic Regulation.

The Commission has provisionally selected a sample of Union producers. Details can be found in the file for inspection by interested parties. Interested parties are hereby invited to consult the file (for this they should contact the Commission using the contact details provided in Section 5.6. below). Other Union producers, or representatives acting on their behalf, that consider that there are reasons why they should be included in the sample, should contact the Commission within 15 days of the date of publication of this notice in the Official Journal of the European Union.

All interested parties wishing to submit any other relevant information regarding the selection of the sample must do so within 21 days of the publication of this notice in the Official Journal of the European Union, unless otherwise specified.

All known Union producers and/or associations of Union producers will be notified by the Commission of the companies finally selected to be in the sample.

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the sampled Union producers and to any known association of Union producers. These parties must submit a completed questionnaire within 37 days from the date of the notification of the sample selection, unless otherwise specified. The questionnaire will contain information on, inter alia, the structure of their company(ies), the financial situation of the company(ies), the activities of the company(ies) in relation to the product under investigation, the cost of production and the sales of the product under investigation.

5.3.   
  Procedure for the assessment of Union interest

Should the existence of dumping and injury caused thereby be established, a decision will be reached, pursuant to Article 21 of the basic Regulation, as to whether the adoption of anti-dumping measures would be against the Union interest. Union producers, importers and their representative associations, users and their representative associations, and representative consumer organisations are invited to make themselves known within 15 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. In order to participate in the investigation, the representative consumer organisations have to demonstrate, within the same deadline, that there is an objective link between their activities and the product under investigation.

Parties that make themselves known within the above deadline may provide the Commission with information on the Union interest within 37 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. This information may be provided either in a free format or by completing a questionnaire prepared by the Commission. In any case, information submitted pursuant to Article 21 will only be taken into account if supported by factual evidence at the time of submission.

5.4.   
  Other written submissions

Subject to the provisions of this notice, all interested parties are hereby invited to make their views known, submit information and provide supporting evidence. Unless otherwise specified, this information and supporting evidence should reach the Commission within 37 days of the date of publication of this notice in the Official Journal of the European Union.

5.5.   
  Possibility to be heard by the Commission investigation services

All interested parties may request to be heard by the Commission investigation services. Any request to be heard should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the initial stage of the investigation the request must be submitted within 15 days of the date of publication of this notice in the Official Journal of the European Union. Thereafter, a request to be heard should be submitted within the specific deadlines set by the Commission in its communication with the parties.

5.6.   
  Instructions for making written submissions and sending completed questionnaires and correspondence

All written submissions, including the information requested in this notice, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested shall be labelled ‘Limited’ (10).

Interested parties providing ‘Limited’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of the basic Regulation, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If an interested party providing confidential information does not furnish a non-confidential summary of it in the requested format and quality, such confidential information may be disregarded.

Interested parties are required to make all submissions and requests in electronic format (the non-confidential submissions via e-mail, the confidential ones on CD-R/DVD), and must indicate the name, address, e-mail address, telephone and fax numbers of the interested party. However, any Powers of Attorney, signed certifications, and any updates thereof, accompanying MET and IT claim forms or questionnaire replies shall be submitted on paper, i.e. by post or by hand, at the address below. If an interested party cannot provide its submissions and requests in electronic format, it must immediately contact the Commission in compliance with Article 18(2) of the basic Regulation. For further information concerning correspondence with the Commission, interested parties may consult the relevant web page on the website of Directorate-General for Trade: http://ec.europa.eu/trade/tackling-unfair-trade/trade-defence

Commission address for correspondence:

| European Commission |
| --- |
| Directorate-General for Trade |
| Directorate H |
| Office: N105 04/092 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |
| Fax +32 22956505 |
| E-mail: TRADE-MALLEABLE-FITTINGS-DUMPING@ec.europa.eu |
| TRADE-MALLEABLE-FITTINGS-INJURY@ec.europa.eu |

European Commission

Directorate-General for Trade

Directorate H

Office: N105 04/092

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

Fax +32 22956505

E-mail: TRADE-MALLEABLE-FITTINGS-DUMPING@ec.europa.eu

TRADE-MALLEABLE-FITTINGS-INJURY@ec.europa.eu

6.   Non-cooperation

In cases where any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made on the basis of facts available, in accordance with Article 18 of the basic Regulation.

Where it is found that any interested party has supplied false or misleading information, the information may be disregarded and use may be made of facts available.

If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

7.   Hearing Officer

Interested parties may request the intervention of the Hearing Officer of Directorate-General for Trade. The Hearing Officer acts as an interface between the interested parties and the Commission investigation services. The Hearing Officer reviews requests for access to the file, disputes on the confidentiality of documents, requests for extension of time limits and requests by third parties to be heard. The Hearing Officer may organise a hearing with an individual interested party and mediate to ensure that the interested parties’ rights of defence are being fully exercised.

A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the initial stage of the investigation the request must be submitted within 15 days of the date of publication of this notice in the Official Journal of the European Union. Thereafter, a request to be heard must be submitted within specific deadlines set by the Commission in its communication with the parties.

The Hearing Officer will also provide opportunities for a hearing involving parties to take place which would allow different views to be presented and rebuttal arguments offered on issues pertaining, among others, to dumping, injury, causal link and Union interest. Such a hearing would, as a rule, take place at the latest at the end of the fourth week following the disclosure of provisional findings.

For further information and contact details interested parties may consult the Hearing Officer’s web pages on DG Trade’s website: http://ec.europa.eu/trade/tackling-unfair-trade/hearing-officer/index_en.htm

8.   Schedule of the investigation

The investigation will be concluded, according to Article 6(9) of the basic Regulation, within 15 months of the date of the publication of this notice in the Official Journal of the European Union. According to Article 7(1) of the basic Regulation, provisional measures may be imposed no later than nine months from the publication of this notice in the Official Journal of the European Union.

9.   Processing of personal data

Any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (11).

10.   Important information for exporting producers in the People’s Republic of China: implications of the WTO Appellate Body Report EC — Anti-dumping measures on fasteners (WT/DS397) on the way in which the Commission will conduct this investigation

The Commission encourages all exporting producers from the People's Republic of China, which is considered to be a non-market economy country in view of the provisions of Article 2(7) of the basic Regulation, to make themselves known within 15 days of the date of publication of this notice in the Official Journal of the European Union, if they are interested in obtaining an individual anti-dumping duty, even if they consider that they do not comply with the criteria for obtaining IT. The Commission draws their attention to the following (12).

In EC — Certain iron or steel fasteners from China (WT/DS397), the WTO Appellate Body found, inter alia, that Article 9(5) of the basic Regulation is inconsistent with certain provisions of the WTO Anti-Dumping Agreement and with Article XVI:4 of the WTO Agreement.

Article 2 of Council Regulation (EC) No 1515/2001 of 23 July 2001 on the measures that may be taken by the Community following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters (13) (‘the enabling Regulation’) provides that the Council of the European Union may, inter alia, amend Union measures taken pursuant to the basic Regulation in order to take into account the legal interpretations made in a report adopted by the WTO Dispute Settlement Body with regard to a non-disputed measure, if it considers this appropriate.

Therefore, should the investigation which is initiated by the present Notice of initiation result in the adoption of final anti-dumping measures, in the Commission's view the aforementioned Article 2 would constitute a legal basis for complying with the legal interpretations developed by the Appellate Body in the abovementioned dispute. This would imply, in more practical terms, that if an exporting producer came forward within the deadline set out above and fully co-operated by furnishing all relevant information but did not apply for IT, or applied but was found not to fulfil the criteria, the aforementioned Article 2 of the enabling Regulation could serve, in duly justified cases, as a legal basis for awarding that exporting producer an individual duty at the time of the imposition of definitive anti-dumping measures. In examining this question, the Commission will take account of the reasoning of the Appellate Body in the abovementioned dispute, and in particular of the elements discussed in paragraphs 371-384 of its report.

Operators obtaining an individual duty on the basis of this part of this Notice of Initiation should be aware that the findings may result in an increase in the duty compared to the one that would apply if no individual duty had been determined.

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(1)  OJ L 343, 22.12.2009, p. 51.

(2)  Dumping is the practice of selling a product for export (‘the product concerned’) at a price below its ‘normal value’. The normal value is usually taken to be a comparable price for the ‘like’ product on the domestic market of the country concerned. The term ‘like product’ is interpreted to mean a product which is alike in all respects to the product concerned or, in the absence of such a product, a product which closely resembles the product.

(3)  An exporting producer is any company in the countries concerned which produces and exports the product under investigation to the Union market, either directly or via third party, including any of its related companies involved in the production, domestic sales or exports of the product concerned.

(4)  Pursuant to Article 9(6) of the basic Regulation, any zero and de minimis margins, and margins established in accordance with the circumstances described in Article 18 of the basic Regulation, shall be disregarded.

(5)  The exporting producers have to demonstrate in particular that: (i) business decisions and costs are made in response to market conditions and without significant State interference; (ii) firms have one clear set of basic accounting records which are independently audited in line with international accounting standards and are applied for all purposes; (iii) there are no significant distortions carried over from the former non-market economy system; (iv) bankruptcy and property laws guarantee legal certainty and stability, and (v) exchange rate conversions are carried out at market rates.

(6)  The exporting producers have to demonstrate in particular that: (i) in the case of wholly or partly foreign owned firms or joint ventures, exporters are free to repatriate capital and profits; (ii) export prices and quantities and conditions and terms of sale are freely determined; (iii) the majority of the shares belong to private persons. State officials appearing on the Board of Directors or holding key management positions shall either be in a minority or it must be demonstrated that the company is nonetheless sufficiently independent from State interference; (iv) exchange rate conversions are carried out at the market rate, and (v) State interference is not such as to permit circumvention of measures if individual exporters are given different rates of duty.

(7)  Only importers not related to exporting producers can be sampled. Importers that are related to exporting producers have to fill in Annex I to the questionnaire for these exporting producers. In accordance with Article 143 of Commission Regulation (EEC) No 2454/93 concerning the implementation of the Community Customs Code, persons shall be deemed to be related only if: (a) they are officers or directors of one another's businesses; (b) they are legally recognised partners in business; (c) they are employer and employee; (d) any person directly or indirectly owns, controls or holds 5 % or more of the outstanding voting stock or shares of both of them; (e) one of them directly or indirectly controls the other; (f) both of them are directly or indirectly controlled by a third person; (g) together they directly or indirectly control a third person; or (h) they are members of the same family. Persons shall be deemed to be members of the same family only if they stand in any of the following relationships to one another: (i) husband and wife; (ii) parent and child; (iii) brother and sister (whether by whole or half blood); (iv) grandparent and grandchild; (v) uncle or aunt and nephew or niece; (vi) parent-in-law and son-in-law or daughter-in-law; (vii) brother-in-law and sister-in-law (OJ L 253, 11.10.1993, p. 1). In this context ‘person’ means any natural or legal person.

(8)  The data provided by unrelated importers may also be used in relation to aspects of this investigation other than the determination of dumping.

(9)  Injury means material injury to the Union industry, or threat of material injury to the industry, or material retardation of the establishment of such an industry.

(10)  A ‘Limited’ document is a document which is considered confidential pursuant to Article 19 of Council Regulation (EC) No 1225/2009 (OJ L 343, 22.12.2009, p. 51) and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-Dumping Agreement). It is also a document protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43).

(11)  OJ L 8, 12.1.2001, p. 1.

(12)  Should sampling for exporting producers be deemed necessary, an individual anti-dumping duty will only be determined for those exporting producers either: (i) selected to be in the sample; or (ii) for which an individual dumping margin has been determined pursuant to Article 17(3) of the basic Regulation.

(13)  OJ L 201, 26.7.2001, p. 10.

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ANNEX A

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ANNEX B

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PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 16.2.2012 | EN | Official Journal of the European Union | C 44/44 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/44

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Prior notification of a concentration

(Case COMP/M.6520 — Cinven/George Topco)

(Text with EEA relevance)

2012/C 44/09

| 1. | On 9 February 2012, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Cinven Limited (‘Cinven’, UK) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of the undertaking George Topco Limited (‘George Topco’, Jersey) by way of acquisition of shares. |
| --- | --- |

1.

On 9 February 2012, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Cinven Limited (‘Cinven’, UK) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of the undertaking George Topco Limited (‘George Topco’, Jersey) by way of acquisition of shares.

| 2. | The business activities of the undertakings concerned are:






  — | Cinven is a private equity business engaged in the provision of investment management advice and services to a number of investment funds, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

Cinven is a private equity business engaged in the provision of investment management advice and services to a number of investment funds,

| — | George Topco is a company active in the legal support services sector, more specifically patent renewal and related services. |
| --- | --- |

—

George Topco is a company active in the legal support services sector, more specifically patent renewal and related services.

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

3.

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

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6520 — Cinven/George Topco, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by e-mail to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference number COMP/M.6520 — Cinven/George Topco, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

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

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OTHER ACTS

European Commission

| 16.2.2012 | EN | Official Journal of the European Union | C 44/45 |
| --- | --- | --- | --- |

16.2.2012

EN

Official Journal of the European Union

C 44/45

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Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs

2012/C 44/10

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 (1). Statements of objection must reach the Commission within six months from the date of this publication.

SINGLE DOCUMENT

COUNCIL REGULATION (EC) No 510/2006

‘FILDERKRAUT/FILDERSPITZKRAUT’

EC No: DE-PGI-0005-0822-09.09.2010

PGI ( X ) PDO ( )

1.   Name:

‘Filderkraut/Filderspitzkraut’

2.   Member State or third country:

Germany

3.   Description of the agricultural product or foodstuff:

3.1.   Type of product:

| Class 1.6: | Fruit, vegetables and cereals, fresh or processed |
| --- | --- |

Class 1.6:

Fruit, vegetables and cereals, fresh or processed

3.2.   Description of product to which the name in (1) applies:

Both in the trade and in common language, ‘Filderkraut’ means a pointed white cabbage grown in the Filder area. Colloquially, ‘Filderkraut’ is also referred to as ‘Filderspitzkraut’. ‘Filderkraut/Filderspitzkraut’ (Brassica oleracea var. capitata for. alba subv. Conica) is a very tasty subvariety of white cabbage with a characteristic ‘point’ which has become a rarity. It belongs to the Brassicaceae family and has fewer and finer leaf ribs than the round cabbage.

The shape of the pointed cabbage varies with the particular holding on which ‘Filderkraut/Filderspitzkrau’t is propagated. However, the striking feature they all share is their pointed head. The shapes range from what looks like a round cabbage with a point stuck on top to large, very pronounced conical tips. The shape and thus, in part, the different stalk and head structure, depend on the individual holding. The heads can be up to 50 cm in size and often weigh over 8 kg.

3.3.   Raw materials (for processed products only):

—

3.4.   Feed (for products of animal origin only):

—

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

To safeguard the reputation of ‘Filderkraut/Filderspitzkraut’ based on its origin, the white cabbage subvariety Brassica oleracea var. capitata for. alba subv. Conica must be grown in the identified geographical area.

3.6.   Specific rules concerning slicing, grating, packaging, etc.:

—

3.7.   Specific rules concerning labelling:

—

4.   Concise definition of the geographical area:

South of the city of Stuttgart (in Baden-Württemberg) lies a plateau covering an area of 22 000 ha. It is called the ‘Filder’ or, colloquially, the ‘Filder plateau’. Its heavy loamy clay loess soils (‘Filder loam’) are particularly well-suited to growing various types of cabbage. Geologically and commercially, the Filder plateau forms a unit in its own right. Its geographical boundaries are formed by the valley of the Neckar river to the south-east and north-east, the steep slopes down to the Stuttgart basin and the Nesenbach valley to the north, and the Schönbuch forest hills to the west and south-west.

The geographical area covers the districts and municipalities of Aichtal, Denkendorf, Filderstadt, Köngen, Leinfelden-Echterdingen, Neuhausen auf den Fildern, Ostfildern and Wolfschlugen and the following districts of Stuttgart: Birkach, Degerloch, Möhringen, Plieningen, Sillenbuch and Vaihingen.

5.   Link with the geographical area:

5.1.   Specificity of the geographical area:

‘Filderkraut/Filderspitzkraut’ has a centuries-old tradition and cabbage growing in the Filder area has a long history. As early as 500 years ago monks at the monastery in Denkendorf were growing pointed cabbage, which would eventually become a speciality of the Filder plateau. The earliest documentary reference to cabbage growing in the Filder area dates back to 1501 in a store ledger at Salem monastery (quoted from the Leinfelden-Echterdingen town archives, 1995: Das Filderkraut. Stadt Filderstadt und Leinfelden-Echterdingen). The earliest written reference to ‘Filderkraut/Filderspitzkraut’ is by the Bernhausen parish priest Bischoff in a document from 1772, writing about cabbage growing in the Filder area: ‘The white, pointed cabbage is the only (cabbage) grown here’ (quoted from Grabinger 1974: Bernhausen, Ortsgeschichte Bernhausen, p. 200).

The unique soil structure of the Filder plateau, consisting of the thick Filder loam topsoil, a mixture of loess, loess loam and weathered loam from the black Jura beta formations, together with an abundant nutrient supply and a constantly high moisture content and its special microclimate, provide excellent growing conditions for ‘Filderkraut/Filderspitzkraut’ (http://www.leinfelden-echterdingen.de, Geschichte des Filderkrauts; Christine Metzger, Deutschland Spezialitätenküche, 1999, p. 293). As early as 1924, a dissertation corroborated the link between water supply through the loess loam soils and the yield physiology of ‘Filderkraut/Filderspitzkraut’ (Frauendörfer, von Siegmund, 1924: Der Krautanbau auf den Fildern bei Stuttgart, University of Hohenheim dissertation). Since time immemorial, the white cabbage subvariety ‘Filderspitzkraut’ in particular has been grown only in the Filder area because it is not regarded as being so successful in other areas (Steng, G. (1947): Das Filderkraut: Eine pflanzenbaul. u. pflanzenzüchter. Studie, University of Hohenheim dissertation, p. 3). The soils in the Filder area are predominantly high-performance soils with a high filter and buffer capacity and a predominantly high retention potential (University of Stuttgart, ILPÖ/IER (2001): Naturraum Nr. 106 Folder. Naturraumsteckbrief. Materialien zum Landschaftsrahmenprogramm, Institute of Landscape Planning and Ecology, University of Stuttgart). The Filder plateau, which has a relatively low precipitation and is exposed to the wind, has a comparatively uniform climate. With an average annual temperature of 8,5 °C (January: – 0,5 °C; July: 17,5 °C; average annual amplitude 18 °C), the plateau is similar to the Neckar basin catchment area. Accordingly, despite its slightly higher elevation, the Filder area is, on the whole, slightly warmer than the lias formations of the central foothills of the Alps, where cold winter air advection from the higher Alps makes itself felt in a marked fall in average January temperatures (– 1,5 °C). The Filder region has the characteristics of a ‘garden city climatope’ with green open spaces and low-density development. These properties shape the physical processes in the air layer close to the ground (Town of Ostfildern (Ed.) (2008): Landschafts- und Umweltplan Ostfildern 2020, Ostfildern/Stuttgart, p. 36 ff.). Compared to the surrounding area, local warming is relatively low and there is marked cooling overnight. The distance from the Alps also affects precipitation, with a long-term average of 650-700 mm favourably spread over the main growing season: around 65 % of annual precipitation falls between May and October (Institute for Regional Studies (1967): Die naturräumliche Einheiten auf Blatt 170 Stuttgart. F. Huttenlocher and H. Dongus Eds. Federal Institution for Regional Studies and Spatial Research, Bad Godesberg, p. 23; LfU (1987): Methodik der Naturraumbewertung: dargestellt am Beispiel des Naturraums Filder, Baden-Württemberg State Institute for Environmental Protection (LfU), Karlsruhe Institute of Ecology and Nature Protection).

5.2.   Specificity of the product:

‘Filderkraut/Filderspitzkraut’ is a prized regional speciality well known in the Stuttgart area and beyond, whose reputation is based essentially on its close link to the defined area of origin. Classical, original ‘Filderkraut/Filderspitzkraut’ has a large, heavy head often weighing more than 8 kg and up to 50 cm in size. Many farms in the Filder area have been growing and propagating their own types of pointed cabbage independently for generations (terra fusca Ingenieure 2003: Filderkraut- derzeitige Situation, Survey, February 2003; terra fusca Ingenieure, Stuttgart; Smolka, R.S. (2010): Bestandsanalyse und Erzeugererhebung zu den Perspektiven des Filderkrauts Brassica oleracea var. capitata for. alba subv. Conica, Nürtingen-Geislingen University of Economics and Environment). As in the past, ‘Filderkraut/Filderspitzkraut’ is still used today predominantly for making sauerkraut, mainly in small businesses. However, the tradition of making sauerkraut from old family recipes is still kept alive in some households. In recent years cabbage has also been grown in the Filder area specifically for the fresh market. These are smaller and lighter to meet market demand.

Pointed white cabbage (Latin name: Brassica oleracea var. capitata for. alba subv. Conica):

| shape | : | pointed, almost conical head; |
| --- | --- | --- |
| colour | : | whitish green; |
| leaves | : | fine leaf ribs; |
| stalk | : | short and smooth. |

shape

:

pointed, almost conical head;

colour

:

whitish green;

leaves

:

fine leaf ribs;

stalk

:

short and smooth.

As early as the 19th century, ‘Filderkraut/Filderspitzkraut’ was already famous throughout the region and beyond for its excellent taste: ‘There are many varieties but the one that stands out here is the tasty, very white, pointed Filderkraut [...]’ (Martens von, K., 1864: Handbuch der Militärverpflegung im Frieden und Krieg — 2nd edition — Rioger'sche Verlagsbuchhandlung). Lengerke, von, A. 1841: Landwirtschaftliche Statistik der deutschen Bundesstaaten — Vol. 2 — Westermann, wrote: ‘Filderkraut is particularly appreciated for its tender leaves, its white colour and above all its superior taste, which is what distinguishes it from the produce grown in other regions’. The good reputation of ‘Filderkraut/Filderspitzkraut’ continues to the present day and it remains the emblem of the Filder area (Stadt Filderstadt, Stadt Leinfelden-Echterdingen, Geschichtswerkstatt Filderstadt, 1995, p. 5). Connoisseurs appreciate its taste, tenderness and fine-ribbed structure (cf. Christine Metzger, Deutschland Spezialitätenküche 1999, p. 293; Buroh, N., Schermer, B., 2007: Das Teubner Buch — deutsche Küche — Westermann-Studios — Gräfe and Unzer, p. 77; Gorys, E., 2001: Das neue Küchen Lexikon. Von Aachener Printen bis Zwischenrippenstück — 7th edition — Deutscher Taschenbuch Verlag, p. 547; Stitz, M. Swoboda, I., 2006: Kulinarisch Reisen Deutschland — Mair Dumont Marco Polo, p. 254).

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

The causal link between ‘Filderkraut/Filderspitzkraut’ and its geographical area is the result of the special reputation which it enjoys as a result of its origin. ‘Filderkraut/Filderspitzkraut’ has a centuries-old tradition. Together with the native variety used and the traditional small holdings in the defined geographical area, these special features also enhance the quality of ‘Filderkraut/Filderspitzkraut’. For example, a dissertation from 1924 refers to the special environmental conditions for growing cabbage in the Filder area (Frauendörfer, von, S. (1924): Der Krautanbau auf den Fildern bei Stuttgart, University of Hohenheim dissertation). The farmers’ traditional ties to the land in the Filder area are reflected in the fact that the seeds for ‘Filderkraut/Filderspitzkraut’ have often been propagated independently as the individual holding’s ‘own variety’. These conditions in the defined geographical area have nurtured a centuries-old tradition of growing ‘Filderkraut/Filderspitzkraut’ with its typical shape and specific features which is still highly valued today for its taste, tenderness and fine-ribbed structure, is well-known to consumers as a regional speciality and enjoys an excellent reputation. In 1884 the Filder-Bote newspaper wrote: ‘Our good old, ever popular Filderkraut, which has been transported far and wide by horse-drawn carriage and steam, has found a new market: thousands and thousands of them are being cut, preserved, packed in barrels and sent across the ocean to America’ (Filder-Bote newspaper of 7 October 1884, No 118). The current renown and reputation of ‘Filderkraut/Filderspitzkraut’ are evidenced by its position as a permanent feature in various festivals and customs in the region. Every year since 1979 the more than 400-year-old tradition of cabbage growing in the Filder area has been celebrated in the town of Leinfelden-Echterdingen by about 50 000 visitors to Germany’s largest cabbage festival. A traditional harvest festival display reminds visitors to the main agricultural show and the Cannstatt festival of the way in which ‘Filderkraut/Filderspitzkraut’ has shaped the region. Also, pointed cabbage is the adopted emblem and logo of one of the carnival associations, the ‘Filderer’ (cf. http://www.leinfelden-echterdingen.de, Geschichte des Filderkrauts; http://www.schmeck-den-sueden.de). Lastly, ‘Filderkraut/Filderspitzkraut’’s reputation is also reflected in music and literature (‘Schwäbische Sauerkrautkantate’ by Emil Kübler 1939, and books by Frank Snyders, Johann Baptist Hofner and Otto Groß; Filderstädter Schriftenreihe Vol. 10, 1995: Das Filderkraut, p. 70, p. 58 and p. 157).

Reference to publication of the specification:

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

Markenblatt Heft (Trade Mark Journal) No 11 of 19 March 2010, Part 7a-aa, p. 4243

(http://register.dpma.de/DPMAregister/geo/detail.pdfdownload/13250)

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(1)  OJ L 93, 31.3.2006, p. 12.

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