# Official Journal C 39/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 39 |
| | |
| English edition | Information and Notices | Volume 644 February 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 39

English edition

Information and Notices

Volume 644 February 2021

---

| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 39/01 | Non-opposition to a notified concentration (Case M.10040 — M Group Services/Skanska Infrastructure Services) (
  1
  ) | 1 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 39/01

Non-opposition to a notified concentration (Case M.10040 — M Group Services/Skanska Infrastructure Services) (
  1
  )

1

1

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 39/02 | Euro exchange rates — 3 February 2021 | 2 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | Standing Committee of the EFTA States |
| 2021/C 39/03 | Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee | 3 |
| 2021/C 39/04 | Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee | 6 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 39/02

Euro exchange rates — 3 February 2021

2

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2021/C 39/03

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee

3

2021/C 39/04

Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2020 – Subcommittee I on the free movement of goods – To be noted by the EEA Joint Committee

6

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| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | European Commission |
| 2021/C 39/05 | Notice of open competition | 19 |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2021/C 39/06 | Request for an Advisory Opinion from the EFTA Court by Fürstlicher Oberster Gerichtshof in the case of Liti-Link AG v LGT Bank AG (Case E-14/20) | 20 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2021/C 39/07 | Prior notification of a concentration (Case M.10067 — ElringKlinger/Plastic Omnium New Energies/EKPO Fuel Cell Technologies/ElringKlinger Fuelcell Systems Austria) – Candidate case for simplified procedure (
  1
  ) | 21 |
| 2021/C 39/08 | Prior notification of a concentration (Case M.10125 — GBL/Canyon) – Candidate case for simplified procedure (
  1
  ) | 23 |
| 2021/C 39/09 | Prior notification of a concentration (Case M.10128 — Stirling Square Capital Partners/TA Associates/Glenigan) – Candidate case for simplified procedure (
  1
  ) | 24 |
| | OTHER ACTS |
| | European Commission |
| 2021/C 39/10 | Publication of an application for registration of a name pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs | 26 |
| 2021/C 39/11 | Publication of the amended single document following the approval of a minor amendment pursuant to the second subparagraph of Article 53(2) of Regulation (EU) No 1151/2012 | 30 |

V   Announcements

ADMINISTRATIVE PROCEDURES

European Commission

2021/C 39/05

Notice of open competition

19

COURT PROCEEDINGS

EFTA Court

2021/C 39/06

Request for an Advisory Opinion from the EFTA Court by Fürstlicher Oberster Gerichtshof in the case of Liti-Link AG v LGT Bank AG (Case E-14/20)

20

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2021/C 39/07

Prior notification of a concentration (Case M.10067 — ElringKlinger/Plastic Omnium New Energies/EKPO Fuel Cell Technologies/ElringKlinger Fuelcell Systems Austria) – Candidate case for simplified procedure (
  1
  )

1

21

2021/C 39/08

Prior notification of a concentration (Case M.10125 — GBL/Canyon) – Candidate case for simplified procedure (
  1
  )

1

23

2021/C 39/09

Prior notification of a concentration (Case M.10128 — Stirling Square Capital Partners/TA Associates/Glenigan) – Candidate case for simplified procedure (
  1
  )

1

24

OTHER ACTS

European Commission

2021/C 39/10

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

26

2021/C 39/11

Publication of the amended single document following the approval of a minor amendment pursuant to the second subparagraph of Article 53(2) of Regulation (EU) No 1151/2012

30

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

---

(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

| 4.2.2021 | EN | Official Journal of the European Union | C 39/1 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/1

---

Non-opposition to a notified concentration

(Case M.10040 — M Group Services/Skanska Infrastructure Services)

(Text with EEA relevance)

(2021/C 39/01)

On 27 January 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). 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/homepage.html?locale=en) under document number 32021M10040. EUR-Lex is the online access to European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10040. EUR-Lex is the online access to European law.

---

(1)  OJ L 24, 29.1.2004, p. 1.

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 4.2.2021 | EN | Official Journal of the European Union | C 39/2 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/2

---

Euro exchange rates (1)

3 February 2021

(2021/C 39/02)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2017 |
| JPY | Japanese yen | 126,25 |
| DKK | Danish krone | 7,4375 |
| GBP | Pound sterling | 0,88145 |
| SEK | Swedish krona | 10,1303 |
| CHF | Swiss franc | 1,0804 |
| ISK | Iceland króna | 156,10 |
| NOK | Norwegian krone | 10,3540 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,925 |
| HUF | Hungarian forint | 355,51 |
| PLN | Polish zloty | 4,4917 |
| RON | Romanian leu | 4,8734 |
| TRY | Turkish lira | 8,6136 |
| AUD | Australian dollar | 1,5781 |
| CAD | Canadian dollar | 1,5373 |
| HKD | Hong Kong dollar | 9,3150 |
| NZD | New Zealand dollar | 1,6695 |
| SGD | Singapore dollar | 1,6021 |
| KRW | South Korean won | 1 341,03 |
| ZAR | South African rand | 17,9412 |
| CNY | Chinese yuan renminbi | 7,7623 |
| HRK | Croatian kuna | 7,5693 |
| IDR | Indonesian rupiah | 16 852,88 |
| MYR | Malaysian ringgit | 4,8681 |
| PHP | Philippine peso | 57,721 |
| RUB | Russian rouble | 91,2217 |
| THB | Thai baht | 36,111 |
| BRL | Brazilian real | 6,4256 |
| MXN | Mexican peso | 24,2190 |
| INR | Indian rupee | 87,6185 |

Currency

Exchange rate

USD

US dollar

1,2017

JPY

Japanese yen

126,25

DKK

Danish krone

7,4375

GBP

Pound sterling

0,88145

SEK

Swedish krona

10,1303

CHF

Swiss franc

1,0804

ISK

Iceland króna

156,10

NOK

Norwegian krone

10,3540

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,925

HUF

Hungarian forint

355,51

PLN

Polish zloty

4,4917

RON

Romanian leu

4,8734

TRY

Turkish lira

8,6136

AUD

Australian dollar

1,5781

CAD

Canadian dollar

1,5373

HKD

Hong Kong dollar

9,3150

NZD

New Zealand dollar

1,6695

SGD

Singapore dollar

1,6021

KRW

South Korean won

1 341,03

ZAR

South African rand

17,9412

CNY

Chinese yuan renminbi

7,7623

HRK

Croatian kuna

7,5693

IDR

Indonesian rupiah

16 852,88

MYR

Malaysian ringgit

4,8681

PHP

Philippine peso

57,721

RUB

Russian rouble

91,2217

THB

Thai baht

36,111

BRL

Brazilian real

6,4256

MXN

Mexican peso

24,2190

INR

Indian rupee

87,6185

---

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

---

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

| 4.2.2021 | EN | Official Journal of the European Union | C 39/3 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/3

---

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the first half of 2020

(2021/C 39/03)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 25/2008 of 14 March 2008, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH) for the period 1 January-30 June 2020, at their meeting on 25 September 2020.

---

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 January-30 June 2020:

| Substance name | Commission decision under Article 64(8) of Regulation (EC) No 1907/2006 | Country | Date of decision |
| --- | --- | --- | --- |
| Chromium trioxide | C(2020) 1655 | Iceland | 8.5.2020 |
| Chromium trioxide | C(2020) 1655 | Liechtenstein | 7.5.2020 |
| Chromium trioxide | C(2020) 1655 | Norway | 28.4.2020 |
| Chromium trioxide | C(2020) 1656 | Iceland | 8.5.2020 |
| Chromium trioxide | C(2020) 1656 | Liechtenstein | 16.4.2020 |
| Chromium trioxide | C(2020) 1656 | Norway | 16.4.2020 |
| Chromium trioxide | C(2020)7 | Iceland | 23.1.2020 |
| Chromium trioxide | C(2020)7 | Liechtenstein | 30.1.2020 |
| Chromium trioxide | C(2020)7 | Norway | 6.2.2020 |
| Dichromium tris(chromate) | C(2020) 2056 | Iceland | 8.5.2020 |
| Dichromium tris(chromate) | C(2020) 2056 | Liechtenstein | 27.4.2020 |
| Dichromium tris(chromate) | C(2020) 2056 | Norway | 28.4.2020 |
| Dichromium tris(chromate) | C(2020) 2090 | Iceland | 8.5.2020 |
| Dichromium tris(chromate) | C(2020) 2090 | Liechtenstein | 7.5.2020 |
| Dichromium tris(chromate) | C(2020) 2090 | Norway | 28.4.2020 |
| Pentazinc chromate octahydroxide | C(2020) 1841 | Iceland | 8.5.2020 |
| Pentazinc chromate octahydroxide | C(2020) 1841 | Liechtenstein | 27.4.2020 |
| Pentazinc chromate octahydroxide | C(2020) 1841 | Norway | 16.4.2020 |
| Potassium dichromate | C(2020) 2073 | Iceland | 8.5.2020 |
| Potassium dichromate | C(2020) 2073 | Liechtenstein | 27.4.2020 |
| Potassium dichromate | C(2020) 2073 | Norway | 28.4.2020 |
| Potassium dichromate | C(2020) 2085 | Iceland | 8.5.2020 |
| Potassium dichromate | C(2020) 2085 | Liechtenstein | 7.5.2020 |
| Potassium dichromate | C(2020) 2085 | Norway | 28.4.2020 |
| Potassium hydroxyoctaoxodizincatedichromate | C(2020) 2089 | Iceland | 8.5.2020 |
| Potassium hydroxyoctaoxodizincatedichromate | C(2020) 2089 | Liechtenstein | 7.5.2020 |
| Potassium hydroxyoctaoxodizincatedichromate | C(2020) 2089 | Norway | 28.4.2020 |
| Sodium dichromate | C(2020) 2084 | Iceland | 8.5.2020 |
| Sodium dichromate | C(2020) 2084 | Liechtenstein | 7.5.2020 |
| Sodium dichromate | C(2020) 2084 | Norway | 28.4.2020 |
| Sodium dichromate | C(2020) 2088 | Iceland | 8.5.2020 |
| Sodium dichromate | C(2020) 2088 | Liechtenstein | 7.5.2020 |
| Sodium dichromate | C(2020) 2088 | Norway | 28.4.2020 |
| Strontium chromate | C(2020) 2076 | Iceland | 8.5.2020 |
| Strontium chromate | C(2020) 2076 | Liechtenstein | 7.5.2020 |
| Strontium chromate | C(2020) 2076 | Norway | 28.4.2020 |

Substance name

Commission decision under Article 64(8) of Regulation (EC) No 1907/2006

Country

Date of decision

Chromium trioxide

C(2020) 1655

Iceland

8.5.2020

Chromium trioxide

C(2020) 1655

Liechtenstein

7.5.2020

Chromium trioxide

C(2020) 1655

Norway

28.4.2020

Chromium trioxide

C(2020) 1656

Iceland

8.5.2020

Chromium trioxide

C(2020) 1656

Liechtenstein

16.4.2020

Chromium trioxide

C(2020) 1656

Norway

16.4.2020

Chromium trioxide

C(2020)7

Iceland

23.1.2020

Chromium trioxide

C(2020)7

Liechtenstein

30.1.2020

Chromium trioxide

C(2020)7

Norway

6.2.2020

Dichromium tris(chromate)

C(2020) 2056

Iceland

8.5.2020

Dichromium tris(chromate)

C(2020) 2056

Liechtenstein

27.4.2020

Dichromium tris(chromate)

C(2020) 2056

Norway

28.4.2020

Dichromium tris(chromate)

C(2020) 2090

Iceland

8.5.2020

Dichromium tris(chromate)

C(2020) 2090

Liechtenstein

7.5.2020

Dichromium tris(chromate)

C(2020) 2090

Norway

28.4.2020

Pentazinc chromate octahydroxide

C(2020) 1841

Iceland

8.5.2020

Pentazinc chromate octahydroxide

C(2020) 1841

Liechtenstein

27.4.2020

Pentazinc chromate octahydroxide

C(2020) 1841

Norway

16.4.2020

Potassium dichromate

C(2020) 2073

Iceland

8.5.2020

Potassium dichromate

C(2020) 2073

Liechtenstein

27.4.2020

Potassium dichromate

C(2020) 2073

Norway

28.4.2020

Potassium dichromate

C(2020) 2085

Iceland

8.5.2020

Potassium dichromate

C(2020) 2085

Liechtenstein

7.5.2020

Potassium dichromate

C(2020) 2085

Norway

28.4.2020

Potassium hydroxyoctaoxodizincatedichromate

C(2020) 2089

Iceland

8.5.2020

Potassium hydroxyoctaoxodizincatedichromate

C(2020) 2089

Liechtenstein

7.5.2020

Potassium hydroxyoctaoxodizincatedichromate

C(2020) 2089

Norway

28.4.2020

Sodium dichromate

C(2020) 2084

Iceland

8.5.2020

Sodium dichromate

C(2020) 2084

Liechtenstein

7.5.2020

Sodium dichromate

C(2020) 2084

Norway

28.4.2020

Sodium dichromate

C(2020) 2088

Iceland

8.5.2020

Sodium dichromate

C(2020) 2088

Liechtenstein

7.5.2020

Sodium dichromate

C(2020) 2088

Norway

28.4.2020

Strontium chromate

C(2020) 2076

Iceland

8.5.2020

Strontium chromate

C(2020) 2076

Liechtenstein

7.5.2020

Strontium chromate

C(2020) 2076

Norway

28.4.2020

---

| 4.2.2021 | EN | Official Journal of the European Union | C 39/6 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/6

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Medicinal products – List of marketing authorisations granted by the EEA EFTA States for the first half of 2020

(2021/C 39/04)

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 2020, at their meeting on 25 September 2020.

| Annex I | List of new marketing authorisations |
| --- | --- |

Annex I

| Annex II | List of renewed marketing authorisations |
| --- | --- |

Annex II

| Annex III | List of extended marketing authorisations |
| --- | --- |

Annex III

| Annex IV | List of withdrawn marketing authorisations |
| --- | --- |

Annex IV

| Annex V | List of suspended marketing authorisations |
| --- | --- |

Annex V

---

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 2020:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/19/1415 | Amsparity | Iceland | 19.2.2020 |
| EU/1/19/1415 | Amsparity | Liechtenstein | 29.2.2020 |
| EU/1/19/1415 | Amsparity | Norway | 20.2.2020 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Iceland | 20.4.2020 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Liechtenstein | 30.4.2020 |
| EU/1/20/1427 | Arsenic trioxide Mylan | Norway | 14.4.2020 |
| EU/2/19/249 | Aservo EquiHaler | Iceland | 18.2.2020 |
| EU/2/19/249 | Aservo EquiHaler | Liechtenstein | 29.2.2020 |
| EU/2/19/249 | Aservo EquiHaler | Norway | 5.3.2020 |
| EU/1/20/1439 | Atectura Breezhaler | Iceland | 23.6.2020 |
| EU/1/20/1439 | Atectura Breezhaler | Liechtenstein | 30.6.2020 |
| EU/1/20/1439 | Atectura Breezhaler | Norway | 8.6.2020 |
| EU/1/19/1413 | Azacitidine Accord | Iceland | 19.2.2020 |
| EU/1/19/1413 | Azacitidine Accord | Liechtenstein | 29.2.2020 |
| EU/1/19/1413 | Azacitidine Accord | Norway | 21.2.2020 |
| EU/1/19/1416 | Azacitidine Betapharm | Iceland | 16.4.2020 |
| EU/1/19/1416 | Azacitidine Betapharm | Liechtenstein | 30.4.2020 |
| EU/1/19/1416 | Azacitidine Betapharm | Norway | 31.3.2020 |
| EU/1/20/1426 | Azacitidine Mylan | Iceland | 17.4.2020 |
| EU/1/20/1426 | Azacitidine Mylan | Liechtenstein | 30.4.2020 |
| EU/1/20/1426 | Azacitidine Mylan | Norway | 2.4.2020 |
| EU/1/19/1406 | Baqsimi | Norway | 13.1.2020 |
| EU/1/20/1441 | Bemrist Breezhaler | Iceland | 22.6.2020 |
| EU/1/20/1441 | Bemrist Breezhaler | Liechtenstein | 30.6.2020 |
| EU/1/20/1441 | Bemrist Breezhaler | Norway | 8.6.2020 |
| EU/1/19/1417 | Beovu | Iceland | 18.2.2020 |
| EU/1/19/1417 | Beovu | Liechtenstein | 29.2.2020 |
| EU/1/19/1417 | Beovu | Norway | 19.2.2020 |
| EU/1/19/1403 | Budesonide/Formoterol Teva Pharma B.V. | Iceland | 22.5.2020 |
| EU/1/19/1403 | Budesonide/Formoterol Teva Pharma B.V. | Liechtenstein | 30.4.2020 |
| EU/1/19/1403 | Budesonide/Formoterol Teva Pharma B.V. | Norway | 14.4.2020 |
| EU/1/19/1409 | Cegfila | Iceland | 9.1.2020 |
| EU/1/20/1429 | Cinacalcet Accordpharma | Iceland | 21.4.2020 |
| EU/1/20/1429 | Cinacalcet Accordpharma | Norway | 14.4.2020 |
| EU/1/19/1395 | Clopidogrel/Acetylsalicylic acid Mylan | Iceland | 20.1.2020 |
| EU/1/19/1395 | Clopidogrel/Acetylsalicylic acid Mylan | Norway | 7.2.2020 |
| EU/1/20/1451 | Daurismo | Liechtenstein | 30.6.2020 |
| EU/1/19/1412 | Deferasirox Accord | Iceland | 15.1.2020 |
| EU/1/19/1412 | Deferasirox Accord | Norway | 22.1.2020 |
| EU/1/19/1418 | Dexmedetomidin Accord | Iceland | 18.2.2020 |
| EU/1/19/1418 | Dexmedetomidin Accord | Liechtenstein | 29.2.2020 |
| EU/1/19/1418 | Dexmedetomidin Accord | Norway | 19.2.2020 |
| EU/1/19/1411 | Evenity | Norway | 3.1.2020 |
| EU/1/20/1434 | Fetcroja | Iceland | 19.5.2020 |
| EU/1/20/1434 | Fetcroja | Liechtenstein | 30.4.2020 |
| EU/1/20/1434 | Fetcroja | Norway | 8.5.2020 |
| EU/1/20/1450 | Fingolimod Accord | Liechtenstein | 30.6.2020 |
| EU/1/20/1433 | Fluad Tetra | Iceland | 16.6.2020 |
| EU/1/20/1433 | Fluad Tetra | Liechtenstein | 30.6.2020 |
| EU/1/20/1433 | Fluad Tetra | Norway | 2.6.2020 |
| EU/1/20/1428 | Givlaari | Iceland | 20.3.2020 |
| EU/1/20/1428 | Givlaari | Liechtenstein | 30.4.2020 |
| EU/1/20/1428 | Givlaari | Norway | 6.3.2020 |
| EU/2/19/245 | Gumbohatch | Norway | 29.6.2020 |
| EU/1/20/1447 | Insulin aspart Sanofi | Liechtenstein | 30.6.2020 |
| EU/1/19/1407 | Isturisa | Liechtenstein | 29.2.2020 |
| EU/1/19/1407 | Isturisa | Iceland | 16.1.2020 |
| EU/1/19/1407 | Isturisa | Liechtenstein | 30.4.2020 |
| EU/1/19/1407 | Isturisa | Norway | 3.2.2020 |
| EU/1/20/1422 | Liumjev | Iceland | 17.4.2020 |
| EU/1/20/1422 | Liumjev | Liechtenstein | 30.4.2020 |
| EU/1/20/1422 | Liumjev | Norway | 31.3.2020 |
| EU/2/20/253 | Lydaxx | Iceland | 2.6.2020 |
| EU/2/20/253 | Lydaxx | Norway | 9.6.2020 |
| EU/1/19/1414 | Mayzent | Iceland | 21.2.2020 |
| EU/1/19/1414 | Mayzent | Liechtenstein | 29.2.2020 |
| EU/1/19/1414 | Mayzent | Norway | 27.1.2020 |
| EU/1/20/1436 | Nepexto | Iceland | 16.6.2020 |
| EU/1/20/1436 | Nepexto | Liechtenstein | 30.6.2020 |
| EU/1/20/1436 | Nepexto | Norway | 9.6.2020 |
| EU/2/19/246 | Neptra | Norway | 6.1.2020 |
| EU/1/20/1425 | Nilemdo | Iceland | 20.4.2020 |
| EU/1/20/1425 | Nilemdo | Liechtenstein | 30.4.2020 |
| EU/1/20/1425 | Nilemdo | Norway | 15.4.2020 |
| EU/1/20/1432 | Nubeqa | Iceland | 17.4.2020 |
| EU/1/20/1432 | Nubeqa | Liechtenstein | 30.4.2020 |
| EU/1/20/1432 | Nubeqa | Norway | 1.4.2020 |
| EU/1/20/1424 | Nustendi | Iceland | 17.4.2020 |
| EU/1/20/1424 | Nustendi | Norway | 3.4.2020 |
| EU/1/20/1453 | Paliperidone Janssen-Cilag International | Iceland | 26.6.2020 |
| EU/1/20/1453 | Paliperidone Janssen-Cilag International | Liechtenstein | 30.6.2020 |
| EU/1/20/1453 | Paliperidone Janssen-Cilag International | Norway | 29.6.2020 |
| EU/1/19/1409 | Pegfilgrastim Mundipharma | Norway | 9.1.2020 |
| EU/1/19/1388 | Polivy | Iceland | 24.1.2020 |
| EU/1/19/1388 | Polivy | Liechtenstein | 29.2.2020 |
| EU/1/19/1388 | Polivy | Norway | 27.1.2020 |
| EU/1/19/1393 | Quofenix | Norway | 9.1.2020 |
| EU/1/20/1452 | Reblozyl | Liechtenstein | 30.6.2020 |
| EU/1/19/1420 | Recarbrio | Iceland | 18.2.2020 |
| EU/1/19/1420 | Recarbrio | Liechtenstein | 29.2.2020 |
| EU/1/19/1420 | Recarbrio | Liechtenstein | 30.4.2020 |
| EU/1/19/1420 | Recarbrio | Norway | 19.2.2020 |
| EU/1/19/1420 | Recarbrio | Norway | 23.4.2020 |
| EU/1/20/1430 | Rybelsus | Liechtenstein | 30.4.2020 |
| EU/1/19/1404 | Rinvoq | Norway | 3.1.2020 |
| EU/1/20/1431 | Ruxience | Iceland | 20.4.2020 |
| EU/1/20/1431 | Ruxience | Norway | 14.4.2020 |
| EU/1/20/1430 | Rybelsus | Iceland | 22.4.2020 |
| EU/1/20/1430 | Rybelsus | Norway | 14.4.2020 |
| EU/1/20/1435 | Sarclisa | Iceland | 23.6.2020 |
| EU/1/20/1435 | Sarclisa | Norway | 12.6.2020 |
| EU/1/19/1387 | Senstend | Liechtenstein | 29.2.2020 |
| EU/1/19/1410 | Spravato | Iceland | 3.1.2020 |
| EU/1/19/1410 | Spravato | Norway | 15.1.2020 |
| EU/1/19/1421 | Staquis | Iceland | 20.4.2020 |
| EU/1/19/1421 | Staquis | Norway | 3.4.2020 |
| EU/2/19/248 | Stelfonta | Iceland | 20.2.2020 |
| EU/2/19/248 | Stelfonta | Liechtenstein | 29.2.2020 |
| EU/2/19/248 | Stelfonta | Norway | 30.1.2020 |
| EU/1/19/1408 | Sunosi | Iceland | 24.1.2020 |
| EU/1/19/1408 | Sunosi | Liechtenstein | 29.2.2020 |
| EU/1/19/1408 | Sunosi | Norway | 27.1.2020 |
| EU/1/19/1405 | Tavlesse | Iceland | 15.1.2020 |
| EU/1/19/1405 | Tavlesse | Liechtenstein | 29.2.2020 |
| EU/1/19/1405 | Tavlesse | Norway | 7.2.2020 |
| EU/1/19/1394 | Tigecycline Accord | Iceland | 29.4.2020 |
| EU/1/19/1394 | Tigecycline Accord | Liechtenstein | 30.4.2020 |
| EU/1/19/1394 | Tigecycline Accord | Norway | 17.4.2020 |
| EU/1/19/1419 | Trepulmix | Iceland | 21.4.2020 |
| EU/1/19/1419 | Trepulmix | Liechtenstein | 30.4.2020 |
| EU/1/19/1419 | Trepulmix | Norway | 14.4.2020 |
| EU/2/20/251 | Tulaven | Iceland | 29.4.2020 |
| EU/2/20/251 | Tulaven | Liechtenstein | 30.4.2020 |
| EU/2/20/251 | Tulaven | Norway | 29.4.2020 |
| EU/2/20/252 | TULISSIN | Iceland | 19.5.2020 |
| EU/1/18/1309 | Ulipristal Acetate Gedeon Richter | Liechtenstein | 30.4.2020 |
| EU/1/20/1423 | Vaxchora | Iceland | 21.4.2020 |
| EU/1/20/1423 | Vaxchora | Liechtenstein | 30.4.2020 |
| EU/1/20/1423 | Vaxchora | Norway | 17.4.2020 |
| EU/2/20/250 | Vectormune FP ILT + AE | Iceland | 29.4.2020 |
| EU/2/20/250 | Vectormune FP ILT + AE | Liechtenstein | 30.4.2020 |
| EU/2/20/250 | Vectormune FP ILT + AE | Norway | 29.4.2020 |
| EU/1/19/1399 | Xospata | Liechtenstein | 29.2.2020 |
| EU/1/20/1442 | Zeposia | Iceland | 22.6.2020 |
| EU/1/20/1442 | Zeposia | Liechtenstein | 30.6.2020 |
| EU/1/20/1442 | Zeposia | Norway | 15.6.2020 |
| EU/1/20/1443 | Zolgensma | Iceland | 20.5.2020 |
| EU/1/20/1443 | Zolgensma | Liechtenstein | 30.6.2020 |
| EU/1/20/1443 | Zolgensma | Norway | 20.5.2020 |

EU-Number

Product

Country

Date of authorisation

EU/1/19/1415

Amsparity

Iceland

19.2.2020

EU/1/19/1415

Amsparity

Liechtenstein

29.2.2020

EU/1/19/1415

Amsparity

Norway

20.2.2020

EU/1/20/1427

Arsenic trioxide Mylan

Iceland

20.4.2020

EU/1/20/1427

Arsenic trioxide Mylan

Liechtenstein

30.4.2020

EU/1/20/1427

Arsenic trioxide Mylan

Norway

14.4.2020

EU/2/19/249

Aservo EquiHaler

Iceland

18.2.2020

EU/2/19/249

Aservo EquiHaler

Liechtenstein

29.2.2020

EU/2/19/249

Aservo EquiHaler

Norway

5.3.2020

EU/1/20/1439

Atectura Breezhaler

Iceland

23.6.2020

EU/1/20/1439

Atectura Breezhaler

Liechtenstein

30.6.2020

EU/1/20/1439

Atectura Breezhaler

Norway

8.6.2020

EU/1/19/1413

Azacitidine Accord

Iceland

19.2.2020

EU/1/19/1413

Azacitidine Accord

Liechtenstein

29.2.2020

EU/1/19/1413

Azacitidine Accord

Norway

21.2.2020

EU/1/19/1416

Azacitidine Betapharm

Iceland

16.4.2020

EU/1/19/1416

Azacitidine Betapharm

Liechtenstein

30.4.2020

EU/1/19/1416

Azacitidine Betapharm

Norway

31.3.2020

EU/1/20/1426

Azacitidine Mylan

Iceland

17.4.2020

EU/1/20/1426

Azacitidine Mylan

Liechtenstein

30.4.2020

EU/1/20/1426

Azacitidine Mylan

Norway

2.4.2020

EU/1/19/1406

Baqsimi

Norway

13.1.2020

EU/1/20/1441

Bemrist Breezhaler

Iceland

22.6.2020

EU/1/20/1441

Bemrist Breezhaler

Liechtenstein

30.6.2020

EU/1/20/1441

Bemrist Breezhaler

Norway

8.6.2020

EU/1/19/1417

Beovu

Iceland

18.2.2020

EU/1/19/1417

Beovu

Liechtenstein

29.2.2020

EU/1/19/1417

Beovu

Norway

19.2.2020

EU/1/19/1403

Budesonide/Formoterol Teva Pharma B.V.

Iceland

22.5.2020

EU/1/19/1403

Budesonide/Formoterol Teva Pharma B.V.

Liechtenstein

30.4.2020

EU/1/19/1403

Budesonide/Formoterol Teva Pharma B.V.

Norway

14.4.2020

EU/1/19/1409

Cegfila

Iceland

9.1.2020

EU/1/20/1429

Cinacalcet Accordpharma

Iceland

21.4.2020

EU/1/20/1429

Cinacalcet Accordpharma

Norway

14.4.2020

EU/1/19/1395

Clopidogrel/Acetylsalicylic acid Mylan

Iceland

20.1.2020

EU/1/19/1395

Clopidogrel/Acetylsalicylic acid Mylan

Norway

7.2.2020

EU/1/20/1451

Daurismo

Liechtenstein

30.6.2020

EU/1/19/1412

Deferasirox Accord

Iceland

15.1.2020

EU/1/19/1412

Deferasirox Accord

Norway

22.1.2020

EU/1/19/1418

Dexmedetomidin Accord

Iceland

18.2.2020

EU/1/19/1418

Dexmedetomidin Accord

Liechtenstein

29.2.2020

EU/1/19/1418

Dexmedetomidin Accord

Norway

19.2.2020

EU/1/19/1411

Evenity

Norway

3.1.2020

EU/1/20/1434

Fetcroja

Iceland

19.5.2020

EU/1/20/1434

Fetcroja

Liechtenstein

30.4.2020

EU/1/20/1434

Fetcroja

Norway

8.5.2020

EU/1/20/1450

Fingolimod Accord

Liechtenstein

30.6.2020

EU/1/20/1433

Fluad Tetra

Iceland

16.6.2020

EU/1/20/1433

Fluad Tetra

Liechtenstein

30.6.2020

EU/1/20/1433

Fluad Tetra

Norway

2.6.2020

EU/1/20/1428

Givlaari

Iceland

20.3.2020

EU/1/20/1428

Givlaari

Liechtenstein

30.4.2020

EU/1/20/1428

Givlaari

Norway

6.3.2020

EU/2/19/245

Gumbohatch

Norway

29.6.2020

EU/1/20/1447

Insulin aspart Sanofi

Liechtenstein

30.6.2020

EU/1/19/1407

Isturisa

Liechtenstein

29.2.2020

EU/1/19/1407

Isturisa

Iceland

16.1.2020

EU/1/19/1407

Isturisa

Liechtenstein

30.4.2020

EU/1/19/1407

Isturisa

Norway

3.2.2020

EU/1/20/1422

Liumjev

Iceland

17.4.2020

EU/1/20/1422

Liumjev

Liechtenstein

30.4.2020

EU/1/20/1422

Liumjev

Norway

31.3.2020

EU/2/20/253

Lydaxx

Iceland

2.6.2020

EU/2/20/253

Lydaxx

Norway

9.6.2020

EU/1/19/1414

Mayzent

Iceland

21.2.2020

EU/1/19/1414

Mayzent

Liechtenstein

29.2.2020

EU/1/19/1414

Mayzent

Norway

27.1.2020

EU/1/20/1436

Nepexto

Iceland

16.6.2020

EU/1/20/1436

Nepexto

Liechtenstein

30.6.2020

EU/1/20/1436

Nepexto

Norway

9.6.2020

EU/2/19/246

Neptra

Norway

6.1.2020

EU/1/20/1425

Nilemdo

Iceland

20.4.2020

EU/1/20/1425

Nilemdo

Liechtenstein

30.4.2020

EU/1/20/1425

Nilemdo

Norway

15.4.2020

EU/1/20/1432

Nubeqa

Iceland

17.4.2020

EU/1/20/1432

Nubeqa

Liechtenstein

30.4.2020

EU/1/20/1432

Nubeqa

Norway

1.4.2020

EU/1/20/1424

Nustendi

Iceland

17.4.2020

EU/1/20/1424

Nustendi

Norway

3.4.2020

EU/1/20/1453

Paliperidone Janssen-Cilag International

Iceland

26.6.2020

EU/1/20/1453

Paliperidone Janssen-Cilag International

Liechtenstein

30.6.2020

EU/1/20/1453

Paliperidone Janssen-Cilag International

Norway

29.6.2020

EU/1/19/1409

Pegfilgrastim Mundipharma

Norway

9.1.2020

EU/1/19/1388

Polivy

Iceland

24.1.2020

EU/1/19/1388

Polivy

Liechtenstein

29.2.2020

EU/1/19/1388

Polivy

Norway

27.1.2020

EU/1/19/1393

Quofenix

Norway

9.1.2020

EU/1/20/1452

Reblozyl

Liechtenstein

30.6.2020

EU/1/19/1420

Recarbrio

Iceland

18.2.2020

EU/1/19/1420

Recarbrio

Liechtenstein

29.2.2020

EU/1/19/1420

Recarbrio

Liechtenstein

30.4.2020

EU/1/19/1420

Recarbrio

Norway

19.2.2020

EU/1/19/1420

Recarbrio

Norway

23.4.2020

EU/1/20/1430

Rybelsus

Liechtenstein

30.4.2020

EU/1/19/1404

Rinvoq

Norway

3.1.2020

EU/1/20/1431

Ruxience

Iceland

20.4.2020

EU/1/20/1431

Ruxience

Norway

14.4.2020

EU/1/20/1430

Rybelsus

Iceland

22.4.2020

EU/1/20/1430

Rybelsus

Norway

14.4.2020

EU/1/20/1435

Sarclisa

Iceland

23.6.2020

EU/1/20/1435

Sarclisa

Norway

12.6.2020

EU/1/19/1387

Senstend

Liechtenstein

29.2.2020

EU/1/19/1410

Spravato

Iceland

3.1.2020

EU/1/19/1410

Spravato

Norway

15.1.2020

EU/1/19/1421

Staquis

Iceland

20.4.2020

EU/1/19/1421

Staquis

Norway

3.4.2020

EU/2/19/248

Stelfonta

Iceland

20.2.2020

EU/2/19/248

Stelfonta

Liechtenstein

29.2.2020

EU/2/19/248

Stelfonta

Norway

30.1.2020

EU/1/19/1408

Sunosi

Iceland

24.1.2020

EU/1/19/1408

Sunosi

Liechtenstein

29.2.2020

EU/1/19/1408

Sunosi

Norway

27.1.2020

EU/1/19/1405

Tavlesse

Iceland

15.1.2020

EU/1/19/1405

Tavlesse

Liechtenstein

29.2.2020

EU/1/19/1405

Tavlesse

Norway

7.2.2020

EU/1/19/1394

Tigecycline Accord

Iceland

29.4.2020

EU/1/19/1394

Tigecycline Accord

Liechtenstein

30.4.2020

EU/1/19/1394

Tigecycline Accord

Norway

17.4.2020

EU/1/19/1419

Trepulmix

Iceland

21.4.2020

EU/1/19/1419

Trepulmix

Liechtenstein

30.4.2020

EU/1/19/1419

Trepulmix

Norway

14.4.2020

EU/2/20/251

Tulaven

Iceland

29.4.2020

EU/2/20/251

Tulaven

Liechtenstein

30.4.2020

EU/2/20/251

Tulaven

Norway

29.4.2020

EU/2/20/252

TULISSIN

Iceland

19.5.2020

EU/1/18/1309

Ulipristal Acetate Gedeon Richter

Liechtenstein

30.4.2020

EU/1/20/1423

Vaxchora

Iceland

21.4.2020

EU/1/20/1423

Vaxchora

Liechtenstein

30.4.2020

EU/1/20/1423

Vaxchora

Norway

17.4.2020

EU/2/20/250

Vectormune FP ILT + AE

Iceland

29.4.2020

EU/2/20/250

Vectormune FP ILT + AE

Liechtenstein

30.4.2020

EU/2/20/250

Vectormune FP ILT + AE

Norway

29.4.2020

EU/1/19/1399

Xospata

Liechtenstein

29.2.2020

EU/1/20/1442

Zeposia

Iceland

22.6.2020

EU/1/20/1442

Zeposia

Liechtenstein

30.6.2020

EU/1/20/1442

Zeposia

Norway

15.6.2020

EU/1/20/1443

Zolgensma

Iceland

20.5.2020

EU/1/20/1443

Zolgensma

Liechtenstein

30.6.2020

EU/1/20/1443

Zolgensma

Norway

20.5.2020

---

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 2020:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/15/1001 | Akynzeo | Iceland | 15.1.2020 |
| EU/1/15/1001 | Akynzeo | Liechtenstein | 29.2.2020 |
| EU/1/15/1001 | Akynzeo | Norway | 22.1.2020 |
| EU/1/15/1005 | Aripiprazole Mylan Pharma | Iceland | 13.3.2020 |
| EU/1/15/1005 | Aripiprazole Mylan Pharma | Norway | 10.3.2020 |
| EU/1/15/1029 | Aripiprazole Sandoz | Liechtenstein | 30.6.2020 |
| EU/1/15/1009 | Aripiprazole Zentiva | Iceland | 22.6.2020 |
| EU/1/15/1009 | Aripiprazole Zentiva | Liechtenstein | 30.6.2020 |
| EU/1/15/1009 | Aripiprazole Zentiva | Norway | 18.6.2020 |
| EU/1/15/1019 | Bortezomib Accord | Iceland | 20.5.2020 |
| EU/1/15/1019 | Bortezomib Accord | Liechtenstein | 30.6.2020 |
| EU/1/15/1019 | Bortezomib Accord | Norway | 15.5.2020 |
| EU/1/13/818 | Bosulif | Iceland | 27.2.2020 |
| EU/1/13/818 | Bosulif | Liechtenstein | 29.2.2020 |
| EU/1/13/818 | Bosulif | Norway | 25.2.2020 |
| EU/1/10/645 | Brinavess | Iceland | 22.6.2020 |
| EU/1/10/645 | Brinavess | Liechtenstein | 30.6.2020 |
| EU/1/10/645 | Brinavess | Norway | 8.6.2020 |
| EU/2/15/183 | Canigen L4 | Liechtenstein | 30.4.2020 |
| EU/2/15/183 | Canigen L4 | Norway | 28.4.2020 |
| EU/1/11/749 | Caprelsa | Iceland | 21.1.2020 |
| EU/1/11/749 | Caprelsa | Liechtenstein | 29.2.2020 |
| EU/1/11/749 | Caprelsa | Norway | 23.1.2020 |
| EU/1/14/974 | Cerdelga | Norway | 3.1.2020 |
| EU/2/14/180 | Coliprotec F4 | Iceland | 24.1.2020 |
| EU/2/14/180 | Coliprotec F4 | Liechtenstein | 29.2.2020 |
| EU/2/14/180 | Coliprotec F4 | Norway | 12.2.2020 |
| EU/1/13/890 | Cometriq | Iceland | 20.3.2020 |
| EU/1/13/890 | Cometriq | Liechtenstein | 29.2.2020 |
| EU/1/13/890 | Cometriq | Liechtenstein | 30.4.2020 |
| EU/1/13/890 | Cometriq | Norway | 10.3.2020 |
| EU/1/15/1048 | Cotellic | Liechtenstein | 30.6.2020 |
| EU/1/17/1262 | Crysvita | Norway | 20.1.2020 |
| EU/1/10/636 | Daxas | Iceland | 2.6.2020 |
| EU/1/10/636 | Daxas | Liechtenstein | 30.6.2020 |
| EU/1/10/636 | Daxas | Norway | 3.6.2020 |
| EU/1/13/875 | Deltyba | Iceland | 19.5.2020 |
| EU/1/13/875 | Deltyba | Liechtenstein | 30.4.2020 |
| EU/1/13/875 | Deltyba | Norway | 30.4.2020 |
| EU/1/15/1010 | Duloxetine Mylan | Iceland | 27.2.2020 |
| EU/1/15/1010 | Duloxetine Mylan | Liechtenstein | 29.2.2020 |
| EU/1/15/1010 | Duloxetine Mylan | Norway | 24.2.2020 |
| EU/1/15/1025 | Evotaz | Norway | 8.4.2020 |
| EU/1/15/1058 | Entresto | Liechtenstein | 30.6.2020 |
| EU/1/15/1023 | Farydak | Iceland | 22.5.2020 |
| EU/1/15/1023 | Farydak | Liechtenstein | 30.4.2020 |
| EU/1/15/1023 | Farydak | Norway | 7.5.2020 |
| EU/1/15/1007 | Gardasil 9 | Iceland | 23.1.2020 |
| EU/1/15/1007 | Gardasil 9 | Liechtenstein | 29.2.2020 |
| EU/1/15/1007 | Gardasil 9 | Norway | 23.1.2020 |
| EU/1/14/987 | Holoclar | Iceland | 13.3.2020 |
| EU/1/14/987 | Holoclar | Liechtenstein | 30.4.2020 |
| EU/1/14/987 | Holoclar | Norway | 16.3.2020 |
| EU/1/15/990 | Ikervis | Iceland | 13.3.2020 |
| EU/2/15/182 | Innovax-ILT | Iceland | 30.4.2020 |
| EU/2/15/182 | Innovax-ILT | Liechtenstein | 30.4.2020 |
| EU/2/15/182 | Innovax-ILT | Norway | 5.5.2020 |
| EU/1/15/1041 | Ivabradine Anpharm | Norway | 2.6.2020 |
| EU/1/15/1040 | Intuniv | Liechtenstein | 30.6.2020 |
| EU/1/15/1000 | Jinarc | Iceland | 22.5.2020 |
| EU/1/15/1000 | Jinarc | Liechtenstein | 30.4.2020 |
| EU/1/15/1000 | Jinarc | Norway | 14.4.2020 |
| EU/1/15/1033 | Kanuma | Iceland | 22.5.2020 |
| EU/1/15/1033 | Kanuma | Liechtenstein | 30.4.2020 |
| EU/1/15/1033 | Kanuma | Norway | 23.4.2020 |
| EU/1/15/994 | Kengrexal | Norway | 13.1.2020 |
| EU/1/15/1024 | Keytruda | Iceland | 16.4.2020 |
| EU/1/15/1024 | Keytruda | Norway | 2.4.2020 |
| EU/1/15/1060 | Kyprolis | Liechtenstein | 30.6.2020 |
| EU/1/15/1002 | Lenvima | Iceland | 3.6.2020 |
| EU/1/15/1002 | Lenvima | Liechtenstein | 30.6.2020 |
| EU/1/15/1002 | Lenvima | Norway | 2.6.2020 |
| EU/1/19/1376 | Libtayo | Iceland | 2.6.2020 |
| EU/1/19/1376 | Libtayo | Liechtenstein | 30.6.2020 |
| EU/1/19/1376 | Libtayo | Norway | 2.6.2020 |
| EU/1/15/993 | Lixiana | Iceland | 13.3.2020 |
| EU/1/15/993 | Lixiana | Norway | 10.3.2020 |
| EU/1/19/1355 | Lorviqua | Iceland | 19.5.2020 |
| EU/1/19/1355 | Lorviqua | Norway | 16.4.2020 |
| EU/1/15/1013 | Lumark | Iceland | 19.5.2020 |
| EU/1/15/1013 | Lumark | Liechtenstein | 30.4.2020 |
| EU/1/15/1013 | Lumark | Norway | 5.5.2020 |
| EU/1/14/988 | Mysimba | Iceland | 23.1.2020 |
| EU/1/14/988 | Mysimba | Liechtenstein | 29.2.2020 |
| EU/1/14/988 | Mysimba | Norway | 23.1.2020 |
| EU/1/15/1078 | Natpar | Iceland | 24.6.2020 |
| EU/1/15/1078 | Natpar | Liechtenstein | 30.4.2020 |
| EU/2/15/186 | Novaquin | Liechtenstein | 30.6.2020 |
| EU/1/16/1139 | Ocaliva | Iceland | 20.5.2020 |
| EU/1/16/1139 | Ocaliva | Liechtenstein | 30.4.2020 |
| EU/1/16/1139 | Ocaliva | Norway | 12.5.2020 |
| EU/1/15/1030 | Odomzo | Iceland | 16.6.2020 |
| EU/1/15/1030 | Odomzo | Liechtenstein | 30.6.2020 |
| EU/1/15/1030 | Odomzo | Norway | 3.6.2020 |
| EU/1/18/1345 | Ondexxya | Iceland | 25.5.2020 |
| EU/1/18/1345 | Ondexxya | Liechtenstein | 30.4.2020 |
| EU/1/15/1014 | Opdivo | Iceland | 19.5.2020 |
| EU/1/15/1014 | Opdivo | Liechtenstein | 30.4.2020 |
| EU/1/15/1014 | Opdivo | Norway | 8.5.2020 |
| EU/1/15/989 | Orbactiv | Iceland | 21.1.2020 |
| EU/1/15/989 | Orbactiv | Liechtenstein | 29.2.2020 |
| EU/1/15/989 | Orbactiv | Norway | 22.1.2020 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Iceland | 20.3.2020 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Liechtenstein | 29.2.2020 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Liechtenstein | 30.4.2020 |
| EU/1/16/1089 | Pandemic influenza vaccine H5N1 AstraZeneca | Norway | 24.3.2020 |
| EU/1/15/1034 | Pemetrexed Lilly | Iceland | 22.6.2020 |
| EU/1/15/1034 | Pemetrexed Lilly | Liechtenstein | 30.6.2020 |
| EU/1/15/1034 | Pemetrexed Lilly | Norway | 15.6.2020 |
| EU/2/15/187 | Porcilis PCV ID | Iceland | 22.6.2020 |
| EU/2/15/187 | Porcilis PCV ID | Liechtenstein | 30.6.2020 |
| EU/1/15/1031 | Praluent | Iceland | 23.6.2020 |
| EU/1/15/1031 | Praluent | Liechtenstein | 30.6.2020 |
| EU/1/15/1031 | Praluent | Norway | 18.6.2020 |
| EU/1/15/997 | Pregabalin Mylan | Iceland | 16.4.2020 |
| EU/1/15/997 | Pregabalin Mylan | Liechtenstein | 30.4.2020 |
| EU/1/15/997 | Pregabalin Mylan | Norway | 16.4.2020 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Iceland | 22.5.2020 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Liechtenstein | 30.4.2020 |
| EU/1/15/998 | Pregabalin Mylan Pharma | Norway | 16.4.2020 |
| EU/1/14/916 | Pregabalin Pfizer | Norway | 10.6.2020 |
| EU/1/15/1011 | Pregabalin Sandoz | Liechtenstein | 30.6.2020 |
| EU/1/15/1012 | Pregabalin Sandoz GmbH | Liechtenstein | 30.6.2020 |
| EU/1/15/1021 | Pregabalin Zentiva | Iceland | 16.6.2020 |
| EU/1/15/1021 | Pregabalin Zentiva | Liechtenstein | 30.6.2020 |
| EU/1/15/1021 | Pregabalin Zentiva | Norway | 2.6.2020 |
| EU/2/15/187 | Porcilis PCV ID | Norway | 9.6.2020 |
| EU/1/10/618 | Prolia | Iceland | 23.1.2020 |
| EU/1/10/618 | Prolia | Liechtenstein | 29.2.2020 |
| EU/1/14/973 | Quinsair | Iceland | 19.2.2020 |
| EU/1/14/973 | Quinsair | Liechtenstein | 29.2.2020 |
| EU/1/14/973 | Quinsair | Norway | 19.2.2020 |
| EU/1/15/1016 | Repatha | Iceland | 22.4.2020 |
| EU/1/15/1016 | Repatha | Liechtenstein | 30.4.2020 |
| EU/1/15/1016 | Repatha | Norway | 22.4.2020 |
| EU/1/15/1006 | Respreeza | Iceland | 22.5.2020 |
| EU/1/15/1006 | Respreeza | Liechtenstein | 30.4.2020 |
| EU/1/15/1006 | Respreeza | Norway | 28.4.2020 |
| EU/1/17/1250 | Rubraca | Iceland | 22.5.2020 |
| EU/1/17/1250 | Rubraca | Liechtenstein | 30.4.2020 |
| EU/1/17/1250 | Rubraca | Norway | 23.4.2020 |
| EU/1/15/992 | Saxenda | Norway | 3.1.2020 |
| EU/2/15/181 | Sileo | Iceland | 19.5.2020 |
| EU/2/15/181 | Sileo | Liechtenstein | 30.4.2020 |
| EU/2/15/181 | Sileo | Norway | 12.5.2020 |
| EU/1/13/901 | Sirturo | Iceland | 15.1.2020 |
| EU/1/13/901 | Sirturo | Liechtenstein | 29.2.2020 |
| EU/1/13/901 | Sirturo | Norway | 23.1.2020 |
| EU/1/15/991 | Sivextro | Iceland | 15.1.2020 |
| EU/1/15/991 | Sivextro | Liechtenstein | 29.2.2020 |
| EU/1/15/991 | Sivextro | Norway | 22.1.2020 |
| EU/1/15/1015 | Strensiq | Iceland | 20.5.2020 |
| EU/1/15/1015 | Strensiq | Norway | 5.5.2020 |
| EU/1/15/1003 | Synjardy | Iceland | 16.4.2020 |
| EU/1/15/1003 | Synjardy | Liechtenstein | 30.4.2020 |
| EU/1/15/1003 | Synjardy | Norway | 14.4.2020 |
| EU/1/15/1004 | Voriconazole Hikma | Iceland | 25.5.2020 |
| EU/1/15/1004 | Voriconazole Hikma | Norway | 24.3.2020 |
| EU/1/19/1360 | Waylivra | Iceland | 21.3.2020 |
| EU/1/19/1360 | Waylivra | Liechtenstein | 30.4.2020 |
| EU/1/19/1360 | Waylivra | Norway | 26.5.2020 |
| EU/1/15/1032 | Zerbaxa | Iceland | 30.4.2020 |
| EU/1/15/1032 | Zerbaxa | Liechtenstein | 30.4.2020 |
| EU/1/15/1032 | Zerbaxa | Norway | 28.4.2020 |
| EU/2/14/178 | Zulvac SBV | Iceland | 21.1.2020 |
| EU/2/14/178 | Zulvac SBV | Liechtenstein | 29.2.2020 |
| EU/2/14/178 | Zulvac SBV | Norway | 12.2.2020 |
| EU/1/19/1367 | Zynteglo | Iceland | 22.5.2020 |
| EU/1/19/1367 | Zynteglo | Liechtenstein | 30.4.2020 |
| EU/1/19/1367 | Zynteglo | Norway | 11.5.2020 |

EU-Number

Product

Country

Date of authorisation

EU/1/15/1001

Akynzeo

Iceland

15.1.2020

EU/1/15/1001

Akynzeo

Liechtenstein

29.2.2020

EU/1/15/1001

Akynzeo

Norway

22.1.2020

EU/1/15/1005

Aripiprazole Mylan Pharma

Iceland

13.3.2020

EU/1/15/1005

Aripiprazole Mylan Pharma

Norway

10.3.2020

EU/1/15/1029

Aripiprazole Sandoz

Liechtenstein

30.6.2020

EU/1/15/1009

Aripiprazole Zentiva

Iceland

22.6.2020

EU/1/15/1009

Aripiprazole Zentiva

Liechtenstein

30.6.2020

EU/1/15/1009

Aripiprazole Zentiva

Norway

18.6.2020

EU/1/15/1019

Bortezomib Accord

Iceland

20.5.2020

EU/1/15/1019

Bortezomib Accord

Liechtenstein

30.6.2020

EU/1/15/1019

Bortezomib Accord

Norway

15.5.2020

EU/1/13/818

Bosulif

Iceland

27.2.2020

EU/1/13/818

Bosulif

Liechtenstein

29.2.2020

EU/1/13/818

Bosulif

Norway

25.2.2020

EU/1/10/645

Brinavess

Iceland

22.6.2020

EU/1/10/645

Brinavess

Liechtenstein

30.6.2020

EU/1/10/645

Brinavess

Norway

8.6.2020

EU/2/15/183

Canigen L4

Liechtenstein

30.4.2020

EU/2/15/183

Canigen L4

Norway

28.4.2020

EU/1/11/749

Caprelsa

Iceland

21.1.2020

EU/1/11/749

Caprelsa

Liechtenstein

29.2.2020

EU/1/11/749

Caprelsa

Norway

23.1.2020

EU/1/14/974

Cerdelga

Norway

3.1.2020

EU/2/14/180

Coliprotec F4

Iceland

24.1.2020

EU/2/14/180

Coliprotec F4

Liechtenstein

29.2.2020

EU/2/14/180

Coliprotec F4

Norway

12.2.2020

EU/1/13/890

Cometriq

Iceland

20.3.2020

EU/1/13/890

Cometriq

Liechtenstein

29.2.2020

EU/1/13/890

Cometriq

Liechtenstein

30.4.2020

EU/1/13/890

Cometriq

Norway

10.3.2020

EU/1/15/1048

Cotellic

Liechtenstein

30.6.2020

EU/1/17/1262

Crysvita

Norway

20.1.2020

EU/1/10/636

Daxas

Iceland

2.6.2020

EU/1/10/636

Daxas

Liechtenstein

30.6.2020

EU/1/10/636

Daxas

Norway

3.6.2020

EU/1/13/875

Deltyba

Iceland

19.5.2020

EU/1/13/875

Deltyba

Liechtenstein

30.4.2020

EU/1/13/875

Deltyba

Norway

30.4.2020

EU/1/15/1010

Duloxetine Mylan

Iceland

27.2.2020

EU/1/15/1010

Duloxetine Mylan

Liechtenstein

29.2.2020

EU/1/15/1010

Duloxetine Mylan

Norway

24.2.2020

EU/1/15/1025

Evotaz

Norway

8.4.2020

EU/1/15/1058

Entresto

Liechtenstein

30.6.2020

EU/1/15/1023

Farydak

Iceland

22.5.2020

EU/1/15/1023

Farydak

Liechtenstein

30.4.2020

EU/1/15/1023

Farydak

Norway

7.5.2020

EU/1/15/1007

Gardasil 9

Iceland

23.1.2020

EU/1/15/1007

Gardasil 9

Liechtenstein

29.2.2020

EU/1/15/1007

Gardasil 9

Norway

23.1.2020

EU/1/14/987

Holoclar

Iceland

13.3.2020

EU/1/14/987

Holoclar

Liechtenstein

30.4.2020

EU/1/14/987

Holoclar

Norway

16.3.2020

EU/1/15/990

Ikervis

Iceland

13.3.2020

EU/2/15/182

Innovax-ILT

Iceland

30.4.2020

EU/2/15/182

Innovax-ILT

Liechtenstein

30.4.2020

EU/2/15/182

Innovax-ILT

Norway

5.5.2020

EU/1/15/1041

Ivabradine Anpharm

Norway

2.6.2020

EU/1/15/1040

Intuniv

Liechtenstein

30.6.2020

EU/1/15/1000

Jinarc

Iceland

22.5.2020

EU/1/15/1000

Jinarc

Liechtenstein

30.4.2020

EU/1/15/1000

Jinarc

Norway

14.4.2020

EU/1/15/1033

Kanuma

Iceland

22.5.2020

EU/1/15/1033

Kanuma

Liechtenstein

30.4.2020

EU/1/15/1033

Kanuma

Norway

23.4.2020

EU/1/15/994

Kengrexal

Norway

13.1.2020

EU/1/15/1024

Keytruda

Iceland

16.4.2020

EU/1/15/1024

Keytruda

Norway

2.4.2020

EU/1/15/1060

Kyprolis

Liechtenstein

30.6.2020

EU/1/15/1002

Lenvima

Iceland

3.6.2020

EU/1/15/1002

Lenvima

Liechtenstein

30.6.2020

EU/1/15/1002

Lenvima

Norway

2.6.2020

EU/1/19/1376

Libtayo

Iceland

2.6.2020

EU/1/19/1376

Libtayo

Liechtenstein

30.6.2020

EU/1/19/1376

Libtayo

Norway

2.6.2020

EU/1/15/993

Lixiana

Iceland

13.3.2020

EU/1/15/993

Lixiana

Norway

10.3.2020

EU/1/19/1355

Lorviqua

Iceland

19.5.2020

EU/1/19/1355

Lorviqua

Norway

16.4.2020

EU/1/15/1013

Lumark

Iceland

19.5.2020

EU/1/15/1013

Lumark

Liechtenstein

30.4.2020

EU/1/15/1013

Lumark

Norway

5.5.2020

EU/1/14/988

Mysimba

Iceland

23.1.2020

EU/1/14/988

Mysimba

Liechtenstein

29.2.2020

EU/1/14/988

Mysimba

Norway

23.1.2020

EU/1/15/1078

Natpar

Iceland

24.6.2020

EU/1/15/1078

Natpar

Liechtenstein

30.4.2020

EU/2/15/186

Novaquin

Liechtenstein

30.6.2020

EU/1/16/1139

Ocaliva

Iceland

20.5.2020

EU/1/16/1139

Ocaliva

Liechtenstein

30.4.2020

EU/1/16/1139

Ocaliva

Norway

12.5.2020

EU/1/15/1030

Odomzo

Iceland

16.6.2020

EU/1/15/1030

Odomzo

Liechtenstein

30.6.2020

EU/1/15/1030

Odomzo

Norway

3.6.2020

EU/1/18/1345

Ondexxya

Iceland

25.5.2020

EU/1/18/1345

Ondexxya

Liechtenstein

30.4.2020

EU/1/15/1014

Opdivo

Iceland

19.5.2020

EU/1/15/1014

Opdivo

Liechtenstein

30.4.2020

EU/1/15/1014

Opdivo

Norway

8.5.2020

EU/1/15/989

Orbactiv

Iceland

21.1.2020

EU/1/15/989

Orbactiv

Liechtenstein

29.2.2020

EU/1/15/989

Orbactiv

Norway

22.1.2020

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Iceland

20.3.2020

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Liechtenstein

29.2.2020

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Liechtenstein

30.4.2020

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Norway

24.3.2020

EU/1/15/1034

Pemetrexed Lilly

Iceland

22.6.2020

EU/1/15/1034

Pemetrexed Lilly

Liechtenstein

30.6.2020

EU/1/15/1034

Pemetrexed Lilly

Norway

15.6.2020

EU/2/15/187

Porcilis PCV ID

Iceland

22.6.2020

EU/2/15/187

Porcilis PCV ID

Liechtenstein

30.6.2020

EU/1/15/1031

Praluent

Iceland

23.6.2020

EU/1/15/1031

Praluent

Liechtenstein

30.6.2020

EU/1/15/1031

Praluent

Norway

18.6.2020

EU/1/15/997

Pregabalin Mylan

Iceland

16.4.2020

EU/1/15/997

Pregabalin Mylan

Liechtenstein

30.4.2020

EU/1/15/997

Pregabalin Mylan

Norway

16.4.2020

EU/1/15/998

Pregabalin Mylan Pharma

Iceland

22.5.2020

EU/1/15/998

Pregabalin Mylan Pharma

Liechtenstein

30.4.2020

EU/1/15/998

Pregabalin Mylan Pharma

Norway

16.4.2020

EU/1/14/916

Pregabalin Pfizer

Norway

10.6.2020

EU/1/15/1011

Pregabalin Sandoz

Liechtenstein

30.6.2020

EU/1/15/1012

Pregabalin Sandoz GmbH

Liechtenstein

30.6.2020

EU/1/15/1021

Pregabalin Zentiva

Iceland

16.6.2020

EU/1/15/1021

Pregabalin Zentiva

Liechtenstein

30.6.2020

EU/1/15/1021

Pregabalin Zentiva

Norway

2.6.2020

EU/2/15/187

Porcilis PCV ID

Norway

9.6.2020

EU/1/10/618

Prolia

Iceland

23.1.2020

EU/1/10/618

Prolia

Liechtenstein

29.2.2020

EU/1/14/973

Quinsair

Iceland

19.2.2020

EU/1/14/973

Quinsair

Liechtenstein

29.2.2020

EU/1/14/973

Quinsair

Norway

19.2.2020

EU/1/15/1016

Repatha

Iceland

22.4.2020

EU/1/15/1016

Repatha

Liechtenstein

30.4.2020

EU/1/15/1016

Repatha

Norway

22.4.2020

EU/1/15/1006

Respreeza

Iceland

22.5.2020

EU/1/15/1006

Respreeza

Liechtenstein

30.4.2020

EU/1/15/1006

Respreeza

Norway

28.4.2020

EU/1/17/1250

Rubraca

Iceland

22.5.2020

EU/1/17/1250

Rubraca

Liechtenstein

30.4.2020

EU/1/17/1250

Rubraca

Norway

23.4.2020

EU/1/15/992

Saxenda

Norway

3.1.2020

EU/2/15/181

Sileo

Iceland

19.5.2020

EU/2/15/181

Sileo

Liechtenstein

30.4.2020

EU/2/15/181

Sileo

Norway

12.5.2020

EU/1/13/901

Sirturo

Iceland

15.1.2020

EU/1/13/901

Sirturo

Liechtenstein

29.2.2020

EU/1/13/901

Sirturo

Norway

23.1.2020

EU/1/15/991

Sivextro

Iceland

15.1.2020

EU/1/15/991

Sivextro

Liechtenstein

29.2.2020

EU/1/15/991

Sivextro

Norway

22.1.2020

EU/1/15/1015

Strensiq

Iceland

20.5.2020

EU/1/15/1015

Strensiq

Norway

5.5.2020

EU/1/15/1003

Synjardy

Iceland

16.4.2020

EU/1/15/1003

Synjardy

Liechtenstein

30.4.2020

EU/1/15/1003

Synjardy

Norway

14.4.2020

EU/1/15/1004

Voriconazole Hikma

Iceland

25.5.2020

EU/1/15/1004

Voriconazole Hikma

Norway

24.3.2020

EU/1/19/1360

Waylivra

Iceland

21.3.2020

EU/1/19/1360

Waylivra

Liechtenstein

30.4.2020

EU/1/19/1360

Waylivra

Norway

26.5.2020

EU/1/15/1032

Zerbaxa

Iceland

30.4.2020

EU/1/15/1032

Zerbaxa

Liechtenstein

30.4.2020

EU/1/15/1032

Zerbaxa

Norway

28.4.2020

EU/2/14/178

Zulvac SBV

Iceland

21.1.2020

EU/2/14/178

Zulvac SBV

Liechtenstein

29.2.2020

EU/2/14/178

Zulvac SBV

Norway

12.2.2020

EU/1/19/1367

Zynteglo

Iceland

22.5.2020

EU/1/19/1367

Zynteglo

Liechtenstein

30.4.2020

EU/1/19/1367

Zynteglo

Norway

11.5.2020

---

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 2020:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/15/1001/003 | Akynzeo | Iceland | 16.4.2020 |
| EU/1/15/1001/003 | Akynzeo | Norway | 23.3.2020 |
| EU/1/16/1101/004 | Darzalex | Iceland | 23.6.2020 |
| EU/1/11/733/005 | Dificlir | Iceland | 20.3.2020 |
| EU/1/11/733/005 | Dificlir | Norway | 20.2.2020 |
| EU/1/14/923/002-007 | Entyvio | Iceland | 24.6.2020 |
| EU/1/14/923/002-007 | Entyvio | Norway | 28.4.2020 |
| EU/1/18/1288/007 | Halimatoz | Iceland | 20.4.2020 |
| EU/1/18/1287/007 | Hefiya | Iceland | 20.4.2020 |
| EU/1/18/1286/007 | Hyrimoz | Iceland | 20.4.2020 |
| EU/1/16/1147/010-018 | Ibrance | Iceland | 22.4.2020 |
| EU/1/16/1147/010-015 | Ibrance | Norway | 19.2.2020 |
| EU/1/17/1254/007-011 | Jorveza | Iceland | 16.6.2020 |
| EU/1/17/1254/007-011 | Jorveza | Norway | 2.6.2020 |
| EU/1/12/782/006 | Kalydeco | Iceland | 2.1.2020 |
| EU/1/16/1115/003-005 | Pemetrexed Fresenius Kabi | Iceland | 19.2.2020 |
| EU/1/16/1115/003-005 | Pemetrexed Fresenius Kabi | Norway | 19.2.2020 |
| EU/1/11/717/003-004 | Vyndaqel | Iceland | 22.4.2020 |
| EU/1/11/717/003-004 | Vyndaqel | Norway | 24.2.2020 |
| EU/1/17/1178/010-013 | XELJANZ | Iceland | 2.1.2020 |

EU-Number

Product

Country

Date of authorisation

EU/1/15/1001/003

Akynzeo

Iceland

16.4.2020

EU/1/15/1001/003

Akynzeo

Norway

23.3.2020

EU/1/16/1101/004

Darzalex

Iceland

23.6.2020

EU/1/11/733/005

Dificlir

Iceland

20.3.2020

EU/1/11/733/005

Dificlir

Norway

20.2.2020

EU/1/14/923/002-007

Entyvio

Iceland

24.6.2020

EU/1/14/923/002-007

Entyvio

Norway

28.4.2020

EU/1/18/1288/007

Halimatoz

Iceland

20.4.2020

EU/1/18/1287/007

Hefiya

Iceland

20.4.2020

EU/1/18/1286/007

Hyrimoz

Iceland

20.4.2020

EU/1/16/1147/010-018

Ibrance

Iceland

22.4.2020

EU/1/16/1147/010-015

Ibrance

Norway

19.2.2020

EU/1/17/1254/007-011

Jorveza

Iceland

16.6.2020

EU/1/17/1254/007-011

Jorveza

Norway

2.6.2020

EU/1/12/782/006

Kalydeco

Iceland

2.1.2020

EU/1/16/1115/003-005

Pemetrexed Fresenius Kabi

Iceland

19.2.2020

EU/1/16/1115/003-005

Pemetrexed Fresenius Kabi

Norway

19.2.2020

EU/1/11/717/003-004

Vyndaqel

Iceland

22.4.2020

EU/1/11/717/003-004

Vyndaqel

Norway

24.2.2020

EU/1/17/1178/010-013

XELJANZ

Iceland

2.1.2020

---

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 2020:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/09/541 | Clopidogrel ratiopharm GmbH | Iceland | 23.1.2020 |
| EU/1/09/541 | Clopidogrel ratiopharm GmbH | Liechtenstein | 29.2.2020 |
| EU/1/09/541 | Clopidogrel ratiopharm GmbH | Norway | 13.1.2020 |
| EU/1/09/510 | Fertavid | Iceland | 30.1.2020 |
| EU/1/09/510 | Fertavid | Norway | 23.1.2020 |
| EU/1/15/1039 | Fexeric | Iceland | 27.2.2020 |
| EU/1/00/144 | Helixate NexGen | Iceland | 3.1.2020 |
| EU/1/19/1357 | KROMEYA | Iceland | 3.1.2020 |
| EU/1/16/1165 | Lifmior | Iceland | 27.2.2020 |
| EU/1/04/287 | Osseor | Iceland | 22.5.2020 |
| EU/1/04/287 | Osseor | Norway | 8.5.2020 |
| EU/1/12/796 | Picato | Iceland | 20.2.2020 |
| EU/1/12/796 | Picato | Liechtenstein | 29.2.2020 |
| EU/1/12/796 | Picato | Norway | 11.2.2020 |
| EU/1/04/288 | Protelos | Iceland | 22.5.2020 |
| EU/1/04/288 | Protelos | Norway | 8.5.2020 |
| EU/2/09/099 | Suvaxyn PCV | Norway | 28.4.2020 |
| EU/1/17/1180 | Varuby | Iceland | 30.1.2020 |
| EU/1/17/1180 | Varuby | Norway | 23.1.2020 |
| EU/1/11/671 | Xiapex | Iceland | 6.1.2020 |
| EU/1/96/009 | Zerit | Liechtenstein | 30.6.2020 |
| EU/2/11/130 | Zulvac 1 Bovis | Iceland | 20.3.2020 |
| EU/2/11/130 | Zulvac 1 Bovis | Norway | 18.2.2020 |
| EU/2/11/131 | Zulvac 1 Ovis | Iceland | 20.3.2020 |
| EU/2/11/131 | Zulvac 1 Ovis | Norway | 13.3.2020 |

EU-Number

Product

Country

Date of withdrawal

EU/1/09/541

Clopidogrel ratiopharm GmbH

Iceland

23.1.2020

EU/1/09/541

Clopidogrel ratiopharm GmbH

Liechtenstein

29.2.2020

EU/1/09/541

Clopidogrel ratiopharm GmbH

Norway

13.1.2020

EU/1/09/510

Fertavid

Iceland

30.1.2020

EU/1/09/510

Fertavid

Norway

23.1.2020

EU/1/15/1039

Fexeric

Iceland

27.2.2020

EU/1/00/144

Helixate NexGen

Iceland

3.1.2020

EU/1/19/1357

KROMEYA

Iceland

3.1.2020

EU/1/16/1165

Lifmior

Iceland

27.2.2020

EU/1/04/287

Osseor

Iceland

22.5.2020

EU/1/04/287

Osseor

Norway

8.5.2020

EU/1/12/796

Picato

Iceland

20.2.2020

EU/1/12/796

Picato

Liechtenstein

29.2.2020

EU/1/12/796

Picato

Norway

11.2.2020

EU/1/04/288

Protelos

Iceland

22.5.2020

EU/1/04/288

Protelos

Norway

8.5.2020

EU/2/09/099

Suvaxyn PCV

Norway

28.4.2020

EU/1/17/1180

Varuby

Iceland

30.1.2020

EU/1/17/1180

Varuby

Norway

23.1.2020

EU/1/11/671

Xiapex

Iceland

6.1.2020

EU/1/96/009

Zerit

Liechtenstein

30.6.2020

EU/2/11/130

Zulvac 1 Bovis

Iceland

20.3.2020

EU/2/11/130

Zulvac 1 Bovis

Norway

18.2.2020

EU/2/11/131

Zulvac 1 Ovis

Iceland

20.3.2020

EU/2/11/131

Zulvac 1 Ovis

Norway

13.3.2020

---

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 2020:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/12/750 | Esmya | Norway | 2.4.2020 |
| EU/1/12/796 | Picato | Norway | 22.1.2020 |
| EU/1/18/1309 | Ulipristal Acetate Richter | Norway | 28.5.2020 |

EU-Number

Product

Country

Date of suspension

EU/1/12/750

Esmya

Norway

2.4.2020

EU/1/12/796

Picato

Norway

22.1.2020

EU/1/18/1309

Ulipristal Acetate Richter

Norway

28.5.2020

---

V Announcements

ADMINISTRATIVE PROCEDURES

European Commission

| 4.2.2021 | EN | Official Journal of the European Union | C 39/19 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/19

---

NOTICE OF OPEN COMPETITION

(2021/C 39/05)

The European Personnel Selection Office (EPSO) is organising the following open competition:

EPSO/AD/389/21 – ADMINISTRATORS (AD 6) IN THE FIELD OF SUSTAINABLE AGRICULTURE AND RURAL DEVELOPMENT

The competition notice is published in 24 languages in
  Official Journal of the European Union C 39 A of 4 February 2021.

Further information can be found on the EPSO website: https://epso.europa.eu/

---

COURT PROCEEDINGS

EFTA Court

| 4.2.2021 | EN | Official Journal of the European Union | C 39/20 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/20

---

Request for an Advisory Opinion from the EFTA Court by Fürstlicher Oberster Gerichtshof in the case of Liti-Link AG v LGT Bank AG

(Case E-14/20)

(2021/C 39/06)

A request has been made to the EFTA Court dated 4 September 2020 from Fürstlicher Oberster Gerichtshof (Princely Supreme Court), which was received at the Court Registry on 16 September 2020, for an Advisory Opinion in the case of Liti-Link AG v LGT Bank AG on the following questions:

| 1. | Must the final paragraph of Article 26 of Implementing Directive 2006/73/EC according to which the essential terms of the arrangements relating to the fee, commission or non-monetary benefit may be disclosed in summary form, be interpreted as meaning that the disclosure of benefits can be in summary form and general in content?
  If the Court answers the first question in the affirmative, the following supplementary question is asked:






  1.1. | Must the final paragraph of Article 26 of Implementing Directive 2006/73/EC according to which the essential terms of the arrangements relating to the fee, commission or non-monetary benefit may be disclosed in summary form be interpreted as meaning that the disclosure of benefits can be in summary form and general in content, for example, in general or other pre-formulated terms and conditions of business or must the disclosure be made individually for each client or each category of clients?
  In addition, the following further questions are referred: |
| --- | --- | --- |

1.

Must the final paragraph of Article 26 of Implementing Directive 2006/73/EC according to which the essential terms of the arrangements relating to the fee, commission or non-monetary benefit may be disclosed in summary form, be interpreted as meaning that the disclosure of benefits can be in summary form and general in content?

If the Court answers the first question in the affirmative, the following supplementary question is asked:

1.1.

Must the final paragraph of Article 26 of Implementing Directive 2006/73/EC according to which the essential terms of the arrangements relating to the fee, commission or non-monetary benefit may be disclosed in summary form be interpreted as meaning that the disclosure of benefits can be in summary form and general in content, for example, in general or other pre-formulated terms and conditions of business or must the disclosure be made individually for each client or each category of clients?

In addition, the following further questions are referred:

| 2. | Is there a correct disclosure within the meaning of point (b)(i) of Article 26 of Implementing Directive 2006/73/EC if the investment firm merely notifies the client that benefits may be provided to it by third parties or must the investment firm clearly indicate whether and when such benefits are provided? |
| --- | --- |

2.

Is there a correct disclosure within the meaning of point (b)(i) of Article 26 of Implementing Directive 2006/73/EC if the investment firm merely notifies the client that benefits may be provided to it by third parties or must the investment firm clearly indicate whether and when such benefits are provided?

| 3. | Is there a correct disclosure within the meaning of point (b)(i) of Article 26 of Implementing Directive 2006/73/EC if the investment firm notifies the client that the amount of the benefit provided by the third party depends on the product and consists of a percentage of the management fees charged for the product concerned, a percentage discount on the issue price or a percentage of the issue price or must the investment firm prior to the provision of the investment or ancillary service concerned disclose to the client at least bands concerning the fees, commissions and benefits received by it? |
| --- | --- |

3.

Is there a correct disclosure within the meaning of point (b)(i) of Article 26 of Implementing Directive 2006/73/EC if the investment firm notifies the client that the amount of the benefit provided by the third party depends on the product and consists of a percentage of the management fees charged for the product concerned, a percentage discount on the issue price or a percentage of the issue price or must the investment firm prior to the provision of the investment or ancillary service concerned disclose to the client at least bands concerning the fees, commissions and benefits received by it?

| 4. | Are the conditions laid down in Article 26 of Implementing Directive 2006/73/EC for a disclosure of benefits in summary form, namely that the investment firm undertakes to disclose further details at the request of the client and that it honours that undertaking, fulfilled if, in relation to transactions already made, the investment firm undertakes merely to disclose to the client further details for the twelve months preceding the request? |
| --- | --- |

4.

Are the conditions laid down in Article 26 of Implementing Directive 2006/73/EC for a disclosure of benefits in summary form, namely that the investment firm undertakes to disclose further details at the request of the client and that it honours that undertaking, fulfilled if, in relation to transactions already made, the investment firm undertakes merely to disclose to the client further details for the twelve months preceding the request?

| 5. | Must a Member State, pursuant to the EEA Agreement, accord horizontal direct effect to an implementing directive that is not correctly transposed, specifically, Implementing Directive 2006/73/EC? |
| --- | --- |

5.

Must a Member State, pursuant to the EEA Agreement, accord horizontal direct effect to an implementing directive that is not correctly transposed, specifically, Implementing Directive 2006/73/EC?

| 6. | Must Article 26 of Implementing Directive 2006/73/EC be interpreted in such a way that rights of banking clients against a bank may be derived from it? |
| --- | --- |

6.

Must Article 26 of Implementing Directive 2006/73/EC be interpreted in such a way that rights of banking clients against a bank may be derived from it?

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 4.2.2021 | EN | Official Journal of the European Union | C 39/21 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/21

---

Prior notification of a concentration

(Case M.10067 — ElringKlinger/Plastic Omnium New Energies/EKPO Fuel Cell Technologies/ElringKlinger Fuelcell Systems Austria)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 39/07)

1.

This notification concerns the following undertakings:

| — | ElringKlinger AG (‘EK’, Germany), |
| --- | --- |

—

ElringKlinger AG (‘EK’, Germany),

| — | Plastic Omnium New Energies S.A. (‘PO NE’, Belgium), belonging to the Compagnie Plastic Omnium SE group (‘PO’, France), a subsidiary of Burelle SA (France), |
| --- | --- |

—

Plastic Omnium New Energies S.A. (‘PO NE’, Belgium), belonging to the Compagnie Plastic Omnium SE group (‘PO’, France), a subsidiary of Burelle SA (France),

| — | EKPO Fuel Cell Technologies GmbH (‘EKPO’, Germany), |
| --- | --- |

—

EKPO Fuel Cell Technologies GmbH (‘EKPO’, Germany),

| — | ElringKlinger Fuelcell Systems Austria GmbH (‘EKAT’, Austria). |
| --- | --- |

—

ElringKlinger Fuelcell Systems Austria GmbH (‘EKAT’, Austria).

EK and PO NE acquire within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation joint control of the whole of EKPO, and PO NE acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of EKAT. Both transactions are interrelated.

The concentration is accomplished by way of purchase of shares.

2.

| — | for EK: the ultimate parent company of the German ElringKlinger group, an automotive supplier with international operations, that specialises in lightweight solutions, emobility, sealing and shielding technology, tooling and engineering services, |
| --- | --- |

—

for EK: the ultimate parent company of the German ElringKlinger group, an automotive supplier with international operations, that specialises in lightweight solutions, emobility, sealing and shielding technology, tooling and engineering services,

| — | for PO NE: part of the PO group, which is an automotive supplier with international operations, offering exterior components (especially bumpers and front-end modules) on the one hand (intelligent exterior systems and HBPO divisions) as well as fuel storage and delivery systems (including tanks and filler pipes), high pressure storage systems and depollution systems on the other hand, |
| --- | --- |

—

for PO NE: part of the PO group, which is an automotive supplier with international operations, offering exterior components (especially bumpers and front-end modules) on the one hand (intelligent exterior systems and HBPO divisions) as well as fuel storage and delivery systems (including tanks and filler pipes), high pressure storage systems and depollution systems on the other hand,

| — | for EKPO: the research and development, design, manufacturing and sale of hydrogen fuel cell stacks and related engineering services, fuel cell stack components (e.g. bipolar plates, media modules, sealing solutions) and assembled fuel cell stack modules primarily for the automotive industry defined as light vehicles (passenger cars and light commercial vehicles) and medium & heavy commercial vehicles (buses and trucks), |
| --- | --- |

—

for EKPO: the research and development, design, manufacturing and sale of hydrogen fuel cell stacks and related engineering services, fuel cell stack components (e.g. bipolar plates, media modules, sealing solutions) and assembled fuel cell stack modules primarily for the automotive industry defined as light vehicles (passenger cars and light commercial vehicles) and medium & heavy commercial vehicles (buses and trucks),

| — | for EKAT: specialised in the development of hydrogen fuel cell system solutions. |
| --- | --- |

—

for EKAT: specialised in the development of hydrogen fuel cell system solutions.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.10067 — ElringKlinger/Plastic Omnuim New Energies/EKPO Fuel Cell Technologies/ElringKlinger Fuelcell Systems Austria

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

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

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

---

| 4.2.2021 | EN | Official Journal of the European Union | C 39/23 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/23

---

Prior notification of a concentration

(Case M.10125 — GBL/Canyon)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 39/08)

1.

This notification concerns the following undertakings:

| — | Groupe Bruxelles Lambert SA (‘GBL’, Belgium), |
| --- | --- |

—

Groupe Bruxelles Lambert SA (‘GBL’, Belgium),

| — | Canyon Bicycles GmbH (‘Canyon’, Germany). |
| --- | --- |

—

Canyon Bicycles GmbH (‘Canyon’, Germany).

GBL acquire(s) within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of Canyon.

The concentration is accomplished by way of purchase of shares.

2.

| — | for GBL: investing in global companies operating in various sectors, mainly in Europe, as an investment holding company, |
| --- | --- |

—

for GBL: investing in global companies operating in various sectors, mainly in Europe, as an investment holding company,

| — | for Canyon: developing, producing and distributing mountain bikes, road bikes, triathlon bikes, urban bikes and commuter bikes as well as related components/parts, bike accessories and apparel. |
| --- | --- |

—

for Canyon: developing, producing and distributing mountain bikes, road bikes, triathlon bikes, urban bikes and commuter bikes as well as related components/parts, bike accessories and apparel.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

Case M.10125 — GBL/Canyon

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

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

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

---

| 4.2.2021 | EN | Official Journal of the European Union | C 39/24 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/24

---

Prior notification of a concentration

(Case M.10128 — Stirling Square Capital Partners/TA Associates/Glenigan)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 39/09)

1.

This notification concerns the following undertakings:

| — | Stirling Square Capital Partners Jersey AIFM Limited (‘SSCP Funds’, Jersey, UK), |
| --- | --- |

—

Stirling Square Capital Partners Jersey AIFM Limited (‘SSCP Funds’, Jersey, UK),

| — | TA Associates, L.P. (‘TA Associates’, USA), |
| --- | --- |

—

TA Associates, L.P. (‘TA Associates’, USA),

| — | Glenigan Limited (‘Glenigan’, UK). |
| --- | --- |

—

Glenigan Limited (‘Glenigan’, UK).

The SSCP Funds and TA Associates acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the whole of Glenigan.

The concentration is accomplished by way of purchase of shares.

2.

| — | for SSCP Funds: SSCP Funds invest through three private equity funds, among others, in unquoted equity and equity-linked instruments via management buy-outs, management buy-ins, growth capital and other private equity transactions throughout Europe, |
| --- | --- |

—

for SSCP Funds: SSCP Funds invest through three private equity funds, among others, in unquoted equity and equity-linked instruments via management buy-outs, management buy-ins, growth capital and other private equity transactions throughout Europe,

| — | for TA Associates: TA Associates is focused on targeted sectors within technology, healthcare, financial services, consumer, and business services, |
| --- | --- |

—

for TA Associates: TA Associates is focused on targeted sectors within technology, healthcare, financial services, consumer, and business services,

| — | for Glenigan: Glenigan supplies market data and intelligence software and services to companies in the construction industry, including in relation to office relocation and refurbishment in relation to project information and contact data, primarily in the UK. |
| --- | --- |

—

for Glenigan: Glenigan supplies market data and intelligence software and services to companies in the construction industry, including in relation to office relocation and refurbishment in relation to project information and contact data, primarily in the UK.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.10128 — Stirling Square Capital Partners/TA Associates/Glenigan

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

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

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

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

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

---

OTHER ACTS

European Commission

| 4.2.2021 | EN | Official Journal of the European Union | C 39/26 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/26

---

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

(2021/C 39/10)

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

SINGLE DOCUMENT

‘Salată cu icre de știucă de Tulcea’

EU No: PGI-RO-02476 – 6.7.2018

PDO ( ) PGI (X)

1.   Name(s) [of PDO or PGI]

‘Salată cu icre de știucă de Tulcea’

2.   Member State or Third Country

Romania

3.   Description of the agricultural product or foodstuff

3.1.   Type of product

Class 1.7. Fresh fish, molluscs and crustaceans and products derived therefrom

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

‘Salata cu icre de știucă de Tulcea’ is a white/yellowish-white cream based on sunflower oil and comprising min. 29 % roe, including at least 15 % whole grain salted pike roe and at most 14 % salted Danube Delta fish roe (from species of the Cyprinidae family: crucian, roach, rudd, unformed carp roe; and from species of the Percidae family: zander, perch), mixed with carbonated water and lemon juice.

The following raw materials and ingredients are required to make ‘Salată cu icre de știucă de Tulcea’.

Raw materials:

| (1) | salted pike roe (Esox lucius), at least 15 % in the finished product, making it the main ingredient; |
| --- | --- |

(1)

salted pike roe (Esox lucius), at least 15 % in the finished product, making it the main ingredient;

| (2) | salted Danube Delta fish roe, maximum 14 %, to ensure optimal texture and viscosity. |
| --- | --- |

(2)

salted Danube Delta fish roe, maximum 14 %, to ensure optimal texture and viscosity.

Ingredients:

| (1) | Sunflower oil; |
| --- | --- |

(1)

Sunflower oil;

| (2) | Carbonated water; |
| --- | --- |

(2)

Carbonated water;

| (3) | Lemon juice, obtained by squeezing and straining; |
| --- | --- |

(3)

Lemon juice, obtained by squeezing and straining;

| (4) | Non-iodised rock salt, used for salting the raw materials. |
| --- | --- |

(4)

Non-iodised rock salt, used for salting the raw materials.

Physico-chemical characteristics of ‘Salată cu icre de știucă de Tulcea’:

| Feature | UM | Values |
| --- | --- | --- |
| Acidity (citric acid) | % | 1 max. |
| Moisture content | % | 30 max. |
| Fat content | % | minimum 63 |
| Protein | % | minimum 6,2 |
| Non-iodised rock salt (sodium chloride) | % | 5 max. |

Feature

UM

Values

Acidity (citric acid)

%

1 max.

Moisture content

%

30 max.

Fat content

%

minimum 63

Protein

%

minimum 6,2

Non-iodised rock salt (sodium chloride)

%

5 max.

Organoleptic characteristics:

| — | Homogeneous appearance, viscous and firm, without oil separation, white/yellowish-white in colour, with a pattern of whole pike roe grains, golden yellow or reddish yellow in colour, with a diameter of approximately 2-2,5 mm, depending on the harvest season. |
| --- | --- |

—

Homogeneous appearance, viscous and firm, without oil separation, white/yellowish-white in colour, with a pattern of whole pike roe grains, golden yellow or reddish yellow in colour, with a diameter of approximately 2-2,5 mm, depending on the harvest season.

| — | The specific flavour of pike roe is highlighted by the flavour of Danube Delta fish roe, and is due to the salting and maturing process. |
| --- | --- |

—

The specific flavour of pike roe is highlighted by the flavour of Danube Delta fish roe, and is due to the salting and maturing process.

| — | The final product has a refined and pure aroma of salted and matured freshwater fish roe. This aroma intensifies when the roe grains burst, producing a gentle crunchy sensation on the tongue and in the mouth. |
| --- | --- |

—

The final product has a refined and pure aroma of salted and matured freshwater fish roe. This aroma intensifies when the roe grains burst, producing a gentle crunchy sensation on the tongue and in the mouth.

| — | Without foreign odours, with a distinct aroma of lemon juice. |
| --- | --- |

—

Without foreign odours, with a distinct aroma of lemon juice.

3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

The annual catch quota set for the geographical area (the Danube Delta) by the Danube Delta Biosphere Reserve Administration may lead to disruptions to the supply of pike roe. In such cases, the pike roe may also come from outside the geographical area.

Danube Delta fish roe is a raw material which comes exclusively from the geographical area (Danube Delta). It is harvested in the defined geographical area, from fish of the Cyprinidae family: crucian, roach, rudd, unformed carp roe; and of the Percidae family: zander, perch).

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

All the steps in the production of ‘Salata cu icre de știucă de Tulcea’ take place in the identified geographical area. The steps are: processes and operations for obtaining the raw material: harvesting (when applicable), separating, salting and maturing the roe, measuring the right amount of raw materials and ingredients, and mixing.

3.5.   Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

—

3.6.   Specific rules concerning labelling of the product the registered name refers to

The following information must be indicated on the label of ‘Salată cu icre de știucă de Tulcea’:

| — | name of the product – ‘Salată cu icre de știucă de Tulcea’, followed by the words ‘Protected Geographical Indication’ or ‘PGI’, |
| --- | --- |

—

name of the product – ‘Salată cu icre de știucă de Tulcea’, followed by the words ‘Protected Geographical Indication’ or ‘PGI’,

| — | name of the producer, |
| --- | --- |

—

name of the producer,

| — | name of the inspection and certification body. |
| --- | --- |

—

name of the inspection and certification body.

4.   Concise definition of the geographical area

The geographical area is Tulcea County, which includes the Danube Delta Biosphere Reserve. Tulcea County is located at the south-eastern tip of Romania, in the central-northern part of Dobrogea, at the mouth of the Danube, with access to the Black Sea in the East. It borders Moldova and Ukraine to the North, Galați County to the North-West, Brăila County to the West and Constanța County to the South. Tulcea County is located at 45°N and 29°E.

5.   Link with the geographical area

The request to register ‘Salată cu icre de știucă de Tulcea’ PGI is based on the product characteristics.

‘Salată cu icre de știucă de Tulcea’ has a specific flavour of fish roe rounded off and highlighted by the flavour of Danube Delta fish roe, and is due to the salting and maturing process.

‘Salata cu icre de știucă de Tulcea’ has a refined and pure aroma, typical of such preparations of salted and matured freshwater fish roe. When the roe grains burst, they produce a gentle crunchy sensation on the tongue and in the mouth, and this aroma intensifies.

The consistency of the product is primarily determined by the Danube Delta fish roe, which is caught in the geographical area and serves to create a homogeneous texture for the pike roe.

A specific characteristic of the whole grain pike roe is the golden yellow or reddish yellow colour of the homogeneous mass.

The final product differs from other products of the same category in that Danube Delta fish roe is used instead of food additives (emulsifiers, stabilisers, thickening agents).

The product does not contain any chemical additives or preservatives (such as sorbic acid or sodium benzoate). It is the quality of the product that guarantees its shelf life. The only conservation methods used are: maintaining a high standard of hygiene and maintaining a refrigeration chain during the production process, transport and when the product is sold.

The difference between ‘Salată cu icre de știucă de Tulcea’ and similar products of the same category is that this recipe is only made in the geographical area with high pike roe levels.

Another factor that sets ‘Salată cu icre de știucă de Tulcea’ apart is the fact that it contains lemon juice obtained by pressing, squeezing and straining, while other products of the same category use synthetic products: citric acid and glucose.

‘Salata cu icre de știucă de Tulcea’ is a product using mainly raw materials from the geographical area, and one of the raw materials (Danube Delta fish roe) comes exclusively from the geographical area, creating a close link to the natural environment of the geographical area.

The geographical area – the Danube Delta – is a natural environment rich in freshwater fishery resources, the largest delta in the EU, one of the largest compact freshwater drainage basins in the EU, and, last but not least, Romania’s biggest area of capture for pike and other freshwater fish.

According to the 2008 scientific publication ‘Danube Delta Biosphere Reserve’ by Petre Gâștescu and Romulus Știucă, the purity of surface waters in the Danube Delta is classified as class I according to environmental quality norms. The high quality of the water in the geographical area has a positive effect mainly on the organoleptic characteristics of the local fishery resources.

‘Salata cu icre de știucă de Tulcea’ represents the local tradition of fish processing, which has evolved from harvesting and consumption of raw roe in the 19th century to processing it for modern cuisine in the 20th century.

A food industry based on fish processing has been operating in the geographical area for decades, resulting in local staff being educated and experienced in evaluating the specific characteristics of fish products.

As a result of this, the method of preparing the pike roe is specific to the defined geographical area.

The process uses methods established in the geographical area, such as separating the roe by means of a special implement, the priboi, and maturing it by seeding. The roe is separated off from membranes using a ‘priboi’, combined with a fishing net. The pike roe grains are separated from each other, giving a homogeneous mass of ‘Salată cu icre de știucă de Tulcea’

The method for separating the roe using a priboi has been documented by the Romanian scholar Grigore Antipa in his work ‘Studii asupra pescăriilor din România’ (Studies on fishing in Romania) (Bucharest, Romania, Imprimeria Statului, 1895, 80 pages).

the salting and maturing process gives ‘Salată cu icre de știucă de Tulcea’ its specific flavour. During the salting and maturing processes, the flavour of the roe changes due to enzyme activity. Under mild heat treatment, this flavour (salty with a note of slight maturation) intensifies, and this intensified flavour is the final flavour of the ingredient.

The local staff are able to use their senses to appraise the type, colour, fragrance and flavour of pike roe or Danube Delta fish roe, and its level of maturation and viscosity, making it possible to obtain a quality product.

The local community specific to the geographical area in the 19th century was multi-ethnic (Romanians, Lipovans, Ukrainians, Greeks, Turks etc.) and comprised of native and immigrant ship owners, merchants, sailors, fishermen and, last but not least, fishmongers from various backgrounds. In this cultural melting pot, the locals adapted the recipe for roe spread (salată de icre) made with saltwater fish roe in order to use the resources available in the geographical area. They replaced the saltwater fish roe with freshwater fish roe, namely pike and Danube Delta fish roe, and perfected the recipe in its present form. ‘Salata cu icre de știucă de Tulcea’ is an indispensable feature on the menus of catering and agri-tourism establishments in the geographical area, especially in the Danube Delta.

All this helped to create an environment in which fishing traditions could develop to a great extent. There is therefore a causal link between the product characteristics and the natural and cultural conditions in the geographical area (Danube Delta).

Reference to publication of the specification

(the second subparagraph of Article 6(1) of this Regulation)

https://www.madr.ro/docs/ind-alimentara/2018/caiet-sarcini-stiuca/Documentatie-salata-cu-icre-de-stiuca-de-Tulcea.pdf

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

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| 4.2.2021 | EN | Official Journal of the European Union | C 39/30 |
| --- | --- | --- | --- |

4.2.2021

EN

Official Journal of the European Union

C 39/30

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Publication of the amended single document following the approval of a minor amendment pursuant to the second subparagraph of Article 53(2) of Regulation (EU) No 1151/2012

(2021/C 39/11)

The European Commission has approved this minor amendment in accordance with the third subparagraph of Article 6(2) of Commission Delegated Regulation (EU) No 664/2014 (1).

The application for approval of this minor amendment can be consulted in the Commission’s eAmbrosia database.

SINGLE DOCUMENT

‘CRUDO DI CUNEO’

EU No: PDO-IT-0490-AM02 – 14.9.2020

PDO (X) PGI ( )

1.   Name(s) [of PDO or PGI]

‘Crudo di Cuneo’

2.   Member State or Third Country

Italy

3.   Description of the agricultural product or foodstuff

3.1.   Type of product

Class 1.2 Meat products (cooked, salted, smoked, etc.)

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

Only fresh legs of pork from animals born, reared and slaughtered in the designated area of production may be used in the production of ‘Crudo di Cuneo’ ham. The ham must be aged for at least 10 months – calculated from the beginning of the manufacturing process – before being released for consumption; weight (after ageing): 8,5-12,00 kg; cutting into the ham reveals an even red colour; the external and the soft internal lean meat are firm, not flaccid; the visible (outer) fat is white, bordering on yellow, and firm, not greasy; aroma and taste when cut: fragrant, seasoned, mild; the internal fat is white and present in small quantities between and within the main muscle tissue; absence of any anomalous smell. When pricked, the fat must not have an excessively rancid or a milky, fishy or other anomalous smell. The lean meat must conform to the following maximum and minimum chemical composition as a proportion of the femoral biceps: salt, between 4,5 and 6,9; moisture content between 57 % and 63 %; and 22 % to 31 % of proteolytic compounds. Absence of external anomalies: the rind and bone must be whole, without any visible incrustation or any excessive softness. Colour when cut: cutting must reveal an even colour, without stains or streaks.

3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

Feedstuffs

The feed intake is geared to obtaining an analytic composition tailored to the animals’ requirements in three discrete phases:

early growth, growing-finishing and fattening:

1.   EARLY GROWTH (to 30 kg live weight)

Characteristics of the feed intake

| — | Crude protein from 16 % to 22 % |
| --- | --- |

—

Crude protein from 16 % to 22 %

| — | Digestible energy/day from 3 230 to 3 900 |
| --- | --- |

—

Digestible energy/day from 3 230 to 3 900

| — | Lysine (g/kg) from 10 to 16 |
| --- | --- |

—

Lysine (g/kg) from 10 to 16

| — | Crude fibre from 3 % to 5 % |
| --- | --- |

—

Crude fibre from 3 % to 5 %

Daily ration (broken down into percentages represented by the various components; ration is 4 % of live weight)

| — | Maize from 35 to 40 |
| --- | --- |

—

Maize from 35 to 40

| — | Soya (flour) from 16 to 20 |
| --- | --- |

—

Soya (flour) from 16 to 20

| — | Wheat from 12 to 15 |
| --- | --- |

—

Wheat from 12 to 15

| — | Barley from 13 to 17 |
| --- | --- |

—

Barley from 13 to 17

| — | Soya bean oil from 1 to 3 |
| --- | --- |

—

Soya bean oil from 1 to 3

| — | Soft wheat bran from 8 to 12 |
| --- | --- |

—

Soft wheat bran from 8 to 12

| — | Mineral and vitamin supplements from 3 to 5 |
| --- | --- |

—

Mineral and vitamin supplements from 3 to 5

During this phase the following may be used:

| — | spray-dried pig plasma, |
| --- | --- |

—

spray-dried pig plasma,

| — | fresh and concentrated milk derivatives and by-products. |
| --- | --- |

—

fresh and concentrated milk derivatives and by-products.

2.   GROWING-FINISHING (30 to 80 kg live weight)

Characteristics of the feed intake

| — | Crude protein from 15,50 % to 18 % |
| --- | --- |

—

Crude protein from 15,50 % to 18 %

| — | Digestible energy/day from 3 200 to 3 600 |
| --- | --- |

—

Digestible energy/day from 3 200 to 3 600

| — | Lysine (g/kg) from 7 to 16 |
| --- | --- |

—

Lysine (g/kg) from 7 to 16

| — | Crude fibre from 3,5 % to 5 % |
| --- | --- |

—

Crude fibre from 3,5 % to 5 %

Daily ration (broken down into percentages represented by the various components; ration is 3 % of live weight)

| — | Maize from 45 to 49 |
| --- | --- |

—

Maize from 45 to 49

| — | Soya (flour) from 14 to 18 |
| --- | --- |

—

Soya (flour) from 14 to 18

| — | Wheat from 10 to 13 |
| --- | --- |

—

Wheat from 10 to 13

| — | Barley from 9 to 12 |
| --- | --- |

—

Barley from 9 to 12

| — | Fat from 1,5 to 2 |
| --- | --- |

—

Fat from 1,5 to 2

| — | Soft wheat bran from 10 to 14 |
| --- | --- |

—

Soft wheat bran from 10 to 14

| — | Mineral and vitamin supplements from 3 to 5 |
| --- | --- |

—

Mineral and vitamin supplements from 3 to 5

3.   FATTENING (80 to 165 kg final live weight)

Characteristics of the feed intake

| — | Crude protein from 13,5 % to 17,5 % |
| --- | --- |

—

Crude protein from 13,5 % to 17,5 %

| — | Digestible energy/day from 3 100 to 3 400 |
| --- | --- |

—

Digestible energy/day from 3 100 to 3 400

| — | Lysine (g/kg) from 6 to 9 |
| --- | --- |

—

Lysine (g/kg) from 6 to 9

| — | Crude fibre from 3,5 % to 5,5 % |
| --- | --- |

—

Crude fibre from 3,5 % to 5,5 %

Daily ration (broken down into percentages represented by the various components; ration is 2,3 % of live weight)

| — | Maize from 49 to 53 |
| --- | --- |

—

Maize from 49 to 53

| — | Soya (flour) from 12 to 16 |
| --- | --- |

—

Soya (flour) from 12 to 16

| — | Wheat from 9 to 12 |
| --- | --- |

—

Wheat from 9 to 12

| — | Barley from 8 to 11 |
| --- | --- |

—

Barley from 8 to 11

| — | Fat from 1 to 1,5 |
| --- | --- |

—

Fat from 1 to 1,5

| — | Soft wheat bran from 10 to 14 |
| --- | --- |

—

Soft wheat bran from 10 to 14

| — | Mineral and vitamin supplements from 3 to 5 |
| --- | --- |

—

Mineral and vitamin supplements from 3 to 5

In this phase it is prohibited to use table scraps, fish-oil (for animals over 40 kg live weight), feed-cakes with over 4 % fat content (animals over 120 kg), biscuits, grissini [breadsticks], snacks (from 60 kg live weight to slaughter), all rendering products and animal meal, and rice by-products.

Requirements within each phase may vary depending on the pigs’ rate of growth or following unusual weather conditions due to exceptionally hot summers. The raw materials used in the feed come mainly from the area in which the ‘Crudo di Cuneo’ is produced and the cereals are in large part grown on the farms where the pigs are reared. The breeds or genetic types to which animals intended for the production of ‘Crudo di Cuneo’ ham must belong are the traditional Italian Large White and Landrace breeds, as improved by the Italian herd book, or offspring of boars of those breeds, offspring of boars of the Italian Duroc breed, as improved by the herd book, and offspring of boars of other breeds or of mixed-breed boars, provided they come from selection or cross-breeding schemes whose aims are in line with those of the herd book for the production of heavy pigs. The use of frozen pork legs is not allowed in the production of ‘Crudo di Cuneo’. Boars and sows may not be used. Pork legs used in the production process must come from animals slaughtered 24 hours or more but not more than 120 hours previously.

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

Only fresh legs of pork from animals born and reared according to high welfare standards may be used in the production of ‘Crudo di Cuneo’ PDO. Such standards are ensured by not subjecting the animals to the stress of transport or rehousing in the weaning, growing-finishing or fattening phases. In addition, the farm must ensure that the fattening phase produces results that are consistent with the characteristics of the final product. One of the trademark characteristics of ‘Crudo di Cuneo’ is that it has just the right amount of external fat. This is why the animals must be born and reared in the area of production. Slaughter must also take place within the production area, partly because no more than a certain time should elapse between slaughter and processing the meat and partly because transport over a long distance could lead to bruising and the formation of haematomas and streaking, which would jeopardise the processing requirements. The processing and ageing of the hams are strictly tied to human and natural factors in the production area; it is thus imperative that the production of ‘Crudo di Cuneo’ be limited to that area.

3.5.   Specific rules concerning the slicing, grating, packaging, etc. of the product the registered name refers to

‘Crudo di Cuneo’ may be sold whole, bone-in and boneless, vacuum packed, in thick slabs or sliced. ‘Crudo di Cuneo’ must be sliced in such a way that the producer’s seal with which the ham was marked during production is visible on the rind of each slice.

3.6.   Specific rules concerning labelling of the product the registered name refers to

When released for consumption, ‘Crudo di Cuneo’ PDO must bear the distinctive seal guaranteeing the origin and identification of the product. The seal, which is made up of a logo, is branded by the ham curers on the two largest sides of the ham. The following must be printed clearly and indelibly, and must be readily distinguishable from any other information present, on the packaging of ‘Crudo di Cuneo’ PDO or on labels placed on the product or on cards, rings or tags tied to it: the specific, unmistakeable logo, the Community symbol referred to in Article 12 of Commission Regulation (EU) No 1151/2012, and the identification number given to each producer within the checking system. The two major components of the ‘Crudo di Cuneo’ PDO logo in terms of product recognition are a stylised representation of a ham and a triangle or wedge, in reference to Cuneo, the provincial capital, which was originally in the shape of a wedge (in Italian: cuneo).

Image 1

4.   Concise definition of the geographical area

The area in which ‘Crudo di Cuneo’ PDO is produced lies within the Ligurian Alps between the Colle di Cadibona and the Colle di Nava, the Maritime Alps to the Colle di Tenda massif, and the Cottian Alps. These mountainous areas form a U-shaped rim surrounding a high plain, crossed from north to south by the Tanaro and Po rivers and their tributaries. This area comprises the provinces of Cuneo and Asti and the following municipalities of the Province of Turin: Airasca, Andezeno, Arignano, Baldissero Torinese, Bibiana, Bricherasio, Buriasco, Cambiano, Campiglione Fenile, Candiolo, Cantalupa, Carignano, Carmagnola, Castagnole Piemonte, Cavour, Cercenasco, Chieri, Cumiana, Frossasco, Garzigliana, Isolabella, Lombriasco, Luserna S. Giovanni, Lusernetta, Macello, Marentino, Mombello di Torino, Montaldo Torinese, Moriondo Torinese, None, Osasco, Osasio, Pancalieri, Pavarolo, Pecetto Torinese, Pinerolo, Pino Torinese, Piobesi Torinese, Piossasco, Piscina, Poirino, Pralormo, Prarostino, Riva, Roletto, Rora’, S. Secondo di Pinerolo, Santena, Scalenghe, Trofarello, Vigone, Villafranca Piemonte, Villastellone and Vinovo. Thanks to the breezes in the area, humidity levels remain stable (between 50 % and 70 %) and these, together with average temperatures that are neither excessively cold in the winter nor too hot in the summer, allow for a uniform ageing process that gives ‘Crudo di Cuneo’ its characteristic protein breakdown and low moisture content.

5.   Link with the geographical area

The link between the PDO production area, pig farming and the manufacture and ageing of ‘Crudo di Cuneo’ dates back to ancient times, thanks to special conditions with regard to soil and climate which help to differentiate the area in relation to others and give the product typical qualitative characteristics that are easily recognisable by the final consumer.

The moisture content of ‘Crudo di Cuneo’, which is closely linked to the salt content, is influenced by mountain breezes that blow in opposing directions in the morning and at night and reduce the moisture in the air, thus providing ideal conditions for curing a product with the low moisture levels, ageing times and protein breakdown that characterise ‘Crudo di Cuneo’. The raw materials also constitute a close link between the product and the environment; indeed, the proteolysis of the ham is brought about by the characteristics of those raw materials. The Cuneo pig is reared at an average of 350 metres above sea level, where the absence of winter fog and summer heat haze are conducive to good animal health. In addition to the healthy air and the purity of the water, it is the traditional healthy and natural nutrition – based on locally produced cereals – which helps to speed up the maturing of the meat. Proteolysis is linked to the development of microorganisms on the surface of the meat: the delicate salting carried out by the craftsmen ensures that the moisture that is still present in the flesh of the leg of pork rises to the surface by capillary action. This produces microclimatic conditions on the lean surfaces of the ham that lead to a slight increase in moisture; this in turn encourages the formation of moulds and yeasts which, by breaking down the proteins present in the lean, release peptides that have a major influence on both the flavour and smell of ‘Crudo di Cuneo’.

Over the centuries it is man who has made a key contribution to the quality of the PDO ham by developing special manufacturing techniques handed down from generation to generation to the present day. In ‘Clypeo del gentilhuomo’, a work dating back to 1618, Guglielmino Prato describes in detail the work done by Piedmont’s norcini (ham craftsmen).

The consumption of ‘Crudo di Cuneo’ is well documented, with numerous historical records of hams ordered by noble households, convents and abbeys in the area. It was indeed the growing demand for ham that encouraged many processors to set up in business.

‘Crudo di Cuneo’ PDO is the outcome of a combination of several human and environmental factors that over time have had an influence on the end product and have contributed to its qualitative characteristics.

Reference to publication of the specification

(second subparagraph of Article 6(1) of this Regulation)

The consolidated text of the product specification is available on the internet:

http://www.politicheagricole.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/3335”

or alternatively:

by going directly to the home page of the Ministry of Agricultural, Food, Forestry and Tourism Policy (www.politicheagricole.it) and clicking on ‘Qualità’ (at the top right of the screen), then on ‘Prodotti DOP IGP STG’ (on the left-hand side of the screen) and finally on ‘Disciplinari di Produzione all’esame dell’UE’.

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(1)  OJ L 179, 19.6.2014, p. 17.

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