ISSN 1977-091X

Official Journal

of the European Union

C 29

European flag  

English edition

Information and Notices

Volume 65
20 January 2022


Contents

page

 

IV   Notices

 

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

 

European Commission

2022/C 29/01

Administrative Commission for the Coordination of Social Security Systems Average costs of benefits in kind

1

2022/C 29/02

Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 February 2022 (Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004)

3

2022/C 29/03

Explanatory Notes to the Combined Nomenclature of the European Union

4

 

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

 

Standing Committee of the EFTA States

2022/C 29/04

Medicinal products - List of marketing authorisations granted by the EEA EFTA States for the first half of 2021

7

2022/C 29/05

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 44(5) of Regulation (EU) 528/2012 in the first half of 2021

30

2022/C 29/06

Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) in the first half of 2021

32


 

V   Announcements

 

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

 

European Commission

2022/C 29/07

Notice of initiation of an expiry review of the anti-dumping measures applicable to imports of certain aluminium road wheels originating in the People’s Republic of China

34

 

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

 

European Commission

2022/C 29/08

Prior notification of a concentration (Case M.10564 – APOLLO / MISSGUIDED) – Candidate case for simplified procedure ( 1 )

46


 


 

(1)   Text with EEA relevance.

EN

 


IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

20.1.2022   

EN

Official Journal of the European Union

C 29/1


ADMINISTRATIVE COMMISSION FOR THE COORDINATION OF SOCIAL SECURITY SYSTEMS AVERAGE COSTS OF BENEFITS IN KIND

(2022/C 29/01)

AVERAGE COSTS OF BENEFITS IN KIND – 2019

Application of Article 64 of Regulation (EC) No 987/2009 (1)

I.

The amounts to be refunded with regard to the benefits in kind provided in 2019 to family members who do not reside in the same State as the insured person, as referred to in Article 17 of Regulation (EC) No 883/2004 (2), will be determined on the basis of the following average costs:

 

Age group

Annual

Net monthly

x=0,20

Cyprus

under 20 years

EUR 515,87

EUR 34,39

20 - 64 years

EUR 566,67

EUR 37,78

65 years and over

EUR 2 228,83

EUR 148,59

II.

The amounts to be refunded with regard to benefits in kind provided in 2019 to pensioners and members of their family, as provided for in Article 24(1) and Articles 25 and 26 of Regulation (EC) No 883/2004, will be determined on the basis of the following average costs:

 

Age group

Annual

Net monthly x=0,20

Net monthly

x=0,15 (3)

Cyprus

under 20 years

EUR 515,87

EUR 34,39

EUR 36,54

20 – 64 years

EUR 566,67

EUR 37,78

EUR 40,14

65 years and over

EUR 2 228,83

EUR 148,59

EUR 157,88

AVERAGE COSTS OF BENEFITS IN KIND – 2020

Application of Article 64 of Regulation (EC) No 987/2009

I.

The amounts to be refunded with regard to the benefits in kind provided in 2020 to family members who do not reside in the same State as the insured person, as referred to in Article 17 of Regulation (EC) No 883/2004, will be determined on the basis of the following average costs:

 

Age group

Annual

Net monthly

x=0,20

Spain

under 20 years

EUR 664,68

EUR 44,31

20 - 64 years

EUR 1 000,19

EUR 66,68

65 years and over

EUR 5 114,42

EUR 340,96

II.

The amounts to be refunded with regard to benefits in kind provided in 2020 to pensioners and members of their family, as provided for in Article 24(1) and Articles 25 and 26 of Regulation (EC) No 883/2004, will be determined on the basis of the following average costs:

 

Age group

Annual

Net monthly x=0,20

Net monthly

x=0,15 (4)

Spain

under 20 years

EUR 664,68

EUR 44,31

EUR 47,08

20 – 64 years

EUR 1 000,19

EUR 66,68

EUR 70,85

65 years and over

EUR 5 114,42

EUR 340,96

EUR 362,27


(1)  OJ L 284, 30.10.2009, p. 1.

(2)  OJ L 166, 30.4.2004, p. 1.

(3)  The reduction applied to the monthly fixed amount ‘shall be equal to 15 % (X = 0,15) for pensioners and members of their family where the competent Member State is not listed in Annex IV of the basic Regulation’ (Article 64(3) of Regulation (EC) No 987/2009).

(4)  The reduction applied to the monthly fixed amount ‘shall be equal to 15 % (X = 0,15) for pensioners and members of their family where the competent Member State is not listed in Annex IV of the basic Regulation’ (Article 64(3) of Regulation (EC) No 987/2009).


20.1.2022   

EN

Official Journal of the European Union

C 29/3


Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 February 2022

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 (1))

(2022/C 29/02)

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6.). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basispoints has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basispoints to the base rate.

Modified rates are indicated in bold.

Previous table published in OJ C 504, 14.12.2021, p. 47.

From

To

AT

BE

BG

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HR

HU

IE

IT

LT

LU

LV

MT

NL

PL

PT

RO

SE

SI

SK

UK

1.2.2022

-0,49

-0,49

0,00

-0,49

3,29

-0,49

-0,03

-0,49

-0,49

-0,49

-0,49

-0,49

0,26

3,17

-0,49

-0,49

-0,49

-0,49

-0,49

-0,49

-0,49

2,04

-0,49

2,74

-0,05

-0,49

-0,49

0,66

1.1.2022

31.1.2022

-0,49

-0,49

0,00

-0,49

2,49

-0,49

-0,01

-0,49

-0,49

-0,49

-0,49

-0,49

0,26

2,38

-0,49

-0,49

-0,49

-0,49

-0,49

-0,49

-0,49

1,21

-0,49

2,27

-0,03

-0,49

-0,49

0,51


(1)  OJ L 140, 30.4.2004, p. 1.


20.1.2022   

EN

Official Journal of the European Union

C 29/4


Explanatory Notes to the Combined Nomenclature of the European Union

(2022/C 29/03)

Pursuant to Article 9(1)(a) of Council Regulation (EEC) No 2658/87 (1), the Explanatory Notes to the Combined Nomenclature of the European Union (2) are hereby amended as follows:

On page 412, the following explanatory note is inserted:

9503 00 41

Stuffed

Stuffed toys of this subheading usually have an outer fabric of a soft material and are usually filled with flexible/soft material that makes the toy pleasant to hold. Musical modules, battery housings or skeletons are not considered as stuffing material. A stuffed toy does not require to be fully stuffed as long as the stuffed parts give the toy the essential character of a stuffed toy.

See Commission Implementing Regulation (EU) 2015/352(*) and Commission Regulation (EC) No 2184/97(**) for toys that are to be classified in subheading 9503 00 41 .

 

 

(*)

Commission Implementing Regulation (EU) 2015/352 of 2 March 2015 concerning the classification of certain goods in the Combined Nomenclature (OJ L 61, 5.3.2015, p. 5).

(**)

Commission Regulation (EC) No 2184/97 of 3 November 1997 concerning the classification of certain goods in the combined nomenclature (OJ L 299, 4.11.1997, p. 6).

Other examples of toys that are to be classified in subheading 9503 00 41 as stuffed toys representing animals or non-human creatures:

Image 1

Stuffed toy representing a bear made of soft fabric, approximately 30 cm high, with a relatively big stuffed head, stuffed legs and stuffed arms and a built-in sound module in the body. Besides the sound module, there is also slight stuffing in the body.

Image 2

Little singing teddy bear with interactive features, approximately 19 cm high.

The body is made out of plastic, it incorporates a battery powered sound module and it has 3 light-up pressing buttons.

It has a stuffed head, stuffed legs, stuffed feet, stuffed arms and hands. The stuffed parts taken together constitute the prevailing part of the interior material filling.

Image 3

A toy representing a stuffed horse’s head attached to a wooden stick (60 to 100 cm long) with two wheels attached at the bottom.

Examples of toys that are to be classified in subheading 9503 00 49 as other toys representing animals or non-human creatures:

Image 4

A toy representing a dog, approximately 25 cm high, covered with soft knitted plush fabric. It has a body and a skeleton of plastics fitted with a battery-powered motor and a sound module. The four paws have a layer of lining attached at the inner side and the head is stuffed.

Image 5

A toy representing a lama, approximately 17 cm high, covered with soft plush fabric. The body, the head and the skeleton are made of plastics. There is a layer of padding between the plastic head and the soft plush fabric covering the head, but the body does not contain any stuffed material. The toy has a battery-powered motor, which allows the toy to move the legs and the tail, and a sound module.

Image 6

A toy representing a kitten, approximately 15 cm high, covered with soft knitted plush fabric. It has a body and a skeleton of plastics fitted with a battery-powered motor and a sound module. The four paws are stuffed.

Image 7

A toy representing a rescue dog, approximately 30 cm high, covered with soft knitted plush fabric. It has a body and skeleton of plastics fitted with a battery-powered motor and a sound module. The four paws and a part of the muzzle are stuffed.’


(1)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

(2)  OJ C 119, 29.3.2019, p. 1.


NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

20.1.2022   

EN

Official Journal of the European Union

C 29/7


Medicinal products - List of marketing authorisations granted by the EEA EFTA States for the first half of 2021

(2022/C 29/04)

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 2021, at their meeting on 24 September 2021:

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations

Annex V

List of suspended marketing authorisations


ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January – 30 June 2021:

EU-Number

Product

Country

Date of authorisation

EU/1/20/1515

Abevmy

Iceland

12.5.2021

EU/1/20/1515

Abevmy

Liechtenstein

30.4.2021

EU/1/20/1515

Abevmy

Norway

28.4.2021

EU/1/20/1512

Abirateron Accord

Liechtenstein

30.4.2021

EU/1/20/1512

Abiraterone Accord

Iceland

14.5.2021

EU/1/20/1512

Abiraterone Accord

Norway

6.5.2021

EU/1/21/1553

Abiraterone Krka

Liechtenstein

30.6.2021

EU/1/21/1553

Abiraterone Krka

Norway

30.6.2021

EU/1/20/1476

Adakveo (conditional)

Liechtenstein

15.1.2021

EU/1/21/1554

Adtralza

Liechtenstein

30.6.2021

EU/1/21/1554

Adtralza

Norway

22.6.2021

EU/1/20/1509

Alymsys

Iceland

14.4.2021

EU/1/20/1509

Alymsys

Liechtenstein

30.4.2021

EU/1/20/1509

Alymsys

Norway

8.4.2021

EU/1/20/1469

Arikayce liposomal

Liechtenstein

15.1.2021

EU/1/20/1475

Arsenic trioxide medac

Liechtenstein

28.2.2021

EU/2/18/228

Arti-Cell Forte

Liechtenstein

28.2.2021

EU/1/20/1473

Ayvakyt

Liechtenstein

28.2.2021

EU/1/18/1339

Bevespi Aerosphere

Liechtenstein

28.2.2021

EU/2/99/017

Bovalto Ibraxion

Liechtenstein

28.2.2021

EU/1/21/1534

BroPair Spiromax

Iceland

14.4.2021

EU/1/21/1534

BroPair Spiromax

Liechtenstein

30.4.2021

EU/1/21/1534

BroPair Spiromax

Norway

8.4.2021

EU/2/10/112

BTVPUR AlSap 1

Liechtenstein

28.2.2021

EU/2/09/094

BTVPUR AlSap 8

Liechtenstein

28.2.2021

EU/1/20/1505

Byfavo

Iceland

26.4.2021

EU/1/20/1505

Byfavo

Norway

8.4.2021

EU/1/20/1505

Byvafo

Liechtenstein

30.4.2021

EU/120/1448

Cabazitaxel Accord

Liechtenstein

28.2.2021

EU/1/20/1479

Calquence

Liechtenstein

15.1.2021

EU/1/21/1560

Celsunax

Liechtenstein

30.6.2021

EU/1/21/1560

Celsunax

Norway

23.6.2021

EU/2/20/264

CircoMax Myco

Iceland

4.1.2021

EU/2/20/264

CircoMax Myco

Liechtenstein

15.1.2021

EU/1/19/1395

Clopidogrel/Acetylsalicylic acid Mylan

Liechtenstein

28.2.2021

EU/1/20/1528

Comirnaty (conditional)

Liechtenstein

15.1.2021

EU/1/21/1542

Copiktra

Iceland

9.6.2021

EU/1/21/1542

Copiktra

Liechtenstein

30.6.2021

EU/1/21/1542

Copiktra

Norway

3.6.2021

EU/2/18/230

Cortacare

Liechtenstein

28.2.2021

EU/1/21/1529

COVID-19 Vaccine AstraZeneca

Iceland

29.1.2021

EU/1/21/1529

COVID-19 Vaccine AstraZeneca

Liechtenstein

28.2.2021

EU/1/20/1529

COVID-19 Vaccine AstraZeneca (Vaxzevria)

Norway

29.1.2021

EU/1/20/1525

COVID-19 Vaccine Janssen

Iceland

11.3.2021

EU/1/20/1525

COVID-19 Vaccine Janssen

Liechtenstein

30.4.2021

EU/1/20/1525

COVID-19 Vaccine Janssen

Norway

11.3.2021

EU/1/20/1507

COVID-19 Vaccine Moderna

Iceland

6.1.2021

EU/1/20/1507

COVID-19 Vaccine Moderna (conditional)

Liechtenstein

15.1.2021

EU/1/20/1507

COVID-19 Vaccine Moderna (Spikevax)

Norway

6.1.2021

EU/2/21/271

Credelio Plus

Iceland

26.4.2021

EU/2/21/271

Credelio Plus

Liechtenstein

30.4.2021

EU/2/21/271

Credelio Plus

Norway

19.4.2021

EU/1/17/1248

Darunavir Krka d.d.

Liechtenstein

28.2.2021

EU/2/21/270

Daxocox

Iceland

14.5.2021

EU/2/21/270

Daxocox

Liechtenstein

30.4.2021

EU/2/21/270

Daxocox

Norway

3.6.2021

EU/1/19/1412

Deferasirox Accord

Liechtenstein

28.2.2021

EU/1/21/1547

Drovelis

Iceland

8.6.2021

EU/1/21/1547

Drovelis

Liechtenstein

30.6.2021

EU/1/21/1547

Drovelis

Norway

3.6.2021

EU/1/18/1284

Dzuveo

Liechtenstein

28.2.2021

EU/1/21/1549

Efmody

Iceland

10.6.2021

EU/1/21/1549

Efmody

Liechtenstein

30.4.2021

EU/1/21/1549

Efmody

Norway

10.6.2021

EU/1/20/1504

Elzonris

Iceland

19.1.2021

EU/1/20/1504

Elzonris

Liechtenstein

28.2.2021

EU/1/20/1504

Elzonris

Norway

18.1.2021

EU/1/18/1330

Emgality

Liechtenstein

28.2.2021

EU/1/20/1438

Enerzair Breezhaler

Liechtenstein

28.2.2021

EU/1/20/1508

Enhertu

Iceland

28.1.2021

EU/1/20/1508

Enhertu

Liechtenstein

28.2.2021

EU/1/20/1508

Enhertu

Norway

26.1.2021

EU/1/21/1559

Enspryng

Liechtenstein

30.6.2021

EU/2/20/268

Enteroporc Coli

Iceland

21.1.2021

EU/2/20/268

Enteroporc Coli

Liechtenstein

15.1.2021

EU/2/20/268

Enteroporc Coli

Norway

3.6.2021

EU/2/20/262

Enteroporc Coli AC

Iceland

8.1.2021

EU/2/20/262

Enteroporc Coli AC

Liechtenstein

15.1.2021

EU/1/20/1472

Equidacent

Liechtenstein

15.1.2021

EU/1/19/1392

Ervebo

Liechtenstein

28.2.2021

EU/1/12/750

Esmya

Iceland

1.2.2021

EU/1/21/1551

Evkeeza

Liechtenstein

30.6.2021

EU/1/21/1551

Evkeeza

Norway

30.6.2021

EU/1/21/1531

Evrysdi

Iceland

14.4.2021

EU/1/21/1531

Evrysdi

Liechtenstein

30.4.2021

EU/1/21/1531

Evrysdi

Norway

8.4.2021

EU/1/20/1489

Exparel liposomal

Liechtenstein

28.2.2021

EU/1/20/1477

Fampridine Accord

Liechtenstein

15.1.2021

EU/1/20/1491

Fintepla

Iceland

22.1.2021

EU/1/20/1491

Fintepla

Liechtenstein

15.1.2021

EU/1/20/1491

Fintepla

Norway

15.1.2021

EU/1/18/1326

Flucelvax Tetra

Liechtenstein

28.2.2021

EU/1/19/1375

Grasustek

Liechtenstein

28.2.2021

EU/1/20/1503

Heplisav B

Iceland

22.2.2021

EU/1/20/1503

Heplisav B

Liechtenstein

28.2.2021

EU/1/20/1503

Heplisav B

Norway

25.2.2021

EU/2/20/258

Increxxa

Liechtenstein

28.2.2021

EU/2/20/258

Increxxa

Norway

22.2.2021

EU/2/17/208

Ingelvac PCV FLEX

Liechtenstein

28.2.2021

EU/2/17/213

Innovax-ND-IBD

Liechtenstein

28.2.2021

EU/2/20/256

Innovax-ND-ILT

Liechtenstein

15.1.2021

EU/2/20/256

Innovax-ND-ILT

Norway

4.1.2021

EU/1/20/1514

Inrebic

Iceland

19.2.2021

EU/1/20/1514

Inrebic

Liechtenstein

28.2.2021

EU/1/20/1514

Inrebic

Norway

11.2.2021

EU/2/18/232

Isemid

Liechtenstein

28.2.2021

EU/1/19/1396

Ivozall

Liechtenstein

28.2.2021

EU/1/21/1557

Jayempi

Liechtenstein

30.6.2021

EU/1/21/1557

Jayempi

Norway

30.6.2021

EU/1/21/1538

Jemperli

Iceland

12.5.2021

EU/1/21/1538

Jemperli

Liechtenstein

30.4.2021

EU/1/21/1538

Jemperli

Norway

28.4.2021

EU/1/20/1480

Jyseleca

Liechtenstein

15.1.2021

EU/1/21/1532

Kesimpta

Iceland

15.4.2021

EU/1/21/1532

Kesimpta

Liechtenstein

30.4.2021

EU/1/21/1532

Kesimpta

Norway

8.4.2021

EU/1/20/1506

Kixelle

Iceland

18.2.2021

EU/1/20/1506

Kixelle

Liechtenstein

28.2.2021

EU/1/20/1506

Kixelle

Norway

11.2.2021

EU/1/21/1552

Koselugo

Liechtenstein

30.6.2021

EU/1/21/1552

Koselugo

Norway

22.6.2021

EU/1/20/1520

Lenalidomide Krka

Iceland

4.3.2021

EU/1/20/1520

Lenalidomide Krka

Liechtenstein

28.2.2021

EU/1/20/1520

Lenalidomide Krka

Norway

21.6.2021

EU/1/20/1521

Lenalidomide Krka d.d.

Iceland

5.3.2021

EU/1/20/1521

Lenalidomide Krka d.d.

Liechtenstein

30.4.2021

EU/1/20/1521

Lenalidomide Krka d.d.

Norway

16.6.2021

EU/1/20/1519

Lenalidomide Krka d.d. Novo mesto

Iceland

24.2.2021

EU/1/20/1519

Lenalidomide Krka d.d. Novo mesto

Liechtenstein

28.2.2021

EU/1/20/1519

Lenalidomide Krka d.d. Novo mesto

Norway

18.6.2021

EU/1/20/1490

Lenalidomide Mylan

Iceland

11.1.2021

EU/1/20/1490

Lenalidomide Mylan

Liechtenstein

28.2.2021

EU/1/20/1494

Leqvio

Iceland

5.1.2021

EU/1/20/1494

Leqvio

Liechtenstein

15.1.2021

EU/1/20/1516

Lextemy

Iceland

12.5.2021

EU/1/20/1516

Lextemy

Liechtenstein

30.4.2021

EU/1/20/1516

Lextemy

Norway

28.4.2021

EU/1/20/1493

Libmeldy

Iceland

14.1.2021

EU/1/20/1493

Libmeldy

Liechtenstein

15.1.2021

EU/1/20/1493

Libmeldy

Norway

8.1.2021

EU/2/20/261

Librela

Liechtenstein

15.1.2021

EU/2/20/261

Librela

Norway

4.1.2021

EU/1/20/1470

Lumeblue

Liechtenstein

28.2.2021

EU/1/20/1522

Lumoxiti

Iceland

19.2.2021

EU/1/20/1522

Lumoxiti

Liechtenstein

28.2.2021

EU/1/20/1522

Lumoxiti

Norway

11.2.2021

EU/1/21/1548

Lydisilka

Iceland

8.6.2021

EU/1/21/1548

Lydisilka

Liechtenstein

30.6.2021

EU/1/21/1548

Lydisilka

Norway

31.5.2021

EU/1/20/1483

MenQuadfi

Liechtenstein

15.1.2021

EU/2/20/259

Mhyosphere PCV ID

Liechtenstein

28.2.2021

EU/2/20/259

Mhyosphere PCV ID

Norway

4.1.2021

EU/1/20/1445

Mvabea

Liechtenstein

28.2.2021

EU/1/18/1325

Namuscla

Liechtenstein

28.2.2021

EU/2/20/267

NexGard Combo

Iceland

25.1.2021

EU/2/20/267

NexGard Combo

Liechtenstein

28.2.2021

EU/2/20/267

NexGard Combo

Norway

20.1.2021

EU/1/21/1537

Nexpovio

Iceland

30.3.2021

EU/1/21/1537

Nexpovio

Liechtenstein

30.4.2021

EU/1/21/1537

Nexpovio

Norway

8.4.2021

EU/1/18/1290

Nityr

Liechtenstein

28.2.2021

EU/2/20/265

Nobivac DP Plus

Iceland

4.1.2021

EU/2/20/265

Nobivac DP Plus

Liechtenstein

15.1.2021

EU/1/19/1364

Nuceiva

Liechtenstein

28.2.2021

EU/1/20/1486

Nyvepria

Liechtenstein

15.1.2021

EU/1/20/1485

Obiltoxaximab SFL (exceptional circumstances)

Liechtenstein

15.1.2021

EU/1/20/1523

Ogluo

Iceland

22.2.2021

EU/1/20/1523

Ogluo

Liechtenstein

28.2.2021

EU/1/20/1523

Ogluo

Norway

23.2.2021

EU/1/20/1499

Onbevzi

Iceland

19.1.2021

EU/1/20/1499

Onbevzi

Liechtenstein

28.2.2021

EU/1/20/1499

Onbevzi

Norway

15.1.2021

EU/1/21/1530

Ontozry

Iceland

15.4.2021

EU/1/21/1530

Ontozry

Liechtenstein

30.4.2021

EU/1/21/1530

Ontozry

Norway

9.4.2021

EU/1/21/1556

Onureg

Liechtenstein

30.6.2021

EU/1/21/1556

Onureg

Norway

22.6.2021

EU/1/21/1544

Orladeyo

Iceland

14.5.2021

EU/1/21/1544

Orladeyo

Liechtenstein

30.6.2021

EU/1/21/1544

Orladeyo

Norway

6.5.2021

EU2/20/260

OvuGel

Liechtenstein

28.2.2021

EU/2/20/260

OvuGel

Norway

4.1.2021

EU/1/20/1496

Oxlumo

Liechtenstein

15.1.2021

EU/1/20/1510

Oyavas

Iceland

14.4.2021

EU/1/20/1510

Oyavas

Liechtenstein

30.4.2021

EU/1/20/1510

Oyavas

Norway

8.4.2021

EU/1/20/1495

Palforzia

Iceland

18.1.2021

EU/1/20/1495

Palforzia

Liechtenstein

28.2.2021

EU/1/20/1495

Palforzia

Norway

15.1.2021

EU/1/21/1535

Pemazyre

Iceland

30.3.2021

EU/1/21/1535

Pemazyre

Liechtenstein

30.4.2021

EU/1/21/1535

Pemazyre

Norway

8.4.2021

EU/1/20/1487

Phelinun

Liechtenstein

28.2.2021

EU/1/20/1497

Phesgo

Iceland

11.1.2021

EU/1/20/1497

Phesgo

Liechtenstein

15.1.2021

EU/1/21/1550

Ponvory

Iceland

9.6.2021

EU/1/21/1550

Ponvory

Liechtenstein

30.6.2021

EU/1/21/1550

Ponvory

Norway

4.6.2021

EU/2/20/254

Prevexxion RN

Liechtenstein

28.2.2021

EU/2/20/255

Prevexxion RN+HVT+IBD

Norway

4.1.2021

EU/2/17/211

Prevomax

Liechtenstein

28.2.2021

EU/1/20/1482

Rekambys

Iceland

11.1.2021

EU/1/20/1482

Rekambys

Liechtenstein

15.1.2021

EU/1/20/1482

Rekambys

Norway

5.1.2021

EU/1/20/1527

Retsevmo

Iceland

19.2.2021

EU/1/20/1527

Retsevmo

Liechtenstein

28.2.2021

EU/1/20/1527

Retsevmo

Norway

11.2.2021

EU/2/20/263

Rexxolide

Iceland

4.1.2021

EU/2/20/263

Rexxolide

Liechtenstein

28.2.2021

EU/1/19/1400

Rhokiinsa

Liechtenstein

28.2.2021

EU/1/20/1488

Rivaroxaban Accord

Liechtenstein

15.1.2021

EU/1/20/1502

Roclanda

Iceland

12.1.2021

EU/1/20/1502

Roclanda

Liechtenstein

28.2.2021

EU/1/20/1502

Roclanda

Norway

14.1.2021

EU/1/20/1460

Rozlytrek

Liechtenstein

28.2.2021

EU/1/20/1518

Rukobia

Iceland

19.2.2021

EU/1/20/1518

Rukobia

Liechtenstein

28.2.2021

EU/1/20/1518

Rukobia

Norway

11.2.2021

EU/1/20/1431

Ruxience

Liechtenstein

28.2.2021

EU/1/20/1435

Sarclisa

Liechtenstein

28.2.2021

EU/1/21/1533

Seffalair Spiromax

Iceland

14.4.2021

EU/1/21/1533

Seffalair Spiromax

Liechtenstein

30.4.2021

EU/1/21/1533

Seffalair Spiromax

Norway

8.4.2021

EU/1/20/1517

Sibnayal

Iceland

14.5.2021

EU/1/20/1517

Sibnayal

Liechtenstein

30.6.2021

EU/1/20/1517

Sibnayal

Norway

5.5.2021

EU/1/20/1501

Sogroya

Iceland

15.4.2021

EU/1/20/1501

Sogroya

Liechtenstein

30.4.2021

EU/1/20/1501

Sogroya

Norway

8.4.2021

EU/2/20/269

Solensia

Liechtenstein

28.2.2021

EU/2/20/269

Solensia

Norway

14.6.2021

EU/1/19/1421

Staquis

Liechtenstein

28.2.2021

EU/1/20/1511

Sunitinib Accord

Iceland

4.3.2021

EU/1/20/1511

Sunitinib Accord

Liechtenstein

30.4.2021

EU/1/20/1511

Sunitinib Accord

Norway

5.3.2021

EU/1/20/1484

Supemtek

Liechtenstein

15.1.2021

EU2/09/099

Suvaxyn PCV

Liechtenstein

28.2.2021

EU/2/18/231

Syvazul BTV

Liechtenstein

28.2.2021

EU/1/20/1492

Tecartus

Iceland

8.1.2021

EU/1/20/1492

Tecartus (conditional)

Liechtenstein

15.1.2021

EU/1/19/1378

Temybric Ellipta

Liechtenstein

28.2.2021

EU/1/21/1536

Thiotepa Riemser

Iceland

15.4.2021

EU/1/21/1536

Thiotepa Riemser

Liechtenstein

30.4.2021

EU/1/21/1536

Thiotepa Riemser

Norway

8.4.2021

EU/1/18/1351

Trecondi

Liechtenstein

15.1.2021

EU/1/19/1419

Trepulmix

Liechtenstein

28.2.2021

EU/1/20/1498

Trixeo Aerosphere

Iceland

8.1.2021

EU/1/20/1498

Trixeo Aerosphere

Liechtenstein

28.2.2021

EU/1/20/1526

Tukysa

Iceland

19.2.2021

EU/1/20/1526

Tukysa

Liechtenstein

28.2.2021

EU/1/20/1526

Tukysa

Norway

25.2.2021

EU/2/20/257

Tulinovet

Liechtenstein

15.1.2021

EU/2/20/252

Tulissin

Liechtenstein

28.2.2021

EU/2/21/272

Ultifend ND IBD

Iceland

12.5.2021

EU/2/21/272

Ultifend ND IBD

Liechtenstein

30.4.2021

EU/2/21/272

Ultifend ND IBD

Norway

29.4.2021

EU/1/20/1524

Vazkepa

Iceland

30.3.2021

EU/1/20/1524

Vazkepa

Liechtenstein

30.4.2021

EU/1/20/1524

Vazkepa

Norway

8.4.2021

EU/2/20/266

Vectormune FP ILT

Iceland

5.1.2021

EU/2/20/266

Vectormune FP ILT

Liechtenstein

15.1.2021

EU/2/20/266

Vectormune FP ILT

Norway

4.1.2021

EU/1/18/1298

Veyvondi

Liechtenstein

28.2.2021

EU/1/20/1481

Vocabria

Iceland

26.1.2021

EU/1/20/1481

Vocabria

Liechtenstein

28.2.2021

EU/1/20/1500

Xofluza

Iceland

12.1.2021

EU/1/20/1500

Xofluza

Liechtenstein

28.2.2021

EU/1/20/1500

Xofluza

Norway

14.1.2021

EU/1/20/1513

Yuflyma

Iceland

24.2.2021

EU/1/20/1513

Yuflyma

Liechtenstein

28.2.2021

EU/1/20/1513

Yuflyma

Norway

25.2.2021

EU/2/17/210

Zeleris

Liechtenstein

28.2.2021

EU/2/09/186

Zulvac 8 Bovis

Liechtenstein

28.2.2021

EU/2/17/207

Zulvac BTV Ovis

Liechtenstein

28.2.2021

EU/1/20/1478

Zynrelef

Liechtenstein

15.1.2021


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 2021:

EU-Number

Product

Country

Date of authorisation

EU/1/12/794

ADCETRIS

Liechtenstein

15.1.2021

EU/1/16/1098

Alprolix

Iceland

25.2.2021

EU/1/16/1098

Alprolix

Liechtenstein

30.4.2021

EU/1/16/1098

Alprolix

Norway

23.3.2021

EU/1/16/1092

Amlodipine/Valsartan Mylan

Iceland

25.1.2021

EU/1/16/1092

Amlodipine/Valsartan Mylan

Liechtenstein

28.2.2021

EU/1/15/1045

Aripiprazole Accord

Liechtenstein

15.1.2021

EU/1/16/1091

Atazanavir Mylan

Iceland

17.5.2021

EU/1/16/1091

Atazanavir Mylan

Liechtenstein

30.4.2021

EU/1/16/1091

Atazanavir Mylan

Norway

3.5.2021

EU/1/15/1074

Benepali

Liechtenstein

15.1.2021

EU/1/20/1474

Blenrep

Liechtenstein

30.6.2021

EU/1/16/1114

Bortezomib Hospira

Iceland

17.5.2021

EU/1/16/1114

Bortezomib Hospira

Liechtenstein

30.6.2021

EU/1/16/1114

Bortezomib Hospira

Norway

7.5.2021

EU/1/16/1102

Bortezomib SUN

Liechtenstein

30.6.2021

EU/1/16/1102

Bortezomib SUN

Norway

30.6.2021

EU/1/13/818

Bosulif

Iceland

22.2.2021

EU/1/13/818

Bosulif

Norway

8.3.2021

EU/1/13/818

Bosulif

Liechtenstein

28.2.2021

EU/1/15/1073

Briviact

Liechtenstein

15.1.2021

EU/1/16/1136

Cabometyx

Iceland

12.5.2021

EU/1/16/1136

Cabometyx

Liechtenstein

30.4.2021

EU/1/16/1136

Cabometyx

Norway

3.5.2021

EU/1/11/749

Caprelsa

Iceland

15.1.2021

EU/1/11/749

Caprelsa

Norway

3.2.2021

EU/1/11/749

Caprelsa

Liechtenstein

28.2.2021

EU/1/15/1055

Ciambra

Liechtenstein

28.2.2021

EU/1/15/1054

Cinacalcet Mylan

Liechtenstein

15.1.2021

EU/1/16/1125

Cinqaero

Iceland

10.6.2021

EU/1/16/1125

Cinqaero

Liechtenstein

30.6.2021

EU/1/16/1125

Cinqaero

Norway

10.6.2021

EU/1/16/1087

Coagadex

Iceland

14.4.2021

EU/1/16/1087

Coagadex

Liechtenstein

30.4.2021

EU/1/16/1087

Coagadex

Norway

7.4.2021

EU/1/13/890

Cometriq

Iceland

11.3.2021

EU/1/13/890

Cometriq

Liechtenstein

28.2.2021

EU/1/17/1262

Crysvita

Iceland

2.2.2021

EU/1/17/1262

Crysvita

Liechtenstein

28.2.2021

EU/1/17/1262

Crysvita

Norway

2.2.2021

EU/1/13/875

Deltyba

Iceland

26.4.2021

EU/1/13/875

Deltyba

Liechtenstein

30.4.2021

EU/1/16/1099

Descovy

Iceland

10.3.2021

EU/1/16/1099

Descovy

Liechtenstein

28.2.2021

EU/1/16/1099

Descovy

Norway

15.3.2021

EU/1/15/1051

Ebymect

Liechtenstein

28.2.2021

EU/1/15/1052

Edistride

Liechtenstein

28.2.2021

EU/1/11/691

Eliquis

Iceland

19.1.2021

EU/1/11/691

Eliquis

Liechtenstein

28.2.2021

EU/1/11/691

Eliquis

Norway

18.1.2021

EU/1/15/1046

Elocta

Norway

22.2.2021

EU/1/16/1088

Empliciti

Iceland

13.1.2021

EU/1/16/1088

Empliciti

Liechtenstein

15.1.2021

EU/1/16/1105

EndolucinBeta

Iceland

18.2.2021

EU/1/16/1105

EndolucinBeta

Liechtenstein

28.2.2021

EU/1/16/1105

EndolucinBeta

Norway

16.2.2021

EU/1/16/1116

Epclusa

Iceland

25.3.2021

EU/1/16/1116

Epclusa

Liechtenstein

30.4.2021

EU/1/16/1116

Epclusa

Norway

25.3.2021

EU/1/15/1069

Episalvan

Liechtenstein

15.1.2021

EU/1/15/1065

Eptifibatid Accord

Liechtenstein

15.1.2021

EU/1/19/1392

Ervebo

Norway

3.2.2021

EU/1/19/1392

Ervebo-Ebola Zaire-Impfstoff

Liechtenstein

15.1.2021

EU/2/16/194

Evalon

Iceland

24.2.2021

EU/2/16/194

Evalon

Liechtenstein

28.2.2021

EU/2/16/194

Evalon

Norway

26.2.2021

EU/1/15/1075

Feraccru

Liechtenstein

15.1.2021

EU/1/16/1106

Flixabi

Iceland

10.3.2021

EU/1/16/1106

Flixabi

Liechtenstein

30.4.2021

EU/1/16/1106

Flixabi

Norway

7.4.2021

EU/1/15/1082

Galafold

Iceland

25.2.2021

EU/1/15/1082

Galafold

Liechtenstein

28.2.2021

EU/1/15/1082

Galafold

Norway

23.2.2021

EU/1/15/1061

Genvoya

Liechtenstein

28.2.2021

EU/1/11/677

Gilenya

Liechtenstein

15.1.2021

EU/1/15/1008

Hetlioz

Liechtenstein

28.2.2021

EU/1/14/987

Holoclar

Iceland

25.1.2021

EU/1/14/987

Holoclar

Liechtenstein

28.2.2021

EU/1/16/1095

Idelvion

Iceland

18.2.2021

EU/1/16/1095

Idelvion

Liechtenstein

28.2.2021

EU/1/16/1095

Idelvion

Norway

11.2.2021

EU/1/15/1064

Imlygic

Liechtenstein

15.1.2021

EU/2/15/193

Imrestor

Liechtenstein

15.1.2021

EU/1/11/676

Jevtana

Iceland

8.1.2021

EU/1/11/676

Jevtana

Liechtenstein

15.1.2021

EU/1/16/1128

Kisplyx

Liechtenstein

30.6.2021

EU/1/16/1128

Kisplyx

Norway

22.6.2021

EU/1/15/1076

Kovaltry

Liechtenstein

15.1.2021

EU/2/16/195

Letifend

Iceland

24.2.2021

EU/2/16/195

Letifend

Liechtenstein

28.2.2021

EU/2/16/195

Letifend

Norway

5.3.2021

EU/1/19/1376

Libtayo

Liechtenstein

30.6.2021

EU/1/19/1376

Libtayo

Iceland

21.5.2021

EU/1/19/1376

Libtayo

Norway

21.5.2021

EU/1/16/1096

Lonsurf

Iceland

8.1.2021

EU/1/16/1096

Lonsurf

Liechtenstein

15.1.2021

EU/1/16/1096

Lonsurf

Norway

8.1.2021

EU/1/15/1067

Lopinavir/Ritonavir Mylan

Liechtenstein

15.1.2021

EU/1/19/1355

Lorviqua

Iceland

26.4.2021

EU/1/19/1355

Lorviqua

Liechtenstein

30.4.2021

EU/1/19/1355

Lorviqua

Norway

8.4.2021

EU/1/15/1078

Natpar

Iceland

27.4.2021

EU/1/15/1078

Natpar

Liechtenstein

30.4.2021

EU/1/15/1078

Natpar

Norway

26.4.2021

EU/1/15/1053

Neofordex

Iceland

15.1.2021

EU/1/15/1053

Neofordex

Liechtenstein

15.1.2021

EU/1/15/1053

Neofordex

Norway

31.1.2021

EU/1/16/1103

Neparvis

Iceland

22.2.2021

EU/1/16/1103

Neparvis

Liechtenstein

28.2.2021

EU/1/16/1103

Neparvis

Norway

16.2.2021

EU/1/16/1094

Ninlaro

Liechtenstein

15.1.2021

EU/1/16/1094

Ninlaro

Norway

22.2.2021

EU/1/16/1124

Nordimet

Liechtenstein

30.6.2021

EU/1/16/1124

Nordimet

Norway

25.6.2021

EU/1/15/1035

Obizur

Liechtenstein

28.2.2021

EU/1/16/1139

Ocaliva

Iceland

25.1.2021

EU/1/16/1139

Ocaliva

Norway

3.2.2021

EU/1/16/1139

Ocaliva

Liechtenstein

28.2.2021

EU/1/16/1112

Odefsey

Iceland

19.1.2021

EU/1/16/1112

Odefsey

Liechtenstein

28.2.2021

EU/1/16/1112

Odefsey

Norway

14.1.2021

EU/1/15/1070

Oncaspar

Liechtenstein

15.1.2021

EU/1/18/1345

Ondexxya

Iceland

2.3.2021

EU/1/18/1345

Ondexxya

Liechtenstein

28.2.2021

EU/1/18/1345

Ondexxya

Norway

8.3.2021

EU/1/15/1066

Ongentys

Iceland

15.3.2021

EU/1/15/1066

Ongentys

Liechtenstein

28.2.2021

EU/1/15/1066

Ongentys

Norway

15.3.2021

EU/1/15/1059

Orkambi

Liechtenstein

15.1.2021

EU/1/16/1104

Palonosetron Accord

Iceland

22.2.2021

EU/1/16/1104

Palonosetron Accord

Liechtenstein

28.2.2021

EU/1/16/1104

Palonosetron Accord

Norway

26.2.2021

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Iceland

16.3.2021

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Liechtenstein

30.4.2021

EU/1/16/1089

Pandemic influenza vaccine H5N1 AstraZeneca

Norway

24.3.2021

EU/1/15/1071

Pemetrexed Accord

Liechtenstein

28.2.2021

EU/1/16/1115

Pemetrexed Fresenius Kabi

Iceland

12.5.2021

EU/1/16/1115

Pemetrexed Fresenius Kabi

Liechtenstein

30.4.2021

EU/1/16/1115

Pemetrexed Fresenius Kabi

Norway

20.5.2021

EU/1/15/1057

Pemetrexed Hospira

Liechtenstein

28.2.2021

EU/1/19/1388

Polivy

Iceland

5.1.2021

EU/1/19/1388

Polivy

Liechtenstein

15.1.2021

EU/1/16/1108

Qtern

Iceland

9.6.2021

EU/1/16/1108

Qtern

Liechtenstein

30.4.2021

EU/1/16/1108

Qtern

Norway

3.6.2021

EU/1/16/1090

Rasagiline Mylan

Liechtenstein

15.1.2021

EU/1/20/1460

Rozlytrek

Liechtenstein

30.6.2021

EU/1/17/1250

Rubraca

Iceland

15.3.2021

EU/1/17/1250

Rubraca

Liechtenstein

30.4.2021

EU/1/17/1250

Rubraca

Norway

11.3.2021

EU/2/16/196

Sevohale

Iceland

14.5.2021

EU/2/16/196

Sevohale

Liechtenstein

30.4.2021

EU/2/16/196

Sevohale

Norway

7.5.2021

EU/1/16/1135

Sialanar

Liechtenstein

30.6.2021

EU/1/16/1135

Sialanar

Norway

30.6.2021

EU/1/13/901

Sirturo

Iceland

14.1.2021

EU/1/13/901

Sirturo

Liechtenstein

28.2.2021

EU/1/13/901

Sirturo

Norway

8.2.2021

EU/1/15/1072

Spectrila

Liechtenstein

15.1.2021

EU/1/16/1097

Strimvelis

Iceland

14.5.2021

EU/1/16/1097

Strimvelis

Liechtenstein

30.6.2021

EU/1/16/1097

Strimvelis

Norway

7.5.2021

EU/1/15/1085

Taltz

Iceland

29.1.2021

EU/1/15/1085

Taltz

Liechtenstein

15.1.2021

EU/1/15/1085

Taltz

Norway

14.1.2021

EU/1/13/902

Translarna

Liechtenstein

28.2.2021

EU/1/15/1083

Uptravi

Iceland

8.1.2021

EU/1/15/1083

Uptravi

Liechtenstein

15.1.2021

EU/1/15/1079

Vaxelis

Liechtenstein

15.1.2021

EU/2/15/188

Vectormune ND

Iceland

18.2.2021

EU/2/15/188

Vectormune ND

Liechtenstein

28.2.2021

EU/1/20/1459

Veklury

Liechtenstein

30.6.2021

EU/1/15/1068

Wakix

Iceland

29.1.2021

EU/1/15/1068

Wakix

Liechtenstein

28.2.2021

EU/1/19/1360

Waylivra

Iceland

18.2.2021

EU/1/19/1360

Waylivra

Norway

1.3.2021

EU/1/19/1360

Waylivra

Liechtenstein

28.2.2021

EU/1/15/1042

Zalviso

Liechtenstein

15.1.2021

EU/1/16/1109

Zavicefta

Iceland

24.2.2021

EU/1/16/1109

Zavicefta

Liechtenstein

28.2.2021

EU/1/16/1109

Zavicefta

Norway

26.2.2021

EU/1/16/1119

Zepatier

Iceland

14.5.2021

EU/1/16/1119

Zepatier

Liechtenstein

30.6.2021

EU/1/16/1119

Zepatier

Norway

18.5.2021

EU/1/11/690

Zoely

Iceland

25.5.2021

EU/1/11/690

Zoely

Liechtenstein

30.6.2021

EU/1/11/690

Zoely

Norway

31.5.2021

EU/1/20/1443

Zolgensma

Iceland

8.6.2021

EU/1/20/1443

Zolgensma

Liechtenstein

30.6.2021

EU/1/20/1443

Zolgensma

Norway

2.6.2021

EU/1/16/1093

Zonisamide Mylan

Iceland

4.1.2021

EU/1/16/1093

Zonisamide Mylan

Liechtenstein

28.2.2021


ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January – 30 June 2021:

EU-Number

Product

Country

Date of authorisation

EU/1/13/838/006

Aubagio

Norway

22.6.2021

EU/1/18/1336/009

Buvidal

Iceland

16.6.2021

EU/1/18/1336/009

Buvidal

Norway

3.6.2021

EU/1/06/367/013

Diacomit

Iceland

10.6.2021

EU/1/06/367/013

Diacomit

Norway

10.6.2021

EU/2/11/128/004-010

Emdocam

Iceland

25.5.2021

EU/1/18/1319/009-010

Hulio

Iceland

18.1.2021

EU/1/18/1319/009-010

Hulio

Norway

18.1.2021

EU/1/20/1447/006-007

Insulin Aspart Sanofi

Iceland

14.5.2021

EU/1/20/1447/006-007

Insulin Aspart Sanofi

Norway

4.5.2021

EU/1/19/1364/002

Nuceiva

Iceland

29.1.2021

EU/1/19/1364/002

Nuceiva

Norway

27.1.2021

EU/1/14/934/007-008

Plegridy

Iceland

8.1.2021

EU/1/08/442/025-031

Pradaxa

Iceland

21.1.2021

EU/1/08/442/025-031

Pradaxa

Norway

19.1.2021

EU/1/13/901/003

Sirturo

Iceland

15.4.2021

EU/1/13/901/003

Sirturo

Norway

8.4.2021

EU/1/19/1361/002-003

Skyrizi

Iceland

10.6.2021

EU/1/19/1361/002-003

Skyrizi

Norway

4.6.2021

EU/1/10/622/003

Tepadina

Iceland

15.4.2021

EU/1/10/622/003

Tepadina

Norway

19.4.2021

EU/1/13/892/007

Tivicay

Iceland

25.1.2021

EU/1/13/892/007

Tivicay

Norway

18.1.2021

EU/1/17/1208/006-009

Trimbow

Iceland

29.1.2021

EU/1/17/1208/010-012

Trimbow

Iceland

26.4.2021

EU/1/17/1208/006-009

Trimbow

Norway

26.1.2021

EU/1/17/1208/010-012

Trimbow

Norway

12.4.2021

EU/1/06/346/002

Tysabri

Iceland

15.4.2021

EU/1/06/346/002

Tysabri

Norway

8.4.2021

EU/1/08/472/050-051

Xarelto

Iceland

1.2.2021

EU/1/17/472/050-051

Xarelto

Norway

26.1.2021

EU/1/18/1312/003-004

Xerava

Iceland

2.3.2021

EU/1/18/1312/003-004

Xerava

Norway

5.3.2021


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 2021:

EU-Number

Product

Country

Date of withdrawal

EU/2/08/088

Acticam

Iceland

26.3.2021

EU/2/08/088

Acticam

Liechtenstein

30.4.2021

EU/2/08/088

Acticam

Norway

26.3.2021

EU/1/16/1122

Aerivio Spiromax

Liechtenstein

28.2.2021

EU/1/16/1123

Airexar Spiromax

Liechtenstein

28.2.2021

EU/1/18/1269

Alpivab

Liechtenstein

15.1.2021

EU/1/07/390

Altargo

Liechtenstein

28.2.2021

EU/1/10/625

Arzerra

Liechtenstein

28.2.2021

EU/1/06/355

ATryn

Liechtenstein

28.2.2021

EU/1/19/1382

Azacitidin Celgene

Liechtenstein

30.6.2021

EU/1/19/1382

Azacitidine Celgene

Iceland

25.5.2021

EU/1/19/1382

Azacitidine Celgene

Norway

16.6.2021

EU/1/15/1081

Caspofungin Accord

Iceland

25.2.2021

EU/1/15/1081

Caspofungin Accord

Liechtenstein

28.2.2021

EU/1/10/623

Clopidogrel/Acetylsalicylic acid Zentiva

Liechtenstein

28.2.2021

EU/1/10/623

Clopidogrel/Acetylsalicylic acid Zentiva

Norway

1.3.2021

EU/1/96/024

Crixivan

Iceland

14.4.2021

EU/1/96/024

Crixivan

Liechtenstein

30.4.2021

EU/1/96/024

Crixivan

Norway

16.6.2021

EU/1/17/1240

Cyltezo

Liechtenstein

28.2.2021

EU/1/01/187

DepoCyte

Liechtenstein

28.2.2021

EU/1/18/1300

Duzallo

Liechtenstein

28.2.2021

EU/1/13/908

Eperzan

Liechtenstein

28.2.2021

EU/1/09/510

Fertavid

Liechtenstein

28.2.2021

EU/1/18/1288

Halimatoz

Iceland

12.1.2021

EU/1/18/1288

Halimatoz

Liechtenstein

28.2.2021

EU/1/18/1288

Halimatoz

Norway

9.2.2021

EU/1/00/144

Helixate NexGen

Liechtenstein

28.2.2021

EU/1/13/876

Imatinib Medac

Liechtenstein

28.2.2021

EU/1/17/1243

Imatinib Teva B.V.

Liechtenstein

28.2.2021

EU/1/08/505

Intanza

Liechtenstein

28.2.2021

EU/1/01/191

Ketek

Liechtenstein

28.2.2021

EU/1/13/895

Kolbam

Liechtenstein

28.2.2021

EU/1/20/1516

Lextemy

Liechtenstein

30.6.2021

EU/1/16/1162

Lusduna

Liechtenstein

28.2.2021

EU/1/05/325

Macugen

Liechtenstein

28.2.2021

EU/1/04/297

Nodetrip (tidl.Xeristar)

Liechtenstein

30.6.2021

EU/1/04/297

Nodetrip (tidl.Xeristar)

Norway

16.6.2021

EU/1/01/186

Nonafact

Liechtenstein

28.2.2021

EU/1/15/1044

Numient

Liechtenstein

28.2.2021

EU/1/14/924

Olysio

Liechtenstein

28.2.2021

EU/1/04/287

Osseor

Liechtenstein

28.2.2021

EU/1/00/131

PegIntron

Iceland

17.5.2021

EU/1/00/131

PegIntron

Liechtenstein

30.4.2021

EU/1/00/131

PegIntron

Norway

6.5.2021

EU/1/15/1084

Portrazza

Iceland

2.3.2021

EU/1/15/1084

Portrazza

Liechtenstein

28.2.2021

EU/1/08/453

Prepandrix

Iceland

14.1.2021

EU/1/08/453

Prepandrix

Liechtenstein

28.2.2021

EU/1/08/453

Prepandrix

Norway

9.2.2021

EU/1/04/288

Protelos

Liechtenstein

28.2.2021

EU/1/20/1463

Qutavina

Liechtenstein

15.1.2021

EU/1/10/634

Ribavirin Mylan

Liechtenstein

28.2.2021

EU/1/07/388

Sebivo

Liechtenstein

15.1.2021

EU/1/06/358

Silgard

Liechtenstein

28.2.2021

EU/1/16/1163

Solymbic

Liechtenstein

28.2.2021

EU/1/15/1017

Taxespira

Liechtenstein

28.2.2021

EU/1/09/610

Telmisartan Teva

Iceland

9.6.2021

EU/1/09/610

Telmisartan Teva

Liechtenstein

30.6.2021

EU/1/09/610

Telmisartan Teva

Norway

16.6.2021

EU/1/09/552

Topotecan Teva

Liechtenstein

28.2.2021

EU/1/16/1126

Truberzi

Iceland

12.1.2021

EU/1/16/1126

Truberzi

Liechtenstein

15.1.2021

EU/1/16/1126

Truberzi

Norway

3.2.2021

EU/1/18/1303

Udenyca

Iceland

18.2.2021

EU/1/18/1303

Udenyca

Liechtenstein

28.2.2021

EU/1/18/1303

Udenyca

Norway

15.2.2021

EU/1/17/1180

Varuby

Liechtenstein

28.2.2021

EU/1/12/752

Vepacel

Liechtenstein

15.1.2021

EU/1/11/705

Vibativ

Liechtenstein

28.2.2021

EU/1/11/704

Victrelis

Liechtenstein

28.2.2021

EU/1/00/132

ViraferonPeg

Iceland

19.1.2021

EU/1/00/132

ViraferonPeg

Liechtenstein

28.2.2021

EU/1/00/132

ViraferonPeg

Norway

29.1.2021

EU/1/11/671

Xiapex

Liechtenstein

28.2.2021

EU/1/16/1121

Zalmoxis

Liechtenstein

28.2.2021


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 2021:

EU-Number

Product

Country

Date of suspension


20.1.2022   

EN

Official Journal of the European Union

C 29/30


Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 44(5) of Regulation (EU) 528/2012 in the first half of 2021

(2022/C 29/05)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 225/2013 of 13 December 2013, the EEA Joint Committee is invited to note the following lists concerning authorisation decisions adopted on the basis of Article 44(5) of Regulation (EU) No 528/2012 for the period 1 January – 30 June 2021, at their meeting on 24 September 2021.


ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 44(5) of Regulation (EU) No 528/2012) have been taken in the EEA EFTA States during the period 1 January – 30 June 2021:

Biocidal Product Name

Union authorisation decisions under Article 44(5) of Regulation (EU) No 528/2012

Country

Date of decision

Aero-Sense Aircraft Insecticide ASD

32021R0368

Iceland

23.4.2021

Aero-Sense Aircraft Insecticide ASD

32021R0368

Liechtenstein

15.4.2021

Aero-Sense Aircraft Insecticide ASD

32021R0368

Norway

22.4.2021

Contec Hydrogen Peroxide

32020D2124

Norway

15.4.2021

DEC-AHOL® Product Family

32021R0552

Iceland

25.6.2021

DEC-AHOL® Product Family

32021R0552

Liechtenstein

17.6.2021

DEC-AHOL® Product Family

32021R0552

Norway

15.6.2021

Iodine Teat Dip Products

32020R0202

Iceland

19.5.2021

Iodine Teat Dip Products

32020R0202

Liechtenstein

18.5.2021

Iodine Teat Dip Products

32020R0202

Norway

20.5.2021

Perform-IPA

32020R1991

Iceland

23.4.2021

Perform-IPA

32020R1991

Liechtenstein

15.4.2021

Perform-IPA

32020R1991

Norway

13.4.2021

PeridoxRTU

32020R1425

Iceland

19.4.2021

PeridoxRTU

32020R1425

Liechtenstein

29.3.2021

PeridoxRTU

32020R1425

Norway

13.4.2021


20.1.2022   

EN

Official Journal of the European Union

C 29/32


Dangerous substances – List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) in the first half of 2021

(2022/C 29/06)

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 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 2021, at their meeting on 24 September 2021.


ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 January – 30 June 2021:

Substance name

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

Country

Date of decision

Chromium trioxide

C(2020) 8735

Iceland

10.2.2021

Chromium trioxide

C(2020) 8735

Liechtenstein

14.1.2021

Chromium trioxide

C(2020) 8735

Norway

11.1.2021

Chromium trioxide

C(2020) 8798

Iceland

10.2.2021

Chromium trioxide

C(2020) 8798

Liechtenstein

14.1.2021

Chromium trioxide

C(2020) 8798

Norway

11.1.2021

Chromium trioxide

C(2020) 8797

Iceland

10.2.2021

Chromium trioxide

C(2020) 8797

Liechtenstein

14.1.2021

Chromium trioxide

C(2020) 8797

Norway

11.1.2021

Chromium trioxide

C(2020) 7104

Liechtenstein

3.2.2021

Pitch, coal tar, high-temp. (‘CTPht’)

C(2021) 47

Iceland

4.3.2021

Pitch, coal tar, high-temp. (‘CTPht’)

C(2021) 47

Liechtenstein

27.1. 2021

Pitch, coal tar, high-temp. (‘CTPht’)

C(2021) 47

Norway

8.2.2021

Trichloroethylene (TCE)

C(2021) 1385

Iceland

7.4.2021

Trichloroethylene (TCE)

C(2021) 1385

Liechtenstein

23.3.2021

Trichloroethylene (TCE)

C(2021) 1385

Norway

23.3.2021


V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL POLICY

European Commission

20.1.2022   

EN

Official Journal of the European Union

C 29/34


Notice of initiation of an expiry review of the anti-dumping measures applicable to imports of certain aluminium road wheels originating in the People’s Republic of China

(2022/C 29/07)

Following the publication of a Notice of impending expiry (1) of the anti-dumping measures in force on the imports of certain aluminium road wheels originating in the People’s Republic of China (‘the country concerned’), the European Commission (’the Commission’) has received a request for review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (2) (’the basic Regulation’).

1.   Request for review

The request was submitted on 21 October 2021 by the Association of European Wheel Manufacturers (’the applicant’) on behalf of the Union industry of certain aluminium road wheels in the sense of Article 5(4) of the basic Regulation.

An open version of the request and the analysis of the degree of support by Union producers for the request are available in the file for inspection by interested parties. Section 5.6 of this Notice provides information about access to the file for interested parties.

2.   Product under review

The product subject to this review is aluminium road wheels of the motor vehicles of headings 8701 to 8705, whether or not with their accessories and whether or not fitted with tyres (’the product under review’), currently falling within CN codes ex 8708 70 10 and ex 8708 70 50 (TARIC codes: 8708701015, 8708701050, 8708705015 and 8708705050). The CN and TARIC codes are given for information only.

3.   Existing measures

The measures currently in force are a definitive anti-dumping duty imposed by Commission Implementing Regulation (EU) No 2017/109 (3).

4.   Grounds for the review

The request is based on the grounds that the expiry of the measures would be likely to result in continuation of dumping and continuation or recurrence of injury to the Union industry.

4.1.    Allegation of likelihood of continuation of dumping

The applicant claimed that it is not appropriate to use domestic prices and costs in the country concerned, due to the existence of significant distortions within the meaning of point (b) of Article 2(6a) of the basic Regulation.

To substantiate the allegations of significant distortions, the applicant relied on the information contained in the country report produced by the Commission services on 20 December 2017 describing the specific market circumstances in the country concerned (4). In particular, the applicant referred to distortions as state presence in general and more specific affecting the aluminium sector. In addition, the applicant relied on publicly available information, in particular on the report ‘Overcapacity in China: An impediment to the Party’s Reform Agenda’ issued by the EU Chamber of Commerce in Beijing (5) and the OECD report ‘Measuring distortions in international markets - The aluminium value chain’ (6). According to the OECD report, non-market forces, and government support in particular, appear to explain increased overcapacity in the aluminium industry in the country concerned. This overcapacity and the consequences thereof are also identified in the report issued by the EU Chamber of Commerce in Beijing. Finally, the applicant also relied on the Commission’s findings in several recent anti-dumping investigations concerning the aluminium sector (7) (8) (9).

As a result, in view of Article 2(6a)(a) of the basic Regulation, the allegation of continuation of dumping from the country concerned is based on a comparison of a constructed normal value on the basis of costs of production and sale reflecting undistorted prices or benchmarks in an appropriate representative country with the export price (at ex- works level) of the product under review from the country concerned when sold for export to the Union.

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

In light of the information available, the Commission considers that there is sufficient evidence pursuant to Article 5(9) of the basic Regulation tending to show that, due to significant distortions affecting prices and costs, the use of domestic prices and costs in the country concerned is inappropriate, thus warranting the initiation of an investigation on the basis of Article 2(6a) of the basic Regulation.

The country report is available in the file for inspection by interested parties and on DG Trade’s website (10).

4.2.    Allegation of likelihood of continuation or recurrence of injury

The applicant alleges the likelihood of continuation or recurrence of injury. In this respect the applicant has provided sufficient evidence that imports of the product under review from the country concerned to the Union have remained significant in absolute terms and in terms of market shares.

The applicant has also provided evidence that, should measures be allowed to lapse, the current import level of the product under review from the country concerned to the Union is likely to increase due to the existence of unused capacity of the manufacturing facilities of the producers in the country concerned and the attractiveness of the Union market. In addition, in the absence of measures, Chinese export prices would be at a level low enough to injure the Union industry. The applicant finally alleges that any substantial increase of imports at dumped prices from the country concerned would be likely to cause further injury to the Union industry should measures be allowed to lapse.

5.   Procedure

Having determined, after consulting the Committee established by Article 15(1) of the basic Regulation, that sufficient evidence of a likelihood of dumping and injury exists to justify the initiation of an expiry review, the Commission hereby initiates a review in accordance with Article 11(2) of the basic Regulation.

The expiry review will determine whether the expiry of the measures would be likely to lead to a continuation or recurrence of dumping of the product under review originating in the country concerned and a continuation or recurrence of injury to the Union industry.

The Commission also draws the attention of the parties to the published Notice (11) on the consequences of the COVID-19 outbreak on anti-dumping and anti-subsidy investigations that may be applicable to this proceeding.

5.1.    Review investigation period and period considered

The investigation of a continuation or recurrence of dumping will cover the period from 1 October 2020 to 30 September 2021 (‘the review investigation period’). The examination of trends relevant for the assessment of the likelihood of a continuation or recurrence of injury will cover the period from 1 January 2018 to the end of the investigation period (‘the period considered’).

5.2.    Comments on the request and the initiation of the investigation

All interested parties wishing to comment on the request (including matters pertaining to continuation or recurrence of injury and causality) or any aspects regarding the initiation of the investigation (including the degree of support for the request) must do so within 37 days of the date of publication of this Notice in the Official Journal of the European Union (12).

Any request for a hearing with regard to the initiation of the investigation must be submitted within 15 days of the date of publication of this Notice.

5.3.    Procedure for the determination of a likelihood of continuation or recurrence of dumping

In an expiry review, the Commission examines exports that were made to the Union in the review investigation period and, irrespective of exports to the Union, considers whether the situation of the companies producing and selling the product under review in the country concerned is such that exports at dumped prices to the Union would be likely to continue or recur if measures expire.

Therefore, all producers (13) of the product under review from the country concerned, including those that did not cooperate in the investigation leading to the measures in force, are invited to participate in the Commission investigation.

5.3.1.   Investigating producers in the country concerned

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

In order to enable the Commission to decide whether sampling is necessary, and if so, to select a sample, all producers, or representatives acting on their behalf, including the ones who did not cooperate in the investigation leading to the measures subject to the present review, are hereby requested to provide the Commission with information on their companies within 7 days of the date of publication of this Notice. This information must be provided via TRON.tdi at the following address: https://tron.trade.ec.europa.eu/tron/tdi/form/R759_SAMPLING_FORM_FOR_EXPORTING_PRODUCER. Tron access information can be found in sections 5.6 and 5.9 below.

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

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

Once the Commission has received the necessary information to select a sample of producers, it will inform the parties concerned of its decision whether they are included in the sample. The sampled producers will have to submit a completed questionnaire within 30 days from the date of notification of the decision of their inclusion in the sample, unless otherwise specified.

The Commission will add a note to the file for inspection by interested parties reflecting the sample selection. Any comment on the sample selection must be received within 3 days of the date of notification of the sample decision.

A copy of the questionnaire for producers in the country concerned is available in the file for inspection by interested parties and on DG Trade’s Internet: https://trade.ec.europa.eu/tdi/case_details.cfm?id=2575.

Without prejudice to the possible application of Article 18 of the basic Regulation, companies that have agreed to their possible inclusion in the sample but are not selected to be in the sample will be considered to be cooperating.

5.3.2.   Additional procedure with regard to the country concerned that is subject to significant distortions

Subject to the provisions of this Notice, all interested parties are hereby invited to make their views known, submit information and provide supporting evidence regarding the application of Article 2(6a) of the basic Regulation. Unless otherwise specified, this information and supporting evidence must reach the Commission within 37 days of the date of publication of this Notice.

In particular, the Commission invites all interested parties to make their views known on the inputs and the Harmonised System (HS) codes provided in the request, propose (an) appropriate representative country(ies) and provide the identity of producers of the product under investigation in those countries. This information and supporting evidence must reach the Commission within 15 days of the date of publication of this Notice.

Pursuant to point (e) of Article 2(6a) of the basic Regulation, the Commission will, shortly after initiation, by means of a note to the file for inspection by interested parties, inform parties to the investigation about the relevant sources that it intends to use for the purpose of determining normal value in the country concerned pursuant to Article 2(6a) of the basic Regulation. This will cover all sources, including the selection of an appropriate representative third country where appropriate. Parties to the investigation shall be given 10 days from the date at which that note is added to that file to submit comments.

According to the information available to the Commission, a possible representative third country for the country concerned in this case is Brazil. With the aim of finally selecting the appropriate representative third country, the Commission will examine whether there are countries with a similar level of economic development as the country concerned, in which there is production and sales of the product under review and in which relevant data are readily available. Where there is more than one such country, preference will be given, where appropriate, to countries with an adequate level of social and environmental protection.

With regard to the relevant sources, the Commission invites all producers in the country concerned to provide information on the materials (raw and processed) and energy used in the production of the product under review within 15 days of the date of publication of this Notice. This information must be provided via TRON.tdi at the following address: https://tron.trade.ec.europa.eu/tron/tdi/form/R759_INFO_ON_INPUTS_FOR_EXPORTING_PRODUCER_FORM. Tron access information can be found in sections 5.6 and 5.9 below.

Furthermore, any submissions of factual information to value costs and prices pursuant to point (a) of Article 2(6a) of the basic Regulation must be filed within 65 days of the date of publication of this Notice. Such factual information should be taken exclusively from publicly available sources.

In order to obtain the information it deems necessary for its investigation with regard to the alleged significant distortions within the meaning of point (b) of Article 2(6a) of the basic Regulation, the Commission will also make available a questionnaire to the Government of the country concerned.

5.3.3.   Investigating unrelated importers (14) (15)

Unrelated importers of the product under review from the country concerned to the Union, including those that did not cooperate in the investigation leading to the measures in force, are invited to participate in this investigation.

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

In order to enable the Commission to decide whether sampling is necessary and, if so, to select a sample, all unrelated importers, or representatives acting on their behalf, including the ones who did not cooperate in the investigation leading to the measures subject to the present review, are hereby requested to make themselves known to the Commission. These parties must do so within 7 days of the date of publication of this Notice by providing the Commission with the information on their company(ies) requested in Annex to this Notice.

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

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

The Commission will also add a note to the file for inspection by interested parties reflecting the sample selection. Any comment on the sample selection must be received within 3 days of the date of notification of the sample decision.

In order to obtain the information it deems necessary for its investigation, the Commission will make available questionnaires to the sampled unrelated importers. Those parties must submit a completed questionnaire within 30 days from the date of the notification of the sample selection, unless otherwise specified.

A copy of the questionnaire for unrelated importers is available in the file for inspection by interested parties and on DG Trade’s Internet: https://trade.ec.europa.eu/tdi/case_details.cfm?id=2575.

5.4.    Procedure for the determination of a likelihood of a continuation or recurrence of injury

In order to establish whether there is a likelihood of a continuation or recurrence of injury to the Union industry, the Commission invites Union producers of the product under review to participate in the investigation.

5.4.1.   Investigating Union producers

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

The Commission has provisionally selected a sample of Union producers. Details can be found in the file for inspection by interested parties.

Interested parties are hereby invited to comment on the provisional sample. In addition, other Union producers, or representatives acting on their behalf, including Union producers who did not cooperate in the investigation leading to the measures in force, that consider that there are reasons why they should be included in the sample must contact the Commission within 7 days of the date of publication of this Notice. All comments regarding the provisional sample must be received within 7 days of the date of publication of this Notice, unless otherwise specified.

The Commission will notify all known Union producers and/or associations of Union producers of the companies finally selected to be in the sample.

The sampled Union producers will have to submit a completed questionnaire within 30 days from the date of notification of the decision of their inclusion in the sample, unless otherwise specified.

A copy of the questionnaire for Union producers is available in the file for inspection by interested parties and on DG Trade’s Internet: https://trade.ec.europa.eu/tdi/case_details.cfm?id=2575.

5.5.    Procedure for the assessment of Union interest

Should the likelihood of continuation or recurrence of dumping and injury be confirmed, a decision will be reached, pursuant to Article 21 of the basic Regulation, as to whether maintaining the anti-dumping measures would not be against the Union interest.

Union producers, importers and their representative associations, users and their representative associations, trade unions and representative consumer organisations are invited to provide the Commission with information on the Union interest.

Information concerning the assessment of the Union interest must be provided within 37 days of the date of publication of this Notice, unless otherwise specified. This information may be provided either in a free format or by completing a questionnaire prepared by the Commission.

A copy of the questionnaires, including the questionnaire for users of the product under review, is available in the file for inspection by interested parties and on DG Trade’s Internet: https://trade.ec.europa.eu/tdi/case_details.cfm?id=2575. In any case, information submitted pursuant to Article 21 will only be taken into account if supported by factual evidence at the time of submission, which substantiates its validity.

5.6.    Interested parties

In order to participate in the investigation, interested parties, such as producers in the country concerned, Union producers, importers and their representative associations, users and their representative associations, trade unions and representative consumer organisations first have to demonstrate that there is an objective link between their activities and the product under review.

Producers in the country concerned, Union producers, importers and representative associations who made information available in accordance to the procedures described in sections 5.3.1, 5.3.3 and 5.4.1 will be considered as interested parties if there is an objective link between their activities and the product under review.

Other parties will only be able to participate in the investigation as interested party from the moment they make themselves known, and provided that there is an objective link between their activities and the product under review. Being considered as an interested party is without prejudice to the application of Article 18 of the basic Regulation.

Access to the file available for inspection for interested parties is made via Tron.tdi at the following address: https://tron.trade.ec.europa.eu/tron/TDI. Please follow the instructions on that page to get access (16).

5.7.    Other written submissions

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

5.8.    Possibility to be heard by the Commission investigation services

All interested parties may request to be heard by the Commission investigation services. Any request to be heard must be made in writing and must specify the reasons for the request as well as a summary of what the interested party wishes to discuss during the hearing. The hearing will be limited to the issues set out by the interested parties in writing beforehand.

In principle, hearings will not be used to present factual information which is not yet on file. Nevertheless, in the interest of good administration and to enable Commission services to progress with the investigation, interested parties may be directed to provide new factual information after a hearing.

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

Information submitted to the Commission for the purpose of trade defence investigations shall be free from copyrights. Interested parties, before submitting to the Commission information and/or data which is subject to third party copyrights, must request specific permission to the copyright holder explicitly allowing the Commission a) to use the information and data for the purpose of this trade defence proceeding and b) to provide the information and/or data to interested parties to this investigation in a form that allows them to exercise their rights of defence.

All written submissions, including the information requested in this Notice, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested shall be labelled ‘Sensitive’ (17). Parties submitting information in the course of this investigation are invited to reason their request for confidential treatment.

Interested parties providing ‘Sensitive’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of the basic Regulation, which will be labelled ’For inspection by interested parties’. These summaries must be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If a party providing confidential information fails to show good cause for a confidential treatment request or does not furnish a non-confidential summary of it in the requested format and quality, the Commission may disregard such information unless it can be satisfactorily demonstrated from appropriate sources that the information is correct.

Interested parties are invited to make all submissions and requests via TRON.tdi (https://tron.trade.ec.europa.eu/ tron/TDI) including scanned powers of attorney and certification sheets. By using TRON.tdi or email, interested parties express their agreement with the rules applicable to electronic submissions contained in the document ‘CORRESPONDENCE WITH THE EUROPEAN COMMISSION IN TRADE DEFENCE CASES’ published on the website of the Directorate-General for Trade: http://trade.ec.europa.eu/doclib/docs/2011/june/tradoc_148003.pdf. The interested parties must indicate their name, address, telephone and a valid email address and they should ensure that the provided email address is a functioning official business email which is checked on a daily basis. Once contact details are provided, the Commission will communicate with interested parties by TRON.tdi or email only, unless they explicitly request to receive all documents from the Commission by another means of communication or unless the nature of the document to be sent requires the use of a registered mail. For further rules and information concerning correspondence with the Commission including principles that apply to submissions via TRON.tdi and by email, interested parties should consult the communication instructions with interested parties referred to above.

Commission address for correspondence:

European Commission

Directorate-General for Trade

Directorate G

Office: CHAR 04/039

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

TRON. tdi: https://tron.trade.ec.europa.eu/tron/tdi

Email:

For dumping issues: TRADE-R759-ARW-CN-DUMPING@ec.europa.eu

For injury and Union interest issues: TRADE-R759-ARW-CN-INJURY@ec.europa.eu

6.   Schedule of the investigation

The investigation shall normally be concluded within 12 months and in any event no later than 15 months from the date of the publication of this Notice, pursuant to Article 11(5) of the basic Regulation.

7.   Submission of information

As a rule, interested parties may only submit information in the timeframes specified in section 5 of this Notice.

In order to complete the investigation within the mandatory deadlines, the Commission will not accept submissions from interested parties after the deadline to provide comments on the final disclosure or, if applicable, after the deadline to provide comments on the additional final disclosure.

8.   Possibility to comment on other parties’ submissions

In order to guarantee the rights of defence, interested parties should have the possibility to comment on information submitted by other interested parties. When doing so, interested parties may only address issues raised in the other interested parties’ submissions and may not raise new issues.

Comments on the information provided by other interested parties in reaction to the disclosure of the definitive findings should be submitted within 5 days from the deadline to comment on the definitive findings, unless otherwise specified. If there is an additional final disclosure, comments on the information provided by other interested parties in reaction to this further disclosure should be made within 1 day from the deadline to comment on this further disclosure, unless otherwise specified.

The outlined timeframe is without prejudice to the Commission’s right to request additional information from interested parties in duly justified cases.

9.   Extension to time limits specified in this Notice

Extensions to time-limits provided for in this Notice may be granted upon request of interested parties showing due cause.

Any extension to the time limits provided for in this Notice should only be requested in exceptional circumstances and will only be granted if duly justified. In any event, any extensions to the deadline to reply to questionnaires will be limited normally to 3 days, and as a rule will not exceed 7 days. Regarding time limits for the submission of other information specified in the Notice of initiation, extensions will be limited to 3 days unless exceptional circumstances are demonstrated.

10.   Non-cooperation

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

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

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

Failure to give a computerised response shall not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. The interested party should immediately contact the Commission.

11.   Hearing Officer

Interested parties may request the intervention of the Hearing Officer in trade proceedings. The Hearing Officer reviews requests for access to the file, disputes regarding the confidentiality of documents, requests for extension of time limits and any other request concerning the rights of defence of interested parties and third parties as may arise during the proceeding.

The Hearing Officer may organise hearings and mediate between the interested party/-ies and Commissions services to ensure that the interested parties’ rights of defence are being fully exercised. A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. The Hearing Officer will examine the reasons for the requests. These hearings should only take place if the issues have not been settled with the Commission services in due course.

Any request must be submitted in good time and expeditiously so as not to jeopardise the orderly conduct of proceedings. To that effect, interested parties should request the intervention of the Hearing Officer at the earliest possible time following the occurrence of the event justifying such intervention. Where hearing requests are submitted outside the relevant timeframes, the Hearing Officer will also examine the reasons for such late requests, the nature of the issues raised and the impact of those issues on the rights of defence, having due regard to the interests of good administration and the timely completion of the investigation.

For further information and contact details interested parties may consult the Hearing Officer’s web pages on DG Trade’s Internet: http://ec.europa.eu/trade/trade-policy-and-you/contacts/hearing-officer/.

12.   Possibility to request a review under Article 11(3) of the basic Regulation

As this expiry review is initiated in accordance with the provisions of Article 11(2) of the basic Regulation, the findings thereof will not lead to the existing measures being amended but will lead to those measures being repealed or maintained in accordance with Article 11(6) of the basic Regulation.

If any interested party considers that a review of the measures is warranted so as to allow for the possibility to amend the measures, that party may request a review pursuant to Article 11(3) of the basic Regulation.

Parties wishing to request such a review, which would be carried out independently of the expiry review mentioned in this Notice, may contact the Commission at the address given above.

13.   Processing of personal data

Any personal data collected in this investigation will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (18).

A data protection notice that informs all individuals of the processing of personal data in the framework of Commission’s trade defence activities is available on DG Trade’s Internet: http://ec.europa.eu/trade/policy/accessing-markets/trade-defence/


(1)  OJ C 161, 3.5.2021, p.2.

(2)  OJ L 176, 30.6.2016, p. 21.

(3)  Commission Implementing Regulation (EU) 2017/109 of 23 January 2017 imposing a definitive anti-dumping duty on imports of certain aluminium road wheels originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 18, 24.1.2017, p. 1).

(4)  Commission Staff Working Document, on Significant Distortions in the Economy of the People’s Republic of China for the Purposes of Trade Defence Investigations, 20 December 2017, SWD(2017) 483 final/2, available at: https://trade.ec.europa.eu/doclib/docs/2017/december/tradoc_156474.pdf

(5)  https://www.europeanchamber.com.cn/en/publications-overcapacity-in-china

(6)  https://www.oecd-ilibrary.org/trade/measuring-distortions-in-international-markets-the-aluminium-value-chain_c82911ab-en

(7)  Commission implementing Regulation (EU) 2019/915 of 4 June 2019 imposing a definitive anti-dumping duty on imports of certain aluminium foil in rolls originating in the People’s Republic of China following an expiry review under Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 146, 5.6.2019, p. 63).

(8)  Commission implementing Regulation (EU) 2021/546 of 29 March 2021 imposing a definitive anti-dumping duty and definitively collecting the provisional duty imposed on imports of aluminium extrusions originating in the People’s Republic of China (OJ L109, 30.3.2021, p. 1).

(9)  Commission implementing Regulation (EU) 2021/582 of 9 April 2021 imposing a provisional anti-dumping duty on imports of aluminium flat-rolled products originating in the People’s Republic of China (OJ L 124, 12.4.2021, p. 40).

(10)  Documents cited in the country report may also be obtained upon a duly reasoned request.

(11)  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020XC0316%2802%29

(12)  All references to the publication of this Notice will be references to publication of this Notice in the Official Journal of the European Union, unless otherwise specified.

(13)  A producer is any company in the country concerned which produces the product under review, including any of its related companies involved in the production, domestic sales or exports of the product under review.

(14)  Only importers not related to producers in the country(ies) concerned can be sampled. Importers that are related to producers have to fill in Annex I to the questionnaire for these producers. In accordance with Article 127 of Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code, two persons shall be deemed to be related if: (a) they are officers or directors of the other person’s business; (b) they are legally recognised partners in business; (c) they are employer and employee; (d) a third party directly or indirectly owns, controls or holds 5 % or more of the outstanding voting stock or shares of both of them; (e) one of them directly or indirectly controls the other; (f) both of them are directly or indirectly controlled by a third person; (g) together they control a third person directly or indirectly; or (h) they are members of the same family (OJ L 343, 29.12.2015, p. 558). Persons shall be deemed to be members of the same family only if they stand in any of the following relationships to one another: (i) husband and wife, (ii) parent and child, (iii) brother and sister (whether by whole or half blood), (iv) grandparent and grandchild, (v) uncle or aunt and nephew or niece, (vi) parent-in-law and son-in-law or daughter-in-law, (vii) brother-in-law and sister-in-law. In accordance with Article 5(4) of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code, ’’person’’ means a natural person, a legal person, and any association of persons which is not a legal person but which is recognised under Union or national law as having the capacity to perform legal acts (OJ L 269, 10.10.2013, p. 1).

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

(16)  In case of technical problems please contact the Trade Service Desk by Email: trade-service-desk@ec.europa.eu or by Tel. +32 22979797.

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

(18)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).


ANNEX

‘Sensitive’ version

Version ‘For inspection by interested parties’

(tick the appropriate box)

ANTI-DUMPING PROCEEDING CONCERNING IMPORTS OF CERTAIN ALUMINIUM ROAD WHEELS ORIGINATING IN THE PEOPLE’S REPUBLIC OF CHINA

INFORMATION FOR THE SELECTION OF THE SAMPLE OF UNRELATED IMPORTERS

This form is designed to assist unrelated importers in responding to the request for sampling information made in point 5.3.3 of the notice of initiation.

Both the ‘Sensitive’ version and the version ‘For inspection by interested parties’ should be returned to the Commission as set out in the notice of initiation.

1.   IDENTITY AND CONTACT DETAILS

Supply the following details about your company:

Company name

 

Address

 

Contact person

 

E-mail address

 

Telephone

 

2.   TURNOVER AND SALES VOLUME

Indicate the total turnover in euros (EUR) of the company, the value in euros (EUR) and volume in pieces and in tonnes for imports into the Union and resales on the Union market after importation from the People’s Republic of China, during the review investigation period, of the product under review as defined in the notice of initiation.

 

Volume in pieces

Volume in tonnes

Value in euros (EUR)

Total turnover of your company in euros (EUR)

 

 

 

Imports of the product under review originating in the People’s Republic of China into the Union

 

 

 

Imports of the product under review into the Union (all origins)

 

 

 

Resales on the Union market after importation from the People’s Republic of China of the product under review

 

 

 

3.   ACTIVITIES OF YOUR COMPANY AND RELATED COMPANIES (1)

Give details of the precise activities of the company and all related companies (please list them and state the relationship to your company) involved in the production and/or selling (export and/or domestic) of the product under review. Such activities could include but are not limited to purchasing the product under review, producing it under sub-contracting arrangements, or processing or trading it.

Company name and location

Activities

Relationship

 

 

 

 

 

 

 

 

 

4.   OTHER INFORMATION

Please provide any other relevant information which the company considers useful to assist the Commission in the selection of the sample.

5.   CERTIFICATION

By providing the above information, the company agrees to its possible inclusion in the sample. If the company is selected to be part of the sample, this will involve completing a questionnaire and accepting a visit at its premises in order to verify its response. If the company indicates that it does not agree to its possible inclusion in the sample, it will be deemed not to have cooperated in the investigation. The Commission’s findings for non-cooperating importers are based on the facts available and the result may be less favourable to that company than if it had cooperated.

Signature of authorised official:

Name and title of authorised official:

Date:


(1)  In accordance with Article 127 of Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code, two persons shall be deemed to be related if: (a) they are officers or directors of the other person’s business; (b) they are legally recognised partners in business; (c) they are employer and employee; (d) a third party directly or indirectly owns, controls or holds 5 % or more of the outstanding voting stock or shares of both of them; (e) one of them directly or indirectly controls the other; (f) both of them are directly or indirectly controlled by a third person; (g) together they control a third person directly or indirectly; or (h) they are members of the same family (OJ L 343, 29.12.2015, p. 558). Persons shall be deemed to be members of the same family only if they stand in any of the following relationships to one another: (i) husband and wife, (ii) parent and child, (iii) brother and sister (whether by whole or half blood), (iv) grandparent and grandchild, (v) uncle or aunt and nephew or niece, (vi) parent-in-law and son-in-law or daughter-in-law, (vii) brother-in-law and sister-in-law. In accordance with Article 5(4) of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code, ’’person’’ means a natural person, a legal person, and any association of persons which is not a legal person but which is recognised under Union or national law as having the capacity to perform legal acts (OJ L 269, 10.10.2013, p. 1).


PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

20.1.2022   

EN

Official Journal of the European Union

C 29/46


Prior notification of a concentration

(Case M.10564 – APOLLO / MISSGUIDED)

Candidate case for simplified procedure

(Text with EEA relevance)

(2022/C 29/08)

1.   

On 13 January 2022, the Commission received notification of a proposed concentration pursuant to Article 4 and following a referral pursuant to Article 4(5) of Council Regulation (EC) No 139/2004 (1).

This notification concerns the following undertakings:

Alteri Investments II SC (‘Alteri’) (Luxembourg), controlled by Apollo Management L.P. (U.S.A.),

Nakai Investments Limited, (‘Nakai Investments’) (British Virgin Islands), controlled by Mr. Rajib Passi,

Missguided Limited (‘Missguided’) (United Kingdom), controlled by Mr. Rajib Passi.

Alteri and Nakai Investments acquire within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation joint control of Missguided Limited.

The concentration is accomplished by way of purchase of shares in a newly created company constituting a joint venture.

2.   

The business activities of the undertakings concerned are:

for Alteri: Alteri is a subsidiary of Apollo. Apollo manages investments in companies worldwide that are active in a variety of sectors, including oil and gas, retail, and information technology. It also controls Walz Group and CBR Group, which are inter alia active in the design, wholesale and retail of women’s apparel.

for Nakai Investments: Nakai Investments is a company indirectly and wholly held by Mr. Rajib Passi. Mr. Rajib Passi also controls By Design LLC, which is a wholesale clothing fashion group active in the U.S.A.

for Missguided: Missguided is a UK-based online retailer (e-commerce) active worldwide. It is active in both the retail and wholesale supply of clothing, apparel, footwear, and ‘health and beauty’ products. Missguided is currently solely controlled by Mr. Rajib Passi, who owns 100 % of Missguided through R Holding Company Limited (‘R Holding’, British Virgin Islands) and Nakai Investments.

3.   

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

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under 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.   

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

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

M.10564 – APOLLO / MISSGUIDED

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


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

(2)  OJ C 366, 14.12.2013, p. 5.