# Official Journal C 426/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 426 |
| | |
| English edition | Information and Notices | Volume 6421 October 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 426

English edition

Information and Notices

Volume 6421 October 2021

---

| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 426/01 | Commission notice concerning the application of the transitional rules of origin providing for diagonal cumulation between the applying Contracting Parties in the pan-Euro-Mediterranean (PEM) zone | 1 |
| 2021/C 426/02 | Non-opposition to a notified concentration (Case M.10338 – GALILEO/M6/JV) (
  1
  ) | 4 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 426/01

Commission notice concerning the application of the transitional rules of origin providing for diagonal cumulation between the applying Contracting Parties in the pan-Euro-Mediterranean (PEM) zone

1

2021/C 426/02

Non-opposition to a notified concentration (Case M.10338 – GALILEO/M6/JV) (
  1
  )

1

4

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 426/03 | Euro exchange rates — 20 October 2021 | 5 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 426/03

Euro exchange rates — 20 October 2021

5

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| | V   Announcements |
| --- | --- |
| | COURT PROCEEDINGS |
| | EFTA Court |
| 2021/C 426/04 | Judgment of the Court of 15 July 2021 in Case E-14/20 – Liti-Link AG v LGT Bank AG
  (Directive 2004/39/EC – Directive 2006/73/EC – Notion of essential terms – Sufficient disclosure of information to clients – Notion of summary form – Admissibility) | 6 |
| 2021/C 426/05 | Judgment of the court of 15 July 2021 in Case E-7/20 – Criminal Proceedings against M & X AG
  (Directive 2001/83/EC – Directive 2011/62/EU – Medicinal products – Wholesale distribution of medicinal products – Brokering of medicinal products – Freedom of establishment) | 8 |
| 2021/C 426/06 | Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 1 July 2021 in the case of PRA Group Europe AS v Staten v/Skatteetaten (Case E-3/21) | 9 |
| 2021/C 426/07 | Judgment of the Court of 15 July 2021 in Case E-11/20 – Eyjólfur Orri Sverrisson v The Icelandic State
  (Directive 2003/88/EC – Protection of the safety and health of workers – Working time – Travel to a location other than a worker’s fixed or habitual place of attendance – International travel) | 10 |
| 2021/C 426/08 | Judgment of the Court of 15 July 2021 in Case E-9/20 – EFTA Surveillance Authority v the Kingdom of Norway
  (Free movement of workers – Freedom of establishment – Regulation (EU) No 492/2011 – Combined residence and nationality requirement for corporate officers – General manager – Members of the board – Consistency) | 11 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2021/C 426/09 | Prior notification of a concentration (Case M.10500 – PSPIB/ADIC/Local) – Candidate case for simplified procedure (
  1
  ) | 12 |
| 2021/C 426/10 | Prior notification of a concentration (Case M.10516 – Bain Capital/ITP Aero) – Candidate case for simplified procedure (
  1
  ) | 14 |
| 2021/C 426/11 | Prior notification of a concentration (Case M.10466 – Goldman Sachs/Eneos/NIPPO) – Candidate case for simplified procedure (
  1
  ) | 15 |

V   Announcements

COURT PROCEEDINGS

EFTA Court

2021/C 426/04

Judgment of the Court of 15 July 2021 in Case E-14/20 – Liti-Link AG v LGT Bank AG
  (Directive 2004/39/EC – Directive 2006/73/EC – Notion of essential terms – Sufficient disclosure of information to clients – Notion of summary form – Admissibility)

(Directive 2004/39/EC – Directive 2006/73/EC – Notion of essential terms – Sufficient disclosure of information to clients – Notion of summary form – Admissibility)

6

2021/C 426/05

Judgment of the court of 15 July 2021 in Case E-7/20 – Criminal Proceedings against M & X AG
  (Directive 2001/83/EC – Directive 2011/62/EU – Medicinal products – Wholesale distribution of medicinal products – Brokering of medicinal products – Freedom of establishment)

(Directive 2001/83/EC – Directive 2011/62/EU – Medicinal products – Wholesale distribution of medicinal products – Brokering of medicinal products – Freedom of establishment)

8

2021/C 426/06

Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 1 July 2021 in the case of PRA Group Europe AS v Staten v/Skatteetaten (Case E-3/21)

9

2021/C 426/07

Judgment of the Court of 15 July 2021 in Case E-11/20 – Eyjólfur Orri Sverrisson v The Icelandic State
  (Directive 2003/88/EC – Protection of the safety and health of workers – Working time – Travel to a location other than a worker’s fixed or habitual place of attendance – International travel)

(Directive 2003/88/EC – Protection of the safety and health of workers – Working time – Travel to a location other than a worker’s fixed or habitual place of attendance – International travel)

10

2021/C 426/08

Judgment of the Court of 15 July 2021 in Case E-9/20 – EFTA Surveillance Authority v the Kingdom of Norway
  (Free movement of workers – Freedom of establishment – Regulation (EU) No 492/2011 – Combined residence and nationality requirement for corporate officers – General manager – Members of the board – Consistency)

(Free movement of workers – Freedom of establishment – Regulation (EU) No 492/2011 – Combined residence and nationality requirement for corporate officers – General manager – Members of the board – Consistency)

11

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2021/C 426/09

Prior notification of a concentration (Case M.10500 – PSPIB/ADIC/Local) – Candidate case for simplified procedure (
  1
  )

1

12

2021/C 426/10

Prior notification of a concentration (Case M.10516 – Bain Capital/ITP Aero) – Candidate case for simplified procedure (
  1
  )

1

14

2021/C 426/11

Prior notification of a concentration (Case M.10466 – Goldman Sachs/Eneos/NIPPO) – Candidate case for simplified procedure (
  1
  )

1

15

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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

| 21.10.2021 | EN | Official Journal of the European Union | C 426/1 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/1

---

Commission notice concerning the application of the transitional rules of origin providing for diagonal cumulation between the applying Contracting Parties in the pan-Euro-Mediterranean (PEM) zone

(2021/C 426/01)

For the purpose of the application of diagonal cumulation of origin among the applying Contracting Parties (1), the applying Contracting Parties concerned notify each other, through the European Commission, of the origin rules in force with the other applying Contracting Parties.

It is recalled that diagonal cumulation can only be applied if the applying Contracting Parties of final manufacture and of final destination have concluded free trade agreements, containing identical rules of origin, with all the applying Contracting Parties participating in the acquisition of originating status, i.e. with all the applying Contracting Parties from which the materials used originate. Materials originating in an applying Contracting Party which has not concluded an agreement with the applying Contracting Parties of final manufacture and/or of final destination shall be treated as non-originating.

Based on the notifications made by the applying Contracting Parties to the European Commission, the tables attached specify:

| | Table 1 – a simplified overview of cumulation possibilities on 1 September 2021. |
| --- | --- |

Table 1 – a simplified overview of cumulation possibilities on 1 September 2021.

| | Table 2 – the date from which diagonal cumulation becomes applicable. |
| --- | --- |

Table 2 – the date from which diagonal cumulation becomes applicable.

In Table 1, an ‘X’ marks the existence between 2 partners of a free trade agreement containing rules of origin allowing cumulation based on the transitional rules of origin. To use diagonal cumulation with a third partner, an ‘X’ should be present in all the intersection of the table between the 3 partners.

In Table 2, the dates mentioned refer to the date of application of diagonal cumulation on the basis of Article 8 of Appendix A to each protocol on rules of origin between the applying Contracting Parties. In that case the date is preceded by ‘(T)’.

The codes for the applying Contracting Parties listed in the tables are given here below.

| — | European Union |
| --- | --- |

—

European Union

EU

| — | EFTA States: |
| --- | --- |

—

EFTA States:

| — | Iceland |
| --- | --- |

—

Iceland

IS

| — | Switzerland (including Liechtenstein) (2) |
| --- | --- |

—

Switzerland (including Liechtenstein) (2)

CH (+ LI)

| — | Norway |
| --- | --- |

—

Norway

NO

| — | The Faroe Islands |
| --- | --- |

—

The Faroe Islands

FO

| — | The participants in the Barcelona Process: |
| --- | --- |

—

The participants in the Barcelona Process:

| — | Jordan |
| --- | --- |

—

Jordan

JO

| — | Palestine (3) |
| --- | --- |

—

Palestine (3)

PS

| — | The participants in the EU’s Stabilisation and Association Process: |
| --- | --- |

—

The participants in the EU’s Stabilisation and Association Process:

| — | Albania |
| --- | --- |

—

Albania

AL

| — | North Macedonia |
| --- | --- |

—

North Macedonia

MK

| — | Georgia |
| --- | --- |

—

Georgia

GE

Table 1

Simplified overview of diagonal cumulation possibilities under the transitional rules of origin in the pan-Euro-Med zone on 1 September 2021

| | EU | CH (+LI) | IS | NO | FO | JO | PS | AL | MK | GE |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| EU | | X | X | X | X | X | X | X | X | X |
| CH (+LI) | X | | | | | | | | | |
| IS | X | | | | | | | | | |
| NO | X | | | | | | | | | |
| FO | X | | | | | | | | | |
| JO | X | | | | | | | | | |
| PS | X | | | | | | | | | |
| AL | X | | | | | | | | | |
| MK | X | | | | | | | | | |
| GE | X | | | | | | | | | |

EU

CH (+LI)

IS

NO

FO

JO

PS

AL

MK

GE

EU

X

X

X

X

X

X

X

X

X

CH (+LI)

X

IS

X

NO

X

FO

X

JO

X

PS

X

AL

X

MK

X

GE

X

Table 2

Date of application of transitional rules of origin providing for diagonal cumulation in the pan-Euro-Med zone

| | EU | CH (+LI) | IS | NO | FO | JO | PS | AL | MK | GE |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| EU | | (T) 01.09.2021 | (T) 01.09.2021 | (T) 01.09.2021 | (T) 01.09.2021 | (T) 01.09.2021 | (T) 01.09.2021 | (T) 01.09.2021 | (T) 09.09.2021 | (T) 01.09.2021 |
| CH (+LI) | (T) 01.09.2021 | | | | | | | | | |
| IS | (T) 01.09.2021 | | | | | | | | | |
| NO | (T) 01.09.2021 | | | | | | | | | |
| FO | (T) 01.09.2021 | | | | | | | | | |
| JO | (T) 01.09.2021 | | | | | | | | | |
| PS | (T) 01.09.2021 | | | | | | | | | |
| AL | (T) 01.09.2021 | | | | | | | | | |
| MK | (T) 09.09.2021 | | | | | | | | | |
| GE | (T) 01.09.2021 | | | | | | | | | |

EU

CH (+LI)

IS

NO

FO

JO

PS

AL

MK

GE

EU

(T) 01.09.2021

(T) 01.09.2021

(T) 01.09.2021

(T) 01.09.2021

(T) 01.09.2021

(T) 01.09.2021

(T) 01.09.2021

(T) 09.09.2021

(T) 01.09.2021

CH (+LI)

(T) 01.09.2021

IS

(T) 01.09.2021

NO

(T) 01.09.2021

FO

(T) 01.09.2021

JO

(T) 01.09.2021

PS

(T) 01.09.2021

AL

(T) 01.09.2021

MK

(T) 09.09.2021

GE

(T) 01.09.2021

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(1)  ’applying Contracting Party’ means a Contracting Party to the PEM Convention that incorporates the PEM transitional rules of origin in its bilateral preferential trade agreements with another Contracting Party to the PEM Convention.

(2)  Switzerland and the Principality of Liechtenstein form a customs union.

(3)  This designation shall not be construed as recognition of a State of Palestine and is without prejudice to the individual positions of the Member States on this issue.

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/4 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/4

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Non-opposition to a notified concentration

(Case M.10338 – GALILEO/M6/JV)

(Text with EEA relevance)

(2021/C 426/02)

On 14 October 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 French 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 policy’ 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 policy’ 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 32021M10338. EUR-Lex is the online point of access to European Union law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10338. EUR-Lex is the online point of access to European Union law.

---

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

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 21.10.2021 | EN | Official Journal of the European Union | C 426/5 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/5

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Euro exchange rates (1)

20 October 2021

(2021/C 426/03)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1623 |
| JPY | Japanese yen | 132,78 |
| DKK | Danish krone | 7,4404 |
| GBP | Pound sterling | 0,84503 |
| SEK | Swedish krona | 10,0150 |
| CHF | Swiss franc | 1,0739 |
| ISK | Iceland króna | 150,00 |
| NOK | Norwegian krone | 9,7435 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,519 |
| HUF | Hungarian forint | 361,59 |
| PLN | Polish zloty | 4,5850 |
| RON | Romanian leu | 4,9487 |
| TRY | Turkish lira | 10,7821 |
| AUD | Australian dollar | 1,5528 |
| CAD | Canadian dollar | 1,4349 |
| HKD | Hong Kong dollar | 9,0375 |
| NZD | New Zealand dollar | 1,6219 |
| SGD | Singapore dollar | 1,5629 |
| KRW | South Korean won | 1 364,31 |
| ZAR | South African rand | 16,8307 |
| CNY | Chinese yuan renminbi | 7,4302 |
| HRK | Croatian kuna | 7,5092 |
| IDR | Indonesian rupiah | 16 404,06 |
| MYR | Malaysian ringgit | 4,8369 |
| PHP | Philippine peso | 58,972 |
| RUB | Russian rouble | 82,5141 |
| THB | Thai baht | 38,774 |
| BRL | Brazilian real | 6,4830 |
| MXN | Mexican peso | 23,4814 |
| INR | Indian rupee | 87,0086 |

Currency

Exchange rate

USD

US dollar

1,1623

JPY

Japanese yen

132,78

DKK

Danish krone

7,4404

GBP

Pound sterling

0,84503

SEK

Swedish krona

10,0150

CHF

Swiss franc

1,0739

ISK

Iceland króna

150,00

NOK

Norwegian krone

9,7435

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,519

HUF

Hungarian forint

361,59

PLN

Polish zloty

4,5850

RON

Romanian leu

4,9487

TRY

Turkish lira

10,7821

AUD

Australian dollar

1,5528

CAD

Canadian dollar

1,4349

HKD

Hong Kong dollar

9,0375

NZD

New Zealand dollar

1,6219

SGD

Singapore dollar

1,5629

KRW

South Korean won

1 364,31

ZAR

South African rand

16,8307

CNY

Chinese yuan renminbi

7,4302

HRK

Croatian kuna

7,5092

IDR

Indonesian rupiah

16 404,06

MYR

Malaysian ringgit

4,8369

PHP

Philippine peso

58,972

RUB

Russian rouble

82,5141

THB

Thai baht

38,774

BRL

Brazilian real

6,4830

MXN

Mexican peso

23,4814

INR

Indian rupee

87,0086

---

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

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V Announcements

COURT PROCEEDINGS

EFTA Court

| 21.10.2021 | EN | Official Journal of the European Union | C 426/6 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/6

---

JUDGMENT OF THE COURT

of 15 July 2021

in Case E-14/20

Liti-Link AG v LGT Bank AG

(Directive 2004/39/EC – Directive 2006/73/EC – Notion of ‘essential terms’ – Sufficient disclosure of information to clients – Notion of ‘summary form’ – Admissibility)

(2021/C 426/04)

In Case E-14/20, Liti-Link AG v LGT Bank AG – REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by the Supreme Court of the Principality of Liechtenstein (Fürstlicher Oberster Gerichtshof) concerning the interpretation of Commission Directive 2006/73/EC of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive, the Court, composed of Páll Hreinsson, President, Per Christiansen (Judge-Rapporteur) and Bernd Hammermann, Judges, gave judgment on 15 July 2021, the operative part of which is as follows:

| 1. | The final paragraph of Article 26 of Commission Directive 2006/73/EC of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive must be interpreted as meaning that an investment firm may disclose the essential terms of the arrangements relating to the fee, commission or non-monetary benefit in summary form provided that the investment firm has clearly disclosed to the client prior to the provision of an investment or ancillary service that such inducements are paid to or received from a third party; has undertaken to disclose further details at the client’s request; and honours this undertaking.
  Disclosure in accordance with Article 26 in summary form may be made in general or pre-formulated terms and conditions provided that each individual client receives the information related to the specific investment service and that the information gives the client a sufficient basis on which to make informed investment decisions. |
| --- | --- |

1.

The final paragraph of Article 26 of Commission Directive 2006/73/EC of 10 August 2006 implementing Directive 2004/39/EC of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive must be interpreted as meaning that an investment firm may disclose the essential terms of the arrangements relating to the fee, commission or non-monetary benefit in summary form provided that the investment firm has clearly disclosed to the client prior to the provision of an investment or ancillary service that such inducements are paid to or received from a third party; has undertaken to disclose further details at the client’s request; and honours this undertaking.

Disclosure in accordance with Article 26 in summary form may be made in general or pre-formulated terms and conditions provided that each individual client receives the information related to the specific investment service and that the information gives the client a sufficient basis on which to make informed investment decisions.

| 2. | A disclosure in accordance with the final paragraph of Article 26 of Directive 2006/73/EC entails an obligation on the investment firm to indicate clearly whether and when a fee, commission or non-monetary benefit is provided in a manner that is comprehensive, accurate and understandable, prior to the provision of the relevant investment or ancillary service. A generic disclosure which merely refers to the possibility that an investment firm might receive a fee, commission or non-monetary benefit from a third party is not sufficient for the purposes of Article 26 of that directive. |
| --- | --- |

2.

A disclosure in accordance with the final paragraph of Article 26 of Directive 2006/73/EC entails an obligation on the investment firm to indicate clearly whether and when a fee, commission or non-monetary benefit is provided in a manner that is comprehensive, accurate and understandable, prior to the provision of the relevant investment or ancillary service. A generic disclosure which merely refers to the possibility that an investment firm might receive a fee, commission or non-monetary benefit from a third party is not sufficient for the purposes of Article 26 of that directive.

| 3. | If the amount of the fees or commissions cannot be ascertained, a correct disclosure in accordance with point (b)(i) of the first paragraph of Article 26 of Directive 2006/73/EC must place the client in a position to calculate the amount of the fees or commissions provided to the investment firm by a third party so that the client is enabled to make an informed decision on an investment. |
| --- | --- |

3.

If the amount of the fees or commissions cannot be ascertained, a correct disclosure in accordance with point (b)(i) of the first paragraph of Article 26 of Directive 2006/73/EC must place the client in a position to calculate the amount of the fees or commissions provided to the investment firm by a third party so that the client is enabled to make an informed decision on an investment.

| 4. | The conditions laid down in the final paragraph of Article 26 of Directive 2006/73/EC for a disclosure of fees, commissions or non-monetary benefits in summary form are not fulfilled if the investment firm undertakes to disclose to the client further details merely for a period of twelve months preceding the request. |
| --- | --- |

4.

The conditions laid down in the final paragraph of Article 26 of Directive 2006/73/EC for a disclosure of fees, commissions or non-monetary benefits in summary form are not fulfilled if the investment firm undertakes to disclose to the client further details merely for a period of twelve months preceding the request.

| 5. | EEA law does not require any direct effect of EEA law provisions not correctly transposed into national law. The national court is nevertheless obliged, as far as possible, to ensure the result sought by EEA law through the interpretation of national law in conformity with EEA law. |
| --- | --- |

5.

EEA law does not require any direct effect of EEA law provisions not correctly transposed into national law. The national court is nevertheless obliged, as far as possible, to ensure the result sought by EEA law through the interpretation of national law in conformity with EEA law.

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/8 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/8

---

JUDGMENT OF THE COURT

of 15 July 2021

in Case E-7/20

Criminal Proceedings against M & X AG

(Directive 2001/83/EC – Directive 2011/62/EU – Medicinal products – Wholesale distribution of medicinal products – Brokering of medicinal products – Freedom of establishment)

(2021/C 426/05)

In Case E-7/20, Criminal Proceedings against M & X AG – REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by the Princely Court of Appeal (Fürstliches Obergericht) concerning the interpretation of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, the Court, composed of Páll Hreinsson, President, Per Christiansen, and Bernd Hammermann (Judge-Rapporteur), Judges, gave judgment on 15 July 2021, the operative part of which is as follows:

| 1. | The determination of whether a product falls within the definition of a medicinal product in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use must be decided on a case-by-case basis taking into account the factors set out in that provision, such as the product’s presentation or pharmacological, immunological or metabolic properties.
  A product, such as that at issue in the main proceedings, which is intended to be administered intravenously, presented as being in accordance with the formula of a medical practitioner and as alleviating the symptoms of diseases in human beings, constitutes a medicinal product within the meaning of point 2 of Article 1. |
| --- | --- |

1.

The determination of whether a product falls within the definition of a medicinal product in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use must be decided on a case-by-case basis taking into account the factors set out in that provision, such as the product’s presentation or pharmacological, immunological or metabolic properties.

A product, such as that at issue in the main proceedings, which is intended to be administered intravenously, presented as being in accordance with the formula of a medical practitioner and as alleviating the symptoms of diseases in human beings, constitutes a medicinal product within the meaning of point 2 of Article 1.

| 2. | In circumstances, such as those of the main proceedings, where a medicinal product has been sold at the wholesale and/or retail level in EEA States, it must be considered as having been intended to be placed on the market in EEA States for the purposes of Directive 2001/83/EC. |
| --- | --- |

2.

In circumstances, such as those of the main proceedings, where a medicinal product has been sold at the wholesale and/or retail level in EEA States, it must be considered as having been intended to be placed on the market in EEA States for the purposes of Directive 2001/83/EC.

| 3. | A medicinal product is prepared industrially or manufactured by a method involving an industrial process if its preparation or manufacture involves an industrial process characterised, in general, by a succession of operations, which may be mechanical or chemical, in order to obtain a significant quantity of a standardised product. |
| --- | --- |

3.

A medicinal product is prepared industrially or manufactured by a method involving an industrial process if its preparation or manufacture involves an industrial process characterised, in general, by a succession of operations, which may be mechanical or chemical, in order to obtain a significant quantity of a standardised product.

| 4. | A medicinal product that has not been prepared in accordance with the prescriptions of a pharmacopoeia or is not intended to be supplied directly to the patients served by the pharmacy in question cannot benefit from the exception contained in Article 3(2) of Directive 2001/83/EC. |
| --- | --- |

4.

A medicinal product that has not been prepared in accordance with the prescriptions of a pharmacopoeia or is not intended to be supplied directly to the patients served by the pharmacy in question cannot benefit from the exception contained in Article 3(2) of Directive 2001/83/EC.

| 5. | The activity of procuring, supplying and exporting medicinal products, apart from supplying medicinal products to the public, constitutes wholesale distribution of medicinal products within the meaning of point 17 of Article 1 of Directive 2001/83/EC even if a wholesale distributor has not physically handled those products. |
| --- | --- |

5.

The activity of procuring, supplying and exporting medicinal products, apart from supplying medicinal products to the public, constitutes wholesale distribution of medicinal products within the meaning of point 17 of Article 1 of Directive 2001/83/EC even if a wholesale distributor has not physically handled those products.

| 6. | A national measure subjecting an activity constituting ‘wholesale distribution of medicinal products’ within the meaning of point 17 of Article 1 of Directive 2001/83/EC to an authorisation requirement in conformity with Article 77(1) of that directive is compatible with EEA law. |
| --- | --- |

6.

A national measure subjecting an activity constituting ‘wholesale distribution of medicinal products’ within the meaning of point 17 of Article 1 of Directive 2001/83/EC to an authorisation requirement in conformity with Article 77(1) of that directive is compatible with EEA law.

| 7. | The fact that a product is not classified in one EEA State as a medicinal product does not have an influence on whether the competent authorities of another EEA State may classify it as a medicinal product in accordance with Directive 2001/83/EC. |
| --- | --- |

7.

The fact that a product is not classified in one EEA State as a medicinal product does not have an influence on whether the competent authorities of another EEA State may classify it as a medicinal product in accordance with Directive 2001/83/EC.

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/9 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/9

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Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 1 July 2021 in the case of PRA Group Europe AS v Staten v/Skatteetaten

(Case E-3/21)

(2021/C 426/06)

A request has been made to the EFTA Court by a letter dated 1 July 2021 from Oslo tingrett (the Oslo District Court), which was received at the Court Registry on 2 July 2021, for an Advisory Opinion in the case of PRA Group Europe AS v Staten v/Skatteetaten on the following questions:

| 1. | Is there a restriction within the meaning of Article 31 EEA, read in conjunction with Article 34, when group contributions from Norwegian companies increase the maximum deduction for interest and thus the entitlement to deduction of interests on debt to affiliated parties under the limited interest deduction rule, a possibility which, under Norwegian tax rules, is not available for investments by or in EEA companies? |
| --- | --- |

1.

Is there a restriction within the meaning of Article 31 EEA, read in conjunction with Article 34, when group contributions from Norwegian companies increase the maximum deduction for interest and thus the entitlement to deduction of interests on debt to affiliated parties under the limited interest deduction rule, a possibility which, under Norwegian tax rules, is not available for investments by or in EEA companies?

| 2. | Is an EEA company that is in a group with a Norwegian company in a comparable situation to that of a Norwegian company that is in a group with another Norwegian company, and what significance does it have for the comparability assessment that no actual group contribution has been made from the EEA company to the Norwegian company, but rather a loan? |
| --- | --- |

2.

Is an EEA company that is in a group with a Norwegian company in a comparable situation to that of a Norwegian company that is in a group with another Norwegian company, and what significance does it have for the comparability assessment that no actual group contribution has been made from the EEA company to the Norwegian company, but rather a loan?

| 3. | In the event that there is a restriction: Which reasons in the public interest may justify such a restriction? |
| --- | --- |

3.

In the event that there is a restriction: Which reasons in the public interest may justify such a restriction?

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/10 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/10

---

JUDGMENT OF THE COURT

of 15 July 2021

in Case E-11/20

Eyjólfur Orri Sverrisson v The Icelandic State

(Directive 2003/88/EC – Protection of the safety and health of workers – Working time – Travel to a location other than a worker’s fixed or habitual place of attendance – International travel)

(2021/C 426/07)

In Case E-11/20, Eyjólfur Orri Sverrisson v The Icelandic State – REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by Reykjavík District Court (Héraðsdómur Reykjavíkur) concerning the interpretation of Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time, in particular Article 2 (1), the Court, composed of Páll Hreinsson, President, Per Christiansen and Bernd Hammermann (Judge-Rapporteur), Judges, gave judgment on 15 July 2021, the operative part of which is as follows:

| 1. | The necessary time spent travelling, outside normal working hours, by a worker, such as the plaintiff in the main proceedings, to a location other than his fixed or habitual place of attendance in order to carry out his activity or duties in that other location, as required by his employer, constitutes ‘working time’ within the meaning of Article 2(1) of Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time. It is immaterial whether that journey is made entirely within the EEA or to or from third countries if the employment agreement is established under and governed by the national law of an EEA State. |
| --- | --- |

1.

The necessary time spent travelling, outside normal working hours, by a worker, such as the plaintiff in the main proceedings, to a location other than his fixed or habitual place of attendance in order to carry out his activity or duties in that other location, as required by his employer, constitutes ‘working time’ within the meaning of Article 2(1) of Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time. It is immaterial whether that journey is made entirely within the EEA or to or from third countries if the employment agreement is established under and governed by the national law of an EEA State.

| 2. | No assessment of the intensity of the work performed while travelling is required. |
| --- | --- |

2.

No assessment of the intensity of the work performed while travelling is required.

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/11 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/11

---

JUDGMENT OF THE COURT

of 15 July 2021

in Case E-9/20

EFTA Surveillance Authority v the Kingdom of Norway

(Free movement of workers – Freedom of establishment – Regulation (EU) No 492/2011 – Combined residence and nationality requirement for corporate officers – General manager – Members of the board – Consistency)

(2021/C 426/08)

In Case E-9/20, EFTA Surveillance Authority v the Kingdom of Norway –APPLICATION seeking a declaration that, by maintaining in force various nationality and/or residence requirements laid down in Norwegian company law in respect of persons who occupy certain management roles in companies registered and incorporated in Norway, the Kingdom of Norway has failed to fulfil its obligations under Articles 31 and 28 of the Agreement on the European Economic Area, as well as Article 1(1) of Regulation (EU) No 492/2011 of the European Parliament and of the Council of 5 April 2011 on freedom of movement for workers within the Union, the Court, composed of Páll Hreinsson, President, Per Christiansen and Bernd Hammermann (Judge-Rapporteur), Judges, gave judgment on 15 July 2021, the operative part of which is as follows:

| 1. | Declares that, by maintaining in force Sections 6-11(1) and 6-36(2) of the Public Limited Companies Act, Section 6-11(1) of the Private Limited Companies Act and Sections 7-5 and 8-4(5) of the Financial Undertakings Act, the Kingdom of Norway has failed to fulfil its obligations under Article 31 of the EEA Agreement. |
| --- | --- |

1.

Declares that, by maintaining in force Sections 6-11(1) and 6-36(2) of the Public Limited Companies Act, Section 6-11(1) of the Private Limited Companies Act and Sections 7-5 and 8-4(5) of the Financial Undertakings Act, the Kingdom of Norway has failed to fulfil its obligations under Article 31 of the EEA Agreement.

| 2. | Dismisses the application as to the remainder. |
| --- | --- |

2.

Dismisses the application as to the remainder.

| 3. | Orders each party to bear its own costs. |
| --- | --- |

3.

Orders each party to bear its own costs.

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PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 21.10.2021 | EN | Official Journal of the European Union | C 426/12 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/12

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Prior notification of a concentration

(Case M.10500 – PSPIB/ADIC/Local)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 426/09)

1.

This notification concerns the following undertakings:

| — | Public Sector Pension Investment Board (‘PSPIB’, Canada), |
| --- | --- |

—

Public Sector Pension Investment Board (‘PSPIB’, Canada),

| — | Abu Dhabi Investment Council Company P.J.S.C (‘ADIC’, the United Arab Emirates), belonging to Mubadala Investment Company wholly owned by the Government of the Emirate of Abu Dhabi, |
| --- | --- |

—

Abu Dhabi Investment Council Company P.J.S.C (‘ADIC’, the United Arab Emirates), belonging to Mubadala Investment Company wholly owned by the Government of the Emirate of Abu Dhabi,

| — | B2R Local No. 1 Pty Ltd (‘Local’, Australia), a newly created joint venture. |
| --- | --- |

—

B2R Local No. 1 Pty Ltd (‘Local’, Australia), a newly created joint venture.

PSPIB and ADIC acquire within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation joint control of Local.

The concentration is accomplished by way of purchase of shares.

2.

| — | for PSPIB: management of a diversified global portfolio including stocks, bonds and other fixed-income securities, as well as investments in private equity, real estate, infrastructure, natural resources and credit investments. |
| --- | --- |

—

for PSPIB: management of a diversified global portfolio including stocks, bonds and other fixed-income securities, as well as investments in private equity, real estate, infrastructure, natural resources and credit investments.

| — | for ADIC: operation of globally diversified investment strategies targeting positive capital returns through an expansive portfolio of highly diversified asset classes and active investment management strategies, |
| --- | --- |

—

for ADIC: operation of globally diversified investment strategies targeting positive capital returns through an expansive portfolio of highly diversified asset classes and active investment management strategies,

| — | for Local: operation of a specialist build-to-rent property development and management business that includes acquiring, developing, managing and operating residential properties in key Australian cities. |
| --- | --- |

—

for Local: operation of a specialist build-to-rent property development and management business that includes acquiring, developing, managing and operating residential properties in key Australian cities.

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.10500 - PSPIB/ADIC/Local

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

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/14 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/14

---

Prior notification of a concentration

(Case M.10516 – Bain Capital/ITP Aero)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 426/10)

1.

This notification concerns the following undertakings:

| — | Bain Capital Investors L.L.C. (‘Bain Capital’, United States), |
| --- | --- |

—

Bain Capital Investors L.L.C. (‘Bain Capital’, United States),

| — | Industria de Turbo Propulsores, S.A.U (‘ITP’, Spain). |
| --- | --- |

—

Industria de Turbo Propulsores, S.A.U (‘ITP’, Spain).

Bain Capital acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of ITP.

The concentration is accomplished by way of purchase of shares.

2.

| — | For Bain Capital: private equity investment firm, |
| --- | --- |

—

For Bain Capital: private equity investment firm,

| — | For ITP: manufacturing of aircraft engine components and provision of maintenance, repair and overhaul services. |
| --- | --- |

—

For ITP: manufacturing of aircraft engine components and provision of maintenance, repair and overhaul services.

3.

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.

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

M.10516 – Bain Capital/ITP Aero

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

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| 21.10.2021 | EN | Official Journal of the European Union | C 426/15 |
| --- | --- | --- | --- |

21.10.2021

EN

Official Journal of the European Union

C 426/15

---

Prior notification of a concentration

(Case M.10466 – Goldman Sachs/Eneos/NIPPO)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 426/11)

1.

This notification concerns the following undertakings:

| — | The Goldman Sachs Group, Inc. (USA); |
| --- | --- |

—

The Goldman Sachs Group, Inc. (USA);

| — | Eneos Holdings, Inc. (Japan); |
| --- | --- |

—

Eneos Holdings, Inc. (Japan);

| — | NIPPO CORPORATION (Japan). |
| --- | --- |

—

NIPPO CORPORATION (Japan).

The Goldman Sachs Group, Inc. and Eneos Holdings, Inc. acquire within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation joint control over NIPPO CORPORATION.

The concentration is accomplished by way of a public bid announced on 7 September 2021.

2.

| — | for the Goldman Sachs Group, Inc.: global investment banking, securities and investment management, including a range of banking, securities and investment services to corporations, financial institutions, governments and individuals; |
| --- | --- |

—

for the Goldman Sachs Group, Inc.: global investment banking, securities and investment management, including a range of banking, securities and investment services to corporations, financial institutions, governments and individuals;

| — | for Eneos Holdings, Inc.: energy business, oil, metal and gas development; |
| --- | --- |

—

for Eneos Holdings, Inc.: energy business, oil, metal and gas development;

| — | for NIPPO CORPORATION: manufacture and sale of asphalt mixtures and construction. |
| --- | --- |

—

for NIPPO CORPORATION: manufacture and sale of asphalt mixtures and construction.

3.

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.

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

M.10466 — Goldman Sachs/Eneos/NIPPO

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

---