# Official Journal C 305/2018

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 305 |
| | |
| English edition | Information and Notices | Volume 6130 August 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 305

English edition

Information and Notices

Volume 6130 August 2018

---

| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 305/01 | Non-opposition to a notified concentration (Case M.8970 — Sumitomo/Parkwind/Northwester2) (
  1
  ) | 1 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 305/01

Non-opposition to a notified concentration (Case M.8970 — Sumitomo/Parkwind/Northwester2) (
  1
  )

1

1

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 305/03 | Euro exchange rates | 2 |
| 2018/C 305/04 | Explanatory Notes to the Combined Nomenclature of the European Union | 3 |
| 2018/C 305/05 | Explanatory Notes to the Combined Nomenclature of the European Union | 4 |
| 2018/C 305/06 | New national side of euro coins intended for circulation | 6 |
| | European Data Protection Supervisor |
| 2018/C 305/07 | Summary of the opinion on the proposal for a recast of the Public Sector Information (PSI) re-use Directive | 7 |
| | NOTICES FROM MEMBER STATES |
| 2018/C 305/08 | Commission information notice pursuant to Article 16 (4) of Regulation (EC) 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community — Imposition of public service obligations in respect of scheduled air services (
  1
  ) | 10 |
| 2018/C 305/09 | Commission information notice pursuant to Article 16(4) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community — Modification of public service obligations in respect of scheduled air services (
  1
  ) | 11 |
| 2018/C 305/10 | Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community — Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations (
  1
  ) | 12 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | Standing Committee of the EFTA States |
| 2018/C 305/11 | Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the second half of 2017 | 13 |
| 2018/C 305/12 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017 | 15 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 305/03

Euro exchange rates

2

2018/C 305/04

Explanatory Notes to the Combined Nomenclature of the European Union

3

2018/C 305/05

Explanatory Notes to the Combined Nomenclature of the European Union

4

2018/C 305/06

New national side of euro coins intended for circulation

6

European Data Protection Supervisor

2018/C 305/07

Summary of the opinion on the proposal for a recast of the Public Sector Information (PSI) re-use Directive

7

NOTICES FROM MEMBER STATES

2018/C 305/08

Commission information notice pursuant to Article 16 (4) of Regulation (EC) 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community — Imposition of public service obligations in respect of scheduled air services (
  1
  )

1

10

2018/C 305/09

Commission information notice pursuant to Article 16(4) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community — Modification of public service obligations in respect of scheduled air services (
  1
  )

1

11

2018/C 305/10

Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community — Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations (
  1
  )

1

12

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

2018/C 305/11

Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the second half of 2017

13

2018/C 305/12

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017

15

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| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | European Personnel Selection Office (EPSO) |
| 2018/C 305/13 | Notice of open competition | 34 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2018/C 305/14 | Prior notification of a concentration (Case M.9072 — KKR/Altice/SFR Filiale) — Candidate case for simplified procedure (
  1
  ) | 35 |

V   Announcements

ADMINISTRATIVE PROCEDURES

European Personnel Selection Office (EPSO)

2018/C 305/13

Notice of open competition

34

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2018/C 305/14

Prior notification of a concentration (Case M.9072 — KKR/Altice/SFR Filiale) — Candidate case for simplified procedure (
  1
  )

1

35

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

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(1)   Text with EEA relevance.

1

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

EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.8.2018 | EN | Official Journal of the European Union | C 305/1 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/1

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Non-opposition to a notified concentration

(Case M.8970 — Sumitomo/Parkwind/Northwester2)

(Text with EEA relevance)

(2018/C 305/01)

On 30 July 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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

| — | in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8970. EUR-Lex is the online access to European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8970. EUR-Lex is the online access to European 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

| 30.8.2018 | EN | Official Journal of the European Union | C 305/2 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/2

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Euro exchange rates (1)

29 August 2018

(2018/C 305/03)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1660 |
| JPY | Japanese yen | 129,73 |
| DKK | Danish krone | 7,4571 |
| GBP | Pound sterling | 0,90500 |
| SEK | Swedish krona | 10,6923 |
| CHF | Swiss franc | 1,1385 |
| ISK | Iceland króna | 124,90 |
| NOK | Norwegian krone | 9,7475 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,745 |
| HUF | Hungarian forint | 324,63 |
| PLN | Polish zloty | 4,2838 |
| RON | Romanian leu | 4,6417 |
| TRY | Turkish lira | 7,5236 |
| AUD | Australian dollar | 1,5989 |
| CAD | Canadian dollar | 1,5093 |
| HKD | Hong Kong dollar | 9,1524 |
| NZD | New Zealand dollar | 1,7413 |
| SGD | Singapore dollar | 1,5941 |
| KRW | South Korean won | 1 299,27 |
| ZAR | South African rand | 16,8176 |
| CNY | Chinese yuan renminbi | 7,9626 |
| HRK | Croatian kuna | 7,4370 |
| IDR | Indonesian rupiah | 17 087,73 |
| MYR | Malaysian ringgit | 4,8076 |
| PHP | Philippine peso | 62,375 |
| RUB | Russian rouble | 79,4075 |
| THB | Thai baht | 38,140 |
| BRL | Brazilian real | 4,8451 |
| MXN | Mexican peso | 22,3252 |
| INR | Indian rupee | 82,3405 |

Currency

Exchange rate

USD

US dollar

1,1660

JPY

Japanese yen

129,73

DKK

Danish krone

7,4571

GBP

Pound sterling

0,90500

SEK

Swedish krona

10,6923

CHF

Swiss franc

1,1385

ISK

Iceland króna

124,90

NOK

Norwegian krone

9,7475

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,745

HUF

Hungarian forint

324,63

PLN

Polish zloty

4,2838

RON

Romanian leu

4,6417

TRY

Turkish lira

7,5236

AUD

Australian dollar

1,5989

CAD

Canadian dollar

1,5093

HKD

Hong Kong dollar

9,1524

NZD

New Zealand dollar

1,7413

SGD

Singapore dollar

1,5941

KRW

South Korean won

1 299,27

ZAR

South African rand

16,8176

CNY

Chinese yuan renminbi

7,9626

HRK

Croatian kuna

7,4370

IDR

Indonesian rupiah

17 087,73

MYR

Malaysian ringgit

4,8076

PHP

Philippine peso

62,375

RUB

Russian rouble

79,4075

THB

Thai baht

38,140

BRL

Brazilian real

4,8451

MXN

Mexican peso

22,3252

INR

Indian rupee

82,3405

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

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| 30.8.2018 | EN | Official Journal of the European Union | C 305/3 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/3

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Explanatory Notes to the Combined Nomenclature of the European Union

(2018/C 305/04)

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 379

| 9401 | Seats (other than those of heading 9402), whether or not convertible into beds, and parts thereof |
| --- | --- |

9401

Seats (other than those of heading 9402), whether or not convertible into beds, and parts thereof

The following text shall be added after the existing text:

‘For the purposes of this heading, any reference to bamboo applies only to vegetable materials of heading 1401. On the other hand, for the purposes of this heading, any reference to wood or wooden applies also to bamboo plates of heading 4412. (See also note 1(b) and note 6 to Chapter 44).’

| 9403 | Other furniture and parts thereof |
| --- | --- |

9403

9403

Other furniture and parts thereof

Other furniture and parts thereof

The following text shall be added after the existing paragraph:

The following text shall be added after the existing paragraph:

‘The Explanatory Note to heading 9401 regarding the references to “bamboo” and “wood or wooden”, applies mutatis mutandis.’

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(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).

1

(2)  OJ C 76, 4.3.2015, p. 1.

2

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| 30.8.2018 | EN | Official Journal of the European Union | C 305/4 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/4

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Explanatory Notes to the Combined Nomenclature of the European Union

(2018/C 305/05)

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 379

| 9403 | Other furniture and parts thereof |
| --- | --- |

9403

Other furniture and parts thereof

The following text shall be added after the existing text:

‘This heading does not include “information displays” such as “street boards” and “roll-ups”.

They are to be classified in other headings of the Nomenclature under which they are more specifically included (for example, street boards with writing or drawing surfaces corresponding to products of heading 9610) or according to their constituent material:

| (a) | under a heading specifically covering these articles (for example, plates of base metal corresponding to products of heading 8310 are classified under this heading), or |
| --- | --- |

(a)

under a heading specifically covering these articles (for example, plates of base metal corresponding to products of heading 8310 are classified under this heading), or

| (b) | under a heading covering various articles of this material (for example, heading 3926 or heading 7616). |
| --- | --- |

(b)

under a heading covering various articles of this material (for example, heading 3926 or heading 7616).

Example of a street board to be classified in heading 9610:

Street board with a blackboard surface.

Example of a street board to be classified in heading 8310:

Street board made solely of base metal.

Examples of “information displays” which are to be classified according to their constituent material, under a heading covering various articles of this material:

| | |
| --- | --- |
| A base of hard plastics, a top of an aluminium frame with a plastic sheet in the middle covered by transparent PVC foils from both sides. | A base and a frame of aluminium with rubber attachments and transparent PVC foils covering a sheet of paper. |
| Heading 7616 (the essential character is provided by the aluminium frame). | Heading 7616 (the essential character is provided by the aluminium frame). |
| | |
| A central plastic plate attached to five plastic rods (bars) of almost equal length, all of which can be tilted in different directions. Four of them have a plastic hook at the end and a plastic cap is mounted on the fifth rod. | |
| Heading 3926 (the article is made solely of plastics).’ | |

Image

Image

A base of hard plastics, a top of an aluminium frame with a plastic sheet in the middle covered by transparent PVC foils from both sides.

A base and a frame of aluminium with rubber attachments and transparent PVC foils covering a sheet of paper.

Heading 7616 (the essential character is provided by the aluminium frame).

Heading 7616 (the essential character is provided by the aluminium frame).

Image

A central plastic plate attached to five plastic rods (bars) of almost equal length, all of which can be tilted in different directions. Four of them have a plastic hook at the end and a plastic cap is mounted on the fifth rod.

Heading 3926 (the article is made solely of plastics).’

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(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 76, 4.3.2015, p. 1.

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| 30.8.2018 | EN | Official Journal of the European Union | C 305/6 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/6

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New national side of euro coins intended for circulation

(2018/C 305/06)

National side of the new commemorative 2-euro coin intended for circulation and issued by Luxembourg

Euro coins intended for circulation have legal tender status throughout the euro area. For the purpose of informing the public and all parties who handle the coins, the Commission publishes a description of the designs of all new coins (1). In accordance with the Council conclusions of 10 February 2009 (2), euro-area Member States and countries that have concluded a monetary agreement with the European Union providing for the issuing of euro coins are allowed to issue commemorative euro coins intended for circulation, provided that certain conditions are met, particularly that only the 2-euro denomination is used. These coins have the same technical characteristics as other 2-euro coins, but their national face features a commemorative design that is highly symbolic in national or European terms.

Issuing country
  : Luxembourg

Subject of commemoration
  : The 175th anniversary of the death of the Grand Duke Guillaume Ist

Description of the design
  : The design shows on the right hand the effigy of His Royal Highness, the Grand Duke Henri, looking to the left and on the left hand the effigy of HRH the Grand Duke Guillaume Ist. Between both effigies are depicted vertically the year-dates ‘1772-1843’ as well as the name ‘Guillaume Ier’. At the bottom appears the text ‘LUXEMBOURG’ and the year-date ‘2018’.

The coin’s outer ring depicts the 12 stars of the European flag.

Estimated number of coins to be issued
  :

Date of issue
  : September 2018

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(1)  See OJ C 373, 28.12.2001, p. 1 for the national faces of all the coins issued in 2002.

(2)  See the conclusions of the Economic and Financial Affairs Council of 10 February 2009 and the Commission Recommendation of 19 December 2008 on common guidelines for the national sides and the issuance of euro coins intended for circulation (OJ L 9, 14.1.2009, p. 52).

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European Data Protection Supervisor

| 30.8.2018 | EN | Official Journal of the European Union | C 305/7 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/7

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Summary of the opinion on the proposal for a recast of the Public Sector Information (PSI) re-use Directive

(The full text of this Opinion can be found in English, French and German on the EDPS website www.edps.europa.eu)

(2018/C 305/07)

The Public Sector Information (PSI) Directive aims to facilitate the re-use of public sector information throughout the European Union by harmonising the basic conditions that make PSI available to re-users, to enhance the development of Community products and services based on PSI and to avoid distortions in competition.

The new provisions include the extension of the scope of the Directive to documents held by public undertakings active in the areas on procurement such as entities operating in the water, energy, transport and postal services sectors. Moreover, it applies to documents held by public undertakings acting as public services operators, as long as such documents are produced as part of the services in the general interest. In addition, the Proposal's scope will also be extended to specific research data such as results of scientific fact-finding processes.

The Opinion focuses on specific recommendations in order to better clarify the relation and coherence of the PSI Directive with the GDPR exceptions and on the reference to applicable data protection law. Additionally it provides for further recommendations on anonymisation and its relation to costs and data protection, also focusing on a data protection impact assessment, while taking into account an ‘acceptable re-use policy’.

The EDPS with this Opinion on PSI re-use builds on the work already done on the ‘Good Big Data’ (the ‘EU values-based data sharing’), and notably on EDPS opinions and formal comments previously issued, consistently with our practice on supervision cases. Moreover, we point out to the issues that need harmonization at EU level to allow the recast of the PSI Directive to rip the expected benefits.

In the context of Article 1(2)(g) of the Proposal, the EDPS recommends to better clarify the relationship and coherence of the PSI with the GDPR by putting forward a drafting suggestion.

Moreover, the EDPS suggests to re-introduce the specific provision currently contained in Article 1(4) of the Directive 2013/37/EU in the main provisions of the Directive and to clealry state in the Proposal that the definition of ‘personal data’ according to Article 4(1) of the GDPR applies. The EDPS also recommends to add the reference to the Supervisory Authority set up by Article 51 of the GDPR under Article 4(4) of the Proposal.

The EDPS also recommends to support the use of anonymisation by making a reference to ‘anonymous information’ in the legal text and extending the scope of the entities entitled to include anonmysation costs within the costs that can be charged to reusers.

As a last recommendation, the EDPS suggests to provide for data protection impact assessments, for specific sectors dealing with sensitive data, such as the health sector, on which the licensor should base its decision and consequently take into account the conditions for re-use.

1.   INTRODUCTION AND BACKGROUND

| 1. | On 25 April 2018, the Commission adopted a Proposal for a Directive amending Directive 2013/37/EU (following a review of Directive 2003/98/EC) on the re-use of public sector information (PSI) (the ‘Proposal’). The Proposal is part of the ‘2018 Data Package’, which also includes other important documents: (i) a Commission Communication entitled ‘Towards a common European data space’ (the ‘Communication’); (ii) Guidance on sharing private sector data, in the form of a Staff Working Document (‘Guidance’); and (iii) an evaluation of the PSI Directive. |
| --- | --- |

1.

| 2. | The objective of the Proposal is to update and amend the existing text of Directive 2013/37/EU and Directive 2003/98/EC on re-use of public sector information (the PSI Directive). |
| --- | --- |

2.

| 3. | The review of the Directive is one of the three ‘measures’ proposed by the Commission towards a common data space in the EU (see the ‘umbrella’ Communication from the Commission COM (2018) 232, hence ‘the Communication’), together with the Guidance on sharing private sector data [...] and the update of the Recommendation on access to and preservation of scientific information [...]. |
| --- | --- |

3.

| 4. | In proposing to amend the PSI Directive, the European Commission aims to facilitate the re-use of public sector information such as legal, traffic, meteorological, economic and financial data throughout the European Union by harmonising the basic conditions that make PSI available to re-users, to enhance the development of Community products and services based on PSI and to avoid distortions in competition. |
| --- | --- |

4.

| 5. | In particular, the Proposal's overall objective is to be in line with the Digital Single Market Strategy's objectives. The Proposal aims to enhance the effect of the Directive by strengthening specific provisions and modifying them accordingly in order to increase the amount of public sector data available for re-use. Specifically, the initiative also aims to strengthen Small and Medium Enterprises' position in the data market by granting fairer competition and an easier access to markets, together with the enhancement of cross-border innovation. |
| --- | --- |

5.

| 6. | Relevant new provisions to the Directive include the extension of its scope to documents held by public undertakings active in the areas on procurement by entities operating in the water, energy, transport and postal services sectors. Moreover, it applies to documents held by public undertakings acting as public services operators, as long as such documents are produced as part of the services in the general interest. The proposal's scope will also be extended to specific research data such as results of scientific fact-finding processes (i.e. experiments and surveys). The Proposal in practice ‘(...) lays down a horizontal framework providing minimum harmonisation of reuse conditions across domains and sectors.’ (1) |
| --- | --- |

6.

| 7. | The EDPS positively notes that according to the European Commission the recast of the PSI Directive aims to foster the reuse of public sector information, as pointed out in the Communication, by ‘reducing market entry barriers, in particular for small and medium-sized enterprises; minimising the risk of excessive first-mover advantage, which benefits large companies and thereby limits the number of users of the data in question; increasing business opportunities by encouraging the publication of dynamic data and the uptake of application programming interfaces (APIs).’ (2) |
| --- | --- |

7.

| 8. | The PSI directive is part of the EU vision on the fostering of ‘Good Big Data’. Public sector information is a key source of ‘the raw material’ of the Big Data of the Digital Single Market. The smart use of data, including its processing via Artificial Intelligence, can have a transformative effect on all sectors of the economy. |
| --- | --- |

8.

| 9. | Already in September 2016, the EDPS, with the Opinion on coherent enforcement of fundamental rights in the age of big data (3), has put forward a strategy for shaping an EU cyberspace based on EU values, pointing out to issues such as concentration of market and informational power; and a weak market for Privacy Enhancing Technologies (‘PETs’) as measures for minimising personal data processing without losing the functionality of a product or a service (as inspired by the principle of privacy by design (4) and by default). |
| --- | --- |

9.

| 10. | Moreover, the EDPS would like to recall the data protection-relevance of the ‘key principles’ that, according to the European Commission, should be respected in the context of data re-use, namely (i) minimised data lock-in and ensure undistorted competition; (ii) transparency and societal participation on the purpose of the reuse vis-à-vis the citizens/data subjects as well as transparency and clear purpose definition between the licensor and the licensees; (iii) data protection impact assessment and appropriate data protection safeguards for reuse (according to a ‘do no harm’- under the data protection viewpoint- principle). |
| --- | --- |

10.

| 11. | While the EDPS has been informally consulted by the European Commission, it has not been formally consulted as required by Article 28(2) of Regulation (EC) No 45/2001. The Opinion is therefore based on Article 41(2) of the same Regulation. The EDPS recommends that a reference to this Opinion be included in the preamble of the adopted instrument. |
| --- | --- |

11.

7.   CONCLUSION

Therefore the EDPS recommends:

| — | to modify Article 1(2)(g) of the Proposal and to provide for specific wording on the difference between ‘documents’ and ‘parts of documents’ to which the PSI Directive would not be applicable on data protection grounds. |
| --- | --- |

—

to modify Article 1(2)(g) of the Proposal and to provide for specific wording on the difference between ‘documents’ and ‘parts of documents’ to which the PSI Directive would not be applicable on data protection grounds.

| — | to add a reference to the Supervisory Autority set up by Article 51 of the GDPR under Article 4(4) of the Proposal, in order to further enhance the link between the re-use of public sector information and the protection of personal data. |
| --- | --- |

—

to add a reference to the Supervisory Autority set up by Article 51 of the GDPR under Article 4(4) of the Proposal, in order to further enhance the link between the re-use of public sector information and the protection of personal data.

| — | to re-introduce the specific provision on applicable data protection law currently contained in Article 1(4) of Directive 2013/37/EU in the substantive part of the Proposal (including the necessary update of references to the legal instruments currently in force). |
| --- | --- |

—

to re-introduce the specific provision on applicable data protection law currently contained in Article 1(4) of Directive 2013/37/EU in the substantive part of the Proposal (including the necessary update of references to the legal instruments currently in force).

| — | to further point out to the use of anonymisation in the context of the reuse of public sector information by including a reference to ‘anonymous information’ in the legal text and extending the scope of the entities entitled to include anonmysation costs within the costs that can be charged to reusers. |
| --- | --- |

—

to further point out to the use of anonymisation in the context of the reuse of public sector information by including a reference to ‘anonymous information’ in the legal text and extending the scope of the entities entitled to include anonmysation costs within the costs that can be charged to reusers.

| — | to clearly state in the Proposal that the definition of ‘personal data’ according to Article 4(1) of the GDPR applies. |
| --- | --- |

—

to clearly state in the Proposal that the definition of ‘personal data’ according to Article 4(1) of the GDPR applies.

| — | to provide for data protection impact assessments, for specific sectors dealing with sensitive data, such as the health sector, on which the licensor should base its decision and consequently take into account the conditions for re-use. |
| --- | --- |

—

to provide for data protection impact assessments, for specific sectors dealing with sensitive data, such as the health sector, on which the licensor should base its decision and consequently take into account the conditions for re-use.

| — | As a last comment, in putting forward these recommendations, the EDPS stresses the data protection-relevance of the following ‘key principles’, that according to the Commission should be respected in the context of data re-use, namely:






  (i) | Minimised data lock-in and ensure undistorted competition; |
| --- | --- | --- |

—

As a last comment, in putting forward these recommendations, the EDPS stresses the data protection-relevance of the following ‘key principles’, that according to the Commission should be respected in the context of data re-use, namely:

(i)

Minimised data lock-in and ensure undistorted competition;

| (ii) | Transparency and societal participation on the purpose of the reuse vis-à-vis the citizens/data subjects as well as transparency and clear purpose definition between the licensor and the licensees; |
| --- | --- |

(ii)

Transparency and societal participation on the purpose of the reuse vis-à-vis the citizens/data subjects as well as transparency and clear purpose definition between the licensor and the licensees;

| (iii) | Data protection impact assessment and appropriate data protection safeguards for reuse (according to a ‘do no harm’ -under the data protection viewpoint- principle). |
| --- | --- |

(iii)

Data protection impact assessment and appropriate data protection safeguards for reuse (according to a ‘do no harm’ -under the data protection viewpoint- principle).

Brussels, 10 July 2018.

Giovanni BUTTARELLI

European Data Protection Supervisor

---

(1)  Explanatory memorandum to the Proposal for a Directive of the European Parliament and the Council on the re-use of public sector information (recast), p. 3.

1

(2)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Towards a common European data space’, p. 5

2

(3)  https://edps.europa.eu/sites/edp/files/publication/16-09-23_bigdata_opinion_en.pdf, on re-use, p. 9.

3

(4)  European Data Protection Supervisor Opinion 05/2018-Preliminary Opinion on Privacy by Design

4

---

NOTICES FROM MEMBER STATES

| 30.8.2018 | EN | Official Journal of the European Union | C 305/10 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/10

---

Commission information notice pursuant to Article 16 (4) of Regulation (EC) 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

Imposition of public service obligations in respect of scheduled air services

(Text with EEA relevance)

(2018/C 305/08)

| Member State | Portugal |
| --- | --- |
| Route concerned | Bragança - Vila Real – Viseu – Cascais – Portimão – Cascais – Viseu – Vila Real - Bragança |
| Date of entry into force of the public service obligations | As from 23 December 2018 |
| Address where the text and any relevant information and/or documentation relating to the public service obligations can be obtained | All documents are available at: http://www.saphety.com
  For more information, please contact:





  Ministry of Planning and Infrastructure |
| Office of the Secretary of State for Infrastructure |
| Av. Barbosa do Bocage n.o 5 – 2.o andar |
| 1049-039 Lisboa |
| PORTUGAL |
| Email: gab.infraestruturas@mpi.gov.pt |

Member State

Portugal

Route concerned

Bragança - Vila Real – Viseu – Cascais – Portimão – Cascais – Viseu – Vila Real - Bragança

Date of entry into force of the public service obligations

As from 23 December 2018

Address where the text and any relevant information and/or documentation relating to the public service obligations can be obtained

All documents are available at: http://www.saphety.com

For more information, please contact:

Ministry of Planning and Infrastructure

Office of the Secretary of State for Infrastructure

Av. Barbosa do Bocage n.o 5 – 2.o andar

1049-039 Lisboa

PORTUGAL

Email: gab.infraestruturas@mpi.gov.pt

---

| 30.8.2018 | EN | Official Journal of the European Union | C 305/11 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/11

---

Commission information notice pursuant to Article 16(4) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

Modification of public service obligations in respect of scheduled air services

(Text with EEA relevance)

(2018/C 305/09)

| Member State | United Kingdom |
| --- | --- |
| Route concerned | Oban – Coll
  Oban – Colonsay
  Oban – Tiree
  Coll – Tiree |
| Original date of entry into force of the public service obligations | 2 March 2007 |
| Date of entry into force of modifications | 16 May 2019 |
| Address where the text and any relevant information and/or documentation relating to the public service obligation can be obtained | All documents will be available from:
  http://www.publiccontractsscotland.gov.uk
  For further information please contact:





  Argyll and Bute Council |
| Council Offices |
| Kilmory |
| Lochgiphead |
| Argyll and Bute Council |
| PA31 8RT |
| Scotland |
| UNITED KINGDOM |
| Tel. +44 1546604239 |
| Contact: Christine Todd |
| Email: Christine.Todd@argyll-bute.gov.uk |

Member State

United Kingdom

Route concerned

Oban – Coll

Oban – Colonsay

Oban – Tiree

Coll – Tiree

Original date of entry into force of the public service obligations

2 March 2007

Date of entry into force of modifications

16 May 2019

Address where the text and any relevant information and/or documentation relating to the public service obligation can be obtained

All documents will be available from:

http://www.publiccontractsscotland.gov.uk

For further information please contact:

Argyll and Bute Council

Council Offices

Kilmory

Lochgiphead

Argyll and Bute Council

PA31 8RT

Scotland

UNITED KINGDOM

Tel. +44 1546604239

Contact: Christine Todd

Email: Christine.Todd@argyll-bute.gov.uk

---

| 30.8.2018 | EN | Official Journal of the European Union | C 305/12 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/12

---

Commission information notice pursuant to Article 17(5) of Regulation (EC) No 1008/2008 of the European Parliament and of the Council on common rules for the operation of air services in the Community

Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations

(Text with EEA relevance)

(2018/C 305/10)

| Member State | United Kingdom |
| --- | --- |
| Route concerned | Oban – Coll
  Oban – Colonsay
  Oban – Tiree
  Coll – Tiree |
| Period of validity of the contract | 16 May 2019-15 May 2022 |
| Deadline for submission of applications and tenders | 19 November 2018 |
| Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained | All documents will be available from:
  http://www.publiccontractsscotland.gov.uk
  For further information please contact:





  Argyll and Bute Council |
| Council Offices |
| Kilmory |
| Lochgiphead |
| Argyll and Bute Council |
| PA31 8RT |
| Scotland |
| UNITED KINGDOM |
| Tel. +44 1546604239 |
| Contact: Christine Todd |
| Email: Christine.Todd@argyll-bute.gov.uk |

Member State

United Kingdom

Route concerned

Oban – Coll

Oban – Colonsay

Oban – Tiree

Coll – Tiree

Period of validity of the contract

16 May 2019-15 May 2022

Deadline for submission of applications and tenders

19 November 2018

Address from which the text of the invitation to tender and any relevant information and/or documentation relating to the public tender and the public service obligation can be obtained

All documents will be available from:

http://www.publiccontractsscotland.gov.uk

For further information please contact:

Argyll and Bute Council

Council Offices

Kilmory

Lochgiphead

Argyll and Bute Council

PA31 8RT

Scotland

UNITED KINGDOM

Tel. +44 1546604239

Contact: Christine Todd

Email: Christine.Todd@argyll-bute.gov.uk

---

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

Standing Committee of the EFTA States

| 30.8.2018 | EN | Official Journal of the European Union | C 305/13 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/13

---

Dangerous substances — List of authorisation decisions taken by the EEA EFTA States in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) in the second half of 2017

(2018/C 305/11)

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 July – 31 December 2017, at their meeting on 27 April 2018.

---

ANNEX

List of authorisation decisions

The following authorisation decisions in accordance with Article 64(8) of Regulation (EC) No 1907/2006 (REACH) have been taken in the EEA EFTA States during the period 1 July – 31 December 2017:

| Substance name | Commission decision under Article 64(8) of Regulation (EC) No 1907/2006 | Country | Date of decision |
| --- | --- | --- | --- |
| Ammonium dichromate | C(2017) 3237 | Iceland | 7.7.2017 |
| Sodium dichromate | C(2017) 3453 | Iceland | 7.7.2017 |
| Sodium dichromate | C(2017) 3764 | Iceland | 7.7.2017 |
| Sodium dichromate | C(2017) 3765 | Iceland | 7.7.2017 |
| Sodium dichromate | C(2017) 3801 | Iceland | 7.7.2017 |
| Sodium dichromate | C(2017) 3806 | Iceland | 7.7.2017 |
| Sodium dichromate | C(2017) 3816 | Iceland | 7.7.2017 |
| 1,2-dichloroethane | C(2017) 3821 | Iceland | 7.7.2017 |
| Potassium dichromate | C(2017) 3910 | Iceland | 7.7.2017 |
| Chromium trioxide and dichromium tris(chromate) | C(2017) 5001 | Iceland | 5.10.2017 |
| Chromium trioxide and dichromium tris(chromate) | C(2017) 5001 | Liechtenstein | 4.9.2017 |
| Chromium trioxide and dichromium tris(chromate) | C(2017) 5001 | Norway | 18.8.2017 |
| Bis(2-methoxyethyl)ether (diglyme) | C(2017) 5025 | Iceland | 5.10.2017 |
| Bis(2-methoxyethyl)ether (diglyme) | C(2017) 5025 | Liechtenstein | 4.9.2017 |
| Bis(2-methoxyethyl)ether (diglyme) | C(2017) 5025 | Norway | 18.8.2017 |
| Lead chromate | C(2017) 5012 | Iceland | 5.10.2017 |
| Lead chromate | C(2017) 5012 | Liechtenstein | 4.9.2017 |
| Lead chromate | C(2017) 5012 | Norway | 18.8.2017 |
| Chromium trioxide | C(2017) 5880 | Iceland | 5.10.2017 |
| Chromium trioxide | C(2017) 5880 | Liechtenstein | 20.9.2017 |
| Chromium trioxide | C(2017) 5880 | Norway | 25.9.2017 |
| Chromium trioxide | C(2017) 6727 | Iceland | 9.11.2017 |
| Chromium trioxide | C(2017) 6727 | Liechtenstein | 25.10.2017 |
| Chromium trioxide | C(2017) 6727 | Norway | 8.11.2017 |

Substance name

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

Country

Date of decision

Ammonium dichromate

C(2017) 3237

Iceland

7.7.2017

Sodium dichromate

C(2017) 3453

Iceland

7.7.2017

Sodium dichromate

C(2017) 3764

Iceland

7.7.2017

Sodium dichromate

C(2017) 3765

Iceland

7.7.2017

Sodium dichromate

C(2017) 3801

Iceland

7.7.2017

Sodium dichromate

C(2017) 3806

Iceland

7.7.2017

Sodium dichromate

C(2017) 3816

Iceland

7.7.2017

1,2-dichloroethane

C(2017) 3821

Iceland

7.7.2017

Potassium dichromate

C(2017) 3910

Iceland

7.7.2017

Chromium trioxide and dichromium tris(chromate)

C(2017) 5001

Iceland

5.10.2017

Chromium trioxide and dichromium tris(chromate)

C(2017) 5001

Liechtenstein

4.9.2017

Chromium trioxide and dichromium tris(chromate)

C(2017) 5001

Norway

18.8.2017

Bis(2-methoxyethyl)ether (diglyme)

C(2017) 5025

Iceland

5.10.2017

Bis(2-methoxyethyl)ether (diglyme)

C(2017) 5025

Liechtenstein

4.9.2017

Bis(2-methoxyethyl)ether (diglyme)

C(2017) 5025

Norway

18.8.2017

Lead chromate

C(2017) 5012

Iceland

5.10.2017

Lead chromate

C(2017) 5012

Liechtenstein

4.9.2017

Lead chromate

C(2017) 5012

Norway

18.8.2017

Chromium trioxide

C(2017) 5880

Iceland

5.10.2017

Chromium trioxide

C(2017) 5880

Liechtenstein

20.9.2017

Chromium trioxide

C(2017) 5880

Norway

25.9.2017

Chromium trioxide

C(2017) 6727

Iceland

9.11.2017

Chromium trioxide

C(2017) 6727

Liechtenstein

25.10.2017

Chromium trioxide

C(2017) 6727

Norway

8.11.2017

---

| 30.8.2018 | EN | Official Journal of the European Union | C 305/15 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/15

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2017

(2018/C 305/12)

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 July-31 December 2017, at their meeting on 23 March 2018:

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

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations

Annex V

List of suspended marketing authorisations

---

ANNEX I

List of new marketing authorisations

The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July-31 December 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/02/226 | InductOs | Iceland | 18.8.2017 |
| EU/1/15/999 | Zykadia (Switch to non-conditional) | Liechtenstein | 31.8.2017 |
| EU/1/16/1138 | Venclyxto | Liechtenstein | 31.12.2017 |
| EU/1/16/1155 | Kyntheum | Iceland | 16.8.2017 |
| EU/1/16/1155 | Kyntheum | Liechtenstein | 31.8.2017 |
| EU/1/16/1155 | Kyntheum | Norway | 14.8.2017 |
| EU/1/17/1179 | Veltassa | Iceland | 11.8.2017 |
| EU/1/17/1179 | Veltassa | Liechtenstein | 31.8.2017 |
| EU/1/17/1179 | Veltassa | Norway | 9.8.2017 |
| EU/1/17/1181 | Spherox | Iceland | 24.7.2017 |
| EU/1/17/1181 | Spherox | Liechtenstein | 31.8.2017 |
| EU/1/17/1181 | Spherox | Norway | 13.9.2017 |
| EU/1/17/1184 | Riximyo | Iceland | 11.7.2017 |
| EU/1/17/1185 | Rixathon | Iceland | 11.7.2017 |
| EU/1/17/1191 | Dinutuximab beta Apeiron | Liechtenstein | 31.8.2017 |
| EU/1/17/1194 | Febuxostat Mylan | Iceland | 11.7.2017 |
| EU/1/17/1195 | Erelzi | Iceland | 14.7.2017 |
| EU/1/17/1195 | Erelzi | Norway | 7.7.2017 |
| EU/1/17/1196 | Kevzara | Iceland | 14.7.2017 |
| EU/1/17/1196 | Kevzara | Norway | 5.7.2017 |
| EU/1/17/1197 | Oxervate | Iceland | 24.7.2017 |
| EU/1/17/1197 | OXERVATE | Liechtenstein | 31.8.2017 |
| EU/1/17/1197 | OXERVATE | Norway | 17.7.2017 |
| EU/1/17/1199 | Cuprior | Iceland | 13.9.2017 |
| EU/1/17/1199 | Cuprior | Liechtenstein | 31.10.2017 |
| EU/1/17/1199 | Cuprior | Norway | 13.9.2017 |
| EU/1/17/1200 | Besponsa | Iceland | 24.7.2017 |
| EU/1/17/1200 | Besponsa | Liechtenstein | 31.8.2017 |
| EU/1/17/1200 | Besponsa | Norway | 13.7.2017 |
| EU/1/17/1201 | Skilarence | Iceland | 14.7.2017 |
| EU/1/17/1201 | Skilarence | Norway | 7.7.2017 |
| EU/1/17/1202 | Ucedane | Iceland | 12.7.2017 |
| EU/1/17/1202 | Ucedane | Norway | 5.7.2017 |
| EU/1/17/1203 | Insulin lispro Sanofi | Iceland | 11.8.2017 |
| EU/1/17/1203 | Insulin Lispro Sanofi | Liechtenstein | 31.8.2017 |
| EU/1/17/1203 | Insulin lispro Sanofi | Norway | 18.8.2017 |
| EU/1/17/1205 | Blitzima | Iceland | 9.8.2017 |
| EU/1/17/1205 | Blitzima | Liechtenstein | 31.8.2017 |
| EU/1/17/1205 | Blitzima | Norway | 1.8.2017 |
| EU/1/17/1206 | Tuxella | Iceland | 9.8.2017 |
| EU/1/17/1206 | Tuxella | Liechtenstein | 31.8.2017 |
| EU/1/17/1206 | Tuxella | Norway | 1.8.2017 |
| EU/1/17/1207 | Ritemvia | Liechtenstein | 31.8.2017 |
| EU/1/17/1207 | Ritemvia | Iceland | 10.8.2017 |
| EU/1/17/1207 | Ritemvia | Norway | 1.8.2017 |
| EU/1/17/1208 | Trimbow | Iceland | 11.8.2017 |
| EU/1/17/1208 | Trimbow | Liechtenstein | 31.8.2017 |
| EU/1/17/1208 | Trimbow | Norway | 9.8.2017 |
| EU/1/17/1209 | Reagila | Iceland | 9.8.2017 |
| EU/1/17/1209 | Reagila | Liechtenstein | 31.8.2017 |
| EU/1/17/1209 | Reaglia | Norway | 9.8.2017 |
| EU/1/17/1210 | Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva | Norway | 8.8.2017 |
| EU/1/17/1210 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Iceland | 10.8.2017 |
| EU/1/17/1210 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Liechtenstein | 31.8.2017 |
| EU/1/17/1211 | Entecavir Accord | Iceland | 5.10.2017 |
| EU/1/17/1211 | Entecavir Accord | Liechtenstein | 31.10.2017 |
| EU/1/17/1211 | Entecavir Accord | Norway | 20.10.2017 |
| EU/1/17/1212 | Mavenclad | Iceland | 13.9.2017 |
| EU/1/17/1212 | MAVENCLAD | Norway | 30.8.2017 |
| EU/1/17/1212 | MAVENCLAD | Liechtenstein | 31.8.2017 |
| EU/1/17/1213 | Maviret | Iceland | 17.8.2017 |
| EU/1/17/1213 | Maviret | Liechtenstein | 31.8.2017 |
| EU/1/17/1213 | Maviret | Norway | 7.8.2017 |
| EU/1/17/1214 | Bavencio | Iceland | 4.10.2017 |
| EU/1/17/1214 | Bavencio | Liechtenstein | 31.10.2017 |
| EU/1/17/1214 | Bavencio | Norway | 25.9.2017 |
| EU/1/17/1215 | Fotivda | Iceland | 13.9.2017 |
| EU/1/17/1215 | Fotivda | Liechtenstein | 31.8.2017 |
| EU/1/17/1215 | Fotivda | Norway | 31.8.2017 |
| EU/1/17/1216 | Imraldi | Iceland | 12.9.2017 |
| EU/1/17/1216 | Imraldi | Liechtenstein | 31.8.2017 |
| EU/1/17/1216 | Imraldi | Norway | 11.9.2017 |
| EU/1/17/1217 | Nitisinone MendeliKABS | Iceland | 19.9.2017 |
| EU/1/17/1217 | Nitisinone MendeliKABS | Liechtenstein | 31.8.2017 |
| EU/1/17/1217 | Nitisinone MendeliKABS | Norway | 1.9.2017 |
| EU/1/17/1218 | Rydapt | Iceland | 4.10.2017 |
| EU/1/17/1218 | Rydapt | Liechtenstein | 31.10.2017 |
| EU/1/17/1218 | Rydapt | Norway | 25.9.2017 |
| EU/1/17/1220 | Tecentriq | Liechtenstein | 31.10.2017 |
| EU/1/17/1220 | Tecentriq | Norway | 27.9.2017 |
| EU/1/17/1220 | Tecentriq | Iceland | 5.10.2017 |
| EU/1/17/1221 | Kisqali | Iceland | 12.9.2017 |
| EU/1/17/1221 | Kisqali | Norway | 30.8.2017 |
| EU/1/17/1221 | Kisqali | Liechtenstein | 31.8.2017 |
| EU/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Iceland | 8.11.2017 |
| EU/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Liechtenstein | 31.10.2017 |
| EU/1/17/1222 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Norway | 27.9.2017 |
| EU/1/17/1223 | Vosevi | Iceland | 16.8.2017 |
| EU/1/17/1223 | Vosevi | Liechtenstein | 31.8.2017 |
| EU/1/17/1223 | Vosevi | Norway | 8.8.2017 |
| EU/1/17/1224 | Xermelo | Iceland | 4.10.2017 |
| EU/1/17/1224 | Xermelo | Liechtenstein | 31.10.2017 |
| EU/1/17/1224 | Xermelo | Norway | 3.10.2017 |
| EU/1/17/1225 | Symtuza | Iceland | 5.10.2017 |
| EU/1/17/1225 | Symtuza | Liechtenstein | 31.10.2017 |
| EU/1/17/1225 | Symtuza | Norway | 11.10.2017 |
| EU/1/17/1226 | Lutathera | Iceland | 10.10.2017 |
| EU/1/17/1226 | Lutathera | Liechtenstein | 31.10.2017 |
| EU/1/17/1226 | Lutathera | Norway | 3.10.2017 |
| EU/1/17/1227 | Entecavir Mylan | Iceland | 4.10.2017 |
| EU/1/17/1227 | Entecavir Mylan | Liechtenstein | 31.10.2017 |
| EU/1/17/1227 | Entecavir Mylan | Norway | 27.9.2017 |
| EU/1/17/1228 | Tookad | Iceland | 29.11.2017 |
| EU/1/17/1228 | TOOKAD | Liechtenstein | 31.12.2017 |
| EU/1/17/1228 | TOOKAD | Norway | 22.11.2017 |
| EU/1/17/1229 | Dupixent | Iceland | 10.10.2017 |
| EU/1/17/1229 | Dupixent | Liechtenstein | 31.10.2017 |
| EU/1/17/1229 | Dupixent | Norway | 10.10.2017 |
| EU/1/17/1230 | Lacosamide Accord | Iceland | 5.10.2017 |
| EU/1/17/1230 | Lacosamide Accord | Liechtenstein | 31.10.2017 |
| EU/1/17/1230 | Lacosamide Accord | Norway | 27.9.2017 |
| EU/1/17/1232 | Miglustat Gen.Orph | Iceland | 30.11.2017 |
| EU/1/17/1232 | Miglustat Gen.Orph | Liechtenstein | 31.12.2017 |
| EU/1/17/1232 | Miglustat Gen.Orph | Norway | 27.11.2017 |
| EU/1/17/1233 | Zubsolv | Iceland | 29.11.2017 |
| EU/1/17/1233 | Zubsolv | Liechtenstein | 31.12.2017 |
| EU/1/17/1233 | Zubsolv | Norway | 22.11.2017 |
| EU/1/17/1234 | Tremfya | Iceland | 4.12.2017 |
| EU/1/17/1235 | Zejula | Iceland | 4.12.2017 |
| EU/1/17/1235 | Zejula | Liechtenstein | 31.12.2017 |
| EU/1/17/1235 | Zejula | Norway | 27.11.2017 |
| EU/1/17/1236 | Trelegy Ellipta | Iceland | 30.11.2017 |
| EU/1/17/1236 | Trelegy Ellipta | Liechtenstein | 31.12.2017 |
| EU/1/17/1236 | Trelegy Ellipta | Norway | 22.11.2017 |
| EU/1/17/1237 | Elebrato Ellipta | Iceland | 30.11.2017 |
| EU/1/17/1237 | Elebrato Ellipta | Liechtenstein | 31.12.2017 |
| EU/1/17/1237 | Elebrato Ellipta | Norway | 27.11.2017 |
| EU/1/17/1238 | Nyxoid | Iceland | 29.11.2017 |
| EU/1/17/1238 | Nyxoid | Liechtenstein | 31.12.2017 |
| EU/1/17/1238 | Nyxoid | Norway | 27.11.2017 |
| EU/1/17/1239 | VeraSeal | Iceland | 30.11.2017 |
| EU/1/17/1239 | VeraSeal | Liechtenstein | 31.12.2017 |
| EU/1/17/1239 | VeraSeal | Norway | 1.12.2017 |
| EU/1/17/1240 | Cyltezo | Iceland | 29.11.2017 |
| EU/1/17/1240 | Cyltezo | Liechtenstein | 31.12.2017 |
| EU/1/17/1240 | Cyltezo | Norway | 1.12.2017 |
| EU/1/17/1241 | Ontruzant | Iceland | 30.11.2017 |
| EU/1/17/1241 | Ontruzant | Liechtenstein | 31.12.2017 |
| EU/1/17/1241 | Ontruzant | Norway | 27.11.2017 |
| EU/1/17/1242 | Ritonavir Mylan | Iceland | 29.11.2017 |
| EU/1/17/1242 | Ritonavir Mylan | Liechtenstein | 31.12.2017 |
| EU/1/17/1242 | Ritonavir Mylan | Norway | 22.11.2017 |
| EU/1/17/1243 | Imatinib Teva B.V. | Iceland | 30.11.2017 |
| EU/1/17/1243 | Imatinib Teva B.V. | Liechtenstein | 31.12.2017 |
| EU/1/17/1243 | Imatinib Teva B.V. | Norway | 22.11.2017 |
| EU/1/17/1244 | Tacforius | Liechtenstein | 31.12.2017 |
| EU/2/16/197 | CLYNAV | Iceland | 13.7.2017 |
| EU/2/16/197 | CLYNAV | Liechtenstein | 31.8.2017 |
| EU/2/16/197 | CLYNAV | Norway | 18.7.2017 |
| EU/2/17/211 | Prevomax | Iceland | 13.7.2017 |
| EU/2/17/211 | Prevomax | Norway | 6.7.2017 |
| EU/2/17/212 | Exzolt | Iceland | 30.8.2017 |
| EU/2/17/212 | Exzolt | Liechtenstein | 31.10.2017 |
| EU/2/17/212 | Exzolt | Norway | 15.9.2017 |
| EU/2/17/213 | Innovax-ND-IBD | Iceland | 11.9.2017 |
| EU/2/17/213 | Innovax-ND-IBD | Norway | 18.9.2017 |
| EU/2/17/214 | VEPURED | Iceland | 12.9.2017 |
| EU/2/17/214 | VEPURED | Norway | 15.9.2017 |
| EU/2/17/215 | Suvaxyn PRRS MLV | Iceland | 11.9.2017 |
| EU/2/17/215 | Suvaxyn PRRS MLV | Liechtenstein | 31.10.2017 |
| EU/2/17/215 | Suvaxyn PRRS MLV | Norway | 18.9.2017 |
| EU/2/17/217 | Nobivac LeuFel | Iceland | 9.11.2017 |
| EU/2/17/217 | Nobivac LeuFel | Liechtenstein | 31.12.2017 |
| EU/2/17/217 | Nobivac LeuFel | Norway | 14.11.2017 |
| EU/2/17/218 | Bovilis Blue-8 | Iceland | 1.12.2017 |
| EU/2/17/218 | Bovilis Blue-8 | Liechtenstein | 31.12.2017 |
| EU/2/17/218 | Bovilis Blue-8 | Norway | 19.12.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/02/226

InductOs

Iceland

18.8.2017

EU/1/15/999

Zykadia (Switch to non-conditional)

Liechtenstein

31.8.2017

EU/1/16/1138

Venclyxto

Liechtenstein

31.12.2017

EU/1/16/1155

Kyntheum

Iceland

16.8.2017

EU/1/16/1155

Kyntheum

Liechtenstein

31.8.2017

EU/1/16/1155

Kyntheum

Norway

14.8.2017

EU/1/17/1179

Veltassa

Iceland

11.8.2017

EU/1/17/1179

Veltassa

Liechtenstein

31.8.2017

EU/1/17/1179

Veltassa

Norway

9.8.2017

EU/1/17/1181

Spherox

Iceland

24.7.2017

EU/1/17/1181

Spherox

Liechtenstein

31.8.2017

EU/1/17/1181

Spherox

Norway

13.9.2017

EU/1/17/1184

Riximyo

Iceland

11.7.2017

EU/1/17/1185

Rixathon

Iceland

11.7.2017

EU/1/17/1191

Dinutuximab beta Apeiron

Liechtenstein

31.8.2017

EU/1/17/1194

Febuxostat Mylan

Iceland

11.7.2017

EU/1/17/1195

Erelzi

Iceland

14.7.2017

EU/1/17/1195

Erelzi

Norway

7.7.2017

EU/1/17/1196

Kevzara

Iceland

14.7.2017

EU/1/17/1196

Kevzara

Norway

5.7.2017

EU/1/17/1197

Oxervate

Iceland

24.7.2017

EU/1/17/1197

OXERVATE

Liechtenstein

31.8.2017

EU/1/17/1197

OXERVATE

Norway

17.7.2017

EU/1/17/1199

Cuprior

Iceland

13.9.2017

EU/1/17/1199

Cuprior

Liechtenstein

31.10.2017

EU/1/17/1199

Cuprior

Norway

13.9.2017

EU/1/17/1200

Besponsa

Iceland

24.7.2017

EU/1/17/1200

Besponsa

Liechtenstein

31.8.2017

EU/1/17/1200

Besponsa

Norway

13.7.2017

EU/1/17/1201

Skilarence

Iceland

14.7.2017

EU/1/17/1201

Skilarence

Norway

7.7.2017

EU/1/17/1202

Ucedane

Iceland

12.7.2017

EU/1/17/1202

Ucedane

Norway

5.7.2017

EU/1/17/1203

Insulin lispro Sanofi

Iceland

11.8.2017

EU/1/17/1203

Insulin Lispro Sanofi

Liechtenstein

31.8.2017

EU/1/17/1203

Insulin lispro Sanofi

Norway

18.8.2017

EU/1/17/1205

Blitzima

Iceland

9.8.2017

EU/1/17/1205

Blitzima

Liechtenstein

31.8.2017

EU/1/17/1205

Blitzima

Norway

1.8.2017

EU/1/17/1206

Tuxella

Iceland

9.8.2017

EU/1/17/1206

Tuxella

Liechtenstein

31.8.2017

EU/1/17/1206

Tuxella

Norway

1.8.2017

EU/1/17/1207

Ritemvia

Liechtenstein

31.8.2017

EU/1/17/1207

Ritemvia

Iceland

10.8.2017

EU/1/17/1207

Ritemvia

Norway

1.8.2017

EU/1/17/1208

Trimbow

Iceland

11.8.2017

EU/1/17/1208

Trimbow

Liechtenstein

31.8.2017

EU/1/17/1208

Trimbow

Norway

9.8.2017

EU/1/17/1209

Reagila

Iceland

9.8.2017

EU/1/17/1209

Reagila

Liechtenstein

31.8.2017

EU/1/17/1209

Reaglia

Norway

9.8.2017

EU/1/17/1210

Efavirenz/Emtricitabin/Tenofovirdisproksil Zentiva

Norway

8.8.2017

EU/1/17/1210

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Iceland

10.8.2017

EU/1/17/1210

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Liechtenstein

31.8.2017

EU/1/17/1211

Entecavir Accord

Iceland

5.10.2017

EU/1/17/1211

Entecavir Accord

Liechtenstein

31.10.2017

EU/1/17/1211

Entecavir Accord

Norway

20.10.2017

EU/1/17/1212

Mavenclad

Iceland

13.9.2017

EU/1/17/1212

MAVENCLAD

Norway

30.8.2017

EU/1/17/1212

MAVENCLAD

Liechtenstein

31.8.2017

EU/1/17/1213

Maviret

Iceland

17.8.2017

EU/1/17/1213

Maviret

Liechtenstein

31.8.2017

EU/1/17/1213

Maviret

Norway

7.8.2017

EU/1/17/1214

Bavencio

Iceland

4.10.2017

EU/1/17/1214

Bavencio

Liechtenstein

31.10.2017

EU/1/17/1214

Bavencio

Norway

25.9.2017

EU/1/17/1215

Fotivda

Iceland

13.9.2017

EU/1/17/1215

Fotivda

Liechtenstein

31.8.2017

EU/1/17/1215

Fotivda

Norway

31.8.2017

EU/1/17/1216

Imraldi

Iceland

12.9.2017

EU/1/17/1216

Imraldi

Liechtenstein

31.8.2017

EU/1/17/1216

Imraldi

Norway

11.9.2017

EU/1/17/1217

Nitisinone MendeliKABS

Iceland

19.9.2017

EU/1/17/1217

Nitisinone MendeliKABS

Liechtenstein

31.8.2017

EU/1/17/1217

Nitisinone MendeliKABS

Norway

1.9.2017

EU/1/17/1218

Rydapt

Iceland

4.10.2017

EU/1/17/1218

Rydapt

Liechtenstein

31.10.2017

EU/1/17/1218

Rydapt

Norway

25.9.2017

EU/1/17/1220

Tecentriq

Liechtenstein

31.10.2017

EU/1/17/1220

Tecentriq

Norway

27.9.2017

EU/1/17/1220

Tecentriq

Iceland

5.10.2017

EU/1/17/1221

Kisqali

Iceland

12.9.2017

EU/1/17/1221

Kisqali

Norway

30.8.2017

EU/1/17/1221

Kisqali

Liechtenstein

31.8.2017

EU/1/17/1222

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Iceland

8.11.2017

EU/1/17/1222

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Liechtenstein

31.10.2017

EU/1/17/1222

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Norway

27.9.2017

EU/1/17/1223

Vosevi

Iceland

16.8.2017

EU/1/17/1223

Vosevi

Liechtenstein

31.8.2017

EU/1/17/1223

Vosevi

Norway

8.8.2017

EU/1/17/1224

Xermelo

Iceland

4.10.2017

EU/1/17/1224

Xermelo

Liechtenstein

31.10.2017

EU/1/17/1224

Xermelo

Norway

3.10.2017

EU/1/17/1225

Symtuza

Iceland

5.10.2017

EU/1/17/1225

Symtuza

Liechtenstein

31.10.2017

EU/1/17/1225

Symtuza

Norway

11.10.2017

EU/1/17/1226

Lutathera

Iceland

10.10.2017

EU/1/17/1226

Lutathera

Liechtenstein

31.10.2017

EU/1/17/1226

Lutathera

Norway

3.10.2017

EU/1/17/1227

Entecavir Mylan

Iceland

4.10.2017

EU/1/17/1227

Entecavir Mylan

Liechtenstein

31.10.2017

EU/1/17/1227

Entecavir Mylan

Norway

27.9.2017

EU/1/17/1228

Tookad

Iceland

29.11.2017

EU/1/17/1228

TOOKAD

Liechtenstein

31.12.2017

EU/1/17/1228

TOOKAD

Norway

22.11.2017

EU/1/17/1229

Dupixent

Iceland

10.10.2017

EU/1/17/1229

Dupixent

Liechtenstein

31.10.2017

EU/1/17/1229

Dupixent

Norway

10.10.2017

EU/1/17/1230

Lacosamide Accord

Iceland

5.10.2017

EU/1/17/1230

Lacosamide Accord

Liechtenstein

31.10.2017

EU/1/17/1230

Lacosamide Accord

Norway

27.9.2017

EU/1/17/1232

Miglustat Gen.Orph

Iceland

30.11.2017

EU/1/17/1232

Miglustat Gen.Orph

Liechtenstein

31.12.2017

EU/1/17/1232

Miglustat Gen.Orph

Norway

27.11.2017

EU/1/17/1233

Zubsolv

Iceland

29.11.2017

EU/1/17/1233

Zubsolv

Liechtenstein

31.12.2017

EU/1/17/1233

Zubsolv

Norway

22.11.2017

EU/1/17/1234

Tremfya

Iceland

4.12.2017

EU/1/17/1235

Zejula

Iceland

4.12.2017

EU/1/17/1235

Zejula

Liechtenstein

31.12.2017

EU/1/17/1235

Zejula

Norway

27.11.2017

EU/1/17/1236

Trelegy Ellipta

Iceland

30.11.2017

EU/1/17/1236

Trelegy Ellipta

Liechtenstein

31.12.2017

EU/1/17/1236

Trelegy Ellipta

Norway

22.11.2017

EU/1/17/1237

Elebrato Ellipta

Iceland

30.11.2017

EU/1/17/1237

Elebrato Ellipta

Liechtenstein

31.12.2017

EU/1/17/1237

Elebrato Ellipta

Norway

27.11.2017

EU/1/17/1238

Nyxoid

Iceland

29.11.2017

EU/1/17/1238

Nyxoid

Liechtenstein

31.12.2017

EU/1/17/1238

Nyxoid

Norway

27.11.2017

EU/1/17/1239

VeraSeal

Iceland

30.11.2017

EU/1/17/1239

VeraSeal

Liechtenstein

31.12.2017

EU/1/17/1239

VeraSeal

Norway

1.12.2017

EU/1/17/1240

Cyltezo

Iceland

29.11.2017

EU/1/17/1240

Cyltezo

Liechtenstein

31.12.2017

EU/1/17/1240

Cyltezo

Norway

1.12.2017

EU/1/17/1241

Ontruzant

Iceland

30.11.2017

EU/1/17/1241

Ontruzant

Liechtenstein

31.12.2017

EU/1/17/1241

Ontruzant

Norway

27.11.2017

EU/1/17/1242

Ritonavir Mylan

Iceland

29.11.2017

EU/1/17/1242

Ritonavir Mylan

Liechtenstein

31.12.2017

EU/1/17/1242

Ritonavir Mylan

Norway

22.11.2017

EU/1/17/1243

Imatinib Teva B.V.

Iceland

30.11.2017

EU/1/17/1243

Imatinib Teva B.V.

Liechtenstein

31.12.2017

EU/1/17/1243

Imatinib Teva B.V.

Norway

22.11.2017

EU/1/17/1244

Tacforius

Liechtenstein

31.12.2017

EU/2/16/197

CLYNAV

Iceland

13.7.2017

EU/2/16/197

CLYNAV

Liechtenstein

31.8.2017

EU/2/16/197

CLYNAV

Norway

18.7.2017

EU/2/17/211

Prevomax

Iceland

13.7.2017

EU/2/17/211

Prevomax

Norway

6.7.2017

EU/2/17/212

Exzolt

Iceland

30.8.2017

EU/2/17/212

Exzolt

Liechtenstein

31.10.2017

EU/2/17/212

Exzolt

Norway

15.9.2017

EU/2/17/213

Innovax-ND-IBD

Iceland

11.9.2017

EU/2/17/213

Innovax-ND-IBD

Norway

18.9.2017

EU/2/17/214

VEPURED

Iceland

12.9.2017

EU/2/17/214

VEPURED

Norway

15.9.2017

EU/2/17/215

Suvaxyn PRRS MLV

Iceland

11.9.2017

EU/2/17/215

Suvaxyn PRRS MLV

Liechtenstein

31.10.2017

EU/2/17/215

Suvaxyn PRRS MLV

Norway

18.9.2017

EU/2/17/217

Nobivac LeuFel

Iceland

9.11.2017

EU/2/17/217

Nobivac LeuFel

Liechtenstein

31.12.2017

EU/2/17/217

Nobivac LeuFel

Norway

14.11.2017

EU/2/17/218

Bovilis Blue-8

Iceland

1.12.2017

EU/2/17/218

Bovilis Blue-8

Liechtenstein

31.12.2017

EU/2/17/218

Bovilis Blue-8

Norway

19.12.2017

---

ANNEX II

List of renewed marketing authorisations

The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July-31 December 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/07/401 | alli | Iceland | 14.7.2017 |
| EU/1/07/401 | alli | Liechtenstein | 31.8.2017 |
| EU/1/07/401 | alli | Norway | 5.7.2017 |
| EU/1/07/402 | Increlex | Iceland | 12.7.2017 |
| EU/1/07/402 | INCRELEX | Norway | 5.7.2017 |
| EU/1/07/403 | Atriance | Iceland | 11.7.2017 |
| EU/1/07/416 | Ecalta | Iceland | 13.9.2017 |
| EU/1/07/416 | Ecalta | Liechtenstein | 31.10.2017 |
| EU/1/07/416 | Ecalta | Norway | 22.9.2017 |
| EU/1/07/421 | Glubrava | Iceland | 30.11.2017 |
| EU/1/07/421 | Glubrava | Liechtenstein | 31.12.2017 |
| EU/1/07/421 | Glubrava | Norway | 22.11.2017 |
| EU/1/07/424 | Torisel | Iceland | 24.7.2017 |
| EU/1/07/424 | Torisel | Liechtenstein | 31.8.2017 |
| EU/1/07/424 | Torisel | Norway | 1.8.2017 |
| EU/1/08/446 | Privigen | Iceland | 4.12.2017 |
| EU/1/08/446 | Privigen | Liechtenstein | 31.12.2017 |
| EU/1/08/446 | Privigen | Norway | 5.12.2017 |
| EU/1/08/453 | Prepandrix | Iceland | 4.12.2017 |
| EU/1/08/453 | Prepandrix | Liechtenstein | 31.12.2017 |
| EU/1/08/453 | Prepandrix | Norway | 5.12.2017 |
| EU/1/12/784 | Cuprymina | Iceland | 11.8.2017 |
| EU/1/12/784 | Cuprymina | Liechtenstein | 31.8.2017 |
| EU/1/12/784 | Cuprymina | Norway | 9.8.2017 |
| EU/1/12/787 | Revestive | Iceland | 13.7.2017 |
| EU/1/12/787 | Revestive | Norway | 5.7.2017 |
| EU/1/12/788 | Seebri Breezhaler | Iceland | 11.8.2017 |
| EU/1/12/788 | Seebri Breezhaler | Liechtenstein | 31.8.2017 |
| EU/1/12/788 | Seebri Breezhaler | Norway | 9.8.2017 |
| EU/1/12/789 | Enurev Breezhaler | Iceland | 24.7.2017 |
| EU/1/12/789 | Enurev Breezhaler | Liechtenstein | 31.8.2017 |
| EU/1/12/789 | Enurev Breezhaler | Norway | 9.8.2017 |
| EU/1/12/790 | Tovanor Breezhaler | Iceland | 14.8.2017 |
| EU/1/12/790 | Tovanor Breezhaler | Liechtenstein | 31.8.2017 |
| EU/1/12/790 | Tovanor Breezhaler | Norway | 9.8.2017 |
| EU/1/12/794 | Adcetris | Iceland | 4.12.2017 |
| EU/1/12/794 | ADCETRIS | Liechtenstein | 31.12.2017 |
| EU/1/12/794 | ADCETRIS | Norway | 27.11.2017 |
| EU/1/12/795 | Forxiga | Iceland | 13.9.2017 |
| EU/1/12/795 | Forxiga | Liechtenstein | 31.10.2017 |
| EU/1/12/795 | Forxiga | Norway | 27.9.2017 |
| EU/1/12/796 | Picato | Iceland | 24.7.2017 |
| EU/1/12/796 | Picato | Liechtenstein | 31.8.2017 |
| EU/1/12/796 | Picato | Norway | 8.8.2017 |
| EU/1/12/797 | Eylea | Iceland | 10.8.2017 |
| EU/1/12/797 | Eylea | Liechtenstein | 31.8.2017 |
| EU/1/12/797 | Eylea | Norway | 18.8.2017 |
| EU/1/12/798 | Ibandronic acid Accord | Iceland | 6.10.2017 |
| EU/1/12/798 | Ibandronic acid Accord | Liechtenstein | 31.10.2017 |
| EU/1/12/798 | Ibandronic acid Accord | Norway | 27.9.2017 |
| EU/1/12/799 | Memantine Merz | Iceland | 24.7.2017 |
| EU/1/12/799 | Memantine Merz | Liechtenstein | 31.8.2017 |
| EU/1/12/799 | Memantine Merz | Norway | 9.8.2017 |
| EU/1/12/800 | Zoledronic Acid Hospira | Iceland | 11.9.2017 |
| EU/1/12/800 | Zoledronic acid Hospira | Liechtenstein | 31.8.2017 |
| EU/1/12/800 | Zoledronsyre Hospira | Norway | 4.9.2017 |
| EU/1/12/801 | Constella | Iceland | 14.9.2017 |
| EU/1/12/801 | Constella | Liechtenstein | 31.10.2017 |
| EU/1/12/801 | Constella | Norway | 22.9.2017 |
| EU/1/12/802 | Capecitabine medac | Iceland | 12.7.2017 |
| EU/1/12/803 | NexoBrid | Iceland | 30.11.2017 |
| EU/1/12/803 | NexoBrid | Liechtenstein | 31.12.2017 |
| EU/1/12/803 | NexoBrid | Norway | 11.12.2017 |
| EU/1/12/805 | AMYViD | Iceland | 9.10.2017 |
| EU/1/12/805 | Amyvid | Liechtenstein | 31.10.2017 |
| EU/1/12/805 | Amyvid | Norway | 3.10.2017 |
| EU/1/12/806 | Ryzodeg | Iceland | 4.10.2017 |
| EU/1/12/806 | Ryzodeg | Liechtenstein | 31.10.2017 |
| EU/1/12/806 | Ryzodeg | Norway | 10.10.2017 |
| EU/1/12/807 | Tresiba | Iceland | 9.10.2017 |
| EU/1/12/807 | Tresiba | Liechtenstein | 31.10.2017 |
| EU/1/12/807 | Tresiba | Norway | 10.10.2017 |
| EU/1/12/808 | Imatinib Teva | Iceland | 9.10.2017 |
| EU/1/12/808 | Imatinib Teva | Liechtenstein | 31.10.2017 |
| EU/1/12/808 | Imatinib Teva | Norway | 27.9.2017 |
| EU/1/12/809 | Betmiga | Iceland | 6.10.2017 |
| EU/1/12/809 | Betmiga | Liechtenstein | 31.10.2017 |
| EU/1/12/809 | Betmiga | Norway | 3.10.2017 |
| EU/1/12/811 | Lyxumia | Iceland | 6.10.2017 |
| EU/1/12/811 | Lyxumia | Liechtenstein | 31.10.2017 |
| EU/1/12/811 | Lyxumia | Norway | 9.10.2017 |
| EU/1/12/812 | Bexsero | Iceland | 9.10.2017 |
| EU/1/12/812 | Bexsero | Liechtenstein | 31.10.2017 |
| EU/1/12/812 | Bexsero | Norway | 3.10.2017 |
| EU/1/12/814 | Zaltrap | Iceland | 9.10.2017 |
| EU/1/12/814 | ZALTRAP | Liechtenstein | 31.10.2017 |
| EU/1/12/814 | ZALTRAP | Norway | 27.9.2017 |
| EU/1/12/815 | Selincro | Iceland | 30.11.2017 |
| EU/1/12/815 | Selincro | Liechtenstein | 31.12.2017 |
| EU/1/12/815 | Selincro | Norway | 1.12.2017 |
| EU/1/13/813 | Perjeta | Iceland | 19.12.2017 |
| EU/1/13/813 | Perjeta | Liechtenstein | 31.12.2017 |
| EU/1/13/817 | Actelsar HCT | Liechtenstein | 31.12.2017 |
| EU/1/13/819 | JETREA | Iceland | 15.12.2017 |
| EU/1/13/819 | JETREA | Liechtenstein | 31.12.2017 |
| EU/1/13/819 | JETREA | Norway | 19.12.2017 |
| EU/1/13/902 | Translarna | Iceland | 12.7.2017 |
| EU/1/13/902 | Translarna | Norway | 5.7.2017 |
| EU/1/14/987 | Holoclar | Iceland | 19.12.2017 |
| EU/1/16/1094 | Ninlaro | Iceland | 6.10.2017 |
| EU/1/16/1094 | Ninlaro | Liechtenstein | 31.10.2017 |
| EU/1/16/1094 | Ninlaro | Norway | 26.9.2017 |
| EU/1/16/1121 | Zalmoxis | Iceland | 24.7.2017 |
| EU/1/16/1121 | Zalmoxis | Liechtenstein | 31.8.2017 |
| EU/1/16/1121 | Zalmoxis | Norway | 4.8.2017 |
| EU/1/16/1138 | Venclyxto | Iceland | 6.11.2017 |
| EU/1/16/1138 | Venclyxto | Norway | 14.11.2017 |
| EU/1/16/1139 | Ocaliva | Iceland | 8.12.2017 |
| EU/1/16/1139 | OCALIVA | Liechtenstein | 31.12.2017 |
| EU/1/16/1139 | OCALIVA | Norway | 18.12.2017 |
| EU/1/16/1143 | Lartruvo | Iceland | 6.10.2017 |
| EU/1/16/1143 | Lartruvo | Liechtenstein | 31.10.2017 |
| EU/1/16/1143 | Lartruvo | Norway | 27.9.2017 |
| EU/1/16/1169 | Alecensa | Iceland | 8.12.2017 |
| EU/1/16/1169 | Alecensa | Liechtenstein | 31.12.2017 |
| EU/1/16/1169 | Alecensa | Norway | 15.12.2017 |
| EU/1/43/890 | Cometriq | Norway | 3.8.2017 |
| EU/2/12/142 | Cardalis | Iceland | 4.7.2017 |
| EU/2/12/144 | Contacera | Iceland | 5.12.2017 |
| EU/2/12/144 | Contacera | Liechtenstein | 31.12.2017 |
| EU/2/12/144 | Contacera | Norway | 15.12.2017 |
| EU/2/12/145 | Kexxtone | Liechtenstein | 31.12.2017 |
| EU/2/12/145 | Kexxtone | Norway | 28.12.2017 |
| EU/2/12/147 | Pexion | Iceland | 5.12.2017 |
| EU/2/12/147 | Pexion | Liechtenstein | 31.12.2017 |
| EU/2/12/147 | Pexion | Norway | 6.12.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/07/401

alli

Iceland

14.7.2017

EU/1/07/401

alli

Liechtenstein

31.8.2017

EU/1/07/401

alli

Norway

5.7.2017

EU/1/07/402

Increlex

Iceland

12.7.2017

EU/1/07/402

INCRELEX

Norway

5.7.2017

EU/1/07/403

Atriance

Iceland

11.7.2017

EU/1/07/416

Ecalta

Iceland

13.9.2017

EU/1/07/416

Ecalta

Liechtenstein

31.10.2017

EU/1/07/416

Ecalta

Norway

22.9.2017

EU/1/07/421

Glubrava

Iceland

30.11.2017

EU/1/07/421

Glubrava

Liechtenstein

31.12.2017

EU/1/07/421

Glubrava

Norway

22.11.2017

EU/1/07/424

Torisel

Iceland

24.7.2017

EU/1/07/424

Torisel

Liechtenstein

31.8.2017

EU/1/07/424

Torisel

Norway

1.8.2017

EU/1/08/446

Privigen

Iceland

4.12.2017

EU/1/08/446

Privigen

Liechtenstein

31.12.2017

EU/1/08/446

Privigen

Norway

5.12.2017

EU/1/08/453

Prepandrix

Iceland

4.12.2017

EU/1/08/453

Prepandrix

Liechtenstein

31.12.2017

EU/1/08/453

Prepandrix

Norway

5.12.2017

EU/1/12/784

Cuprymina

Iceland

11.8.2017

EU/1/12/784

Cuprymina

Liechtenstein

31.8.2017

EU/1/12/784

Cuprymina

Norway

9.8.2017

EU/1/12/787

Revestive

Iceland

13.7.2017

EU/1/12/787

Revestive

Norway

5.7.2017

EU/1/12/788

Seebri Breezhaler

Iceland

11.8.2017

EU/1/12/788

Seebri Breezhaler

Liechtenstein

31.8.2017

EU/1/12/788

Seebri Breezhaler

Norway

9.8.2017

EU/1/12/789

Enurev Breezhaler

Iceland

24.7.2017

EU/1/12/789

Enurev Breezhaler

Liechtenstein

31.8.2017

EU/1/12/789

Enurev Breezhaler

Norway

9.8.2017

EU/1/12/790

Tovanor Breezhaler

Iceland

14.8.2017

EU/1/12/790

Tovanor Breezhaler

Liechtenstein

31.8.2017

EU/1/12/790

Tovanor Breezhaler

Norway

9.8.2017

EU/1/12/794

Adcetris

Iceland

4.12.2017

EU/1/12/794

ADCETRIS

Liechtenstein

31.12.2017

EU/1/12/794

ADCETRIS

Norway

27.11.2017

EU/1/12/795

Forxiga

Iceland

13.9.2017

EU/1/12/795

Forxiga

Liechtenstein

31.10.2017

EU/1/12/795

Forxiga

Norway

27.9.2017

EU/1/12/796

Picato

Iceland

24.7.2017

EU/1/12/796

Picato

Liechtenstein

31.8.2017

EU/1/12/796

Picato

Norway

8.8.2017

EU/1/12/797

Eylea

Iceland

10.8.2017

EU/1/12/797

Eylea

Liechtenstein

31.8.2017

EU/1/12/797

Eylea

Norway

18.8.2017

EU/1/12/798

Ibandronic acid Accord

Iceland

6.10.2017

EU/1/12/798

Ibandronic acid Accord

Liechtenstein

31.10.2017

EU/1/12/798

Ibandronic acid Accord

Norway

27.9.2017

EU/1/12/799

Memantine Merz

Iceland

24.7.2017

EU/1/12/799

Memantine Merz

Liechtenstein

31.8.2017

EU/1/12/799

Memantine Merz

Norway

9.8.2017

EU/1/12/800

Zoledronic Acid Hospira

Iceland

11.9.2017

EU/1/12/800

Zoledronic acid Hospira

Liechtenstein

31.8.2017

EU/1/12/800

Zoledronsyre Hospira

Norway

4.9.2017

EU/1/12/801

Constella

Iceland

14.9.2017

EU/1/12/801

Constella

Liechtenstein

31.10.2017

EU/1/12/801

Constella

Norway

22.9.2017

EU/1/12/802

Capecitabine medac

Iceland

12.7.2017

EU/1/12/803

NexoBrid

Iceland

30.11.2017

EU/1/12/803

NexoBrid

Liechtenstein

31.12.2017

EU/1/12/803

NexoBrid

Norway

11.12.2017

EU/1/12/805

AMYViD

Iceland

9.10.2017

EU/1/12/805

Amyvid

Liechtenstein

31.10.2017

EU/1/12/805

Amyvid

Norway

3.10.2017

EU/1/12/806

Ryzodeg

Iceland

4.10.2017

EU/1/12/806

Ryzodeg

Liechtenstein

31.10.2017

EU/1/12/806

Ryzodeg

Norway

10.10.2017

EU/1/12/807

Tresiba

Iceland

9.10.2017

EU/1/12/807

Tresiba

Liechtenstein

31.10.2017

EU/1/12/807

Tresiba

Norway

10.10.2017

EU/1/12/808

Imatinib Teva

Iceland

9.10.2017

EU/1/12/808

Imatinib Teva

Liechtenstein

31.10.2017

EU/1/12/808

Imatinib Teva

Norway

27.9.2017

EU/1/12/809

Betmiga

Iceland

6.10.2017

EU/1/12/809

Betmiga

Liechtenstein

31.10.2017

EU/1/12/809

Betmiga

Norway

3.10.2017

EU/1/12/811

Lyxumia

Iceland

6.10.2017

EU/1/12/811

Lyxumia

Liechtenstein

31.10.2017

EU/1/12/811

Lyxumia

Norway

9.10.2017

EU/1/12/812

Bexsero

Iceland

9.10.2017

EU/1/12/812

Bexsero

Liechtenstein

31.10.2017

EU/1/12/812

Bexsero

Norway

3.10.2017

EU/1/12/814

Zaltrap

Iceland

9.10.2017

EU/1/12/814

ZALTRAP

Liechtenstein

31.10.2017

EU/1/12/814

ZALTRAP

Norway

27.9.2017

EU/1/12/815

Selincro

Iceland

30.11.2017

EU/1/12/815

Selincro

Liechtenstein

31.12.2017

EU/1/12/815

Selincro

Norway

1.12.2017

EU/1/13/813

Perjeta

Iceland

19.12.2017

EU/1/13/813

Perjeta

Liechtenstein

31.12.2017

EU/1/13/817

Actelsar HCT

Liechtenstein

31.12.2017

EU/1/13/819

JETREA

Iceland

15.12.2017

EU/1/13/819

JETREA

Liechtenstein

31.12.2017

EU/1/13/819

JETREA

Norway

19.12.2017

EU/1/13/902

Translarna

Iceland

12.7.2017

EU/1/13/902

Translarna

Norway

5.7.2017

EU/1/14/987

Holoclar

Iceland

19.12.2017

EU/1/16/1094

Ninlaro

Iceland

6.10.2017

EU/1/16/1094

Ninlaro

Liechtenstein

31.10.2017

EU/1/16/1094

Ninlaro

Norway

26.9.2017

EU/1/16/1121

Zalmoxis

Iceland

24.7.2017

EU/1/16/1121

Zalmoxis

Liechtenstein

31.8.2017

EU/1/16/1121

Zalmoxis

Norway

4.8.2017

EU/1/16/1138

Venclyxto

Iceland

6.11.2017

EU/1/16/1138

Venclyxto

Norway

14.11.2017

EU/1/16/1139

Ocaliva

Iceland

8.12.2017

EU/1/16/1139

OCALIVA

Liechtenstein

31.12.2017

EU/1/16/1139

OCALIVA

Norway

18.12.2017

EU/1/16/1143

Lartruvo

Iceland

6.10.2017

EU/1/16/1143

Lartruvo

Liechtenstein

31.10.2017

EU/1/16/1143

Lartruvo

Norway

27.9.2017

EU/1/16/1169

Alecensa

Iceland

8.12.2017

EU/1/16/1169

Alecensa

Liechtenstein

31.12.2017

EU/1/16/1169

Alecensa

Norway

15.12.2017

EU/1/43/890

Cometriq

Norway

3.8.2017

EU/2/12/142

Cardalis

Iceland

4.7.2017

EU/2/12/144

Contacera

Iceland

5.12.2017

EU/2/12/144

Contacera

Liechtenstein

31.12.2017

EU/2/12/144

Contacera

Norway

15.12.2017

EU/2/12/145

Kexxtone

Liechtenstein

31.12.2017

EU/2/12/145

Kexxtone

Norway

28.12.2017

EU/2/12/147

Pexion

Iceland

5.12.2017

EU/2/12/147

Pexion

Liechtenstein

31.12.2017

EU/2/12/147

Pexion

Norway

6.12.2017

---

ANNEX III

List of extended marketing authorisations

The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July-31 December 2017:

| EU Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/01/177/002 | SonoVue | Norway | 4.9.2017 |
| EU/1/03/256/022 | Humira | Iceland | 19.12.2017 |
| EU/1/03/256/022 | Humira | Norway | 10.11.2017 |
| EU/1/04/292/013-015 | Mimpara | Iceland | 15.9.2017 |
| EU/1/04/292/013-015 | Mimpara | Norway | 28.8.2017 |
| EU/1/06/356/020-022 | Exjade | Norway | 28.11.2017 |
| EU/1/06/356/020-022 | Exjade | Iceland | 1.12.2017 |
| EU/1/07/418/011-013 | Celsentri | Norway | 3.8.2017 |
| EU/1/07/418/011-013 | Celsentri | Iceland | 13.7.2017 |
| EU/1/07/422/015 | Tasigna | Iceland | 4.12.2017 |
| EU/1/07/422/015 | Tasigna | Norway | 28.11.2017 |
| EU/1/07/436/006 | Isentress | Iceland | 9.8.2017 |
| EU/1/07/436/006 | Isentress | Norway | 7.8.2017 |
| EU/1/08/481/004-005 | Kuvan | Iceland | 10.8.2017 |
| EU/1/08/481/004-005 | Kuvan | Norway | 13.7.2017 |
| EU/1/09/522/003 | ellaOne | Iceland | 1.12.2017 |
| EU/1/09/522/003 | ellaOne | Norway | 10.11.2017 |
| EU/1/09/531/022-033 | Instanyl | Iceland | 6.11.2017 |
| EU/1/09/539/005-006 | Samsca | Iceland | 5.10.2017 |
| EU/1/09/539/005-006 | Samsca | Norway | 18.9.2017 |
| EU/1/10/618 | Prolia | Norway | 27.9.2017 |
| EU/1/11/703 | Xgeva | Norway | 27.9.2017 |
| EU/1/12/753/018-019 | Signifor | Iceland | 4.10.2017 |
| EU/1/12/753/018-019 | Signifor | Norway | 18.9.2017 |
| EU/1/12/787/003 | Revestive | Norway | 5.7.2017 |
| EU/1/12/787/003 | Revestive | Iceland | 13.7.2017 |
| EU/1/13/846/002-003 | Xtandi | Norway | 3.10.2017 |
| EU/1/13/846/002-003 | Xtandi | Iceland | 6.10.2017 |
| EU/1/13/860/003 | Nexium Control | Iceland | 11.7.2017 |
| EU/1/13/860/003 | Nexium Control | Norway | 5.7.2017 |
| EU/1/15/1070/002 | Oncaspar | Iceland | 19.12.2017 |

EU Number

Product

Country

Date of authorisation

EU/1/01/177/002

SonoVue

Norway

4.9.2017

EU/1/03/256/022

Humira

Iceland

19.12.2017

EU/1/03/256/022

Humira

Norway

10.11.2017

EU/1/04/292/013-015

Mimpara

Iceland

15.9.2017

EU/1/04/292/013-015

Mimpara

Norway

28.8.2017

EU/1/06/356/020-022

Exjade

Norway

28.11.2017

EU/1/06/356/020-022

Exjade

Iceland

1.12.2017

EU/1/07/418/011-013

Celsentri

Norway

3.8.2017

EU/1/07/418/011-013

Celsentri

Iceland

13.7.2017

EU/1/07/422/015

Tasigna

Iceland

4.12.2017

EU/1/07/422/015

Tasigna

Norway

28.11.2017

EU/1/07/436/006

Isentress

Iceland

9.8.2017

EU/1/07/436/006

Isentress

Norway

7.8.2017

EU/1/08/481/004-005

Kuvan

Iceland

10.8.2017

EU/1/08/481/004-005

Kuvan

Norway

13.7.2017

EU/1/09/522/003

ellaOne

Iceland

1.12.2017

EU/1/09/522/003

ellaOne

Norway

10.11.2017

EU/1/09/531/022-033

Instanyl

Iceland

6.11.2017

EU/1/09/539/005-006

Samsca

Iceland

5.10.2017

EU/1/09/539/005-006

Samsca

Norway

18.9.2017

EU/1/10/618

Prolia

Norway

27.9.2017

EU/1/11/703

Xgeva

Norway

27.9.2017

EU/1/12/753/018-019

Signifor

Iceland

4.10.2017

EU/1/12/753/018-019

Signifor

Norway

18.9.2017

EU/1/12/787/003

Revestive

Norway

5.7.2017

EU/1/12/787/003

Revestive

Iceland

13.7.2017

EU/1/13/846/002-003

Xtandi

Norway

3.10.2017

EU/1/13/846/002-003

Xtandi

Iceland

6.10.2017

EU/1/13/860/003

Nexium Control

Iceland

11.7.2017

EU/1/13/860/003

Nexium Control

Norway

5.7.2017

EU/1/15/1070/002

Oncaspar

Iceland

19.12.2017

---

ANNEX IV

List of withdrawn marketing authorisations

The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July-31 December 2017:

| EU Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/167 | Prevenar | Liechtenstein | 31.12.2017 |
| EU/1/00/167 | Prevenar | Norway | 11.12.2017 |
| EU/1/00/167 | Prevenar | Iceland | 1.12.2017 |
| EU/1/07/394 | Optaflu | Norway | 18.10.2017 |
| EU/1/07/398 | Optimark | Iceland | 10.10.2017 |
| EU/1/09/561 | Clopidogrel Teva Pharma | Iceland | 11.7.2017 |
| EU/1/11/674 | Repso | Liechtenstein | 31.8.2017 |
| EU/1/11/674 | Repso | Norway | 8.8.2017 |
| EU/1/11/674 | Repso | Iceland | 10.8.2017 |
| EU/1/13/868 | EVARREST | Liechtenstein | 31.12.2017 |
| EU/1/13/868 | EVARREST | Norway | 28.11.2017 |
| EU/1/13/868 | EVARREST | Iceland | 4.12.2017 |
| EU/1/14/976 | Zontivity | Liechtenstein | 31.8.2017 |
| EU/1/15/996 | Ristempa | Liechtenstein | 31.10.2017 |
| EU/1/15/996 | Ristempa | Norway | 9.10.2017 |
| EU/1/15/996 | Ristempa | Iceland | 9.10.2017 |
| EU/1/16/1113 | Enzepi | Iceland | 11.8.2017 |
| EU/1/16/1113 | Enzepi | Liechtenstein | 31.8.2017 |
| EU/1/16/1113 | Enzepi | Norway | 8.8.2017 |

EU Number

Product

Country

Date of withdrawal

EU/1/00/167

Prevenar

Liechtenstein

31.12.2017

EU/1/00/167

Prevenar

Norway

11.12.2017

EU/1/00/167

Prevenar

Iceland

1.12.2017

EU/1/07/394

Optaflu

Norway

18.10.2017

EU/1/07/398

Optimark

Iceland

10.10.2017

EU/1/09/561

Clopidogrel Teva Pharma

Iceland

11.7.2017

EU/1/11/674

Repso

Liechtenstein

31.8.2017

EU/1/11/674

Repso

Norway

8.8.2017

EU/1/11/674

Repso

Iceland

10.8.2017

EU/1/13/868

EVARREST

Liechtenstein

31.12.2017

EU/1/13/868

EVARREST

Norway

28.11.2017

EU/1/13/868

EVARREST

Iceland

4.12.2017

EU/1/14/976

Zontivity

Liechtenstein

31.8.2017

EU/1/15/996

Ristempa

Liechtenstein

31.10.2017

EU/1/15/996

Ristempa

Norway

9.10.2017

EU/1/15/996

Ristempa

Iceland

9.10.2017

EU/1/16/1113

Enzepi

Iceland

11.8.2017

EU/1/16/1113

Enzepi

Liechtenstein

31.8.2017

EU/1/16/1113

Enzepi

Norway

8.8.2017

---

ANNEX V

List of suspended marketing authorisations

The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 July-31 December 2017:

| EU Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| | | | |
| | | | |
| | | | |

EU Number

Product

Country

Date of suspension

---

V Announcements

ADMINISTRATIVE PROCEDURES

European Personnel Selection Office (EPSO)

| 30.8.2018 | EN | Official Journal of the European Union | C 305/34 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/34

---

NOTICE OF OPEN COMPETITION

(2018/C 305/13)

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

| | EPSO/AST-SC/07/18 — ARMED SECURITY AND PROTECTION OFFICERS (SC 1/SC 2) |
| --- | --- |

EPSO/AST-SC/07/18 — ARMED SECURITY AND PROTECTION OFFICERS (SC 1/SC 2)

The competition notice is published in 24 languages in
  Official Journal of the European Union C 305 A of 30 August 2018.

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

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 30.8.2018 | EN | Official Journal of the European Union | C 305/35 |
| --- | --- | --- | --- |

30.8.2018

EN

Official Journal of the European Union

C 305/35

---

Prior notification of a concentration

(Case M.9072 — KKR/Altice/SFR Filiale)

Candidate case for simplified procedure

(Text with EEA relevance)

(2018/C 305/14)

1.

This notification concerns the following undertakings:

| — | KKR & Co. Inc (‘KKR’) (USA), |
| --- | --- |

—

KKR & Co. Inc (‘KKR’) (USA),

| — | Altice France S.A. (‘Altice’) (France), belonging to the Altice group, |
| --- | --- |

—

Altice France S.A. (‘Altice’) (France), belonging to the Altice group,

| — | SFR Filiale SAS (‘SFR Filiale’), controlled by Altice. |
| --- | --- |

—

SFR Filiale SAS (‘SFR Filiale’), controlled by Altice.

KKR and Altice acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of the whole of SFR Filiale.

The concentration is accomplished by way of purchase of shares.

2.

—   for KKR: investment firm that provides asset management services and capital markets solutions,

—   for Altice: telecoms, content, media, entertainment and advertising services.

—   for SFR Filiale: telecommunication towers business of Altice’s subsidiary in France, SFR S.A.

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.9072 — KKR/Altice/SFR Filiale

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

| E-mail: COMP-MERGER-REGISTRY@ec.europa.eu |
| --- |
| Fax +32 22964301 |
| Postal address: |
| European Commission |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

E-mail: 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’).

1

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

2

---