# Official Journal C 302/2011

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2011.302.eng |
| --- | --- |
| Official Journal
  of the European Union | C 302 |
| | |
| English edition | Information and Notices | Volume 5413 October 2011 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2011.302.eng

Official Journal

of the European Union

C 302

English edition

Information and Notices

Volume 5413 October 2011

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| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2011/C 302/01 | Non-opposition to a notified concentration (Case COMP/M.6230 — Solvay/Rhodia) (
  1
  ) | 1 |
| 2011/C 302/02 | Non-opposition to a notified concentration (Case COMP/M.6313 — Ashland/International Specialty Products) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 302/01

Non-opposition to a notified concentration (Case COMP/M.6230 — Solvay/Rhodia) (
  1
  )

1

1

2011/C 302/02

Non-opposition to a notified concentration (Case COMP/M.6313 — Ashland/International Specialty Products) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2011/C 302/03 | Euro exchange rates | 2 |
| | European Systemic Risk Board |
| 2011/C 302/04 | Decision of the European Systemic Risk Board of 21 September 2011 on the provision and collection of information for the macro-prudential oversight of the financial system within the Union (ESRB/2011/6) | 3 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2011/C 302/05 | EFTA Surveillance Authority Recommendation of 2 December 2009 on notifications, time limits and consultations provided for in Article 7 of the Act referred to at point 5cl of Annex XI to the Agreement on the European Economic Area (Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services), as adapted by Protocol 1 thereto | 12 |
| | Standing Committee of the EFTA States |
| 2011/C 302/06 | Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2010 | 22 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 302/03

Euro exchange rates

2

European Systemic Risk Board

2011/C 302/04

Decision of the European Systemic Risk Board of 21 September 2011 on the provision and collection of information for the macro-prudential oversight of the financial system within the Union (ESRB/2011/6)

3

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2011/C 302/05

EFTA Surveillance Authority Recommendation of 2 December 2009 on notifications, time limits and consultations provided for in Article 7 of the Act referred to at point 5cl of Annex XI to the Agreement on the European Economic Area (Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services), as adapted by Protocol 1 thereto

12

Standing Committee of the EFTA States

2011/C 302/06

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2010

22

| | |
| --- | --- |
| | (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

| 13.10.2011 | EN | Official Journal of the European Union | C 302/1 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/1

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Non-opposition to a notified concentration

(Case COMP/M.6230 — Solvay/Rhodia)

(Text with EEA relevance)

2011/C 302/01

On 5 August 2011, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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

| — | in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32011M6230. EUR-Lex is the on-line access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32011M6230. EUR-Lex is the on-line access to the European law.

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| 13.10.2011 | EN | Official Journal of the European Union | C 302/1 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/1

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Non-opposition to a notified concentration

(Case COMP/M.6313 — Ashland/International Specialty Products)

(Text with EEA relevance)

2011/C 302/02

On 18 August 2011, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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

| — | in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32011M6313. EUR-Lex is the on-line access to the European law. |
| --- | --- |

—

in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/en/index.htm) under document number 32011M6313. EUR-Lex is the on-line access to the European law.

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 13.10.2011 | EN | Official Journal of the European Union | C 302/2 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/2

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Euro exchange rates (1)

12 October 2011

2011/C 302/03

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3766 |
| JPY | Japanese yen | 105,77 |
| DKK | Danish krone | 7,4444 |
| GBP | Pound sterling | 0,87535 |
| SEK | Swedish krona | 9,1171 |
| CHF | Swiss franc | 1,2367 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 7,7830 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 24,779 |
| HUF | Hungarian forint | 292,03 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7054 |
| PLN | Polish zloty | 4,2941 |
| RON | Romanian leu | 4,3131 |
| TRY | Turkish lira | 2,5188 |
| AUD | Australian dollar | 1,3609 |
| CAD | Canadian dollar | 1,3996 |
| HKD | Hong Kong dollar | 10,7104 |
| NZD | New Zealand dollar | 1,7373 |
| SGD | Singapore dollar | 1,7583 |
| KRW | South Korean won | 1 603,63 |
| ZAR | South African rand | 10,7389 |
| CNY | Chinese yuan renminbi | 8,7534 |
| HRK | Croatian kuna | 7,4780 |
| IDR | Indonesian rupiah | 12 260,14 |
| MYR | Malaysian ringgit | 4,3038 |
| PHP | Philippine peso | 59,782 |
| RUB | Russian rouble | 42,8550 |
| THB | Thai baht | 42,399 |
| BRL | Brazilian real | 2,4462 |
| MXN | Mexican peso | 18,2463 |
| INR | Indian rupee | 67,3980 |

Currency

Exchange rate

USD

US dollar

1,3766

JPY

Japanese yen

105,77

DKK

Danish krone

7,4444

GBP

Pound sterling

0,87535

SEK

Swedish krona

9,1171

CHF

Swiss franc

1,2367

ISK

Iceland króna

NOK

Norwegian krone

7,7830

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

24,779

HUF

Hungarian forint

292,03

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7054

PLN

Polish zloty

4,2941

RON

Romanian leu

4,3131

TRY

Turkish lira

2,5188

AUD

Australian dollar

1,3609

CAD

Canadian dollar

1,3996

HKD

Hong Kong dollar

10,7104

NZD

New Zealand dollar

1,7373

SGD

Singapore dollar

1,7583

KRW

South Korean won

1 603,63

ZAR

South African rand

10,7389

CNY

Chinese yuan renminbi

8,7534

HRK

Croatian kuna

7,4780

IDR

Indonesian rupiah

12 260,14

MYR

Malaysian ringgit

4,3038

PHP

Philippine peso

59,782

RUB

Russian rouble

42,8550

THB

Thai baht

42,399

BRL

Brazilian real

2,4462

MXN

Mexican peso

18,2463

INR

Indian rupee

67,3980

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

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European Systemic Risk Board

| 13.10.2011 | EN | Official Journal of the European Union | C 302/3 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/3

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DECISION OF THE EUROPEAN SYSTEMIC RISK BOARD

of 21 September 2011

on the provision and collection of information for the macro-prudential oversight of the financial system within the Union

(ESRB/2011/6)

2011/C 302/04

THE GENERAL BOARD OF THE EUROPEAN SYSTEMIC RISK BOARD,

Having regard to Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (1), and in particular Articles 3(2), 4(2) and 8(2) and Article 15 thereof,

Having regard to Council Regulation (EU) No 1096/2010 of 17 November 2010 conferring specific tasks upon the European Central Bank concerning the functioning of the European Systemic Risk Board (2), and in particular Article 2(b), Article 5 and Article 6(4) thereof,

Having regard to Decision ESRB/2011/1 of the European Systemic Risk Board of 20 January 2011 adopting the Rules of Procedure of the European Systemic Risk Board (3), and in particular Article 28(1) thereof,

Whereas:

| (1) | Article 3(2) of Regulation (EU) No 1092/2010 provides that the European Systemic Risk Board (ESRB) has to determine and/or collect and analyse all relevant and necessary information for the macro-prudential oversight of the financial system within the Union in order to contribute to the prevention or mitigation of systemic risks to financial stability in the Union arising from developments within the financial system, taking into account macroeconomic developments, so as to avoid periods of widespread financial distress. |
| --- | --- |

(1)

Article 3(2) of Regulation (EU) No 1092/2010 provides that the European Systemic Risk Board (ESRB) has to determine and/or collect and analyse all relevant and necessary information for the macro-prudential oversight of the financial system within the Union in order to contribute to the prevention or mitigation of systemic risks to financial stability in the Union arising from developments within the financial system, taking into account macroeconomic developments, so as to avoid periods of widespread financial distress.

| (2) | Article 15(2) of Regulation (EU) No 1092/2010 provides that the European Supervisory Authorities (ESAs), the European System of Central Banks (ESCB), the European Commission, the national supervisory authorities (NSAs) and national statistics authorities have to cooperate closely with the ESRB and provide it with all the information necessary for the fulfilment of its tasks in accordance with Union legislation. |
| --- | --- |

(2)

Article 15(2) of Regulation (EU) No 1092/2010 provides that the European Supervisory Authorities (ESAs), the European System of Central Banks (ESCB), the European Commission, the national supervisory authorities (NSAs) and national statistics authorities have to cooperate closely with the ESRB and provide it with all the information necessary for the fulfilment of its tasks in accordance with Union legislation.

| (3) | Pursuant to Article 15(3) of Regulation (EU) No 1092/2010, the ESRB may request information from the ESAs, as a rule in summary or aggregate form such that individual financial institutions cannot be identified. |
| --- | --- |

(3)

Pursuant to Article 15(3) of Regulation (EU) No 1092/2010, the ESRB may request information from the ESAs, as a rule in summary or aggregate form such that individual financial institutions cannot be identified.

| (4) | Recital 10 of Regulation (EU) No 1096/2010 states that ‘The ECB should be entrusted with the task of providing statistical support to the ESRB’, in accordance with recital 9 thereof. |
| --- | --- |

(4)

Recital 10 of Regulation (EU) No 1096/2010 states that ‘The ECB should be entrusted with the task of providing statistical support to the ESRB’, in accordance with recital 9 thereof.

| (5) | This Decision does not interfere with the ECB’s entitlement to use for its own purposes the information that it collects under Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (4). |
| --- | --- |

(5)

This Decision does not interfere with the ECB’s entitlement to use for its own purposes the information that it collects under Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (4).

| (6) | The content of the aggregated information necessary in the short term for the ESRB’s activity has been defined in cooperation with the ECB and the ESAs on the basis of a joint report, |
| --- | --- |

(6)

The content of the aggregated information necessary in the short term for the ESRB’s activity has been defined in cooperation with the ECB and the ESAs on the basis of a joint report,

HAS ADOPTED THIS DECISION:

Article 1

Scope

This Decision sets out the aggregated information required by the ESRB for the performance of its tasks and lays down the detailed rules for provision and collection of that information.

Article 2

Regular provision of aggregated information

1.   Regular provision of the aggregated information required by the ESRB for the performance of its tasks shall take place as specified in Annexes I and II.

2.   The aggregated information set out in Annex I shall be provided by the ECB.

3.   The aggregated information set out in Annex II shall be provided by the respective ESAs.

4.   The ESRB Secretariat shall:

| (a) | lay down, where necessary, the technical specifications concerning the information referred to in paragraph 1, after having consulted the ECB and/or ESAs as appropriate; and |
| --- | --- |

(a)

lay down, where necessary, the technical specifications concerning the information referred to in paragraph 1, after having consulted the ECB and/or ESAs as appropriate; and

| (b) | collect the information referred to in paragraph 1 and cooperate with the ECB and the ESAs accordingly. |
| --- | --- |

(b)

collect the information referred to in paragraph 1 and cooperate with the ECB and the ESAs accordingly.

Article 3

Ad hoc provision of aggregated information

The procedures that the ESRB Secretariat shall apply to carry out requests for aggregated information on an ad hoc basis are set out in Annex III.

Article 4

Entry into force

This Decision shall enter into force on 15 October 2011.

Done at Frankfurt am Main, 21 September 2011.

The Chair of the ESRB

Jean-Claude TRICHET

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(1)  OJ L 331, 15.12.2010, p. 1.

1

(2)  OJ L 331, 15.12.2010, p. 162.

2

(3)  OJ C 58, 24.2.2011, p. 4.

3

(4)  OJ L 318, 27.11.1998, p. 8.

4

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ANNEX I

Regular provision of aggregated information by the European Central Bank

The European Central Bank (ECB) reports datasets, published and non-published, for the Member States whose currency is the euro in the area of monetary and financial statistics, which are regulated in respect of content, frequency and timeliness by the legal acts referred to below, or as established by common practice. To the extent that data for Member States whose currency is not the euro are made available on a voluntary basis with the approval of the relevant national central banks, the ECB also reports that data.

| 1. | Monetary financial institutions (MFIs) balance sheet data as defined in Regulation ECB/2008/32 of 19 December 2008 concerning the balance sheet of the monetary financial institutions sector (recast) (1). |
| --- | --- |

1.

Monetary financial institutions (MFIs) balance sheet data as defined in Regulation ECB/2008/32 of 19 December 2008 concerning the balance sheet of the monetary financial institutions sector (recast) (1).

| 2. | MFI interest rate statistics as defined in Regulation ECB/2001/18 of 20 December 2001 concerning statistics on interest rates applied by monetary financial institutions to deposits and loans vis-à-vis households and non-financial corporations (2). |
| --- | --- |

2.

MFI interest rate statistics as defined in Regulation ECB/2001/18 of 20 December 2001 concerning statistics on interest rates applied by monetary financial institutions to deposits and loans vis-à-vis households and non-financial corporations (2).

| 3. | Investment funds statistics as defined in Regulation ECB/2007/8 of 27 July 2007 concerning statistics on the assets and liabilities of investment funds (3). |
| --- | --- |

3.

Investment funds statistics as defined in Regulation ECB/2007/8 of 27 July 2007 concerning statistics on the assets and liabilities of investment funds (3).

| 4. | Statistics on securitisation as defined in Regulation ECB/2008/30 of 19 December 2008 concerning statistics on the assets and liabilities of financial vehicle corporations engaged in securitisation transactions (4). |
| --- | --- |

4.

Statistics on securitisation as defined in Regulation ECB/2008/30 of 19 December 2008 concerning statistics on the assets and liabilities of financial vehicle corporations engaged in securitisation transactions (4).

| 5. | Selected monetary, financial institutions and markets statistics as defined in Guideline ECB/2007/9 of 1 August 2007 on monetary, financial institutions and markets statistics (recast) (5). |
| --- | --- |

5.

Selected monetary, financial institutions and markets statistics as defined in Guideline ECB/2007/9 of 1 August 2007 on monetary, financial institutions and markets statistics (recast) (5).

| 6. | Consolidated banking data, as approved by the ECB’s Governing Council and General Council, which cover data on balance sheet, profit and loss account and solvency of banking groups on an aggregated basis. |
| --- | --- |

6.

Consolidated banking data, as approved by the ECB’s Governing Council and General Council, which cover data on balance sheet, profit and loss account and solvency of banking groups on an aggregated basis.

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(1)  OJ L 15, 20.1.2009, p. 14.

(2)  OJ L 10, 12.1.2002, p. 24.

(3)  OJ L 211, 14.8.2007, p. 8.

(4)  OJ L 15, 20.1.2009, p. 1.

(5)  OJ L 341, 27.12.2007, p. 1.

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ANNEX II

Regular provision of aggregated information by the European Supervisory Authorities

GENERAL RULE

Aggregated information provided by the European Supervisory Authorities (ESAs) comprises data on at least three legal persons, none of which represents 85 % or more of the relevant market, whether it consists of one or more Member States or the Union as a whole. However, if dispersion measures are provided in addition to the aggregated information, the aggregated information comprises data on at least five legal persons when referring to publicly available data, and data on at least six legal persons when there is a need to protect confidential firm-level data.

A.   European Banking Authority (EBA)

EBA reports the following datasets for a sample of large banking groups as defined between the ESRB and EBA:

A1.   Dataset: quarterly data from COREP and FINREP templates
   (1)

To the extent that the relevant information has been collected in cooperation with the NSAs, EBA transmits to the ESRB data necessary to compile the indicators listed below, which are also provided by the EBA, as well as correlations between the indicators and the following dispersion measures: minimum, first (lower) and third (upper) quartiles, median, average, maximum. EBA should transmit this information quarterly, five working days following EBA’s receipt of data from the NSAs, which occurs 90 days after the reference date. The date for the first transmission of information will be agreed between the ESRB and EBA. Consistent back data for the previous five to eight quarters should also be submitted, if available, on a best effort basis.

The following indicators are to be provided:

| (a) | solvency indicators:
  tier 1 capital ratio; total capital ratio; tier 1 ratio (excluding hybrid instruments); credit risk capital requirements of total capital requirements; standardised approach capital requirements of total capital requirements; securitisation capital requirements of total capital requirements; ‘internal ratings-based’ approach capital requirements of total capital requirements; market risk capital requirements of total capital requirements; operational risk capital requirements of total capital requirements; settlement and delivery risk capital requirements of total capital requirements; other capital requirements of total capital requirements; |
| --- | --- |

(a)

solvency indicators:

tier 1 capital ratio; total capital ratio; tier 1 ratio (excluding hybrid instruments); credit risk capital requirements of total capital requirements; standardised approach capital requirements of total capital requirements; securitisation capital requirements of total capital requirements; ‘internal ratings-based’ approach capital requirements of total capital requirements; market risk capital requirements of total capital requirements; operational risk capital requirements of total capital requirements; settlement and delivery risk capital requirements of total capital requirements; other capital requirements of total capital requirements;

| (b) | credit risk and asset quality indicators:
  past due (> 90 days) loans to total loans and advances; impaired loans to total loans; coverage ratio (specific allowances for loans to total gross impaired loans); past due (> 90 days) loans and debt instruments to total loans and debt instruments; coverage ratio (specific allowances for loans and debt instruments to total gross impaired loans and debt instruments); coverage ratio (all allowances for loans and debt instruments to total gross impaired loans and debt instruments); impaired financial assets to total assets; impaired debt instruments to total debt instruments; accumulated impairments on financial assets to total (gross) assets; |
| --- | --- |

(b)

credit risk and asset quality indicators:

past due (> 90 days) loans to total loans and advances; impaired loans to total loans; coverage ratio (specific allowances for loans to total gross impaired loans); past due (> 90 days) loans and debt instruments to total loans and debt instruments; coverage ratio (specific allowances for loans and debt instruments to total gross impaired loans and debt instruments); coverage ratio (all allowances for loans and debt instruments to total gross impaired loans and debt instruments); impaired financial assets to total assets; impaired debt instruments to total debt instruments; accumulated impairments on financial assets to total (gross) assets;

| (c) | earnings risks indicators:
  return on equity; return on regulatory capital requirements; cost-income ratio; return on assets; net interest income to total operating income; net fee and commission income to total operating income; dividend income to total operating income; net realised gains (losses) on financial assets and liabilities not measured at fair value through profit and loss to total operating income; net gains on financial assets and liabilities held for trading to total operating income; net gains on financial assets and liabilities designated at fair value through profit or loss to total operating income; net other operating income to total operating income; net income to total operating income; impairment on financial assets to total operating income; |
| --- | --- |

(c)

earnings risks indicators:

return on equity; return on regulatory capital requirements; cost-income ratio; return on assets; net interest income to total operating income; net fee and commission income to total operating income; dividend income to total operating income; net realised gains (losses) on financial assets and liabilities not measured at fair value through profit and loss to total operating income; net gains on financial assets and liabilities held for trading to total operating income; net gains on financial assets and liabilities designated at fair value through profit or loss to total operating income; net other operating income to total operating income; net income to total operating income; impairment on financial assets to total operating income;

| (d) | balance sheet structure:
  loan-to-deposit ratio; customer deposits to total liabilities; leverage ratio (tier 1 capital to (total assets — intangible assets)); debt securities to total liabilities; deposits from credit institutions to total liabilities; equity to total liabilities and equity; cash and trading assets to total assets; cash, trading and available-for-sale assets to total assets; financial assets held for trading to total assets; financial liabilities held for trading to total liabilities and equity; loans and advances (excluding trading book) to total assets; debt-to-equity ratio; off-balance-sheet items to total assets; |
| --- | --- |

(d)

balance sheet structure:

loan-to-deposit ratio; customer deposits to total liabilities; leverage ratio (tier 1 capital to (total assets — intangible assets)); debt securities to total liabilities; deposits from credit institutions to total liabilities; equity to total liabilities and equity; cash and trading assets to total assets; cash, trading and available-for-sale assets to total assets; financial assets held for trading to total assets; financial liabilities held for trading to total liabilities and equity; loans and advances (excluding trading book) to total assets; debt-to-equity ratio; off-balance-sheet items to total assets;

| (e) | growth rates (%) per annum:
  total assets; total loans; total customer deposits; total operating income; impairments on financial assets; past due (> 90 days) loans and debt instruments; total gross impaired loans and debt instruments; risk-weighted assets. |
| --- | --- |

(e)

growth rates (%) per annum:

total assets; total loans; total customer deposits; total operating income; impairments on financial assets; past due (> 90 days) loans and debt instruments; total gross impaired loans and debt instruments; risk-weighted assets.

A2.   Dataset: quarterly data on liquidity

EBA transmits to the ESRB data necessary to compile the indicators listed below, which are also provided by the EBA, as well as the following dispersion measures: minimum, first (lower) and third (upper) quartiles, median, average, maximum. This information is transmitted quarterly, five working days following EBA’s receipt of data from the NSAs, which occurs 90 days after the reference date. The information in the first transmission will refer to mid-2013, depending on the final changes to provisions on reporting set forth in Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (recast) (2) and Directive 2006/49/EC of the European Parliament and of the Council of 14 June 2006 on the capital adequacy of investment firms and credit institutions (recast) (3). The date for the first transmission of information will be agreed between the ESRB and EBA. No historical information is required.

The following indicators are to be provided: proxies on the basis of available data for liquidity coverage ratio and net stable funding ratio.

A3.   Dataset: quarterly data from EBA common reporting of large exposures templates
   (4)

To the extent that the relevant information has been collected in cooperation with the NSAs and in accordance with the general rule on aggregated information, EBA transmits to the ESRB data necessary to compile the indicators listed below, which are also provided by the EBA, as well as dispersion measures agreed between the ESRB and EBA. This information is transmitted quarterly, five working days following receipt of data from the NSAs, which occurs 90 days after the reference date. The information in the first transmission will refer to end-December 2011. The date for the first transmission of information will be agreed between the ESRB and EBA. No historical information is required.

The following indicators are to be provided: number of large exposures of the large Union banking groups; amount of large exposures broken down by country and sector of counterparty (government; other large Union banking groups; other banks; other financial intermediaries; non-financial corporations; retail); amount (exposure before credit risk mitigation) of large exposures of the large Union banking groups broken down by instrument (assets; derivatives; off-balance-sheet; indirect exposures) and percentage of own funds; amount (exposure after credit risk mitigation, of which banking book) of the large exposures of the large Union banking groups and percentage of own funds.

B.   European Insurance and Occupational Pensions Authority (EIOPA)

EIOPA reports the following datasets. The B1 dataset refers to large Union insurance companies, as identified by EIOPA. The B2 dataset refers to all Union insurance companies, with such aggregated information being collected on a solo basis.

B1.   Dataset: annual fast-track reporting

To the extent that the relevant information has been collected in cooperation with the NSAs and in accordance with the general rule on aggregated information, EIOPA transmits to the ESRB data necessary to compile the indicators listed below, which are also provided by EIOPA, either as total amounts or as the following dispersion measures: unweighted average, weighted average by gross premiums, median, first quartile, third quartile, minimum, maximum. Information is transmitted annually, approximately 80 calendar days after the reference year. The date for the first transmission of information will be agreed between the ESRB and EIOPA.

The following indicators are to be provided:

| (a) | total amounts (sum):






  (i) | total insurance business (life and non-life): gross premiums written; net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital; |
| --- | --- | --- |

(a)

total amounts (sum):

(i)

total insurance business (life and non-life): gross premiums written; net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital;

| (ii) | non-life insurance business: gross premiums written with breakdown by line of business (accident and health; motor vehicle; motor vehicle third party liability; other classes; marine, aviation and transport; fire and other damage to property; general liability; credit and suretyship; other non-life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital; |
| --- | --- |

(ii)

non-life insurance business: gross premiums written with breakdown by line of business (accident and health; motor vehicle; motor vehicle third party liability; other classes; marine, aviation and transport; fire and other damage to property; general liability; credit and suretyship; other non-life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital;

| (iii) | life insurance business: gross premiums written with breakdown by line of business (linked life insurance; non-linked life insurance; capital redemption insurance; group pension insurance; other life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital; |
| --- | --- |

(iii)

life insurance business: gross premiums written with breakdown by line of business (linked life insurance; non-linked life insurance; capital redemption insurance; group pension insurance; other life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital;

| (b) | dispersion measures:






  (i) | total insurance business (life and non-life): gross premiums written growth rate; return on equity; return on assets; solvency ratio; |
| --- | --- | --- |

(b)

dispersion measures:

(i)

total insurance business (life and non-life): gross premiums written growth rate; return on equity; return on assets; solvency ratio;

| (ii) | non-life insurance business: gross premiums written growth rate with breakdown by line of business (accident and health; motor vehicle; motor vehicle third party liability; other classes; marine, aviation and transport; fire and other damage to property; general liability; credit and suretyship; other non-life insurance); loss ratio; expense ratio; combined ratio; return on equity; return on assets; solvency ratio; |
| --- | --- |

(ii)

non-life insurance business: gross premiums written growth rate with breakdown by line of business (accident and health; motor vehicle; motor vehicle third party liability; other classes; marine, aviation and transport; fire and other damage to property; general liability; credit and suretyship; other non-life insurance); loss ratio; expense ratio; combined ratio; return on equity; return on assets; solvency ratio;

| (iii) | life insurance business: gross premiums written growth rate with breakdown by line of business (linked life insurance; non-linked life insurance; capital redemption insurance; group pension insurance; other life insurance); return on equity; return on assets; solvency ratio. |
| --- | --- |

(iii)

life insurance business: gross premiums written growth rate with breakdown by line of business (linked life insurance; non-linked life insurance; capital redemption insurance; group pension insurance; other life insurance); return on equity; return on assets; solvency ratio.

B2.   Dataset: annual regular reporting

To the extent that the relevant information has been collected in cooperation with the NSAs and in accordance with the general rule on aggregated information, EIOPA transmits to the ESRB data necessary to compile the indicators listed below, which are also provided by EIOPA, as total amounts: unweighted average, weighted average by gross premiums, total large Union insurers’ ratios, median, first quartile, third quartile, minimum, maximum. This information is transmitted annually, approximately 270 calendar days after the reference year. The date for the first transmission of data will be agreed between the ESRB and EIOPA. Historical series are provided from 2003.

The following indicators are to be provided:

| (a) | total insurance business (life and non-life): gross premiums written; net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital; |
| --- | --- |

(a)

total insurance business (life and non-life): gross premiums written; net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital;

| (b) | non-life insurance business: gross premiums written with breakdown by line of business (accident and health; motor vehicle; motor vehicle third party liability; other classes; marine, aviation and transport; fire and other damage to property; general liability; credit and suretyship; other non-life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital; |
| --- | --- |

(b)

non-life insurance business: gross premiums written with breakdown by line of business (accident and health; motor vehicle; motor vehicle third party liability; other classes; marine, aviation and transport; fire and other damage to property; general liability; credit and suretyship; other non-life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital;

| (c) | life insurance business: gross premiums written with breakdown by line of business (linked life insurance; non-linked life insurance; capital redemption insurance; group pension insurance; other life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital. |
| --- | --- |

(c)

life insurance business: gross premiums written with breakdown by line of business (linked life insurance; non-linked life insurance; capital redemption insurance; group pension insurance; other life insurance); net premiums earned; net claims incurred; net operating expenses; available solvency capital; required solvency capital.

C.   European Securities Markets Authority (ESMA)

ESMA provides the following datasets:

C1.   Dataset: Markets in Financial Instruments Directive
   (5)
  database

ESMA transmits to the ESRB data, collected in cooperation with the NSAs, necessary to compile the indicators listed below, which are also provided by ESMA. This information is transmitted on a quarterly basis, five days after the reference period. The date for the first transmission of information will be agreed between the ESRB and ESMA. Historical information is provided from November 2007.

The following indicators are to be provided: name and designation of the Member State of the competent authority that has authorised the systematic internalisers; name and designation of the Member State of the competent authority that has authorised the multilateral trading facilities; name and designation of the Member State of the competent authority that has authorised the regulated market; name and designation of the Member State of the competent authority that has authorised the central counterparty clearing houses.

C2.   Dataset: reference data system database

ESMA transmits to the ESRB data, collected in cooperation with the NSAs, necessary to compile the indicators listed below, which are also provided by ESMA, as well as dispersion measures agreed between the ESRB and ESMA. This information is transmitted on a quarterly basis, five days after the reference period. The date for the first transmission of information will be agreed between the ESRB and ESMA. Historical information is provided from June 2009.

The following indicators are to be provided: breakdown of financial instruments admitted to trading in European Economic Area markets whose Classification of Financial Instruments code is ES (common/ordinary shares); number of instruments by Member States; number of instruments admitted by market; number of new instruments issued by market; number of new instruments issued by Member States.

---

(1)  COREP and FINREP templates, in force on the reporting date, as produced in the form of EBA guidelines published on EBA’s website at http://www.eba.europa.eu or, as appropriate, in the form of technical standards developed by EBA and adopted by the Commission under Article 74(2) of Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (OJ L 177, 30.6.2006, p. 1).

(2)  OJ L 177, 30.6.2006, p. 1.

(3)  OJ L 177, 30.6.2006, p. 201.

(4)  Large exposure templates, in force on the reporting date, as produced in the form of EBA guidelines published on EBA’s website at http://www.eba.europa.eu or, as appropriate, in the form of technical standards (part of the COREP framework) developed by EBA and adopted by the Commission under Article 110 of Directive 2006/48/EC.

(5)  Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (OJ L 145, 30.4.2004, p. 1).

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ANNEX III

Ad hoc requests for aggregated information by the ESRB

A.   GENERAL CONSIDERATIONS

1.   Identification of the need for an ad hoc survey

1.1.   The European Systemic Risk Board (ESRB) may request aggregated information to be provided on an ad hoc basis. Such ad hoc ESRB information requests may be addressed by: (a) providing information already available from the European System of Central Banks (ESCB), the European Supervisory Authorities (ESAs), commercial data providers or the databases of international organisations, e.g. the Bank for International Settlements (BIS); or (b) conducting an ad hoc survey.

1.2.   In view of the above, initial ad hoc requests for aggregated information submitted by ESRB structures will generally first trigger an investigation phase, the aim of which is to identify whether an ad hoc survey needs to be carried out. The investigation phase will, in particular, assess what quantitative and qualitative data are already available and whether they are fit for purpose. Where the available data are not fit for purpose and the need arises for the data to be collected from reporting agents through an ad hoc survey, the investigation phase may already identify the relevant reporting population and broad cost implications for the reporting agents in carrying out an ad hoc survey. The outcome of the investigation may entail the adoption of a decision by the ESRB’s General Board for aggregated information to be collected via an ad hoc survey.

1.3.   The ESRB and one or more ESAs may agree, due to their common interest in a specific topic, to launch a joint ad hoc survey, in which case an investigation phase is unnecessary.

2.   Types of ad hoc surveys

2.1.   Two types of ad hoc surveys may be used:

| (a) | Type 1 surveys focus on specific issues, e.g. adequate assessment of exposures, and usually aim to provide more detailed breakdowns within regular data collection exercises, e.g. ‘of which’ positions. Type 1 surveys may also cover datasets that give rise to (regular) data collection in a different context or by a different organisation, such as the International Monetary Fund or the BIS, and for which established methodological frameworks already exist; |
| --- | --- |

(a)

Type 1 surveys focus on specific issues, e.g. adequate assessment of exposures, and usually aim to provide more detailed breakdowns within regular data collection exercises, e.g. ‘of which’ positions. Type 1 surveys may also cover datasets that give rise to (regular) data collection in a different context or by a different organisation, such as the International Monetary Fund or the BIS, and for which established methodological frameworks already exist;

| (b) | Type 2 surveys cover phenomena not previously analysed and for which no methodology has been established and no regular data collection is carried out. Type 2 surveys are considerably more work-intensive than type 1 surveys and may have no benchmark. Information extracted from type 2 surveys may be more difficult to interpret. The need to identify the relevant reporting agents and establish a methodological framework may imply that considerable time is required before information is collected. |
| --- | --- |

(b)

Type 2 surveys cover phenomena not previously analysed and for which no methodology has been established and no regular data collection is carried out. Type 2 surveys are considerably more work-intensive than type 1 surveys and may have no benchmark. Information extracted from type 2 surveys may be more difficult to interpret. The need to identify the relevant reporting agents and establish a methodological framework may imply that considerable time is required before information is collected.

2.2.   In deciding whether an ad hoc survey is needed, the ESRB’s General Board will be informed of and will take into account the likely costs involved and the timetable for conducting such a survey.

B.   PRINCIPLES AND PROCEDURE FOR HANDLING AD HOC REQUESTS

3.   Principles

The ESRB Secretariat, the European Central Bank (ECB) and the ESAs (hereinafter the ‘parties’) will adhere to the following principles when fulfilling ad hoc ESRB information requests:

| (a) | follow agreed procedural steps, which should be applied in transparent manner; |
| --- | --- |

(a)

follow agreed procedural steps, which should be applied in transparent manner;

| (b) | avoid excessive interaction with reporting agents; |
| --- | --- |

(b)

avoid excessive interaction with reporting agents;

| (c) | maximise the use of existing information for various analytical and operational purposes, while respecting the necessary legal constraints and confidentiality safeguards; |
| --- | --- |

(c)

maximise the use of existing information for various analytical and operational purposes, while respecting the necessary legal constraints and confidentiality safeguards;

| (d) | use existing, to the extent possible harmonised, methodologies and data collections as much as possible; |
| --- | --- |

(d)

use existing, to the extent possible harmonised, methodologies and data collections as much as possible;

| (e) | develop best practices for ad hoc surveys by introducing feedback mechanisms and sharing information on methodologies among all parties involved. |
| --- | --- |

(e)

develop best practices for ad hoc surveys by introducing feedback mechanisms and sharing information on methodologies among all parties involved.

4.   Procedure

4.1.   Investigation phase

| 4.1.1. | ESRB structures convey their initial requests for an ad hoc collection of aggregated information to the ESRB Secretariat, which then organises the investigation phase with the support of the ECB, by taking the actions described below. The initial information request is transformed into actual data requirements and the availability and quality of relevant information is assessed within relevant organisations. The ESAs and the Joint Committee of the ESAs are informed of the content of the initial ad hoc request and invited to cooperate with the ECB in the assessment of the available information, with a view to maximising the use of previously collected information and avoiding an increased reporting burden. The investigation phase may also rely on the ESCB, including the ESCB Statistics Committee (STC), the ESCB Financial Stability Committee (FSC), or other sources within the European Statistical System, commercial data providers and international organisations, e.g. the BIS. |
| --- | --- |

4.1.1.

ESRB structures convey their initial requests for an ad hoc collection of aggregated information to the ESRB Secretariat, which then organises the investigation phase with the support of the ECB, by taking the actions described below. The initial information request is transformed into actual data requirements and the availability and quality of relevant information is assessed within relevant organisations. The ESAs and the Joint Committee of the ESAs are informed of the content of the initial ad hoc request and invited to cooperate with the ECB in the assessment of the available information, with a view to maximising the use of previously collected information and avoiding an increased reporting burden. The investigation phase may also rely on the ESCB, including the ESCB Statistics Committee (STC), the ESCB Financial Stability Committee (FSC), or other sources within the European Statistical System, commercial data providers and international organisations, e.g. the BIS.

| 4.1.2. | If, as a result of the investigation phase: (a) fit for purpose data or acceptable proxies are available and of sufficient quality, and (b) the owner’s permission is obtained to use data not fully in the public domain, such data are provided via the ESRB Secretariat to the relevant ESRB structure requesting the information, together with the required quality assessment and information on the cost of data obtained from commercial sources. |
| --- | --- |

4.1.2.

If, as a result of the investigation phase: (a) fit for purpose data or acceptable proxies are available and of sufficient quality, and (b) the owner’s permission is obtained to use data not fully in the public domain, such data are provided via the ESRB Secretariat to the relevant ESRB structure requesting the information, together with the required quality assessment and information on the cost of data obtained from commercial sources.

| 4.1.3. | In other cases, in particular where any of the following occur: (a) proxies are available but are of unknown or insufficient quality; (b) data and proxies are unavailable; (c) permission to use data not fully in the public domain is not obtained, the ECB provides the ESRB with the outcome of the assessment related to the availability of information and proposes possible sources and methodologies for an ad hoc survey, including: (i) categories and the number of reporting agents, (ii) reporting channels, e.g. the STC, the FSC or the ESAs, (iii) approximate estimate of the costs and timeframe, (iv) anticipated difficulties. |
| --- | --- |

4.1.3.

In other cases, in particular where any of the following occur: (a) proxies are available but are of unknown or insufficient quality; (b) data and proxies are unavailable; (c) permission to use data not fully in the public domain is not obtained, the ECB provides the ESRB with the outcome of the assessment related to the availability of information and proposes possible sources and methodologies for an ad hoc survey, including: (i) categories and the number of reporting agents, (ii) reporting channels, e.g. the STC, the FSC or the ESAs, (iii) approximate estimate of the costs and timeframe, (iv) anticipated difficulties.

4.2.   Data collection phase

| 4.2.1. | After receiving the investigation results, the ESRB Secretariat submits via the ESRB’s Steering Committee for approval by the ESRB’s General Board a proposal for follow-up action together with an approximate assessment of merits and costs. The ESRB’s General Board decides whether to undertake an ad hoc survey, which may require the involvement of reporting agents. The decision of the General Board may determine, in particular: (a) the granularity of the required information on an institutional and item level, (b) the confidentiality regime to be applied, in particular who will be allowed to access which data and how data will be stored and transmitted, (c) the time limits for provision of the information. |
| --- | --- |

4.2.1.

After receiving the investigation results, the ESRB Secretariat submits via the ESRB’s Steering Committee for approval by the ESRB’s General Board a proposal for follow-up action together with an approximate assessment of merits and costs. The ESRB’s General Board decides whether to undertake an ad hoc survey, which may require the involvement of reporting agents. The decision of the General Board may determine, in particular: (a) the granularity of the required information on an institutional and item level, (b) the confidentiality regime to be applied, in particular who will be allowed to access which data and how data will be stored and transmitted, (c) the time limits for provision of the information.

| 4.2.2. | Where an ad hoc survey is conducted by an ESA, the ESRB Secretariat contacts the relevant ESA and the Joint Committee. Data may be transmitted via the ECB, in full compliance with Article 8 of Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (1). |
| --- | --- |

4.2.2.

Where an ad hoc survey is conducted by an ESA, the ESRB Secretariat contacts the relevant ESA and the Joint Committee. Data may be transmitted via the ECB, in full compliance with Article 8 of Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (1).

| 4.2.3. | Where an ad hoc survey is conducted by the ESCB, the ESRB Secretariat contacts the ECB, which then initiates contact with the potential reporting agents via national competent authorities using the appropriate ESCB committees and respecting applicable confidentiality constraints. |
| --- | --- |

4.2.3.

Where an ad hoc survey is conducted by the ESCB, the ESRB Secretariat contacts the ECB, which then initiates contact with the potential reporting agents via national competent authorities using the appropriate ESCB committees and respecting applicable confidentiality constraints.

| 4.2.4. | Following completion of each ad hoc survey, the parties will share information on the survey’s implementation and, in particular, on the applied methodologies and quality checks as well as on any encountered difficulties, with a view to improving the effectiveness and efficiency of future surveys. |
| --- | --- |

4.2.4.

Following completion of each ad hoc survey, the parties will share information on the survey’s implementation and, in particular, on the applied methodologies and quality checks as well as on any encountered difficulties, with a view to improving the effectiveness and efficiency of future surveys.

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(1)  OJ L 331, 15.12.2010, p. 1.

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NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 13.10.2011 | EN | Official Journal of the European Union | C 302/12 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/12

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EFTA SURVEILLANCE AUTHORITY RECOMMENDATION

of 2 December 2009

on notifications, time limits and consultations provided for in Article 7 of the Act referred to at point 5cl of Annex XI to the Agreement on the European Economic Area (Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services), as adapted by Protocol 1 thereto

2011/C 302/05

THE EFTA SURVEILLANCE AUTHORITY (1),

HAVING REGARD to the Agreement on the European Economic Area (2),

HAVING REGARD to the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice, and in particular Article 5(2)(b) thereof,

HAVING REGARD to the Act referred to at point 5cl of Annex XI to the EEA Agreement (Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services) (3) (Framework Directive), as adapted by Protocol 1 thereto, and in particular Article 19(1) thereof,

Whereas:

| (1) | Under the regulatory framework for electronic communications networks and services, national regulatory authorities are obliged to contribute to the development of the internal market by cooperating with each other and with the Authority in a transparent manner in order to ensure the development of consistent regulatory practice and the consistent application of the Directives making up the regulatory framework. |
| --- | --- |

(1)

Under the regulatory framework for electronic communications networks and services, national regulatory authorities are obliged to contribute to the development of the internal market by cooperating with each other and with the Authority in a transparent manner in order to ensure the development of consistent regulatory practice and the consistent application of the Directives making up the regulatory framework.

| (2) | To ensure that decisions taken at national level do not have an adverse effect on the single market or on the objectives pursued by the regulatory framework, national regulatory authorities must notify the Authority and other national regulatory authorities of those draft measures stipulated in Article 7(3) of Directive 2002/21/EC (Framework Directive). |
| --- | --- |

(2)

To ensure that decisions taken at national level do not have an adverse effect on the single market or on the objectives pursued by the regulatory framework, national regulatory authorities must notify the Authority and other national regulatory authorities of those draft measures stipulated in Article 7(3) of Directive 2002/21/EC (Framework Directive).

| (3) | As an additional requirement, national regulatory authorities must obtain the Authority’s authorisation for obligations covered by the second subparagraph of Article 8(3) of the Act referred to at point 5cj of Annex XI to the EEA Agreement (Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities) (4) (Access Directive), as adapted by Protocol 1 thereto, which is a separate process. |
| --- | --- |

(3)

As an additional requirement, national regulatory authorities must obtain the Authority’s authorisation for obligations covered by the second subparagraph of Article 8(3) of the Act referred to at point 5cj of Annex XI to the EEA Agreement (Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities) (4) (Access Directive), as adapted by Protocol 1 thereto, which is a separate process.

| (4) | The Authority will give national regulatory authorities, if they so request, the opportunity to discuss any draft measures before formal notification of such measures under Article 7 of Directive 2002/21/EC (Framework Directive) and Article 8(3) of Directive 2002/19/EC (Access Directive). Where, pursuant to Article 7(4) of Directive 2002/21/EC (Framework Directive), the Authority has indicated to the national regulatory authority that it considers that the draft measure would create a barrier to the functioning of the EEA Agreement or where it has serious doubts as to its compatibility with the EEA law, the national regulatory authority concerned should be given an early opportunity to express its views regarding the issues raised by the Authority. |
| --- | --- |

(4)

The Authority will give national regulatory authorities, if they so request, the opportunity to discuss any draft measures before formal notification of such measures under Article 7 of Directive 2002/21/EC (Framework Directive) and Article 8(3) of Directive 2002/19/EC (Access Directive). Where, pursuant to Article 7(4) of Directive 2002/21/EC (Framework Directive), the Authority has indicated to the national regulatory authority that it considers that the draft measure would create a barrier to the functioning of the EEA Agreement or where it has serious doubts as to its compatibility with the EEA law, the national regulatory authority concerned should be given an early opportunity to express its views regarding the issues raised by the Authority.

| (5) | Directive 2002/21/EC (Framework Directive) lays down certain binding time limits for the consideration of notifications under Article 7. |
| --- | --- |

(5)

Directive 2002/21/EC (Framework Directive) lays down certain binding time limits for the consideration of notifications under Article 7.

| (6) | To ensure the effectiveness of cooperation and the consultation mechanism set out in Article 7 of Directive 2002/21/EC (Framework Directive) and to guarantee legal certainty, clear rules dealing with the main procedural aspects of the notifications made under Article 7 were put in place by the EFTA Surveillance Authority Recommendation of 14 July 2004 on notifications, time limits and consultations provided for in Article 7 of Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services (5). Recommendation of 14 July 2004 should be replaced by this Recommendation with a view to further simplifying and improving the notification process and ensure a harmonised application of the regulatory framework on electronic communications networks and services across the European Economic Area. |
| --- | --- |

(6)

To ensure the effectiveness of cooperation and the consultation mechanism set out in Article 7 of Directive 2002/21/EC (Framework Directive) and to guarantee legal certainty, clear rules dealing with the main procedural aspects of the notifications made under Article 7 were put in place by the EFTA Surveillance Authority Recommendation of 14 July 2004 on notifications, time limits and consultations provided for in Article 7 of Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services (5). Recommendation of 14 July 2004 should be replaced by this Recommendation with a view to further simplifying and improving the notification process and ensure a harmonised application of the regulatory framework on electronic communications networks and services across the European Economic Area.

| (7) | To give further guidance to national regulatory authorities on the content of draft measures and to increase legal certainty on the completeness of a notification, certain minimum information should be provided on what a draft measure should contain in order to be properly assessed. |
| --- | --- |

(7)

To give further guidance to national regulatory authorities on the content of draft measures and to increase legal certainty on the completeness of a notification, certain minimum information should be provided on what a draft measure should contain in order to be properly assessed.

| (8) | Account has to be taken of the need to ensure effective assessment, on the one hand, and to simplify administration as far as possible, on the other hand. In this respect, the notification mechanism should not involve any unnecessary administrative burden on the national regulatory authorities. It would also be beneficial to clarify procedural arrangements in the context of the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive). |
| --- | --- |

(8)

Account has to be taken of the need to ensure effective assessment, on the one hand, and to simplify administration as far as possible, on the other hand. In this respect, the notification mechanism should not involve any unnecessary administrative burden on the national regulatory authorities. It would also be beneficial to clarify procedural arrangements in the context of the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive).

| (9) | To help simplify the examination of a notified draft measure and to make the process quicker, national regulatory authorities should use standard formats for notifications. |
| --- | --- |

(9)

To help simplify the examination of a notified draft measure and to make the process quicker, national regulatory authorities should use standard formats for notifications.

| (10) | By common accord between the EFTA States, Contracting Parties to the EEA Agreement, the English language is to be used as the working language for all communications between the EFTA States and the Authority. This is without prejudice to the rights of private parties and undertakings to submit documents in any of the EEA languages, as provided for by the EEA Agreement. |
| --- | --- |

(10)

By common accord between the EFTA States, Contracting Parties to the EEA Agreement, the English language is to be used as the working language for all communications between the EFTA States and the Authority. This is without prejudice to the rights of private parties and undertakings to submit documents in any of the EEA languages, as provided for by the EEA Agreement.

| (11) | In order to improve the efficiency of the notification mechanism, to increase legal certainty for national regulatory authorities and market players and to ensure timely implementation of regulatory measures, it is desirable that a notification by a national regulatory authority covering a market analysis also includes the remedies proposed by the national regulatory authority to address the market failures identified. Where the draft measure relates to a market which is found to be competitive and remedies already exist in relation to that market, the notification should also include the proposals for withdrawing those obligations. |
| --- | --- |

(11)

In order to improve the efficiency of the notification mechanism, to increase legal certainty for national regulatory authorities and market players and to ensure timely implementation of regulatory measures, it is desirable that a notification by a national regulatory authority covering a market analysis also includes the remedies proposed by the national regulatory authority to address the market failures identified. Where the draft measure relates to a market which is found to be competitive and remedies already exist in relation to that market, the notification should also include the proposals for withdrawing those obligations.

| (12) | In general, a short notification form should be used for certain categories of draft measures in order to reduce the administrative burden on national regulatory authorities and the Authority. However, notification of these categories by way of the standard notification procedure remains possible. |
| --- | --- |

(12)

In general, a short notification form should be used for certain categories of draft measures in order to reduce the administrative burden on national regulatory authorities and the Authority. However, notification of these categories by way of the standard notification procedure remains possible.

| (13) | Where a national regulatory authority intends to withdraw regulatory obligations in relation to markets not included in the Authority’s Recommendation of 5 November 2008 on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation (6), notification of such a draft measure under Article 7 of Directive 2002/21/EC (Framework Directive) should be made by means of the short notification form. |
| --- | --- |

(13)

Where a national regulatory authority intends to withdraw regulatory obligations in relation to markets not included in the Authority’s Recommendation of 5 November 2008 on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation (6), notification of such a draft measure under Article 7 of Directive 2002/21/EC (Framework Directive) should be made by means of the short notification form.

| (14) | Where a national regulatory authority carries out a review of a market that has been found to be effectively competitive in a previous review and finds once more that this market is effectively competitive, the notification should be made by means of the short notification form. |
| --- | --- |

(14)

Where a national regulatory authority carries out a review of a market that has been found to be effectively competitive in a previous review and finds once more that this market is effectively competitive, the notification should be made by means of the short notification form.

| (15) | National regulatory authorities frequently amend technical details of the remedies imposed to take account of changes in economic indicators (such as equipment, labour, inflation, cost of capital, property rental rates, etc.), or to update forecasts or assumptions. Changes or updates of details which do not change the nature or the general scope of remedies (e.g. extension of reporting obligations, details of required insurance coverage, amounts of penalties, or delivery times) should be notified by means of the short notification form. Only material changes to the nature or scope of the remedies that have an appreciable impact on the market (such as price levels, amendments to the methodologies used to calculate costs or prices, determination of glide paths) should be notified by the standard notification procedure. |
| --- | --- |

(15)

National regulatory authorities frequently amend technical details of the remedies imposed to take account of changes in economic indicators (such as equipment, labour, inflation, cost of capital, property rental rates, etc.), or to update forecasts or assumptions. Changes or updates of details which do not change the nature or the general scope of remedies (e.g. extension of reporting obligations, details of required insurance coverage, amounts of penalties, or delivery times) should be notified by means of the short notification form. Only material changes to the nature or scope of the remedies that have an appreciable impact on the market (such as price levels, amendments to the methodologies used to calculate costs or prices, determination of glide paths) should be notified by the standard notification procedure.

| (16) | With regard to certain markets (in particular, voice call termination markets), national regulatory authorities may come to the same conclusion as in a previous review and wish to impose remedies on further operators (e.g. new entrants) with a similar customer base or total turnover to operators covered by a previous review which do not materially differ from draft measures already notified. The short notification form should be used for these draft measures. |
| --- | --- |

(16)

With regard to certain markets (in particular, voice call termination markets), national regulatory authorities may come to the same conclusion as in a previous review and wish to impose remedies on further operators (e.g. new entrants) with a similar customer base or total turnover to operators covered by a previous review which do not materially differ from draft measures already notified. The short notification form should be used for these draft measures.

| (17) | A draft measure notified by means of a short notification form will in principle not give raise to comments by the Authority to the national regulatory authority in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive). |
| --- | --- |

(17)

A draft measure notified by means of a short notification form will in principle not give raise to comments by the Authority to the national regulatory authority in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive).

| (18) | In order to increase transparency on a notified draft measure and to facilitate the exchange of information about such measures between national regulatory authorities both the standard and the short notification forms should contain a summarised description of the main elements of the notified draft measure. |
| --- | --- |

(18)

In order to increase transparency on a notified draft measure and to facilitate the exchange of information about such measures between national regulatory authorities both the standard and the short notification forms should contain a summarised description of the main elements of the notified draft measure.

| (19) | The European Regulators Group for Electronic Communications Networks and Services established by Commission Decision 2002/627/EC (7) has recognised the need for these arrangements. |
| --- | --- |

(19)

The European Regulators Group for Electronic Communications Networks and Services established by Commission Decision 2002/627/EC (7) has recognised the need for these arrangements.

| (20) | To meet the objectives laid down in Article 8 of Directive 2002/21/EC (Framework Directive), in particular the need to ensure consistent regulatory practices and consistent application of that Directive, full compliance with the notification mechanism laid down in Article 7 is essential. |
| --- | --- |

(20)

To meet the objectives laid down in Article 8 of Directive 2002/21/EC (Framework Directive), in particular the need to ensure consistent regulatory practices and consistent application of that Directive, full compliance with the notification mechanism laid down in Article 7 is essential.

| (21) | In order to allow for a consistent application of the regulatory framework across the whole of the EEA and to reap the full benefits of the cooperation between the national regulatory authorities, it is vital that the flow of information between both the EFTA and the EC pillars of the EEA is ensured. A specific adaptation to Article 7(3) of Directive 2002/21/EC (Framework Directive) to this effect contained in the EEA Joint Committee Decision No 11/2004 provides that ‘The exchange of information between the national regulatory authorities of the EFTA States on the one hand and the national regulatory authorities of the EC Member States on the other hand shall pass through the EFTA Surveillance Authority and the Commission.’. |
| --- | --- |

(21)

In order to allow for a consistent application of the regulatory framework across the whole of the EEA and to reap the full benefits of the cooperation between the national regulatory authorities, it is vital that the flow of information between both the EFTA and the EC pillars of the EEA is ensured. A specific adaptation to Article 7(3) of Directive 2002/21/EC (Framework Directive) to this effect contained in the EEA Joint Committee Decision No 11/2004 provides that ‘The exchange of information between the national regulatory authorities of the EFTA States on the one hand and the national regulatory authorities of the EC Member States on the other hand shall pass through the EFTA Surveillance Authority and the Commission.’.

| (22) | The EFTA Communications Committee has delivered its opinion in accordance with Article 22(2) of Directive 2002/21/EC (Framework Directive), |
| --- | --- |

(22)

The EFTA Communications Committee has delivered its opinion in accordance with Article 22(2) of Directive 2002/21/EC (Framework Directive),

HEREBY RECOMMENDS:

| 1. | Terms defined in Directive 2002/21/EC (Framework Directive) and the specific directives have the same meaning when used in this Recommendation. In addition:






  (a) | ‘Recommendation on relevant markets’ means EFTA Surveillance Authority Recommendation of 5 November 2008 on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation (8) and any subsequent Recommendation on relevant markets; |
| --- | --- | --- |

1.

Terms defined in Directive 2002/21/EC (Framework Directive) and the specific directives have the same meaning when used in this Recommendation. In addition:

(a)

‘Recommendation on relevant markets’ means EFTA Surveillance Authority Recommendation of 5 November 2008 on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation (8) and any subsequent Recommendation on relevant markets;

| (b) | ‘notification’ means the notification to the Authority by a national regulatory authority of a draft measure pursuant to Article 7(3) of Directive 2002/21/EC (Framework Directive) or a request pursuant to the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive), accompanied by the standard notification form or the short notification form as provided in this Recommendation (Annex I and Annex II). |
| --- | --- |

(b)

‘notification’ means the notification to the Authority by a national regulatory authority of a draft measure pursuant to Article 7(3) of Directive 2002/21/EC (Framework Directive) or a request pursuant to the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive), accompanied by the standard notification form or the short notification form as provided in this Recommendation (Annex I and Annex II).

| 2. | Notifications should exclusively be made through an electronic notifications system operated by the Authority.
  Documents sent through the electronic notifications system will be presumed to have been received by the addressee on the day on which they were sent.
  Notifications will be registered in the order in which they are received. |
| --- | --- |

2.

Notifications should exclusively be made through an electronic notifications system operated by the Authority.

Documents sent through the electronic notifications system will be presumed to have been received by the addressee on the day on which they were sent.

Notifications will be registered in the order in which they are received.

| 3. | Notifications will become effective on the date on which the Authority registers them (date of registration). The date of registration will be the date on which a complete notification is received by the Authority.
  Notice will be given on the Authority’s website and by electronic means to all national regulatory authorities of the date of registration of the notification, the subject matter of the notification and any supporting documentation received. |
| --- | --- |

3.

Notifications will become effective on the date on which the Authority registers them (date of registration). The date of registration will be the date on which a complete notification is received by the Authority.

Notice will be given on the Authority’s website and by electronic means to all national regulatory authorities of the date of registration of the notification, the subject matter of the notification and any supporting documentation received.

| 4. | Draft national measure, together with the reasoning on which the measure is based, as well as the standard notification form (Annex I) and the short notification form (Annex II), shall be in the English language. |
| --- | --- |

4.

Draft national measure, together with the reasoning on which the measure is based, as well as the standard notification form (Annex I) and the short notification form (Annex II), shall be in the English language.

| 5. | Draft measures notified by a national regulatory authority should be accompanied by the documentation needed for the Authority to carry out its tasks. For those draft measures that fall under point 6 below and are notified by means of the short notification form, the Authority does not need in principle any additional documentation to carry out its tasks.
  Draft measures should be duly substantiated. |
| --- | --- |

5.

Draft measures notified by a national regulatory authority should be accompanied by the documentation needed for the Authority to carry out its tasks. For those draft measures that fall under point 6 below and are notified by means of the short notification form, the Authority does not need in principle any additional documentation to carry out its tasks.

Draft measures should be duly substantiated.

| 6. | The following draft measures should be made available to the Authority by means of the short notification form contained in Annex II:






  (a) | draft measures concerning markets which have been removed from or have not been previously listed in the Recommendation on relevant markets, either where the market is found to be competitive by the national regulatory authority, or where the national regulatory authority considers that the three cumulative criteria referred to in point 2 of the Recommendation on relevant markets for identifying markets that are susceptible to ex ante regulation are no longer met; |
| --- | --- | --- |

6.

The following draft measures should be made available to the Authority by means of the short notification form contained in Annex II:

(a)

draft measures concerning markets which have been removed from or have not been previously listed in the Recommendation on relevant markets, either where the market is found to be competitive by the national regulatory authority, or where the national regulatory authority considers that the three cumulative criteria referred to in point 2 of the Recommendation on relevant markets for identifying markets that are susceptible to ex ante regulation are no longer met;

| (b) | draft measures concerning markets which, while included in the Recommendation on relevant markets in force, had been found to be competitive in a previous market review, and remain competitive; |
| --- | --- |

(b)

draft measures concerning markets which, while included in the Recommendation on relevant markets in force, had been found to be competitive in a previous market review, and remain competitive;

| (c) | draft measures that change the technical details of previously imposed regulatory remedies and do not have an appreciable impact on the market (e.g. annual updates of costs and estimates of accounting models, reporting times, delivery times); and |
| --- | --- |

(c)

draft measures that change the technical details of previously imposed regulatory remedies and do not have an appreciable impact on the market (e.g. annual updates of costs and estimates of accounting models, reporting times, delivery times); and

| (d) | draft measures concerning a relevant market that has already been analysed and notified in relation to other undertakings, where the national regulatory authorities imposes similar remedies on other undertakings, without materially changing the principles applied in the previous notification. |
| --- | --- |

(d)

draft measures concerning a relevant market that has already been analysed and notified in relation to other undertakings, where the national regulatory authorities imposes similar remedies on other undertakings, without materially changing the principles applied in the previous notification.

| 7. | The Authority, in close cooperation with the national regulatory authorities, will monitor the practical consequences of the short notification procedure with a view to make any further adjustments as may be necessary or add other categories of draft measures that should be notified using the short notification form. |
| --- | --- |

7.

The Authority, in close cooperation with the national regulatory authorities, will monitor the practical consequences of the short notification procedure with a view to make any further adjustments as may be necessary or add other categories of draft measures that should be notified using the short notification form.

| 8. | Draft measures not falling under point 6 above should be made available to the Authority by means of the standard notification form set out in Annex I. The draft measures notified should include each of the following where applicable:






  (a) | the relevant product or service market, in particular, a description of the products and services to be included in and excluded from the relevant market on the basis of demand-side and supply-side substitutability; |
| --- | --- | --- |

8.

Draft measures not falling under point 6 above should be made available to the Authority by means of the standard notification form set out in Annex I. The draft measures notified should include each of the following where applicable:

(a)

the relevant product or service market, in particular, a description of the products and services to be included in and excluded from the relevant market on the basis of demand-side and supply-side substitutability;

| (b) | the relevant geographic market, including a reasoned analysis of the competitive conditions on the basis of demand-side and supply-side substitutability; |
| --- | --- |

(b)

the relevant geographic market, including a reasoned analysis of the competitive conditions on the basis of demand-side and supply-side substitutability;

| (c) | the main undertakings active on the relevant market; |
| --- | --- |

(c)

the main undertakings active on the relevant market;

| (d) | the results of the analysis of the relevant market, in particular the findings as to the presence or absence of effective competition, together with the reasons therefore. For these purposes, the draft measure should contain an analysis of the market shares of the different undertakings and a reference to other relevant criteria, as appropriate, such as barriers to entry, economies of scale and scope, vertical integration, control of infrastructure not easily duplicated, technological advantages or superiority, absence of or low countervailing buying power, easy or privileged access to capital markets/financial resources, overall size of the undertaking, product/services diversification, highly developed distribution and sales network, absence of potential competition and barriers to expansion; |
| --- | --- |

(d)

the results of the analysis of the relevant market, in particular the findings as to the presence or absence of effective competition, together with the reasons therefore. For these purposes, the draft measure should contain an analysis of the market shares of the different undertakings and a reference to other relevant criteria, as appropriate, such as barriers to entry, economies of scale and scope, vertical integration, control of infrastructure not easily duplicated, technological advantages or superiority, absence of or low countervailing buying power, easy or privileged access to capital markets/financial resources, overall size of the undertaking, product/services diversification, highly developed distribution and sales network, absence of potential competition and barriers to expansion;

| (e) | where appropriate, the undertakings to be designated as having, individually or jointly, significant market power within the meaning of Article 14 of Directive 2002/21/EC (Framework Directive) and the reasoning, evidence and any other relevant factual information in support of such designation; |
| --- | --- |

(e)

where appropriate, the undertakings to be designated as having, individually or jointly, significant market power within the meaning of Article 14 of Directive 2002/21/EC (Framework Directive) and the reasoning, evidence and any other relevant factual information in support of such designation;

| (f) | the results of the prior public consultation carried out by the national regulatory authority; |
| --- | --- |

(f)

the results of the prior public consultation carried out by the national regulatory authority;

| (g) | the opinion issued by the national competition authority, where provided; |
| --- | --- |

(g)

the opinion issued by the national competition authority, where provided;

| (h) | evidence that, at the time of notification to the Authority, appropriate steps had been taken to notify the draft measures to the national regulatory authorities in all other EFTA States, to the extent that the electronic system operated by the Authority does not ensure such notification; |
| --- | --- |

(h)

evidence that, at the time of notification to the Authority, appropriate steps had been taken to notify the draft measures to the national regulatory authorities in all other EFTA States, to the extent that the electronic system operated by the Authority does not ensure such notification;

| (i) | in the case of notification of draft measures which fall within the scope of Articles 5 or 8 of Directive 2002/19/EC (Access Directive) or Article 16 of the Act referred to at point 5cm of Annex XI to the EEA Agreement (Directive 2002/22/EC of the European Parliament and of the Council on universal service and users’ rights relating to electronic communications networks and services) (9) (Universal Service Directive), as adapted by Protocol 1, the specific regulatory obligations proposed to address the lack of effective competition in the relevant market concerned or, in cases where a relevant market is found to be effectively competitive and such obligations have already been imposed in respect of that market, the draft measures proposed to withdraw those obligations. |
| --- | --- |

(i)

in the case of notification of draft measures which fall within the scope of Articles 5 or 8 of Directive 2002/19/EC (Access Directive) or Article 16 of the Act referred to at point 5cm of Annex XI to the EEA Agreement (Directive 2002/22/EC of the European Parliament and of the Council on universal service and users’ rights relating to electronic communications networks and services) (9) (Universal Service Directive), as adapted by Protocol 1, the specific regulatory obligations proposed to address the lack of effective competition in the relevant market concerned or, in cases where a relevant market is found to be effectively competitive and such obligations have already been imposed in respect of that market, the draft measures proposed to withdraw those obligations.

| 9. | Where, for the purposes of the market analysis, a draft measure defines a relevant market which differs from those in the Recommendation on relevant markets, national regulatory authorities should provide sufficient reasoning of the criteria used for such a market definition. |
| --- | --- |

9.

Where, for the purposes of the market analysis, a draft measure defines a relevant market which differs from those in the Recommendation on relevant markets, national regulatory authorities should provide sufficient reasoning of the criteria used for such a market definition.

| 10. | Notifications made in accordance with the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive) should also contain adequate reasoning as to why obligations other than those listed in Articles 9 to 13 of the Directive 2002/19/EC (Access Directive) should be imposed on operators with significant market power. |
| --- | --- |

10.

Notifications made in accordance with the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive) should also contain adequate reasoning as to why obligations other than those listed in Articles 9 to 13 of the Directive 2002/19/EC (Access Directive) should be imposed on operators with significant market power.

| 11. | Notifications falling within the scope of Article 8(5) of Directive 2002/19/EC (Access Directive) should also contain adequate reasoning as to why the intended draft measures are required to comply with international commitments. |
| --- | --- |

11.

Notifications falling within the scope of Article 8(5) of Directive 2002/19/EC (Access Directive) should also contain adequate reasoning as to why the intended draft measures are required to comply with international commitments.

| 12. | Notifications made by means of the standard notification procedure that include the applicable information within the meaning of point 8 above will be presumed to be complete. Where the information, including documents, contained in the notification is incomplete in any material respect, the Authority will inform the national regulatory authority concerned within five working days and specify to what extent it considers the notification to be incomplete. The notification will not be registered until the national regulatory authority concerned has provided the requisite information. In such cases, for the purposes of Article 7 of Directive 2002/21/EC (Framework Directive), the notification will become effective on the date on which the Authority receives the complete information. |
| --- | --- |

12.

Notifications made by means of the standard notification procedure that include the applicable information within the meaning of point 8 above will be presumed to be complete. Where the information, including documents, contained in the notification is incomplete in any material respect, the Authority will inform the national regulatory authority concerned within five working days and specify to what extent it considers the notification to be incomplete. The notification will not be registered until the national regulatory authority concerned has provided the requisite information. In such cases, for the purposes of Article 7 of Directive 2002/21/EC (Framework Directive), the notification will become effective on the date on which the Authority receives the complete information.

| 13. | Without prejudice to point 8 above, following registration of a notification, the Authority, acting in accordance with Article 5(2) of Directive 2002/21/EC (Framework Directive), may seek further information or clarification from the national regulatory authority concerned. National regulatory authorities should endeavour to provide the information requested within three working days, where this is readily available. |
| --- | --- |

13.

Without prejudice to point 8 above, following registration of a notification, the Authority, acting in accordance with Article 5(2) of Directive 2002/21/EC (Framework Directive), may seek further information or clarification from the national regulatory authority concerned. National regulatory authorities should endeavour to provide the information requested within three working days, where this is readily available.

| 14. | The Authority will verify whether or not the draft measure made available by means of a short notification form falls within the categories listed under point 6 above. Where the Authority considers this not to be the case, it will inform the national regulatory authority concerned within five working days and ask the notifying regulatory authority to submit the draft measure by means of the standard notification procedure. |
| --- | --- |

14.

The Authority will verify whether or not the draft measure made available by means of a short notification form falls within the categories listed under point 6 above. Where the Authority considers this not to be the case, it will inform the national regulatory authority concerned within five working days and ask the notifying regulatory authority to submit the draft measure by means of the standard notification procedure.

| 15. | Where the Authority makes comments in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive), it will notify the national regulatory authority concerned by electronic means and publish such comments on its website. |
| --- | --- |

15.

Where the Authority makes comments in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive), it will notify the national regulatory authority concerned by electronic means and publish such comments on its website.

| 16. | Where a national regulatory authority makes comments in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive), it shall communicate those comments to the Authority and the other national regulatory authorities by electronic means. |
| --- | --- |

16.

Where a national regulatory authority makes comments in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive), it shall communicate those comments to the Authority and the other national regulatory authorities by electronic means.

| 17. | Where, in application of Article 7(4) of Directive 2002/21/EC (Framework Directive), the Authority considers that a draft measure would create a barrier to the functioning of the EEA Agreement or it has serious doubts as to its compatibility with EEA law and in particular the objectives referred to in Article 8 of Directive 2002/21/EC (Framework Directive); or it subsequently withdraws its objections, or takes a decision requiring a national regulatory authority to withdraw a draft measure, it will notify the national regulatory authority concerned by electronic means and post a notice on its website. |
| --- | --- |

17.

Where, in application of Article 7(4) of Directive 2002/21/EC (Framework Directive), the Authority considers that a draft measure would create a barrier to the functioning of the EEA Agreement or it has serious doubts as to its compatibility with EEA law and in particular the objectives referred to in Article 8 of Directive 2002/21/EC (Framework Directive); or it subsequently withdraws its objections, or takes a decision requiring a national regulatory authority to withdraw a draft measure, it will notify the national regulatory authority concerned by electronic means and post a notice on its website.

| 18. | With regard to notifications made pursuant to the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive), the Authority, acting in accordance with Article 14(2) of Directive 2002/19/EC (Access Directive), will normally take a decision authorising or preventing the national regulatory authority from adopting the proposed draft measure within a period not exceeding three months. The Authority may decide to extend this period for a further two months in view of the difficulties raised. |
| --- | --- |

18.

With regard to notifications made pursuant to the second subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive), the Authority, acting in accordance with Article 14(2) of Directive 2002/19/EC (Access Directive), will normally take a decision authorising or preventing the national regulatory authority from adopting the proposed draft measure within a period not exceeding three months. The Authority may decide to extend this period for a further two months in view of the difficulties raised.

| 19. | A national regulatory authority may decide at any time to withdraw the notified draft measure, in which case the notified measure will be removed from the register. The Authority will publish a notice to that effect on its website. |
| --- | --- |

19.

A national regulatory authority may decide at any time to withdraw the notified draft measure, in which case the notified measure will be removed from the register. The Authority will publish a notice to that effect on its website.

| 20. | Where a national regulatory authority adopts the draft measure after receiving comments from the Authority or another national regulatory authority made in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive), it shall communicate to the Authority and other national regulatory authorities of the manner in which it took the utmost account of the comments made. |
| --- | --- |

20.

Where a national regulatory authority adopts the draft measure after receiving comments from the Authority or another national regulatory authority made in accordance with Article 7(3) of Directive 2002/21/EC (Framework Directive), it shall communicate to the Authority and other national regulatory authorities of the manner in which it took the utmost account of the comments made.

| 21. | When requested by a national regulatory authority, the Authority will informally discuss a draft measure prior to notification. |
| --- | --- |

21.

When requested by a national regulatory authority, the Authority will informally discuss a draft measure prior to notification.

| 22. | Any period of time referred to in Directive 2002/21/EC (Framework Directive) or in this Recommendation will be calculated as follows:






  (a) | where a period expressed in days, weeks or months is to be calculated from the moment at which an event occurs, the day during which that event occurs shall not be counted as falling within the period in question; |
| --- | --- | --- |

22.

Any period of time referred to in Directive 2002/21/EC (Framework Directive) or in this Recommendation will be calculated as follows:

(a)

where a period expressed in days, weeks or months is to be calculated from the moment at which an event occurs, the day during which that event occurs shall not be counted as falling within the period in question;

| (b) | a period expressed in weeks or in months shall end with the expiry of whichever day in the last week or month is the same day of the week or falls on the same date as the day during which the event from which the period is to be calculated occurred. Where, in a period expressed in months, the day on which it should expire does not occur in the last month, the period shall end with the expiry of the last day of that month; |
| --- | --- |

(b)

a period expressed in weeks or in months shall end with the expiry of whichever day in the last week or month is the same day of the week or falls on the same date as the day during which the event from which the period is to be calculated occurred. Where, in a period expressed in months, the day on which it should expire does not occur in the last month, the period shall end with the expiry of the last day of that month;

| (c) | time periods shall include public holidays, Saturdays and Sundays, save where these are expressly excluded or where the periods are expressed in working days. Public holidays means all days designated as such by the EFTA State concerned or by the Authority; |
| --- | --- |

(c)

time periods shall include public holidays, Saturdays and Sundays, save where these are expressly excluded or where the periods are expressed in working days. Public holidays means all days designated as such by the EFTA State concerned or by the Authority;

| (d) | working days mean all days other than public holidays, Saturdays and Sundays. |
| --- | --- |

(d)

working days mean all days other than public holidays, Saturdays and Sundays.

Should a time period end on a Saturday, Sunday or a public holiday, it shall be extended until the end of the first following working day.

The Authority publishes a list of public holidays designated by the EFTA States and by the Authority each year in the EEA Supplement to the Official Journal of the European Union. The EFTA States shall transmit a list of public holidays to the Authority upon request.

| 23. | The Authority, together with the national regulatory authorities, will evaluate the necessity of reviewing this Recommendation as appropriate after the date established in the review of the regulatory framework, as incorporated into the EEA law, for the transposition by the EFTA States into national law. |
| --- | --- |

23.

The Authority, together with the national regulatory authorities, will evaluate the necessity of reviewing this Recommendation as appropriate after the date established in the review of the regulatory framework, as incorporated into the EEA law, for the transposition by the EFTA States into national law.

| 24. | This Recommendation is addressed to the EFTA States. |
| --- | --- |

24.

This Recommendation is addressed to the EFTA States.

Done at Brussels, 2 December 2009.

For the EFTA Surveillance Authority

Per SANDERUD

President

Kurt JÄGER

College Member

---

(1)  Hereinafter referred to as the ‘Authority’.

1

(2)  Hereinafter referred to as the ‘EEA Agreement’.

2

(3)  OJ L 108, 24.4.2002, p. 33. Directive as amended by Regulation (EC) No 717/2007, OJ L 171, 29.6.2007, p. 32.

3

(4)  OJ L 108, 24.4.2002, p. 7.

4

(5)  Adopted by Decision No 193/04/COL (OJ L 113, 27.4.2006, p. 10).

5

(6)  EFTA Surveillance Authority Recommendation of 5 November 2008 on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation in accordance with the Act referred to at point 5cl of Annex XI to the EEA Agreement (Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services), as adapted by Protocol 1 thereto. Hereinafter referred to as the Recommendation on relevant markets. The Recommendation was adopted by Decision No 688/08/COL of 5 November 2008 adopting a Recommendation on relevant markets within the electronic communications sector susceptible to ex ante regulation and published in OJ C 156, 9.7.2009, p. 18 and EEA Supplement No 36, 9.7.2009, p. 1.

6

ex ante

ex ante

(7)  OJ L 200, 30.7.2002, p. 38, as amended.

7

(8)  See footnote 5 above.

8

(9)  OJ L 108, 24.4.2002, p. 51.

9

---

ANNEX I

Standard form relating to notifications of draft measures pursuant to Article 7 of Directive 2002/21/EC (Framework Directive)

(Standard notification form)

INTRODUCTION

The standard notification form specifies the summary information to be provided by national regulatory authorities to the Authority when notifying draft measures under the standard notification procedure in accordance with Article 7 of Directive 2002/21/EC (Framework Directive).

The Authority intends to discuss issues relating to the implementation of Article 7 with national regulatory authorities, especially during pre-notification meetings. Accordingly, national regulatory authorities are encouraged to consult the Authority on any aspect of the standard notification form and in particular on the kind of information they are requested to supply or, conversely, the possibility of dispensing with the obligation to provide certain information in relation to the market analysis carried out pursuant to Articles 15 and 16 of Directive 2002/21/EC (Framework Directive).

CORRECT AND COMPLETE INFORMATION

All information submitted by national regulatory authorities should be correct and complete and summarised on the standard notification form set out below. The standard notification form is not meant to replace the notified draft measure, but it should enable the Authority and the national regulatory authorities of other EEA States to verify that the notified draft measure does indeed contain, by reference to the information contained in the standard notification form, all the information needed for the Authority to carry out its tasks under Article 7 of Directive 2002/21/EC (Framework Directive) within the time frame set therein.

The information required should be set out in the sections and paragraphs of the standard notification form, with cross-references to the body of the draft measure where this information is to be found.

LANGUAGE

The standard notification form should be completed in the English language.

Section 1

Market definition

Please state where applicable:

| 1.1. | The relevant product/service market. Is this market mentioned in the Recommendation on relevant markets? |
| --- | --- |

1.1.

The relevant product/service market. Is this market mentioned in the Recommendation on relevant markets?

| 1.2. | The relevant geographic market. |
| --- | --- |

1.2.

The relevant geographic market.

| 1.3. | A brief summary of the opinion of the national competition authority, where provided. |
| --- | --- |

1.3.

A brief summary of the opinion of the national competition authority, where provided.

| 1.4. | A brief overview of the results of the public consultation to date on the proposed market definition (e.g. how many comments were received, which respondents agreed with the proposed market definition, which respondents disagreed with it). |
| --- | --- |

1.4.

A brief overview of the results of the public consultation to date on the proposed market definition (e.g. how many comments were received, which respondents agreed with the proposed market definition, which respondents disagreed with it).

| 1.5. | Where the relevant market is different from those listed in the Recommendation on relevant markets, a summary of the main reasons justifying the proposed market definition by reference to Section 2 of the Authority’s Guidelines of 14 July 2004 on market analysis and the assessment of significant market power under the regulatory framework for electronic communications networks and services (1), and the three main criteria mentioned in recitals 6 to 14 of the Recommendation on relevant markets and Section 2.2 of the Explanatory Note accompanying the corresponding Commission’s Recommendation on relevant markets (2). |
| --- | --- |

1.5.

Where the relevant market is different from those listed in the Recommendation on relevant markets, a summary of the main reasons justifying the proposed market definition by reference to Section 2 of the Authority’s Guidelines of 14 July 2004 on market analysis and the assessment of significant market power under the regulatory framework for electronic communications networks and services (1), and the three main criteria mentioned in recitals 6 to 14 of the Recommendation on relevant markets and Section 2.2 of the Explanatory Note accompanying the corresponding Commission’s Recommendation on relevant markets (2).

Section 2

Designation of undertakings with significant market power

Please state where applicable:

| 2.1. | The name of the undertakings designated as having, individually or jointly, significant market power.
  Where applicable, the name of the undertakings considered no longer to have significant market power. |
| --- | --- |

2.1.

The name of the undertakings designated as having, individually or jointly, significant market power.

Where applicable, the name of the undertakings considered no longer to have significant market power.

| 2.2. | The criteria used to designate an undertaking as having significant market power, individually or jointly, or not. |
| --- | --- |

2.2.

The criteria used to designate an undertaking as having significant market power, individually or jointly, or not.

| 2.3. | The name of the main undertakings (competitors) active in the relevant market. |
| --- | --- |

2.3.

The name of the main undertakings (competitors) active in the relevant market.

| 2.4. | The market shares of the undertakings mentioned above and the basis for calculation of market share (e.g. turnover, number of subscribers). |
| --- | --- |

2.4.

The market shares of the undertakings mentioned above and the basis for calculation of market share (e.g. turnover, number of subscribers).

Please provide a brief summary of:

| 2.5. | The opinion of the national competition authority, where provided. |
| --- | --- |

2.5.

The opinion of the national competition authority, where provided.

| 2.6. | The results of the public consultation to date on the proposed designation(s) as undertakings having significant market power (e.g. total number of comments received, numbers agreeing/disagreeing). |
| --- | --- |

2.6.

The results of the public consultation to date on the proposed designation(s) as undertakings having significant market power (e.g. total number of comments received, numbers agreeing/disagreeing).

Section 3

Regulatory obligations

Please state where applicable:

| 3.1. | The legal basis for the obligations to be imposed, maintained, amended or withdrawn (Articles 9 to 13 of Directive 2002/19/EC (Access Directive)). |
| --- | --- |

3.1.

The legal basis for the obligations to be imposed, maintained, amended or withdrawn (Articles 9 to 13 of Directive 2002/19/EC (Access Directive)).

| 3.2. | The reasons for which the imposition, maintenance or amendment of obligations on undertakings is considered proportional and justified in the light of the objectives laid down in Article 8 of Directive 2002/21/EC (Framework Directive). Alternatively, indicate the paragraphs, sections or pages of the draft measure where such information is to be found. |
| --- | --- |

3.2.

The reasons for which the imposition, maintenance or amendment of obligations on undertakings is considered proportional and justified in the light of the objectives laid down in Article 8 of Directive 2002/21/EC (Framework Directive). Alternatively, indicate the paragraphs, sections or pages of the draft measure where such information is to be found.

| 3.3. | Where the remedies proposed are other than those set out in Articles 9 to 13 of Directive 2002/19/EC (Access Directive), please indicate what ‘exceptional circumstances’ within the meaning of Article 8(3) of that Directive justify the imposition of such remedies. Alternatively, indicate the paragraphs, sections or pages of the draft measure where such information is to be found. |
| --- | --- |

3.3.

Where the remedies proposed are other than those set out in Articles 9 to 13 of Directive 2002/19/EC (Access Directive), please indicate what ‘exceptional circumstances’ within the meaning of Article 8(3) of that Directive justify the imposition of such remedies. Alternatively, indicate the paragraphs, sections or pages of the draft measure where such information is to be found.

Section 4

Compliance with international obligations

In relation to the third intend of the first subparagraph of Article 8(3) of Directive 2002/19/EC (Access Directive), please state where applicable:

| 4.1. | Whether the proposed draft measure intends to impose, amend or withdraw obligations on market players as provided for in Article 8(5) of Directive 2002/19/EC (Access Directive). |
| --- | --- |

4.1.

Whether the proposed draft measure intends to impose, amend or withdraw obligations on market players as provided for in Article 8(5) of Directive 2002/19/EC (Access Directive).

| 4.2. | The name of the undertakings concerned. |
| --- | --- |

4.2.

The name of the undertakings concerned.

| 4.3. | What international commitments entered into by the EFTA State are to be met. |
| --- | --- |

4.3.

What international commitments entered into by the EFTA State are to be met.

---

(1)  EFTA Surveillance Authority Guidelines of 14 July 2004 on market analysis and the assessment of significant market power under the regulatory framework for electronic communications networks and services referred to in Annex XI of the Agreement on the European Economic Area. Adopted by Decision No 194/04/COL, OJ C 101, 27.4.2006, p. 1 and the EEA Supplement No 21 of 27.4.2006, p. 1.

(2)  Explanatory Note accompanying the Commission Recommendation on relevant product and service markets within the electronic communications sector susceptible to ex ante regulation in accordance with Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services, SEC(2007) 1483 final.

---

ANNEX II

Short form relating to notifications of draft measures pursuant to Article 7 of Directive 2002/21/EC (Framework Directive)

(Short notification form)

INTRODUCTION

The short notification form specifies the summary information to be provided by national regulatory authorities to the Authority when notifying draft measures under the short notification procedure in accordance with Article 7 of Directive 2002/21/EC (Framework Directive).

It is not necessary to provide a copy of the draft regulatory measure or to attach any other document to the short notification form. However, it is necessary to indicate the Internet reference through which the draft measure can be accessible in the short notification form.

| 1. | One or several markets which has/have been removed from or have not been previously listed in the Recommendation on relevant markets is/are found to be competitive or not to meet the three criteria |
| --- | --- |

1.

One or several markets which has/have been removed from or have not been previously listed in the Recommendation on relevant markets is/are found to be competitive or not to meet the three criteria

Please briefly describe the content of the notified draft measure. In particular, please refer to the relevant market concerned and the reasons why you consider that the market is effectively competitive or the three criteria are not met:

Please indicate the Article 7 notification reference of the previously notified draft measures:

Does the NCA agree with the proposed draft measure as regards the analysis of the relevant market?

Yes



If no, please outline reasons:

No



Internet reference to the draft measure:

Comments:

| 2. | One or several markets which was/were found to be competitive in a previous market review is/are still competitive |
| --- | --- |

2.

One or several markets which was/were found to be competitive in a previous market review is/are still competitive

Please briefly describe the content of the draft measure, indicating the relevant market concerned:

Please indicate the Article 7 notification reference of the previously notified draft measures:

Are there changes to the market definition, as compared with previously notified draft measures?

Yes



If yes, please describe briefly:

No



Does the NCA agree with the proposed draft measure as regards the analysis of the relevant market?

Yes



If no, please outline reasons:

No



Internet reference to the draft measure:

Comments:

| 3. | Changes to technical details of a previously imposed regulatory remedy |
| --- | --- |

3.

Changes to technical details of a previously imposed regulatory remedy

Please summarise the notified changes to the remedies indicating the relevant market concerned:

Please justify your conclusion that the measure consists of a change on a technical detail of a remedy and does not change the nature or the general scope of a remedy:

Please indicate the Article 7 notification reference of the previously notified draft measures:

Internet reference to the draft measure:

Comments:

| 4. | Imposition on further operators of remedies already analysed and notified in relation to other undertakings that are similar as regards their customer base or total turnover in telecoms markets, without changing the principles applied by the NRA in the previous notification |
| --- | --- |

4.

Imposition on further operators of remedies already analysed and notified in relation to other undertakings that are similar as regards their customer base or total turnover in telecoms markets, without changing the principles applied by the NRA in the previous notification

Please briefly summarise the content of the draft measure, indicating the relevant market concerned:

Please indicate the Article 7 notification reference of the previously notified draft measures:

Please list the operators on whom this draft measure imposes obligations:

Does the NCA agree with the proposed draft measure as regards the analysis of the relevant market?

Yes



If no, please outline reasons:

No



Internet reference to the draft measure:

Comments:

---

Standing Committee of the EFTA States

| 13.10.2011 | EN | Official Journal of the European Union | C 302/22 |
| --- | --- | --- | --- |

13.10.2011

EN

Official Journal of the European Union

C 302/22

---

Medicinal products — List of marketing authorisations granted by the EEA EFTA States for the second half of 2010

2011/C 302/06

Subcommittee I on the free movement of goods

To be noted by the EEA Joint Committee

With reference to EEA Joint Committee Decision No 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 2010, at their meeting on 1 April 2011:

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

Annex I

List of new marketing authorisations

Annex II

List of renewed marketing authorisations

Annex III

List of extended marketing authorisations

Annex IV

List of withdrawn marketing authorisations

Annex V

List of suspended marketing authorisations

---

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 2010:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/09/605/001/NO-012/NO | Temomedac | Norway | 8.7.2010 |
| EU/1/10/626/001-004 | Ribavirin BioPartners | Liechtenstein | 31.8.2010 |
| EU/1/10/629/001/NO | Humenza | Norway | 17.8.2010 |
| EU/1/10/631/001/NO-009/NO | Nivestim | Norway | 15.9.2010 |
| EU/1/10/631/001-009/IS | Nivestim | Iceland | 27.8.2010 |
| EU/1/10/632/001/NO-021/NO | Tolura | Norway | 26.8.2010 |
| EU/1/10/632/001-021/IS | Tolura | Iceland | 2.7.2010 |
| EU/1/10/633/001-002/IS | Topotecan Hospira | Iceland | 1.9.2010 |
| EU/1/10/634/001/NO-004/NO | Ribavirin Three Rivers | Norway | 19.8.2010 |
| EU/1/10/636/001/NO-003/NO | Daxas | Norway | 12.8.2010 |
| EU/1/10/636/001-003 | Daxas | Liechtenstein | 31.8.2010 |
| EU/1/10/636/001-003/IS | Daxas | Iceland | 3.8.2010 |
| EU/1/10/637/001/NO-009/NO | Leflunomide medac | Norway | 25.8.2010 |
| EU/1/10/637/001-009 | Leflunomide medac | Liechtenstein | 31.10.2010 |
| EU/1/10/637/001-009/IS | Leflunomide medac | Iceland | 26.8.2010 |
| EU/1/10/638/001 | Ozurdex | Liechtenstein | 31.8.2010 |
| EU/1/10/638/001/IS | Ozurdex | Iceland | 26.8.2010 |
| EU/1/10/638/001/NO | Ozurdex | Norway | 8.10.2010 |
| EU/1/10/639/001-030 | Telmisartan Actavis | Liechtenstein | 31.12.2010 |
| EU/1/10/639/001-030/IS | Telmisartan Actavis | Iceland | 15.12.2010 |
| EU/1/10/640/001/NO-006/NO | Sycrest | Norway | 15.11.2010 |
| EU/1/10/640/001-006 | Sycrest | Liechtenstein | 31.10.2010 |
| EU/1/10/640/001-006/IS | Sycrest | Iceland | 23.9.2010 |
| EU/1/10/641/001/NO | Ruconest | Norway | 2.12.2010 |
| EU/1/10/642/001-004 | Ibandronic acid | Liechtenstein | 31.10.2010 |
| EU/1/10/643/001 | Rapiscan | Liechtenstein | 31.10.2010 |
| EU/1/10/643/001/IS | Rapiscan | Iceland | 26.10.2010 |
| EU/1/10/643/001/NO | Rapiscan | Norway | 27.9.2010 |
| EU/1/10/644/001/NO-004/NO | PecFent | Norway | 15.9.2010 |
| EU/1/10/644/001-004 | PecFent | Liechtenstein | 31.10.2010 |
| EU/1/10/644/001-004/IS | PecFent | Iceland | 29.9.2010 |
| EU/1/10/645/001/NO-002/NO | Brinavess | Norway | 28.9.2010 |
| EU/1/10/645/001-002 | Brinavess | Liechtenstein | 31.10.2010 |
| EU/1/10/645/001-002/IS | Brinavess | Iceland | 23.9.2010 |
| EU/1/10/646/001/NO-002/NO | VPRIV | Norway | 2.11.2010 |
| EU/1/10/646/001-002 | VPRIV | Liechtenstein | 31.10.2010 |
| EU/1/10/646/001-002/IS | VPRIV | Iceland | 17.9.2010 |
| EU/1/10/647/001/NO-002/NO | Myclausen | Norway | 17.11.2010 |
| EU/1/10/647/001-002 | Myclausen | Liechtenstein | 31.10.2010 |
| EU/1/10/648/001/NO-028/NO | Twynsta | Norway | 29.11.2010 |
| EU/1/10/648/001-028 | Twynsta | Liechtenstein | 31.10.2010 |
| EU/1/10/650/001/NO-015/NO | Clopidogrel Teva Generics B.V. | Norway | 26.11.2010 |
| EU/1/10/650/001-015 | Clopidogrel Teva Generics B.V. | Liechtenstein | 31.12.2010 |
| EU/1/10/651/001/NO-015/NO | Clopidogrel HCS | Norway | 26.11.2010 |
| EU/1/10/651/001-015 | Clopidogrel HCS | Liechtenstein | 31.12.2010 |
| EU/1/10/654/001-004 | Leflunomide Ratiopharm | Liechtenstein | 31.12.2010 |
| EU/1/10/655/001/NO-006/NO | Brilique | Norway | 16.12.2010 |
| EU/1/10/655/001-006 | Brilique | Liechtenstein | 31.12.2010 |
| EU/1/10/655/001-006/IS | Brilique | Iceland | 10.12.2010 |
| EU/1/10/656/001-006 | Possia | Liechtenstein | 31.12.2010 |
| EU/1/10/657/001-002 | Präpandemischer Influenzaimpfstoff (H5N1) | Liechtenstein | 31.12.2010 |
| EU/1/10/658/001-002 | Aflunov | Liechtenstein | 31.12.2010 |
| EU/2/10/106/001/NO-014/NO | Bovilis BTV8 | Norway | 5.10.2010 |
| EU/2/10/106/001-014 | Bovilis BTV8 | Liechtenstein | 31.10.2010 |
| EU/2/10/106/001-014/IS | Bovilis BTV8 | Iceland | 20.10.2010 |
| EU/2/10/108/001/NO-005/NO | BTVPUR Alsap 2-4 | Norway | 22.11.2010 |
| EU/2/10/108/001-005 | BTVPUR Alsap 2-4 | Liechtenstein | 31.12.2010 |
| EU/2/10/109/001-009 | Rhiniseng | Liechtenstein | 31.10.2010 |
| EU/2/10/109/001-009/IS | Rhiniseng | Iceland | 10.12.2010 |
| EU/2/10/110/001-002 | Coxevac | Liechtenstein | 31.10.2010 |
| EU/2/10/111/001-004 | Meloxoral | Liechtenstein | 31.12.2010 |

EU-Number

Product

Country

Date of authorisation

EU/1/09/605/001/NO-012/NO

Temomedac

Norway

8.7.2010

EU/1/10/626/001-004

Ribavirin BioPartners

Liechtenstein

31.8.2010

EU/1/10/629/001/NO

Humenza

Norway

17.8.2010

EU/1/10/631/001/NO-009/NO

Nivestim

Norway

15.9.2010

EU/1/10/631/001-009/IS

Nivestim

Iceland

27.8.2010

EU/1/10/632/001/NO-021/NO

Tolura

Norway

26.8.2010

EU/1/10/632/001-021/IS

Tolura

Iceland

2.7.2010

EU/1/10/633/001-002/IS

Topotecan Hospira

Iceland

1.9.2010

EU/1/10/634/001/NO-004/NO

Ribavirin Three Rivers

Norway

19.8.2010

EU/1/10/636/001/NO-003/NO

Daxas

Norway

12.8.2010

EU/1/10/636/001-003

Daxas

Liechtenstein

31.8.2010

EU/1/10/636/001-003/IS

Daxas

Iceland

3.8.2010

EU/1/10/637/001/NO-009/NO

Leflunomide medac

Norway

25.8.2010

EU/1/10/637/001-009

Leflunomide medac

Liechtenstein

31.10.2010

EU/1/10/637/001-009/IS

Leflunomide medac

Iceland

26.8.2010

EU/1/10/638/001

Ozurdex

Liechtenstein

31.8.2010

EU/1/10/638/001/IS

Ozurdex

Iceland

26.8.2010

EU/1/10/638/001/NO

Ozurdex

Norway

8.10.2010

EU/1/10/639/001-030

Telmisartan Actavis

Liechtenstein

31.12.2010

EU/1/10/639/001-030/IS

Telmisartan Actavis

Iceland

15.12.2010

EU/1/10/640/001/NO-006/NO

Sycrest

Norway

15.11.2010

EU/1/10/640/001-006

Sycrest

Liechtenstein

31.10.2010

EU/1/10/640/001-006/IS

Sycrest

Iceland

23.9.2010

EU/1/10/641/001/NO

Ruconest

Norway

2.12.2010

EU/1/10/642/001-004

Ibandronic acid

Liechtenstein

31.10.2010

EU/1/10/643/001

Rapiscan

Liechtenstein

31.10.2010

EU/1/10/643/001/IS

Rapiscan

Iceland

26.10.2010

EU/1/10/643/001/NO

Rapiscan

Norway

27.9.2010

EU/1/10/644/001/NO-004/NO

PecFent

Norway

15.9.2010

EU/1/10/644/001-004

PecFent

Liechtenstein

31.10.2010

EU/1/10/644/001-004/IS

PecFent

Iceland

29.9.2010

EU/1/10/645/001/NO-002/NO

Brinavess

Norway

28.9.2010

EU/1/10/645/001-002

Brinavess

Liechtenstein

31.10.2010

EU/1/10/645/001-002/IS

Brinavess

Iceland

23.9.2010

EU/1/10/646/001/NO-002/NO

VPRIV

Norway

2.11.2010

EU/1/10/646/001-002

VPRIV

Liechtenstein

31.10.2010

EU/1/10/646/001-002/IS

VPRIV

Iceland

17.9.2010

EU/1/10/647/001/NO-002/NO

Myclausen

Norway

17.11.2010

EU/1/10/647/001-002

Myclausen

Liechtenstein

31.10.2010

EU/1/10/648/001/NO-028/NO

Twynsta

Norway

29.11.2010

EU/1/10/648/001-028

Twynsta

Liechtenstein

31.10.2010

EU/1/10/650/001/NO-015/NO

Clopidogrel Teva Generics B.V.

Norway

26.11.2010

EU/1/10/650/001-015

Clopidogrel Teva Generics B.V.

Liechtenstein

31.12.2010

EU/1/10/651/001/NO-015/NO

Clopidogrel HCS

Norway

26.11.2010

EU/1/10/651/001-015

Clopidogrel HCS

Liechtenstein

31.12.2010

EU/1/10/654/001-004

Leflunomide Ratiopharm

Liechtenstein

31.12.2010

EU/1/10/655/001/NO-006/NO

Brilique

Norway

16.12.2010

EU/1/10/655/001-006

Brilique

Liechtenstein

31.12.2010

EU/1/10/655/001-006/IS

Brilique

Iceland

10.12.2010

EU/1/10/656/001-006

Possia

Liechtenstein

31.12.2010

EU/1/10/657/001-002

Präpandemischer Influenzaimpfstoff (H5N1)

Liechtenstein

31.12.2010

EU/1/10/658/001-002

Aflunov

Liechtenstein

31.12.2010

EU/2/10/106/001/NO-014/NO

Bovilis BTV8

Norway

5.10.2010

EU/2/10/106/001-014

Bovilis BTV8

Liechtenstein

31.10.2010

EU/2/10/106/001-014/IS

Bovilis BTV8

Iceland

20.10.2010

EU/2/10/108/001/NO-005/NO

BTVPUR Alsap 2-4

Norway

22.11.2010

EU/2/10/108/001-005

BTVPUR Alsap 2-4

Liechtenstein

31.12.2010

EU/2/10/109/001-009

Rhiniseng

Liechtenstein

31.10.2010

EU/2/10/109/001-009/IS

Rhiniseng

Iceland

10.12.2010

EU/2/10/110/001-002

Coxevac

Liechtenstein

31.10.2010

EU/2/10/111/001-004

Meloxoral

Liechtenstein

31.12.2010

---

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 2010:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/135/001/NO-002/NO | DaTSCAN | Norway | 6.9.2010 |
| EU/1/00/135/001-002 | DaTSCAN | Liechtenstein | 31.8.2010 |
| EU/1/00/141/001/NO | Myocet | Norway | 3.8.2010 |
| EU/1/00/141/001 | Myocet | Liechtenstein | 31.8.2010 |
| EU/1/00/141/001/IS | Myocet | Iceland | 30.8.2010 |
| EU/1/00/142/004/NO-005/NO, 009/NO-022/NO | NovoMix | Norway | 4.8.2010 |
| EU/1/00/142/004-005, 009-022 | NovoMix | Liechtenstein | 31.8.2010 |
| EU/1/00/142/004-005, 009-022/IS | NovoMix | Iceland | 31.8.2010 |
| EU/1/00/143/001/NO-011/NO | Kogenate Bayer | Norway | 26.8.2010 |
| EU/1/00/143/001-011 | Kogenate Bayer | Liechtenstein | 31.8.2010 |
| EU/1/00/143/004-011/IS | Kogenate Bayer | Iceland | 8.9.2010 |
| EU/1/00/144/001/NO-004/NO | Helixate NexGen | Norway | 25.8.2010 |
| EU/1/00/144/001-004 | Helixate NexGen | Liechtenstein | 31.8.2010 |
| EU/1/00/144/001-004/IS | Helixate NexGen | Iceland | 29.9.2010 |
| EU/1/00/145/001 | Herceptin | Liechtenstein | 31.8.2010 |
| EU/1/00/145/001/IS | Herceptin | Iceland | 6.9.2010 |
| EU/1/00/145/001/NO | Herceptin | Norway | 24.8.2010 |
| EU/1/00/146/001/NO-032/NO | Keppra | Norway | 1.11.2010 |
| EU/1/00/146/001-032 | Keppra | Liechtenstein | 31.10.2010 |
| EU/1/00/146/001-032/IS | Keppra | Iceland | 2.9.2010 |
| EU/1/00/149/001 | Panretin | Liechtenstein | 31.10.2010 |
| EU/1/00/149/001/NO | Panretin | Norway | 22.10.2010 |
| EU/1/00/150/001/NO-024/NO | Actos | Norway | 19.10.2010 |
| EU/1/00/150/001-030 | Actos | Liechtenstein | 31.10.2010 |
| EU/1/00/150/001-030/IS | Actos | Iceland | 22.9.2010 |
| EU/1/00/151/001/NO-024/NO | Glustin | Norway | 19.10.2010 |
| EU/1/00/151/001-024 | Glustin | Liechtenstein | 31.10.2010 |
| EU/1/00/151/001-024/IS | Glustin | Iceland | 23.9.2010 |
| EU/1/00/152/001/NO-020/NO | Infanrix Hexa | Norway | 6.12.2010 |
| EU/1/00/152/001-020 | Infanrix Hexa | Liechtenstein | 31.10.2010 |
| EU/1/00/152/001-020/IS | Infanrix Hexa | Iceland | 22.9.2010 |
| EU/1/00/153/001/NO-010/NO | Infanrix Penta | Norway | 3.12.2010 |
| EU/1/00/153/001-010 | Infanrix Penta | Liechtenstein | 31.10.2010 |
| EU/1/00/153/001-010/IS | Infanrix Penta | Iceland | 22.9.2010 |
| EU/1/00/156/002/NO-004/NO | Trizivir | Norway | 13.12.2010 |
| EU/1/00/156/002-004 | Trizivir | Liechtenstein | 31.12.2010 |
| EU/1/00/166/001-003 | NeuroBloc | Liechtenstein | 31.12.2010 |
| EU/1/05/310/001/NO-009/NO | Fosavance | Norway | 13.9.2010 |
| EU/1/05/310/001-009 | Fosavance | Liechtenstein | 31.8.2010 |
| EU/1/05/310/001-009/IS | Fosavance | Iceland | 13.9.2010 |
| EU/1/05/311/001/NO-003/NO | Tarceva | Norway | 24.8.2010 |
| EU/1/05/311/001-003 | Tarceva | Liechtenstein | 31.8.2010 |
| EU/1/05/311/001-003/IS | Tarceva | Iceland | 19.8.2010 |
| EU/1/05/312/001 | Xyrem | Liechtenstein | 31.10.2010 |
| EU/1/05/312/001/NO | Xyrem | Norway | 16.11.2010 |
| EU/1/05/313/001/NO-009/NO | Vasovist | Norway | 22.12.2010 |
| EU/1/05/313/001-009 | Vasovist | Liechtenstein | 31.10.2010 |
| EU/1/05/314/001 | Kepivance | Liechtenstein | 31.12.2010 |
| EU/1/05/315/001/NO-002/NO | Aptivus | Norway | 13.12.2010 |
| EU/1/05/315/001-002 | Aptivus | Liechtenstein | 31.10.2010 |
| EU/1/05/316/001/NO-014/NO | Procoralan | Norway | 28.9.2010 |
| EU/1/05/316/001-014 | Procoralan | Liechtenstein | 31.10.2010 |
| EU/1/05/316/001-014/IS | Procoralan | Iceland | 21.9.2010 |
| EU/1/05/317/001/NO-014/NO | Corlentor | Norway | 28.9.2010 |
| EU/1/05/317/001-014 | Corlentor | Liechtenstein | 31.10.2010 |
| EU/1/05/317/001-014/IS | Corlentor | Iceland | 21.9.2010 |
| EU/1/05/318/001/NO-002/NO | Revatio | Norway | 6.10.2010 |
| EU/1/05/318/001-002 | Revatio | Liechtenstein | 31.10.2010 |
| EU/1/05/318/001-002/IS | Revatio | Iceland | 20.12.2010 |
| EU/1/05/319/001/NO-010/NO | Xolair | Norway | 19.10.2010 |
| EU/1/05/319/001-010 | Xolair | Liechtenstein | 31.10.2010 |
| EU/1/05/319/001-010/IS | Xolair | Iceland | 15.12.2010 |
| EU/1/05/320/001/NO | Noxafil | Norway | 13.12.2010 |
| EU/1/05/328/001-004 | Cubicin | Liechtenstein | 31.12.2010 |
| EU/1/05/331/001-055 | Neupro | Liechtenstein | 31.12.2010 |
| EU/1/06/338/001/NO-003/NO | Duo Trav | Norway | 18.11.2010 |
| EU/1/06/338/001-003 | Duo Trav | Liechtenstein | 31.10.2010 |
| EU/1/07/423/001-003 | Vectibix | Liechtenstein | 31.12.2010 |
| EU/1/07/440/001-002 | Tyverb | Liechtenstein | 31.10.2010 |
| EU/1/08/468/001 | Intelence | Liechtenstein | 31.8.2010 |
| EU/1/08/468/001/IS | Intelence | Iceland | 30.8.2010 |
| EU/1/08/468/001/NO | Intelence | Norway | 19.8.2010 |
| EU/1/09/543/001 | Cayston | Liechtenstein | 31.10.2010 |
| EU/1/09/543/001/NO | Cayston | Norway | 28.9.2010 |
| EU/1/09/543/001-002/IS | Cayston | Iceland | 16.9.2010 |
| EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS | Gonal-f | Iceland | 26.8.2010 |
| EU/1/95/001/005, 021, 025-027, 031-033, 035 | Gonal-f | Liechtenstein | 31.8.2010 |
| EU/1/95/001/005/NO, EU/1/95/001/025/NO-027/NO, EU/1/95/001/031/NO-035/NO | Gonal-f | Norway | 9.9.2010 |
| EU/2/00/018/001 | Incurin | Liechtenstein | 31.8.2010 |
| EU/2/05/053/001-003/IS | Naxcel | Iceland | 15.12.2010 |
| EU/2/05/054/001/NO-031/NO | Profender | Norway | 4.10.2010 |
| EU/2/05/054/001-031 | Profender | Liechtenstein | 31.8.2010 |
| EU/2/05/054/001-031/IS | Profender | Iceland | 1.9.2010 |
| EU/2/05/055/001/NO-002/NO | Equilis Te | Norway | 3.9.2010 |
| EU/2/05/055/001-002/IS | Equilis Te | Iceland | 6.9.2010 |
| EU/2/05/056/001/NO-004/NO | Equilis Prequenza | Norway | 6.9.2010 |
| EU/2/05/056/001-004/IS | Equilis Prequenza | Iceland | 6.9.2010 |
| EU/2/05/057/001/NO-004/NO | Equilis Prequenza Te | Norway | 6.9.2010 |
| EU/2/05/057/001-004 | Equilis Prequenza Te | Liechtenstein | 31.8.2010 |
| EU/2/05/057/001-004/IS | Equilis Prequenza Te | Iceland | 6.9.2010 |
| EU/2/055/001-002 | Equilis Te | Liechtenstein | 31.8.2010 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/135/001/NO-002/NO

DaTSCAN

Norway

6.9.2010

EU/1/00/135/001-002

DaTSCAN

Liechtenstein

31.8.2010

EU/1/00/141/001/NO

Myocet

Norway

3.8.2010

EU/1/00/141/001

Myocet

Liechtenstein

31.8.2010

EU/1/00/141/001/IS

Myocet

Iceland

30.8.2010

EU/1/00/142/004/NO-005/NO, 009/NO-022/NO

NovoMix

Norway

4.8.2010

EU/1/00/142/004-005, 009-022

NovoMix

Liechtenstein

31.8.2010

EU/1/00/142/004-005, 009-022/IS

NovoMix

Iceland

31.8.2010

EU/1/00/143/001/NO-011/NO

Kogenate Bayer

Norway

26.8.2010

EU/1/00/143/001-011

Kogenate Bayer

Liechtenstein

31.8.2010

EU/1/00/143/004-011/IS

Kogenate Bayer

Iceland

8.9.2010

EU/1/00/144/001/NO-004/NO

Helixate NexGen

Norway

25.8.2010

EU/1/00/144/001-004

Helixate NexGen

Liechtenstein

31.8.2010

EU/1/00/144/001-004/IS

Helixate NexGen

Iceland

29.9.2010

EU/1/00/145/001

Herceptin

Liechtenstein

31.8.2010

EU/1/00/145/001/IS

Herceptin

Iceland

6.9.2010

EU/1/00/145/001/NO

Herceptin

Norway

24.8.2010

EU/1/00/146/001/NO-032/NO

Keppra

Norway

1.11.2010

EU/1/00/146/001-032

Keppra

Liechtenstein

31.10.2010

EU/1/00/146/001-032/IS

Keppra

Iceland

2.9.2010

EU/1/00/149/001

Panretin

Liechtenstein

31.10.2010

EU/1/00/149/001/NO

Panretin

Norway

22.10.2010

EU/1/00/150/001/NO-024/NO

Actos

Norway

19.10.2010

EU/1/00/150/001-030

Actos

Liechtenstein

31.10.2010

EU/1/00/150/001-030/IS

Actos

Iceland

22.9.2010

EU/1/00/151/001/NO-024/NO

Glustin

Norway

19.10.2010

EU/1/00/151/001-024

Glustin

Liechtenstein

31.10.2010

EU/1/00/151/001-024/IS

Glustin

Iceland

23.9.2010

EU/1/00/152/001/NO-020/NO

Infanrix Hexa

Norway

6.12.2010

EU/1/00/152/001-020

Infanrix Hexa

Liechtenstein

31.10.2010

EU/1/00/152/001-020/IS

Infanrix Hexa

Iceland

22.9.2010

EU/1/00/153/001/NO-010/NO

Infanrix Penta

Norway

3.12.2010

EU/1/00/153/001-010

Infanrix Penta

Liechtenstein

31.10.2010

EU/1/00/153/001-010/IS

Infanrix Penta

Iceland

22.9.2010

EU/1/00/156/002/NO-004/NO

Trizivir

Norway

13.12.2010

EU/1/00/156/002-004

Trizivir

Liechtenstein

31.12.2010

EU/1/00/166/001-003

NeuroBloc

Liechtenstein

31.12.2010

EU/1/05/310/001/NO-009/NO

Fosavance

Norway

13.9.2010

EU/1/05/310/001-009

Fosavance

Liechtenstein

31.8.2010

EU/1/05/310/001-009/IS

Fosavance

Iceland

13.9.2010

EU/1/05/311/001/NO-003/NO

Tarceva

Norway

24.8.2010

EU/1/05/311/001-003

Tarceva

Liechtenstein

31.8.2010

EU/1/05/311/001-003/IS

Tarceva

Iceland

19.8.2010

EU/1/05/312/001

Xyrem

Liechtenstein

31.10.2010

EU/1/05/312/001/NO

Xyrem

Norway

16.11.2010

EU/1/05/313/001/NO-009/NO

Vasovist

Norway

22.12.2010

EU/1/05/313/001-009

Vasovist

Liechtenstein

31.10.2010

EU/1/05/314/001

Kepivance

Liechtenstein

31.12.2010

EU/1/05/315/001/NO-002/NO

Aptivus

Norway

13.12.2010

EU/1/05/315/001-002

Aptivus

Liechtenstein

31.10.2010

EU/1/05/316/001/NO-014/NO

Procoralan

Norway

28.9.2010

EU/1/05/316/001-014

Procoralan

Liechtenstein

31.10.2010

EU/1/05/316/001-014/IS

Procoralan

Iceland

21.9.2010

EU/1/05/317/001/NO-014/NO

Corlentor

Norway

28.9.2010

EU/1/05/317/001-014

Corlentor

Liechtenstein

31.10.2010

EU/1/05/317/001-014/IS

Corlentor

Iceland

21.9.2010

EU/1/05/318/001/NO-002/NO

Revatio

Norway

6.10.2010

EU/1/05/318/001-002

Revatio

Liechtenstein

31.10.2010

EU/1/05/318/001-002/IS

Revatio

Iceland

20.12.2010

EU/1/05/319/001/NO-010/NO

Xolair

Norway

19.10.2010

EU/1/05/319/001-010

Xolair

Liechtenstein

31.10.2010

EU/1/05/319/001-010/IS

Xolair

Iceland

15.12.2010

EU/1/05/320/001/NO

Noxafil

Norway

13.12.2010

EU/1/05/328/001-004

Cubicin

Liechtenstein

31.12.2010

EU/1/05/331/001-055

Neupro

Liechtenstein

31.12.2010

EU/1/06/338/001/NO-003/NO

Duo Trav

Norway

18.11.2010

EU/1/06/338/001-003

Duo Trav

Liechtenstein

31.10.2010

EU/1/07/423/001-003

Vectibix

Liechtenstein

31.12.2010

EU/1/07/440/001-002

Tyverb

Liechtenstein

31.10.2010

EU/1/08/468/001

Intelence

Liechtenstein

31.8.2010

EU/1/08/468/001/IS

Intelence

Iceland

30.8.2010

EU/1/08/468/001/NO

Intelence

Norway

19.8.2010

EU/1/09/543/001

Cayston

Liechtenstein

31.10.2010

EU/1/09/543/001/NO

Cayston

Norway

28.9.2010

EU/1/09/543/001-002/IS

Cayston

Iceland

16.9.2010

EU/1/95/001/001, 003-005, 009, 012, 021-022, 025-028, 031-035/IS

Gonal-f

Iceland

26.8.2010

EU/1/95/001/005, 021, 025-027, 031-033, 035

Gonal-f

Liechtenstein

31.8.2010

EU/1/95/001/005/NO, EU/1/95/001/025/NO-027/NO, EU/1/95/001/031/NO-035/NO

Gonal-f

Norway

9.9.2010

EU/2/00/018/001

Incurin

Liechtenstein

31.8.2010

EU/2/05/053/001-003/IS

Naxcel

Iceland

15.12.2010

EU/2/05/054/001/NO-031/NO

Profender

Norway

4.10.2010

EU/2/05/054/001-031

Profender

Liechtenstein

31.8.2010

EU/2/05/054/001-031/IS

Profender

Iceland

1.9.2010

EU/2/05/055/001/NO-002/NO

Equilis Te

Norway

3.9.2010

EU/2/05/055/001-002/IS

Equilis Te

Iceland

6.9.2010

EU/2/05/056/001/NO-004/NO

Equilis Prequenza

Norway

6.9.2010

EU/2/05/056/001-004/IS

Equilis Prequenza

Iceland

6.9.2010

EU/2/05/057/001/NO-004/NO

Equilis Prequenza Te

Norway

6.9.2010

EU/2/05/057/001-004

Equilis Prequenza Te

Liechtenstein

31.8.2010

EU/2/05/057/001-004/IS

Equilis Prequenza Te

Iceland

6.9.2010

EU/2/055/001-002

Equilis Te

Liechtenstein

31.8.2010

---

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 2010:

| EU-Number | Product | Country | Date of authorisation |
| --- | --- | --- | --- |
| EU/1/00/143/012/NO-013/NO | Kogenate Bayer | Norway | 26.8.2010 |
| EU/1/00/143/012-013 | Kogenate Bayer | Liechtenstein | 31.8.2010 |
| EU/1/00/143/012-013/IS | Kogenate Bayer | Iceland | 8.9.2010 |
| EU/1/00/144/005 | Helixate NexGen | Liechtenstein | 31.8.2010 |
| EU/1/00/144/005/IS | Helixate NexGen | Iceland | 29.9.2010 |
| EU/1/00/152/019-020/IS | Infanrix Hexa | Iceland | 7.7.2010 |
| EU/1/00/152/019/NO-020/NO | Infanrix Hexa | Norway | 6.12.2010 |
| EU/1/01/171/013/NO-014/NO | Rapamune | Norway | 18.8.2010 |
| EU/1/01/171/013-014/IS | Rapamune | Iceland | 6.7.2010 |
| EU/1/01/171013-014 | Rapamune | Liechtenstein | 31.8.2010 |
| EU/1/01/172/008 | Kaletra | Liechtenstein | 31.10.2010 |
| EU/1/02/218/030 | Axura | Liechtenstein | 31.12.2010 |
| EU/1/02/237/009 | Cialis | Liechtenstein | 31.10.2010 |
| EU/1/03/248/013/NO-015/NO | Levitra | Norway | 24.9.2010 |
| EU/1/03/248/013-015/IS | Levitra | Iceland | 24.9.2010 |
| EU/1/03/269/002 | Faslodex | Liechtenstein | 31.12.2010 |
| EU/1/04/179/044/NO | Lyrica | Norway | 2.9.2010 |
| EU/1/04/279/044/IS | Lyrica | Iceland | 19.8.2010 |
| EU/1/04/307/014/NO-021/NO | Zonegran | Norway | 26.8.2010 |
| EU/1/04/307/014-021 | Zonegran | Liechtenstein | 31.8.2010 |
| EU/1/04/307/014-021/IS | Zonegran | Iceland | 27.7.2010 |
| EU/1/05/328/003-004 | Cubicin | Liechtenstein | 31.10.2010 |
| EU/1/06/363/012/NO-015/NO | Sprycel | Norway | 26.10.2010 |
| EU/1/06/363/012-015 | Sprycel | Liechtenstein | 31.10.2010 |
| EU/1/06/363/012-015/IS | Sprycel | Iceland | 22.11.2010 |
| EU/1/07/401/012-015 | Alli | Liechtenstein | 31.12.2010 |
| EU/1/07/420/002 | Cyanokit | Liechtenstein | 31.10.2010 |
| EU/1/07/437/003/NO-004/NO | Ivemend | Norway | 28.9.2010 |
| EU/1/07/437/003-004 | Ivemend | Liechtenstein | 31.10.2010 |
| EU/1/07/437/003-004/IS | Ivemend | Iceland | 23.9.2010 |
| EU/1/070/401/011 | Alli | Liechtenstein | 31.8.2010 |
| EU/1/08/447/005-012 | Adenuric | Liechtenstein | 31.10.2010 |
| EU/1/08/454/006-007 | Extavia | Liechtenstein | 31.8.2010 |
| EU/1/08/463/004/NO-011/NO | Relistor | Norway | 26.10.2010 |
| EU/1/08/463/004-0011/IS | Relistor | Iceland | 16.9.2010 |
| EU/1/08/472/009-010 | Xarelto | Liechtenstein | 31.10.2010 |
| EU/1/08/495/009-016 | Zarzio | Liechtenstein | 31.12.2010 |
| EU/1/08/496/009-016 | Filgrastim Hexal | Liechtenstein | 31.12.2010 |
| EU/1/08/504/003 | Firmagon | Liechtenstein | 31.12.2010 |
| EU/1/09/535/015-016 | Grepid | Liechtenstein | 31.8.2010 |
| EU/1/09/543/002 | Cayston | Liechtenstein | 31.10.2010 |
| EU/1/09/580/019-021 | Enyglid | Liechtenstein | 31.12.2010 |
| EU/1/10/619/015 | DuoPlavin | Liechtenstein | 31.8.2010 |
| EU/1/10/623/015 | DuoCover | Liechtenstein | 31.8.2010 |
| EU/1/96/006/007 | NovoSeven | Liechtenstein | 31.12.2010 |
| EU/1/96/016/007 | Norvir | Liechtenstein | 31.12.2010 |
| EU/1/97/050/028/NO-033/NO | Sifrol | Norway | 10.8.2010 |
| EU/1/97/050/028-033/IS | Sifrol | Iceland | 18.8.2010 |
| EU/1/97/051/028/NO-033/NO | Mirapexin | Norway | 30.8.2010 |
| EU/1/97/051/028-033/IS | Mirapexin | Iceland | 18.8.2010 |
| EU/1/99/108/004/NO-006/NO | Ferriprox | Norway | 10.9.2010 |
| EU/1/99/108/004-006 | Ferriprox | Liechtenstein | 31.8.2010 |
| EU/1/99/108/004-006/IS | Ferriprox | Iceland | 2.9.2010 |
| EU/2/97/004/039-040 | Metacam | Liechtenstein | 31.8.2010 |
| EU/2/00/026/005-006 | Porcilis AR | Liechtenstein | 31.10.2010 |
| EU/2/06/070/005-008/IS | Meloxidyl | Iceland | 15.9.2010 |
| EU/2/06/070/008 | Meloxidyl | Liechtenstein | 31.10.2010 |
| EU/2/06/070/008/NO | Meloxidyl | Norway | 5.10.2010 |
| EU/2/07/072/003/NO-004/NO | Suprelorin | Norway | 5.10.2010 |
| EU/2/07/072/003-004 | Suprelorin | Liechtenstein | 31.8.2010 |
| EU/2/07/072/003-004/IS | Suprelorin | Iceland | 24.8.2010 |
| EU/2/08/083/004-005 | Equioxx | Liechtenstein | 31.10.2010 |
| EU/2/09/095/004-006 | Improvac | Liechtenstein | 31.10.2010 |
| EU/2/97/004/039/NO-040/NO | Metacam | Norway | 8.9.2010 |
| EU/2/97/004/039-042/IS | Metacam | Iceland | 6.7.2010 |
| EU/2/97/004/041/NO-042/NO | Metacam | Norway | 8.9.2010 |

EU-Number

Product

Country

Date of authorisation

EU/1/00/143/012/NO-013/NO

Kogenate Bayer

Norway

26.8.2010

EU/1/00/143/012-013

Kogenate Bayer

Liechtenstein

31.8.2010

EU/1/00/143/012-013/IS

Kogenate Bayer

Iceland

8.9.2010

EU/1/00/144/005

Helixate NexGen

Liechtenstein

31.8.2010

EU/1/00/144/005/IS

Helixate NexGen

Iceland

29.9.2010

EU/1/00/152/019-020/IS

Infanrix Hexa

Iceland

7.7.2010

EU/1/00/152/019/NO-020/NO

Infanrix Hexa

Norway

6.12.2010

EU/1/01/171/013/NO-014/NO

Rapamune

Norway

18.8.2010

EU/1/01/171/013-014/IS

Rapamune

Iceland

6.7.2010

EU/1/01/171013-014

Rapamune

Liechtenstein

31.8.2010

EU/1/01/172/008

Kaletra

Liechtenstein

31.10.2010

EU/1/02/218/030

Axura

Liechtenstein

31.12.2010

EU/1/02/237/009

Cialis

Liechtenstein

31.10.2010

EU/1/03/248/013/NO-015/NO

Levitra

Norway

24.9.2010

EU/1/03/248/013-015/IS

Levitra

Iceland

24.9.2010

EU/1/03/269/002

Faslodex

Liechtenstein

31.12.2010

EU/1/04/179/044/NO

Lyrica

Norway

2.9.2010

EU/1/04/279/044/IS

Lyrica

Iceland

19.8.2010

EU/1/04/307/014/NO-021/NO

Zonegran

Norway

26.8.2010

EU/1/04/307/014-021

Zonegran

Liechtenstein

31.8.2010

EU/1/04/307/014-021/IS

Zonegran

Iceland

27.7.2010

EU/1/05/328/003-004

Cubicin

Liechtenstein

31.10.2010

EU/1/06/363/012/NO-015/NO

Sprycel

Norway

26.10.2010

EU/1/06/363/012-015

Sprycel

Liechtenstein

31.10.2010

EU/1/06/363/012-015/IS

Sprycel

Iceland

22.11.2010

EU/1/07/401/012-015

Alli

Liechtenstein

31.12.2010

EU/1/07/420/002

Cyanokit

Liechtenstein

31.10.2010

EU/1/07/437/003/NO-004/NO

Ivemend

Norway

28.9.2010

EU/1/07/437/003-004

Ivemend

Liechtenstein

31.10.2010

EU/1/07/437/003-004/IS

Ivemend

Iceland

23.9.2010

EU/1/070/401/011

Alli

Liechtenstein

31.8.2010

EU/1/08/447/005-012

Adenuric

Liechtenstein

31.10.2010

EU/1/08/454/006-007

Extavia

Liechtenstein

31.8.2010

EU/1/08/463/004/NO-011/NO

Relistor

Norway

26.10.2010

EU/1/08/463/004-0011/IS

Relistor

Iceland

16.9.2010

EU/1/08/472/009-010

Xarelto

Liechtenstein

31.10.2010

EU/1/08/495/009-016

Zarzio

Liechtenstein

31.12.2010

EU/1/08/496/009-016

Filgrastim Hexal

Liechtenstein

31.12.2010

EU/1/08/504/003

Firmagon

Liechtenstein

31.12.2010

EU/1/09/535/015-016

Grepid

Liechtenstein

31.8.2010

EU/1/09/543/002

Cayston

Liechtenstein

31.10.2010

EU/1/09/580/019-021

Enyglid

Liechtenstein

31.12.2010

EU/1/10/619/015

DuoPlavin

Liechtenstein

31.8.2010

EU/1/10/623/015

DuoCover

Liechtenstein

31.8.2010

EU/1/96/006/007

NovoSeven

Liechtenstein

31.12.2010

EU/1/96/016/007

Norvir

Liechtenstein

31.12.2010

EU/1/97/050/028/NO-033/NO

Sifrol

Norway

10.8.2010

EU/1/97/050/028-033/IS

Sifrol

Iceland

18.8.2010

EU/1/97/051/028/NO-033/NO

Mirapexin

Norway

30.8.2010

EU/1/97/051/028-033/IS

Mirapexin

Iceland

18.8.2010

EU/1/99/108/004/NO-006/NO

Ferriprox

Norway

10.9.2010

EU/1/99/108/004-006

Ferriprox

Liechtenstein

31.8.2010

EU/1/99/108/004-006/IS

Ferriprox

Iceland

2.9.2010

EU/2/97/004/039-040

Metacam

Liechtenstein

31.8.2010

EU/2/00/026/005-006

Porcilis AR

Liechtenstein

31.10.2010

EU/2/06/070/005-008/IS

Meloxidyl

Iceland

15.9.2010

EU/2/06/070/008

Meloxidyl

Liechtenstein

31.10.2010

EU/2/06/070/008/NO

Meloxidyl

Norway

5.10.2010

EU/2/07/072/003/NO-004/NO

Suprelorin

Norway

5.10.2010

EU/2/07/072/003-004

Suprelorin

Liechtenstein

31.8.2010

EU/2/07/072/003-004/IS

Suprelorin

Iceland

24.8.2010

EU/2/08/083/004-005

Equioxx

Liechtenstein

31.10.2010

EU/2/09/095/004-006

Improvac

Liechtenstein

31.10.2010

EU/2/97/004/039/NO-040/NO

Metacam

Norway

8.9.2010

EU/2/97/004/039-042/IS

Metacam

Iceland

6.7.2010

EU/2/97/004/041/NO-042/NO

Metacam

Norway

8.9.2010

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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 2010:

| EU-Number | Product | Country | Date of withdrawal |
| --- | --- | --- | --- |
| EU/1/00/148/001/NO-004/NO | Agenerase | Norway | 14.9.2010 |
| EU/1/00/154/001/NO-002/NO | NeoSpect | Norway | 8.12.2010 |
| EU/1/00/154/001-002 | NeoSpect | Liechtenstein | 31.12.2010 |
| EU/1/02/239/001-030/IS | Bextra | Iceland | 31.8.2010 |
| EU/1/02/244/001-020/IS | Valdyn | Iceland | 31.8.2010 |
| EU/1/07/406/001-020 | Enviage | Liechtenstein | 31.10.2010 |
| EU/1/10/613/001-002 | ImmunoGam | Liechtenstein | 31.10.2010 |
| EU/1/10/613/001/NO-002/NO | ImmunoGam | Norway | 1.11.2010 |
| EU/1/10/613/001-002/IS | ImmunoGam | Iceland | 30.9.2010 |
| EU/1/10/624/001 | Arepanrix | Liechtenstein | 31.12.2010 |
| EU/2/00/024/001 | Pruban | Liechtenstein | 31.8.2010 |
| EU/2/07/073/001-004 | Nobilis Influenza H7N1 | Liechtenstein | 31.8.2010 |
| EU/2/00/024/001/IS | Pruban 0,1 % | Iceland | 16.11.2010 |
| EU/2/06/067/001-002 | Medicinal Oxygen Air Liquide Santé | Liechtenstein | 31.8.2010 |
| EU/2/06/067/001-002/IS | Medicinal oxygen | Iceland | 1.9.2010 |
| EU/2/07/073/001-004/IS | Nobilis Influenza H7N1 | Iceland | 1.9.2010 |
| EU/2/07/076/001-004 | Nobilis Influenza H5N6 | Liechtenstein | 31.8.2010 |
| EU/2/07/076/001-004/IS | Nobilis Influenza H5N6 | Iceland | 1.9.2010 |

EU-Number

Product

Country

Date of withdrawal

EU/1/00/148/001/NO-004/NO

Agenerase

Norway

14.9.2010

EU/1/00/154/001/NO-002/NO

NeoSpect

Norway

8.12.2010

EU/1/00/154/001-002

NeoSpect

Liechtenstein

31.12.2010

EU/1/02/239/001-030/IS

Bextra

Iceland

31.8.2010

EU/1/02/244/001-020/IS

Valdyn

Iceland

31.8.2010

EU/1/07/406/001-020

Enviage

Liechtenstein

31.10.2010

EU/1/10/613/001-002

ImmunoGam

Liechtenstein

31.10.2010

EU/1/10/613/001/NO-002/NO

ImmunoGam

Norway

1.11.2010

EU/1/10/613/001-002/IS

ImmunoGam

Iceland

30.9.2010

EU/1/10/624/001

Arepanrix

Liechtenstein

31.12.2010

EU/2/00/024/001

Pruban

Liechtenstein

31.8.2010

EU/2/07/073/001-004

Nobilis Influenza H7N1

Liechtenstein

31.8.2010

EU/2/00/024/001/IS

Pruban 0,1 %

Iceland

16.11.2010

EU/2/06/067/001-002

Medicinal Oxygen Air Liquide Santé

Liechtenstein

31.8.2010

EU/2/06/067/001-002/IS

Medicinal oxygen

Iceland

1.9.2010

EU/2/07/073/001-004/IS

Nobilis Influenza H7N1

Iceland

1.9.2010

EU/2/07/076/001-004

Nobilis Influenza H5N6

Liechtenstein

31.8.2010

EU/2/07/076/001-004/IS

Nobilis Influenza H5N6

Iceland

1.9.2010

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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 2010:

| EU-Number | Product | Country | Date of suspension |
| --- | --- | --- | --- |
| EU/1/00/137/002/NO-018/NO | Avandia (1) | Norway | 3.12.2010 |
| EU/1/00/137/002-018 | Avandia | Liechtenstein | 31.12.2010 |
| EU/1/03/258/001/NO-022/NO | Avandamet (1) | Norway | 3.12.2010 |
| EU/1/03/258/001-022 | Avandamet | Liechtenstein | 31.12.2010 |
| EU/1/06/349/001/NO-010/NO | Avaglim (1) | Norway | 3.12.2010 |
| EU/1/06/349/001-010 | Avaglim | Liechtenstein | 31.12.2010 |
| EU/2/06/058/001-003 | Flexicam | Liechtenstein | 31.10.2010 |

EU-Number

Product

Country

Date of suspension

EU/1/00/137/002/NO-018/NO

Avandia (1)

Norway

3.12.2010

EU/1/00/137/002-018

Avandia

Liechtenstein

31.12.2010

EU/1/03/258/001/NO-022/NO

Avandamet (1)

Norway

3.12.2010

EU/1/03/258/001-022

Avandamet

Liechtenstein

31.12.2010

EU/1/06/349/001/NO-010/NO

Avaglim (1)

Norway

3.12.2010

EU/1/06/349/001-010

Avaglim

Liechtenstein

31.12.2010

EU/2/06/058/001-003

Flexicam

Liechtenstein

31.10.2010

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(1)  Suspended in Norway without notification.

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