# Official Journal C 133/2006

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 133 |
| | |
| English edition | Information and Notices | Volume 498 June 2006 |

ISSN 1725-2423

Official Journal

of the European Union

C 133

English edition

Information and Notices

Volume 498 June 2006

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2006/C 133/1 | Euro exchange rates | 1 |
| 2006/C 133/2 | Commission notice on current State aid recovery interest rates and reference/discount rates for 25 Member States applicable as from 1 June 2006— Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1) and the Commission notice on the method for setting the reference and discount rates (OJ C 273, 9.9.1997, p. 3) | 2 |
| 2006/C 133/3 | Prior notification of a concentration (Case COMP/M.4170 — LSG Lufthansa Service Holding/Gate Gourmet Switzerland) (
  1
  ) | 3 |
| 2006/C 133/4 | Prior notification of a concentration (Case COMP/M.4240 — Teck Cominco/Inco) — Candidate case for simplified procedure (
  1
  ) | 4 |
| 2006/C 133/5 | Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC — March 2006 | 5 |
| | EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2006/C 133/6 | 53rd amendment of the State aid guidelines — EFTA Surveillance Authority decision to propose appropriate measures | 8 |

Notice No

Contents

page

I   Information

Commission

2006/C 133/1

Euro exchange rates

1

2006/C 133/2

Commission notice on current State aid recovery interest rates and reference/discount rates for 25 Member States applicable as from 1 June 2006— Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1) and the Commission notice on the method for setting the reference and discount rates (OJ C 273, 9.9.1997, p. 3)

— Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1) and the Commission notice on the method for setting the reference and discount rates (OJ C 273, 9.9.1997, p. 3)

2

2006/C 133/3

Prior notification of a concentration (Case COMP/M.4170 — LSG Lufthansa Service Holding/Gate Gourmet Switzerland) (
  1
  )

1

3

2006/C 133/4

Prior notification of a concentration (Case COMP/M.4240 — Teck Cominco/Inco) — Candidate case for simplified procedure (
  1
  )

1

4

2006/C 133/5

Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC — March 2006

5

EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2006/C 133/6

53rd amendment of the State aid guidelines — EFTA Surveillance Authority decision to propose appropriate measures

8

| | III   Notices |
| --- | --- |
| | Commission |
| 2006/C 133/7 | Leonardo Da Vinci Programme — Second phase (2000-2006) — Call for proposals EAC/21/06 — Award of grants for activities (conferences, seminars) to exploit and disseminate the results of Leonardo da Vinci projects — Notice of publication of a call for proposals on the Internet | 9 |

III   Notices

Commission

2006/C 133/7

Leonardo Da Vinci Programme — Second phase (2000-2006) — Call for proposals EAC/21/06 — Award of grants for activities (conferences, seminars) to exploit and disseminate the results of Leonardo da Vinci projects — Notice of publication of a call for proposals on the Internet

9

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

---

(1)   Text with EEA relevance

1

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

EN

---

I Information

Commission

| 8.6.2006 | EN | Official Journal of the European Union | C 133/1 |
| --- | --- | --- | --- |

8.6.2006

EN

Official Journal of the European Union

C 133/1

---

Euro exchange rates (1)

7 June 2006

(2006/C 133/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2789 |
| JPY | Japanese yen | 144,89 |
| DKK | Danish krone | 7,4587 |
| GBP | Pound sterling | 0,6878 |
| SEK | Swedish krona | 9,223 |
| CHF | Swiss franc | 1,5613 |
| ISK | Iceland króna | 93,77 |
| NOK | Norwegian krone | 7,8045 |
| BGN | Bulgarian lev | 1,9558 |
| CYP | Cyprus pound | 0,575 |
| CZK | Czech koruna | 28,195 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 262,84 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6961 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 3,9542 |
| RON | Romanian leu | 3,5145 |
| SIT | Slovenian tolar | 239,67 |
| SKK | Slovak koruna | 37,725 |
| TRY | Turkish lira | 2,001 |
| AUD | Australian dollar | 1,726 |
| CAD | Canadian dollar | 1,4264 |
| HKD | Hong Kong dollar | 9,926 |
| NZD | New Zealand dollar | 2,0444 |
| SGD | Singapore dollar | 2,0269 |
| KRW | South Korean won | 1 212,65 |
| ZAR | South African rand | 8,645 |
| CNY | Chinese yuan renminbi | 10,2527 |
| HRK | Croatian kuna | 7,257 |
| IDR | Indonesian rupiah | 11 986,49 |
| MYR | Malaysian ringgit | 4,6769 |
| PHP | Philippine peso | 67,679 |
| RUB | Russian rouble | 34,351 |
| THB | Thai baht | 48,965 |

Currency

Exchange rate

USD

US dollar

1,2789

JPY

Japanese yen

144,89

DKK

Danish krone

7,4587

GBP

Pound sterling

0,6878

SEK

Swedish krona

9,223

CHF

Swiss franc

1,5613

ISK

Iceland króna

93,77

NOK

Norwegian krone

7,8045

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,575

CZK

Czech koruna

28,195

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

262,84

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6961

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,9542

RON

Romanian leu

3,5145

SIT

Slovenian tolar

239,67

SKK

Slovak koruna

37,725

TRY

Turkish lira

2,001

AUD

Australian dollar

1,726

CAD

Canadian dollar

1,4264

HKD

Hong Kong dollar

9,926

NZD

New Zealand dollar

2,0444

SGD

Singapore dollar

2,0269

KRW

South Korean won

1 212,65

ZAR

South African rand

8,645

CNY

Chinese yuan renminbi

10,2527

HRK

Croatian kuna

7,257

IDR

Indonesian rupiah

11 986,49

MYR

Malaysian ringgit

4,6769

PHP

Philippine peso

67,679

RUB

Russian rouble

34,351

THB

Thai baht

48,965

---

(1)

Source: reference exchange rate published by the ECB.

---

| 8.6.2006 | EN | Official Journal of the European Union | C 133/2 |
| --- | --- | --- | --- |

8.6.2006

EN

Official Journal of the European Union

C 133/2

---

Commission notice on current State aid recovery interest rates and reference/discount rates for 25 Member States applicable as from 1 June 2006

Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1) and the Commission notice on the method for setting the reference and discount rates (OJ C 273, 9.9.1997, p. 3)

(2006/C 133/02)

| From | To | AT | BE | CY | CZ | DE | DK | EE | EL | ES | FI | FR | HU | IE | IT | LT | LU | LV | MT | NL | PL | PT | SE | SI | SK | UK |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1.6.2006 | ... | 4,36 | 4,36 | 6,34 | 3,72 | 4,36 | 4,49 | 5,50 | 4,36 | 4,36 | 4,36 | 4,36 | 7,04 | 4,36 | 4,36 | 6,49 | 4,36 | 6,64 | 7,00 | 4,36 | 5,56 | 4,36 | 4,31 | 4,43 | 4,77 | 5,33 |
| 1.3.2006 | 31.5.2006 | 3,70 | 3,70 | 6,34 | 3,72 | 3,70 | 3,74 | 5,50 | 3,70 | 3,70 | 3,70 | 3,70 | 7,04 | 3,70 | 3,70 | 6,49 | 3,70 | 6,64 | 7,00 | 3,70 | 5,56 | 3,70 | 3,74 | 4,43 | 3,98 | 5,33 |
| 1.1.2006 | 28.2.2006 | 3,70 | 3,70 | 6,34 | 3,72 | 3,70 | 3,74 | 5,50 | 3,70 | 3,70 | 3,70 | 3,70 | 7,04 | 3,70 | 3,70 | 6,49 | 3,70 | 6,64 | 7,00 | 3,70 | 5,56 | 3,70 | 3,74 | 5,10 | 3,98 | 5,33 |
| 1.12.2005 | 31.12.2005 | 4,08 | 4,08 | 6,34 | 3,40 | 4,08 | 3,54 | 5,50 | 4,08 | 4,08 | 4,08 | 4,08 | 8,59 | 4,08 | 4,08 | 6,49 | 4,08 | 6,64 | 7,00 | 4,08 | 6,24 | 4,08 | 3,96 | 5,10 | 7,55 | 5,81 |
| 1.9.2005 | 30.11.2005 | 4,08 | 4,08 | 7,53 | 3,40 | 4,08 | 3,54 | 5,50 | 4,08 | 4,08 | 4,08 | 4,08 | 8,59 | 4,08 | 4,08 | 6,49 | 4,08 | 6,64 | 7,00 | 4,08 | 6,24 | 4,08 | 3,96 | 5,10 | 7,55 | 5,81 |
| 1.7.2005 | 31.8.2005 | 4,08 | 4,08 | 7,53 | 4,05 | 4,08 | 4,23 | 5,50 | 4,08 | 4,08 | 4,08 | 4,08 | 8,59 | 4,08 | 4,08 | 6,49 | 4,08 | 6,64 | 7,00 | 4,08 | 6,24 | 4,08 | 3,96 | 5,10 | 7,55 | 5,81 |
| 1.6.2005 | 30.6.2005 | 4,08 | 4,08 | 7,53 | 4,05 | 4,08 | 4,23 | 5,50 | 4,08 | 4,08 | 4,08 | 4,08 | 8,59 | 4,08 | 4,08 | 6,49 | 4,08 | 6,64 | 7,00 | 4,08 | 6,24 | 4,08 | 4,69 | 5,10 | 7,55 | 5,81 |
| 1.4.2005 | 31.5.2005 | 4,08 | 4,08 | 7,88 | 4,05 | 4,08 | 4,23 | 5,50 | 4,08 | 4,08 | 4,08 | 4,08 | 8,59 | 4,08 | 4,08 | 6,49 | 4,08 | 6,64 | 7,00 | 4,08 | 7,62 | 4,08 | 4,69 | 5,10 | 7,55 | 5,81 |
| 1.1.2005 | 31.3.2005 | 4,08 | 4,08 | 7,88 | 4,86 | 4,08 | 4,23 | 5,50 | 4,08 | 4,08 | 4,08 | 4,08 | 8,59 | 4,08 | 4,08 | 6,49 | 4,08 | 6,64 | 7,00 | 4,08 | 7,62 | 4,08 | 4,69 | 5,10 | 7,55 | 5,81 |

From

To

AT

BE

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HU

IE

IT

LT

LU

LV

MT

NL

PL

PT

SE

SI

SK

UK

1.6.2006

...

4,36

4,36

6,34

3,72

4,36

4,49

5,50

4,36

4,36

4,36

4,36

7,04

4,36

4,36

6,49

4,36

6,64

7,00

4,36

5,56

4,36

4,31

4,43

4,77

5,33

1.3.2006

31.5.2006

3,70

3,70

6,34

3,72

3,70

3,74

5,50

3,70

3,70

3,70

3,70

7,04

3,70

3,70

6,49

3,70

6,64

7,00

3,70

5,56

3,70

3,74

4,43

3,98

5,33

1.1.2006

28.2.2006

3,70

3,70

6,34

3,72

3,70

3,74

5,50

3,70

3,70

3,70

3,70

7,04

3,70

3,70

6,49

3,70

6,64

7,00

3,70

5,56

3,70

3,74

5,10

3,98

5,33

1.12.2005

31.12.2005

4,08

4,08

6,34

3,40

4,08

3,54

5,50

4,08

4,08

4,08

4,08

8,59

4,08

4,08

6,49

4,08

6,64

7,00

4,08

6,24

4,08

3,96

5,10

7,55

5,81

1.9.2005

30.11.2005

4,08

4,08

7,53

3,40

4,08

3,54

5,50

4,08

4,08

4,08

4,08

8,59

4,08

4,08

6,49

4,08

6,64

7,00

4,08

6,24

4,08

3,96

5,10

7,55

5,81

1.7.2005

31.8.2005

4,08

4,08

7,53

4,05

4,08

4,23

5,50

4,08

4,08

4,08

4,08

8,59

4,08

4,08

6,49

4,08

6,64

7,00

4,08

6,24

4,08

3,96

5,10

7,55

5,81

1.6.2005

30.6.2005

4,08

4,08

7,53

4,05

4,08

4,23

5,50

4,08

4,08

4,08

4,08

8,59

4,08

4,08

6,49

4,08

6,64

7,00

4,08

6,24

4,08

4,69

5,10

7,55

5,81

1.4.2005

31.5.2005

4,08

4,08

7,88

4,05

4,08

4,23

5,50

4,08

4,08

4,08

4,08

8,59

4,08

4,08

6,49

4,08

6,64

7,00

4,08

7,62

4,08

4,69

5,10

7,55

5,81

1.1.2005

31.3.2005

4,08

4,08

7,88

4,86

4,08

4,23

5,50

4,08

4,08

4,08

4,08

8,59

4,08

4,08

6,49

4,08

6,64

7,00

4,08

7,62

4,08

4,69

5,10

7,55

5,81

---

| 8.6.2006 | EN | Official Journal of the European Union | C 133/3 |
| --- | --- | --- | --- |

8.6.2006

EN

Official Journal of the European Union

C 133/3

---

Prior notification of a concentration

(Case COMP/M.4170 — LSG Lufthansa Service Holding/Gate Gourmet Switzerland)

(2006/C 133/03)

(Text with EEA relevance)

| 1. | On 30 May 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings LSG/Sky Chefs Europe Holdings Ltd (‘LSG’, UK) belonging to the Lufthansa group and Gate Gourmet GmbH (‘Gate Gourmet’, Switzerland) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of a newly created company (‘JV’) constituting a joint venture by way of purchase of shares. |
| --- | --- |

1.

On 30 May 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings LSG/Sky Chefs Europe Holdings Ltd (‘LSG’, UK) belonging to the Lufthansa group and Gate Gourmet GmbH (‘Gate Gourmet’, Switzerland) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of a newly created company (‘JV’) constituting a joint venture by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | for LSG: airline catering and related business activities; |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for LSG: airline catering and related business activities;

| — | for Gate Gourmet: airline catering and related business activities; |
| --- | --- |

—

for Gate Gourmet: airline catering and related business activities;

| — | for JV: airline food catering in the Paris region airports in France. |
| --- | --- |

—

for JV: airline food catering in the Paris region airports in France.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4170 — LSG Lufthansa Service Holding/Gate Gourmet Switzerland, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition, |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4170 — LSG Lufthansa Service Holding/Gate Gourmet Switzerland, to the following address:

European Commission

Directorate-General for Competition,

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

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| 8.6.2006 | EN | Official Journal of the European Union | C 133/4 |
| --- | --- | --- | --- |

8.6.2006

EN

Official Journal of the European Union

C 133/4

---

Prior notification of a concentration

(Case COMP/M.4240 — Teck Cominco/Inco)

Candidate case for simplified procedure

(2006/C 133/04)

(Text with EEA relevance)

| 1. | On 1 June 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Teck Cominco Limited (‘Teck Cominco’, Canada) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Inco Limited (‘Inco’, Canada) by way of public bid announced on 23 May 2006, that is conditional upon, inter alia, Inco not acquiring Falconbridge Limited. |
| --- | --- |

1.

On 1 June 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Teck Cominco Limited (‘Teck Cominco’, Canada) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Inco Limited (‘Inco’, Canada) by way of public bid announced on 23 May 2006, that is conditional upon, inter alia, Inco not acquiring Falconbridge Limited.

| 2. | The business activities of the undertakings concerned are:






  — | for Teck Cominco: mining, processing, refining and sale of zinc, copper, coal, and other metal products as well as sulphur products; |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Teck Cominco: mining, processing, refining and sale of zinc, copper, coal, and other metal products as well as sulphur products;

| — | for Inco: mining, processing, refining and sale of various nickel products, copper, cobalt and precious metals as well as sulphur products. |
| --- | --- |

—

for Inco: mining, processing, refining and sale of various nickel products, copper, cobalt and precious metals as well as sulphur products.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4240 — Teck Cominco/Inco, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition, |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

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

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4240 — Teck Cominco/Inco, to the following address:

European Commission

Directorate-General for Competition,

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

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

(2)  OJ C 56, 5.3.2005, p. 32.

---

| 8.6.2006 | EN | Official Journal of the European Union | C 133/5 |
| --- | --- | --- | --- |

8.6.2006

EN

Official Journal of the European Union

C 133/5

---

Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC — March 2006

(2006/C 133/05)

1.   Introduction

Based on Article 29(2) of Directive 2001/83/EC as amended (1) the scope of this guideline is to set out in more detail in which exceptional cases a Member State concerned in a mutual recognition procedure as referred to in Article 28(2) or in a decentralised procedure as referred to in Article 28(3) can refuse to recognise a marketing authorisation or a positive assessment on the basis of a potential serious risk to public health.

In the case that at least one of the Member States (2) concerned by the application cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of a potential serious risk to public health, as set out in Article 29(1) of Directive 2001/83/EC, when requested to mutually recognise a marketing authorisation granted by another Member State, it shall give a detailed explanation of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant.

As the Community pharmaceutical legislation fully harmonises the standards for quality, safety and efficacy of a medicinal product, a marketing authorisation granted by one Member State should generally be recognizable by the other Member States.

In the mutual recognition procedure, according to Article 28(2) of Directive 2001/83/EC, the reference Member State will assess the data in the dossier and issue a national marketing authorisation, provided the risk-benefit balance of the product is considered to be favourable and the quality, safety and efficacy of the medicinal product is sufficiently guaranteed and no other or further reasons for the refusal of the marketing authorisation according to Article 26 of Directive 2001/83/EC is given. For the process of mutual recognition the reference Member States has to provide an assessment report that is sufficiently detailed to explain to the Member State concerned why this risk-benefit balance is considered to be favourable, together with the approved summary of product characteristics, labelling and package leaflet. In the decentralised procedure, according to Article 28(3) of Directive 2001/83/EC, no prior national procedure is intended and no existing marketing authorisation is in place at that time. After receipt of a valid application it is the duty of the reference Member State to prepare, within 120 days, a draft assessment report, a draft summary of products characteristics and a draft of the labelling and package leaflet.

Article 29(1) of Directive 2001/83/EC describes the procedure to be followed if a concerned Member State cannot approve the assessment report, summary of products characteristics, package leaflet and labelling as prepared by the reference Member State. In Article 29(1) reference is made to Article 28(4), which in turn refers to Article 28(2) and (3). These articles concern both the mutual recognition procedure and the decentralised procedure. Consequently, the grounds for refusal are the same irrespective of whether the concerned Member State evaluates an assessment report, summary of products characteristics, labelling and package leaflet from the reference Member State in a mutual recognition procedure, or a draft assessment report, draft summary of products characteristics and draft of the labelling and package leaflet and from the reference Member State in a decentralised procedure.

By defining in which exceptional cases the concerned Member State can refuse to recognise a marketing authorisation in a mutual recognition procedure, or a draft assessment report, a draft summary of products characteristics, and a draft of the labelling and package leaflet from the reference Member State in a decentralised procedure, on the basis of a potential serious risk to public health, this will also concurrently limit the variety and number of objections raised by Member States.

A concerned Member State that raises major objections based on a potential serious risk to public health shall give a detailed explanation of the reasons for its position.

In this context, it should be considered that a Member State plays a different role when it is called upon to approve the evaluation report, the summary of product characteristics, the labelling and package leaflet for a medicinal product submitted to it by the reference Member State and the role that it plays when it is the only one to issue a national marketing authorisation for a medicinal product that has not yet been the subject of an application for authorisation in another Member State of the Community, or when it is itself the reference Member State.

In the case of an authorisation not referring to another authorisation the Member State is fully competent to determine the content of the marketing authorisation for the medicinal product in accordance with Directive 2001/83/EC, while in recognising the first authorisation or evaluation, done by the reference Member State it is consequently for the Member States that are informed of authorisation or evaluation not to decide whether or not it can be improved on, but rather to establish clearly and in a well-argued fashion why the proposed authorisation (or refusal) presents a potential serious risk to public health.

2.   Definition of potential serious risk to public health

Directive 2001/83/EC does not provide for a definition of a ‘potential serious risk to public health’. However, the following definitions are given in that Directive:

| — | The term ‘risk related to the use of the medicinal product’ is defined in point 28 of Article 1, first indent of Directive 2001/83/EC as ‘any risk relating to the quality, safety or efficacy of the medicinal product as regards to patients' health or public health’ (or any risk of undesirable effects on the environment). |
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The term ‘risk related to the use of the medicinal product’ is defined in point 28 of Article 1, first indent of Directive 2001/83/EC as ‘any risk relating to the quality, safety or efficacy of the medicinal product as regards to patients' health or public health’ (or any risk of undesirable effects on the environment).

| — | The term ‘risk-benefit balance’ is defined in point 28a of Article 1of that Directive as ‘an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28, first indent’ |
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The term ‘risk-benefit balance’ is defined in point 28a of Article 1of that Directive as ‘an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28, first indent’

For the application of this guideline, the following definitions shall apply:

| — | A ‘risk’ is defined as the probability that an event will occur |
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A ‘risk’ is defined as the probability that an event will occur

| — | A ‘potential serious risk to public health’ is defined as a situation where there is a significant probability that a serious hazard resulting from a human medicinal product in the context of its proposed use will affect public health. |
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A ‘potential serious risk to public health’ is defined as a situation where there is a significant probability that a serious hazard resulting from a human medicinal product in the context of its proposed use will affect public health.

| — | ‘Serious’ in this context means a hazard that could result in death, could be life-threatening, could result in patient hospitalisation or prolongation of existing hospitalisation, could result in persistent or significant disability or incapacity, or could be a congenital anomaly/birth defect or permanent or prolonged signs in exposed humans. |
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‘Serious’ in this context means a hazard that could result in death, could be life-threatening, could result in patient hospitalisation or prolongation of existing hospitalisation, could result in persistent or significant disability or incapacity, or could be a congenital anomaly/birth defect or permanent or prolonged signs in exposed humans.

The assessment of a ‘potential serious risk to public health’ cannot be made in isolation but has to take into account the positive therapeutic effects of the medicinal product in question. Consequently, the term ‘potential serious risk to public health’ as used in Article 29(1) of Directive 2001/83/EC has to be understood as relating to the overall risk-benefit assessment of the medicinal product, taking into account the positive therapeutic effects of the medicinal product in relation to the risks.

Therefore, a potential serious risk to public health in relation to a particular medicinal product can mainly be considered to exist under the following circumstances:

| — | Efficacy: the data submitted to support therapeutic efficacy in the proposed indication(s), target population(s), and proposed dosing regimen (as defined by the proposed labelling), do not provide sound scientific justification for the claims for efficacy; adequate proof for bioequivalence demonstrated by generic medicinal products to the reference medicinal product is lacking. |
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Efficacy: the data submitted to support therapeutic efficacy in the proposed indication(s), target population(s), and proposed dosing regimen (as defined by the proposed labelling), do not provide sound scientific justification for the claims for efficacy; adequate proof for bioequivalence demonstrated by generic medicinal products to the reference medicinal product is lacking.

| — | Safety: the evaluation of the preclinical toxicity/safety pharmacology, clinical safety data and post-marketing data does not provide adequate support for the conclusion that all potential safety issues for the target population have been appropriately and adequately addressed in the proposed labelling or the absolute level of risk from the medicinal product, in the context of its proposed use, is considered unacceptable. |
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Safety: the evaluation of the preclinical toxicity/safety pharmacology, clinical safety data and post-marketing data does not provide adequate support for the conclusion that all potential safety issues for the target population have been appropriately and adequately addressed in the proposed labelling or the absolute level of risk from the medicinal product, in the context of its proposed use, is considered unacceptable.

| — | Quality: the proposed production and quality control methods cannot guarantee that a major deficiency in the quality of the product will not occur. |
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Quality: the proposed production and quality control methods cannot guarantee that a major deficiency in the quality of the product will not occur.

| — | Overall risk-benefit: the risk-benefit-balance for the product is not considered to be favourable, taking into account the nature of the identified risk(s) and the potential benefit in the proposed indication(s) and target patient population(s). |
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Overall risk-benefit: the risk-benefit-balance for the product is not considered to be favourable, taking into account the nature of the identified risk(s) and the potential benefit in the proposed indication(s) and target patient population(s).

| — | Product Information: the information is misleading or incorrect for either the prescribers or the patients to ensure the safe use of the medicinal product. |
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Product Information: the information is misleading or incorrect for either the prescribers or the patients to ensure the safe use of the medicinal product.

Any major objection must be scientifically justified taking into account the nature and degree of any hazards, the magnitude of the risks involved, the benefits associated with the use of the product and the feasibility and practicality of the implementation of any measures to mitigate the risks. The Member State intending to refuse the application for marketing authorisation for the medicinal product should be prepared to substantiate its grounds for refusal in the coordination group procedure and if that procedure fails in a referral to the Committee of Human Medicinal Products. This would also cover any existing knowledge of the substance and specific risks in the Member State concerned which are not outlined in the dossier of the medicinal product or the assessment report of the reference Member State and which are not included in the summary of products characteristics during the mutual recognition procedure or decentralised procedure.

Member States have accepted common rules and guidelines relating to manufacturing, quality control, evaluation of medicinal product efficacy, evaluation of medicinal product safety and quality assurance and labelling. These scientific guidelines give guidance for the evaluation of an application in general, but different interpretations cannot be excluded on a specific set of data. It has to be recognised that in these circumstances a lack of compliance with the scientific guidelines may not automatically result in a serious risk to public health unless they fulfil the conditions as described under section 2 of this guideline.

Any objection on the ground of a potential serious risk to public health cannot be justified by differences in national administrative or national scientific requirements, or internal national policies, unless the conditions or Article 29(1) of Directive 2001/83/EC are fulfilled.

DG Enterprise and Industry will publish a list of examples related to the above definitions of issues which normally would not be considered as grounds for a ‘Potential Serious Risk to Public Health’. This list will be updated based on experience gained with the decentralised and mutual recognition procedure.

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(1)  Amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(2)  Member States in this context refers to all countries of the European Economic Area.

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EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 8.6.2006 | EN | Official Journal of the European Union | C 133/8 |
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8.6.2006

EN

Official Journal of the European Union

C 133/8

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53rd amendment of the State aid guidelines

EFTA Surveillance Authority decision to propose appropriate measures

(2006/C 133/06)

Date of adoption:

EFTA State: n.a.

Case No: 55134

Title: Introduction of a new Chapter 18 C to the Authority's State Aid Guidelines on ‘State aid in the form of public service compensation’ and proposal for appropriate measures.

Legal basis: College Decision No 328/05/COL

Decision: The appropriate measures, proposed by the Authority and accepted by the EFTA States are as follows:

that the EFTA States bring their existing schemes regarding public service compensation into line with the new guidelines, within 18 months following the notification of the Decision to the EFTA States.

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III Notices

Commission

| 8.6.2006 | EN | Official Journal of the European Union | C 133/9 |
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8.6.2006

EN

Official Journal of the European Union

C 133/9

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LEONARDO DA VINCI PROGRAMME

Second phase (2000-2006)

Call for proposals EAC/21/06

‘Award of grants for activities (conferences, seminars) to exploit and disseminate the results of Leonardo da Vinci projects’

Notice of publication of a call for proposals on the Internet

(2006/C 133/07)

1.   Objectives and description

The objective of this call for proposals is to support dissemination and valorisation activities (particularly conferences and seminars) to encourage the transfer and use of results obtained by the Leonardo da Vinci programme and to promote the harmonisation of supply and demand on two to three subjects.

The initiative should have the following three stages, namely preparatory activities, the main activity and the follow-up. Only those proposals that conform to the requirements defined for these three stages will be considered:

| 1) | Preparatory phase: identification and bringing into line of users' needs and the results of the selected projects. On the basis of an analysis of the users' needs identified, the products and results of at least five different Leonardo da Vinci projects, in at least three different countries should be defined and selected with a view to their promotion and exploitation. |
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1)

Preparatory phase: identification and bringing into line of users' needs and the results of the selected projects. On the basis of an analysis of the users' needs identified, the products and results of at least five different Leonardo da Vinci projects, in at least three different countries should be defined and selected with a view to their promotion and exploitation.

| 2) | Organisation of the main activity (event): Organisation of a conference, a seminar, an exhibition, a workshop or interactive sessions for building partnerships to address supply and demand. Interactive exchanges between project promoters and users should be arranged to facilitate the transfer and exploitation of the project results, with a view to responding to the needs of new users. |
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2)

Organisation of the main activity (event): Organisation of a conference, a seminar, an exhibition, a workshop or interactive sessions for building partnerships to address supply and demand. Interactive exchanges between project promoters and users should be arranged to facilitate the transfer and exploitation of the project results, with a view to responding to the needs of new users.

| 3) | Final phase: Follow-up activities: proposals for follow-up activities to facilitate the transfer of results and the development of indicators for assessing the impact of the event. |
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3)

Final phase: Follow-up activities: proposals for follow-up activities to facilitate the transfer of results and the development of indicators for assessing the impact of the event.

2.   Eligible applicants

Applications for subsidies are welcome from European, national, regional, local and sectoral organisations or companies, including European networks, meeting the eligibility criteria, working in the field of Vocational Education and Training and wishing to organise an activity in the specific areas covered by this call for proposals. The applicants must have been legally established for more than three years and be established in one of the following countries:

the 25 EU Member States, the EFTA/EEA countries (Iceland, Liechtenstein, Norway) or one of the candidate countries (Bulgaria, Romania, Turkey).

3.   Potential beneficiaries

This call is addressed to bodies who can demonstrate their ‘multiplier’ effect (organisations active in the field of Vocational Education and Training (VET), national agencies, etc.) to improve VET systems and practices.

4.   Selection criteria

Only applications from candidates who meet the following criteria shall be considered.

| — | Candidates with the financial capacity to complete the proposed activity (see text of the call for proposals). |
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Candidates with the financial capacity to complete the proposed activity (see text of the call for proposals).

| — | Candidates with the operational capacity to complete the proposed activity. |
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Candidates with the operational capacity to complete the proposed activity.

5.   Award criteria

The decision on whether or not to grant a subsidy will be based on the following criteria:

| — | relevance of the content and the expected results of the event (conference/seminar) in relation to the aims of this call for proposals, that is, contribution to the dissemination and exploitation (valorisation) of the innovative results of Leonardo da Vinci projects; identification of the training needs and the response to the needs identified; |
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relevance of the content and the expected results of the event (conference/seminar) in relation to the aims of this call for proposals, that is, contribution to the dissemination and exploitation (valorisation) of the innovative results of Leonardo da Vinci projects; identification of the training needs and the response to the needs identified;

| — | quality of the organisational structure proposed, in particular its capacity for dissemination and valorisation and guarantee of an effective follow-up; |
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quality of the organisational structure proposed, in particular its capacity for dissemination and valorisation and guarantee of an effective follow-up;

| — | number, profile and quality of participants in the event (range of users/current and potential target groups, project promoters and partners, decision-makers at all levels, key stakeholders in vocational education); |
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number, profile and quality of participants in the event (range of users/current and potential target groups, project promoters and partners, decision-makers at all levels, key stakeholders in vocational education);

| — | quality and efficiency of the methodology, tools and practical approaches proposed for analysing and adapting products to users' needs; possibility of standardisation/viability; |
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quality and efficiency of the methodology, tools and practical approaches proposed for analysing and adapting products to users' needs; possibility of standardisation/viability;

| — | European dimension of the event, measured in terms of the contribution to its content and aims; number of participants (promoters and users) from different countries participating in the Leonardo da Vinci programme; potential impact expected; |
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European dimension of the event, measured in terms of the contribution to its content and aims; number of participants (promoters and users) from different countries participating in the Leonardo da Vinci programme; potential impact expected;

| — | work plan (clarity and appropriateness with regard to the objectives and means proposed); |
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work plan (clarity and appropriateness with regard to the objectives and means proposed);

| — | time schedule for the project; |
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time schedule for the project;

| — | coherence of the budget with the work plan; |
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coherence of the budget with the work plan;

| — | follow-up and evaluation methodology. |
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follow-up and evaluation methodology.

6.   Indicative amount, maximum rate of funding, timetable

The amount allocated for this call for proposals is EUR 1 000 000. With this sum, the Directorate-General for Education and Culture plans to support projects which will benefit from grants of up to EUR 100 000, covering a maximum of 75 % of eligible expenditure. 30 % of this budget must be devoted to funding follow-up actions (third stage).

The activities should start after the signature of the contracts, scheduled for between 1 November and 31 December 2006 at the latest.

The proposed activities for dissemination and valorisation should be finished in such a way as to allow enough time to move on to follow-up activities before the end of the project (four to six months).

In principle, the maximum duration of the projects will be18 months.

7.   Deadline

Proposals must be sent to the Commission no later than 10 July 2006.

8.   Additional information

The full text of the call for proposals and the application forms are available on the following website:

http://www.europa.eu.int/comm/education/programmes/calls/2106/index_en.html

For further information, please e-mail:

Eac-B5-Call-Eac/21/06@ec.europa.eu

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