23.9.2008

Official Journal of the European Union

C 242/1

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(Text with EEA relevance)

(2008/C 242/01)

Date of adoption of the decision

8.8.2008

Reference number of the aid

N 68/08 & N 69/08

Member State

Italy

Region

—

Title (and/or name of the beneficiary)

Cantiere Navale F.lli Giacalone S.p.A

Legal basis

Decreto ministeriale del 2 febbraio 2004«Attuazione del regolamento (CE) n. 1177/2002 del Consiglio, del 27 giugno 2002, relativo a un meccanismo difensivo temporaneo per la costruzione navale»

Type of measure

Individual aid

Objective

Contract-related aid

Form of aid

Direct grant

Budget

—

Intensity

—

Duration

—

Economic sectors

Shipbuilding

Name and address of the granting authority

Ministero dei Trasporti

Viale dell'Arte, 16

I-00144 Roma

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

2.7.2008

Reference number of the aid

N 72/08

Member State

Spain

Region

Comunidad de Madrid

Title (and/or name of the beneficiary)

Ayudas a la prommoción de largometrajes

Legal basis

Ley no 2/95, de 8 de marzo, de Subvenciones de la Comunidad de Madrid; Ley no 38/2003, de 17 de noviembre, General de Subvenciones (Ley Estatal); Ley no 55/2007, de 28 de diciembre, del Cine (Ley Estatal). Proyecto de Orden por la que se establecen las bases reguladoras y la convocatoria de ayudas a la producción de largometrajes para 2008, dedicadas a la promoción y publicidad

Type of measure

Aid scheme

Objective

Culture, Sectoral development

Form of aid

Direct grant

Budget

Annual budget: EUR 0,5 million

Overall budget: EUR 0,5 million

Intensity

50 %

Duration

7.2008-11.2008

Economic sectors

Recreational, cultural sporting activities

Name and address of the granting authority

Consejería de Cultura y Deportes de la Comunidad de Madrid

C/ Alcalá, no 31

E-28014 Madrid

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

Date of adoption of the decision

16.7.2008

Reference number of the aid

N 279/08

Member State

France

Region

France

Title (and/or name of the beneficiary)

Dotation en capital à France Télévisions

Legal basis

Ad hoc

Type of measure

Individual aid

Objective

Services of general economic interest

Form of aid

Other forms of equity intervention

Budget

Overall budget: EUR 150 million

Intensity

—

Duration

—

Economic sectors

Media

Name and address of the granting authority

Ministère de l'économie, des finances et de l'emploi — Agence des participations de l'État

139, rue de Bercy

F-75572 Paris

Other information

—

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://ec.europa.eu/community_law/state_aids/

23.9.2008

Official Journal of the European Union

C 242/6

Euro exchange rates (1)

22 September 2008

(2008/C 242/05)

1 euro=

	Currency	Exchange rate
USD	US dollar	1,4571
JPY	Japanese yen	155,2
DKK	Danish krone	7,4593
GBP	Pound sterling	0,792
SEK	Swedish krona	9,536
CHF	Swiss franc	1,5988
ISK	Iceland króna	130,68
NOK	Norwegian krone	8,1675
BGN	Bulgarian lev	1,9558
CZK	Czech koruna	24,075
EEK	Estonian kroon	15,6466
HUF	Hungarian forint	239,93
LTL	Lithuanian litas	3,4528
LVL	Latvian lats	0,708
PLN	Polish zloty	3,303
RON	Romanian leu	3,6282
SKK	Slovak koruna	30,29
TRY	Turkish lira	1,8096
AUD	Australian dollar	1,7436
CAD	Canadian dollar	1,5305
HKD	Hong Kong dollar	11,3263
NZD	New Zealand dollar	2,1166
SGD	Singapore dollar	2,0674
KRW	South Korean won	1 646,52
ZAR	South African rand	11,7209
CNY	Chinese yuan renminbi	9,952
HRK	Croatian kuna	7,1147
IDR	Indonesian rupiah	13 536,46
MYR	Malaysian ringgit	4,9818
PHP	Philippine peso	67,35
RUB	Russian rouble	36,7209
THB	Thai baht	49,396
BRL	Brazilian real	2,6283
MXN	Mexican peso	15,4198

(1)

Source: reference exchange rate published by the ECB.

23.9.2008

Official Journal of the European Union

C 242/8

Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000 of the European Parliament and of the Council: Review of the period of market exclusivity of orphan medicinal products

(2008/C 242/07)

1. INTRODUCTION

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (1) entered into force on 28 April 2000. It lays down a Community procedure for the designation of medicinal products as orphan medicinal products and provides incentives for the research, development and placing on the market of designated orphan medicinal products.

In accordance with Article 3(2) and 8(4) of Regulation (EC) No 141/2000, the Commission adopted Commission Regulation (EC) No 847/2000 of 27 April 2000, laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (2).

In July 2003, following the first three years of application of Regulation (EC) No 141/2000, the Commission published a Communication (3) that sets out general considerations on certain matters relating to the application of that Regulation.

In accordance with Article 10 of Regulation (EC) No 141/2000, the Commission services adopted in June 2006 a general report on the experience acquired as a result of the application of Regulation (EC) No 141/2000 (4).

This guideline sets out the general principles and procedures by which the period of market exclusivity of orphan medicinal products is reviewed and may be reduced to six years. If necessary, this guideline will be updated when further experience is gained on the application of Article 8(2) of Regulation (EC) No 141/2000 (5).

2. BACKGROUND AND LEGAL BASIS

Designation as an orphan medicinal product is governed by Articles 3 and 5 of Regulation (EC) No 141/2000. The designation criteria are laid down in Article 3(1), which reads:

‘A medicinal product shall be designated orphan medicinal product if its sponsor can establish:

(a)

that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10 thousand persons in the Community when the application is made (so-called “prevalence” criterion), or

that is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment;

and

(b)	that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.’ (emphasis added).

According to Article 8(1) of Regulation (EC) No 141/2000, where a marketing authorisation in respect of an orphan medicinal product is granted in all Member States, the Community and the Member States shall not, for a period of ten years (6), accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product.

Article 8(2) of the same Regulation provides that this period may be reduced to six years (7) if, at the end of the fifth year, it is established, in respect of the medicinal product concerned, that the designation criteria laid down in Article 3 are no longer met, inter alia, where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Article 8(5) provides the legal basis for the Commission to draw up detailed guidelines for the application of Article 8. This guideline fulfils part of that requirement as it relates specifically to Article 8(2).

3. GENERAL PRINCIPLES FOR THE REVIEW UNDER ARTICLE 8(2)

The review procedure of Article 8(2) is triggered by information received from a Member State relating to a specific designation of an orphan medicinal product. The initiation of the procedure established in Article 8(2) is not intended to be systematic for all orphan designated products; on the contrary, Member States should only inform the European Medicines Agency (hereinafter ‘the Agency’) if they have sufficient indications suggesting that the designation criteria are no longer met; in that case, they have to do so. The review procedure under Article 8(2) is therefore expected to be the exception.

If and when the procedure is triggered by a Member State, an assessment will be carried out within the Agency by the Committee on Orphan Medicinal Products (‘COMP’), according to the procedure laid down in Article 5(4) to 5(8) of Regulation (EC) No 141/2000. COMP will provide an opinion as to whether the market exclusivity should be maintained or reduced. For a given product, all authorised therapeutic indications falling within the scope of the same orphan designation will be assessed in the same procedure.

The review of market exclusivity by COMP will be based, in a first step, on the same set of criteria on which designation was granted according to Article 3 of the same Regulation. The period of market exclusivity will not be reduced to six years, if at the end of the fifth year the original designation criteria are still met. If the original criteria are no longer met, COMP will also review, in a second step of its assessment, the situation of the product concerned as regards the other designation criteria of Article 3(1) of Regulation (EC) No 141/2000.

The guidance provided in Section 5 below should be read jointly with the existing provisions and guidance as regards the factors that should be considered when initially assessing the designation criteria and the documentation relevant to that effect, and when re-evaluating the designation criteria before granting marketing authorisation. These factors and documentation will apply by analogy at the time of the review of the period of market exclusivity. In particular, they are laid down in the following texts:

—	Regulation (EC) No 847/2000 and the Commission communication of 2003, referred to above, which contain various rules on the evaluation of the designation criteria, and

—	the Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designation from one sponsor to another (8), which contains practical advice on how to compile the documents substantiating fulfilment of the designation criteria.

After receipt of the opinion, the Commission will adopt a decision, according to the procedure laid down in Article 5(8) of Regulation (EC) No 141/2000. Where the decision is to reduce the period of market exclusivity, the product concerned will be removed from the Community Register of Orphan Medicinal Products, in accordance with Article 5(12) of Regulation (EC) No 141/2000.

The evaluation of the product by the Agency and the Commission will generally take place at the end of the fifth year from marketing authorisation in all Member States. If as a result of such evaluation the orphan status of the product is maintained, no other revision is foreseen between the sixth year and the end of the period of market exclusivity.

4. INFORMATION BY A MEMBER STATE

Article 8(2) of Regulation (EC) No 141/2000 establishes that a Member State shall inform the Agency that at least one of the designation criteria, on the basis of which market exclusivity was granted, may not be met.

According to Article 8(2) of Regulation (EC) No 141/2000, the period of market exclusivity may be reduced when appropriate evidence is established at the end of the fifth year of market exclusivity. To allow for the handling of Member States' information within this time frame, Member States are advised to submit this information by the end of the fourth year of market exclusivity.

The Member State in question should provide the rationale for its doubts and include appropriate data justifying why at least one of the original designation criteria of the orphan medicinal product concerned may no longer be met. In preparing its information to the Agency, the Member State may use data which supported the initial designation, held by the Agency.

5. ASSESSMENT BY THE AGENCY

Once the Agency has received information by one or more Member State(s) according to Article 8(2) of Regulation (EC) No 141/2000, the Agency will inform the Commission and the marketing authorisation holder before the assessment procedure is initiated. The market authorisation holder shall be provided with the Member State's reasons why at least one of the designation criteria on the basis of which market exclusivity was granted may not be met; he shall be given the opportunity to submit its views and appropriate data in writing, and may be invited to a hearing in front of COMP.

COMP will issue an opinion as a result of the assessment, justifying whether or not the orphan status of the product should be maintained. In its assessment, COMP will review the relevant designation criteria based on the evidence available to it, in particular provided by the sponsor and the referring Member State. If the available evidence is insufficient to establish with reasonable confidence whether or not the designation criteria continue to be met, COMP will recommend that the period of market exclusivity is not reduced.

The assessment will be done in two steps. In a first step (see under 5.1 below), COMP will review the initial designation criteria. If the initial designation criteria are still met, COMP will adopt an opinion recommending that the period of market exclusivity is not reduced.

If the original criteria are no longer met, step two will be performed (see under 5.2): after receiving the necessary information from the sponsor COMP will review whether the other designation criteria of Article 3(1) of Regulation (EC) No 141/2000 are met.

If the other designation criteria of Article 3(1) of Regulation (EC) No 141/2000 are fulfilled, COMP will adopt an opinion recommending that the period of market exclusivity is not reduced.

If none of the criteria for designation under Article 3(1) of Regulation (EC) No 141/2000 are met, COMP will adopt an opinion which may recommend that the period of market exclusivity shall be reduced.

5.1. First step

COMP will review the initial designation criteria, i.e. the criterion under Article 3(1)(a) and the criterion under Article 3(1)(b) of Regulation (EC) No 141/2000 which led to the designation as an orphan medicinal product.

5.1.1. Alternative criteria of Article 3(1)(a) of Regulation (EC) No 141/2000

5.1.1.1. Products initially designated on the basis of prevalence

For products initially designated on the basis of the prevalence criterion of Article 3(1)(a), first subparagraph, the Agency's assessment will include an evaluation of the prevalence of the orphan condition at the time of the review of market exclusivity.

The prevalence in the Community will be calculated for the designated orphan condition under review following the same standards as the ones used at the moment of designation.

The sponsor will be requested to provide a critical review of possible changes in the estimated prevalence of the condition, including a discussion on the impact of the product on the prevalence in comparison with the natural development of the prevalence of the condition. The prevalence estimate may in principle rise over time either because the prevalence was previously underestimated (e.g. better estimates due to increasing awareness of the condition) or because the true prevalence of the condition has risen (e.g. increasing incidence or increased survival).

A prolongation of patient survival attributable to the effect of the drug would not be used as a reason to reduce market exclusivity. However, an increase in the prevalence of the condition due to improved survival as a result of other advances in the management of the condition not directly related to the product or due to increased incidence would need to be taken into consideration.

5.1.1.2. Products initially designated on the basis of insufficient return on investment

For products initially designated on the basis of the insufficient return on investment criterion of Article 3(1)(a), second subparagraph, the Agency will use the same methodology at the time of the review of market exclusivity as the one used at the moment of designation.

The test used under Article 3(1)(a) at the time of designation is whether ‘without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment’ (emphasis added). The criterion is thus based on a prognosis: the unlikelihood that the expected return would justify the required investment. The test is fulfilled, if it appears unlikely that a sponsor would be prepared to make the investment as the expected return would not be sufficient to compensate for the sponsor's risks.

The corresponding test at the time of the review of market exclusivity would use the same principles. Therefore, the criterion would still be fulfilled if the marketing of the medicinal product in the Community, without the incentive, would not generate sufficient return on investment to balance the risks already taken or still to be taken by the sponsor. If, after subtraction of the financial benefits gained as a result of the incentives under the Regulation, the return on investment is insufficient, market exclusivity will not be reduced.

5.1.2. Alternative criteria of Article 3(1)(b) of Regulation (EC) No 141/2000

For the criteria of Article 3(1)(b) — inexistence of a satisfactory method or significant benefit — the Agency will take into account any changes affecting the treatment, prevention or diagnosis of patients within the designated condition since the date of the marketing authorisation.

The sponsor may be requested to provide a critical review of its product at the time of the review of market exclusivity. The critical review will include any available data, for instance:

—	results of any comparative studies performed,

—	a comprehensive and balanced bibliographic review,

—	marketing studies, or

—	patients' surveys.

However, sponsors will not be required to generate new comparative data against another treatment/treatment method that has become available since a marketing authorisation was granted for the designated product.

5.1.2.1. Products initially designated on the basis of inexistence of a satisfactory method

For products initially designated on the basis of inexistence of a satisfactory method (Article 3(1)(b), first part), information which may be requested from the sponsor includes a critical review of the place of the product in the therapeutic, diagnostic or prophylactic management of patients within the authorised therapeutic indication at the time of the review of market exclusivity.

5.1.2.2. Products initially designated on the basis of significant benefit

For products initially designated on the basis of significant benefit (Article 3(1)(b), second part), information which may be requested from the sponsor includes a critical review of the maintenance of the significant benefit of the product in the designated condition, in comparison with methods of treatment, diagnosis or prophylaxis at the time of the review of market exclusivity.

5.1.3. COMP opinion

If COMP comes to the conclusion that the initial designation criteria are still met, it will recommend that the period of market exclusivity is not reduced.

5.2. Second step

If COMP is of the opinion that the initial criteria for designation are no longer met, it will provide the sponsor with an opportunity to demonstrate that the market exclusivity can be maintained based on the other designation criteria of Article 3(1) of Regulation (EC) No 141/2000. The sponsor will be requested to provide the Agency with the information necessary for that purpose.

5.2.1. Alternative criteria of Article 3(1)(a) of Regulation (EC) No 141/2000

Where the initial designation was based on prevalence and it is concluded that this criterion is no longer met, COMP will assess the return on investment of the product at the time of the review of market exclusivity.

On the other hand, where the initial designation was based on return on investment and it is concluded that this criterion is no longer met, COMP will assess the prevalence of the product at the time of the review of market exclusivity.

5.2.2. Alternative criteria of Article 3(1)(b) of Regulation (EC) No 141/2000

Where the initial designation was based on the inexistence of a satisfactory method and it is concluded that this criterion is no longer fulfilled, COMP will assess the significant benefit of the product at the time of the review of market exclusivity.

On the other hand, where the initial designation was based on significant benefit, and it is concluded that this criterion is no longer fulfilled, there would normally not be an alternative test available. However, COMP would assess the inexistence of a satisfactory method at the time of the review of market exclusivity in exceptional cases; this could for instance be the case if a method existing at the time of designation had in the meantime disappeared.

5.2.3. COMP opinion

If the COMP assessment under step two shows that the alternative designation criteria of Article 3(1)(a) and Article 3(1)(b) are met, COMP will adopt an opinion recommending that the period of market exclusivity is not reduced.

If following the assessments in steps one and two it turns out that neither the initial, nor the alternative designation criteria of Article 3(1)(a) and Article 3(1)(b) are met, COMP will adopt an opinion which may recommend that the period of market exclusivity shall be reduced. Relevant criteria for the COMP, on whether or not to recommend a reduction of market exclusivity, would include the extent according to which a designation criterion is not fulfilled. Furthermore, COMP should consider insufficient profitability as an argument against the reduction of market exclusivity.

6. DECISION BY THE EUROPEAN COMMISSION

The Commission will take a decision on whether market exclusivity is to be maintained or reduced, on the basis of the opinion of COMP. According to Article 5(8) of Regulation (EC) No 141/2000, this decision shall be adopted within 30 days of receipt of the opinion.

According to Article 5(8) of Regulation (EC) No 141/2000, the Commission may in exceptional circumstances adopt a decision which is not in accordance with the opinion of COMP. In exercising this discretion, the Commission will take into account the specific circumstances of the product concerned in the light of the Regulation's key objectives, i.e. improving the availability of orphan medicinal products and ensuring appropriate and effective incentives for research and development in this sector.

(1) OJ L 18, 22.1.2000, p. 1.

(2) OJ L 103, 28.4.2000, p. 5.

(3) OJ C 178, 29.7.2003, p. 2.

(4) Commission staff working document of 20 June 2006, on the experience acquired as a result of the application of Regulation (EC) No 141/2000 on orphan medicinal products and account of the public health benefits obtained — Document on the basis of Article 10 of Regulation (EC) No 141/2000, SEC(2006) 832, available at:

http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/orphan_en_06-2006.pdf

(5) Certain principles for this review and possible reduction of market exclusivity were already contained in Section D.4 of the above-cited Commission Communication of 2003. However, following additional experience gained with the application of Regulation (EC) No 141/2000, the Commission developed its interpretation of Article 8(2) further, as set out in the present guideline. Consequently, the present guideline supersedes Section D.4 of the 2003 Communication.

(6) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1) provides in its Article 37 that for medicinal products designated as orphan medicinal products, if specified criteria in the paediatric Regulation are met, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to twelve years (two-year extension as reward for compliance with paediatric investigation plan).

(7) For products falling under Article 37 of the above-cited paediatric Regulation the reduced period under Article 8(2) of Regulation (EC) No 141/2000 will be equally six years; Article 37 of the paediatric Regulation only affects the calculation of the period referred to in Article 8(1) of Regulation (EC) No 141/2000.

(8) Available at:

http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/index.htm and regularly updated

23.9.2008

Official Journal of the European Union

C 242/12

Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity

(2008/C 242/08)

1. INTRODUCTION

Paragraph 5 of Article 8 of Regulation (EC) No 141/2000 requires the Commission to draw up detailed guidelines for the application of Article 8 of that Regulation. This guideline fulfils part of that requirement, providing guidance on the application of Articles 8(1) and 8(3) of that Regulation.

This guideline should be read in conjunction with:

—	Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products,

—	Commission Regulation (EC) No 847/2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’,

—	Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (1), hereafter ‘Commission Communication’.

According to Article 8(1) of Regulation (EC) No 141/2000, where a marketing authorisation in respect of an orphan medicinal product is granted either by centralised procedure or in all Members States, the Community and the Member States shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product (so-called 10 year market exclusivity) (2). The scenarios ‘application for a marketing authorisation’ and ‘application to extend an existing marketing authorisation’ will hereafter be referred to together as ‘application for a marketing authorisation’.

With regard to Article 8(1), the present guideline provides guidance on the following questions:

What are the relevant criteria for assessing similarity of a medicinal product? See under Section 2 below.

What is the procedure used by the competent authorities for assessing similarity? See under Section 3 below.

Article 8(3) of Regulation (EC) No 141/2000 describes three types of derogations from the market exclusivity provided under Article 8(1) of that Regulation: (a) consent of the original marketing authorisation holder; (b) inability of the original marketing authorisation holder to supply sufficient quantities; (c) the second medicinal product is safer, more effective or otherwise clinically superior.

With regard to Article 8(3) of Regulation (EC) No 141/2000, the present guideline provides guidance on the following questions:

What is the relevant procedure for assessing whether one of the derogations applies? See Section 3 below.

2. GENERAL PRINCIPLES FOR ASSESSMENT OF SIMILARITY

Article 3 of Regulation (EC) No 847/2000 provides the following definitions:

—	‘similar medicinal product’ means a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication,

—	‘similar active substance’ means an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular features) and which acts via the same mechanism. Regulation (EC) No 847/2000 then provides specific examples,

—	‘active substance’ means a substance with physiological or pharmacological activity.

Based on the definitions set out in Article 3 of Regulation (EC) No 847/2000, the assessment of similarity between two medicinal products under Article 8 of Regulation (EC) No 141/2000 takes into consideration principal molecular structural features, mechanism of action and therapeutic indication. If significant differences exist within one or more of these criteria, then the two products will be considered as not similar. These three criteria are further explained below.

The International Non proprietary Names (INN) may provide preliminary information in assessing the similarity of the molecular structural features and the mechanism of action. In the INN system, the names of pharmacologically-related substances may show their relationship by using a common ‘suffix’/substem.

2.1. Same principal molecular structural features

The following, general considerations should be taken into account for the assessment of the molecular structural features of the active substance (though for macromolecules, particularly complex biological medicinal products, not all of these considerations may be appropriate).

The applicant should demonstrate the proposed structure of the molecule as follows:

—	the evidence relating to the demonstration of structure should be summarised in unambiguous two-and three dimensional graphical representations, whenever possible,

—	where possible, the active substance should be described precisely using systematic terminology, e.g. IUPAC (3) or CAS (4) nomenclature,

—	where the active substances have a recommended INN name, the World Health Organisation structures and reports should be provided.

If any of the above information is not provided or not available, a justification should be given.

The principal molecular structural features of the product should be described, based on evidence and compared to those of the authorised orphan medicinal product. It should be noted that certain observed differences in structure may appear major in the molecule's crystalline state (i.e. based on X-Ray data). However, since molecules exert their biological action in solution, these differences seen in the crystalline state may not be relevant for the assessment of similarity.

Software programs may be used to measure the degree of structural similarity between molecules; many of them allowing ‘similarity searching’ to identify molecules having common or similar molecular architectural features (2- or 3-dimensional).

2.2. Same mechanism of action

The mechanism of action of an active substance is the functional description of the interaction of the substance with a pharmacological target that elicits a pharmacodynamic effect. In case the mechanism of action is not fully known, it will be for the applicant to demonstrate that the two active substances do not act via the same mechanisms.

Two active substances may only be considered to have the same mechanism of action, provided that both share the same pharmacological target and pharmacodynamic effect.

Factors not relevant to the mechanism of action are differences between two substances in terms of:

—	mode of administration,

—	pharmacokinetic properties,

—	potency, or

—	tissue distribution of the target.

A prodrug is considered to have the same mechanism of action as its active metabolite.

A pharmacological target is usually a receptor, enzyme, channel, carrier or an intracellular coupling process.

The pharmacodynamic effect is the action of the active substance on the body (e.g. bradycardia). For the purpose of assessing similarity of the second product with an authorised orphan medicinal product, the pharmacodynamic effect relevant to the ‘mechanism of action’ is the primary pharmacodynamic effect of the active substance, which determines the therapeutic indication.

Two substances with the same pharmacological target may elicit a different pharmacodynamic effect depending on the location of the target, or depending on whether the target is activated or inhibited.

Two active substances with the same pharmacodynamic effect may act at different pharmacological targets. In case these two active substances act at multiple targets (including subtypes of the same receptor) and share at least one common target, it should be considered whether the common target(s) explain the primary pharmacodynamic effects which determine the therapeutic indication (5).

2.3. Same therapeutic indication

The therapeutic indication of an orphan medicinal product is determined by the marketing authorisation and has to fall within the scope of the (possibly broader) designated orphan condition, cf. Section C.1 of the Commission Communication.

If an orphan medicinal product has been granted a marketing authorisation for an indication which is a subset of the designated condition, an application for marketing authorisation of a second product, which claims to cover a different therapeutic indication, and thus another subset of the same designated orphan condition, will have to establish that the difference between the two subsets is clinically meaningful. If there is an overlap of the target populations of two allegedly different therapeutic indications, the second applicant would have to provide the authority with an estimate of its extent. The extent of the overlap will be a relevant factor for the authority to establish whether the claim for two different therapeutic indications can be upheld.

3. PROCEDURE FOR ASSESSING SIMILARITY AND FOR APPLYING THE DEROGATIONS IN ARTICLE 8(3)

3.1. Competent authority

According to Article 8(1) of Regulation (EC) No 141/2000, the Community and the Member States shall not, for a period of 10 years, accept a marketing authorisation application for a medicinal product (hereafter also ‘second product’) which is similar to an authorised orphan medicinal product (hereafter also ‘first product’).

The competent authority for providing the assessment of similarity, and if applicable the fulfilment of the criteria for one of the derogations set out in Article 8(3) (‘competent assessing body’) is to be determined depending on the route of marketing authorisation of the second product. The second medicinal product may be authorised either nationally (non-orphan product (6)) or centrally (either orphan or non-orphan product).

For centralised marketing authorisation applications of a second product to be compared with an authorised orphan medicinal product, the competent assessing body is the Agency.

For applications filed through National, Mutual Recognition or Decentralised Procedures, the competent assessing body/ies is/are the national competent authority/ies concerned.

3.2. Validation

The applicant for a marketing authorisation of a (‘second’) product potentially similar to an authorised orphan medicinal (‘first’) product will have to provide appropriate documentation on his position regarding similarity of the second product with the first product and, if relevant, a justification that one of the derogations set out in Article 8(3) applies (see Section 3.3 ‘information to be submitted by the applicant’ and Section 3.4 ‘identification of relevant products …’).

The application for the second product will be validated by the competent assessing body if this documentation/justification is contained in the application. Applicants should be aware that validation implies a formal check (all relevant documents have been submitted) but does not give any indication as to the outcome of the material assessment of their application.

If the application concerns a generic medicinal product, similarity is assumed. Consequently, the application cannot be validated before the end of the period of market exclusivity unless justification is provided to support one of the derogations laid down in Article 8(3).

3.3. Information to be submitted by the applicant

Information to address potential ‘similarity’ and, where applicable, to justify that one of the derogations laid down in Article 8(3) of Regulation (EC) No 141/2000 applies should be submitted in module 1.7 of the application for marketing authorisation.

3.3.1. Similarity

For similarity, a report should be included in module 1.7.1 comparing the product with authorised orphan medicinal products in the context of similarity as defined in Article 3(3) of Regulation (EC) No 847/2000 and concluding on similarity or ‘non’ similarity, addressing the three criteria for assessing similarity:

—	molecular structural features,

—	mechanism of action, and

—	therapeutic indication.

Particular emphasis should be made on the explanation of the first two criteria. If the applicant claims that the two products are not similar, he should provide reasons to support this claim.

3.3.2. Derogations

To support that one of the derogations laid down in Article 8(3), paragraphs (a) to (c) of the same Regulation applies, the following information should be submitted in module 1.7.2, as applicable:

3.3.2.1. Article 8(3)(a)

If the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant:

A signed letter from the holder of authorised orphan medicinal product confirming his/her consent for the second applicant to file an application for marketing authorisation, in accordance with Article 8(3)(a) of Regulation (EC) No 141/2000.

3.3.2.2. Article 8(3)(b)

If the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product:

A report describing why supply of the authorised orphan medicinal product is deemed to be insufficient, in accordance with Article 8(3)(b) of Regulation (EC) No 141/2000.

The report should include details of the supply problem and an explanation as to why patients' needs in the orphan indication are not being met. All claims should be substantiated by qualitative and quantitative references.

3.3.2.3. Article 8(3)(c)

If the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior:

A critical report which justifies why the second product is deemed to be ‘clinically superior’ to the authorised orphan medicinal product, in accordance with Article 8(3)(c) of Regulation (EC) No 141/2000.

The report should include a comparison of the two products in the context of ‘clinical superiority’ as defined in Article 3(3)(d) of Regulation (EC) No 847/2000, with particular reference to:

—	the results of clinical studies,

—	the scientific literature.

3.4. Identification of relevant products to perform similarity check

For any application for marketing authorisation, the competent assessing body should check which authorised orphan medicinal products need to be taken into consideration for an assessment of possible similarity. This check should first be performed prior to validating the application.

If a competent assessing body identifies a possible similarity issue not addressed by the applicant before validation, the applicant will be asked to complete the application with information on ‘similarity’ and, if applicable, on one of the derogations in Article 8(3). Validation of the application will only proceed once the applicant has submitted either a report justifying the lack of similarity or information justifying one of the derogations in Article 8(3), see above under 3.3 ‘information to be submitted by the applicant’.

As considerable time may elapse between validation of an application and adoption of the opinion/granting of a marketing authorisation, the competent assessing body should repeat its check of possibly similar orphan medicinal products prior to the granting/amendment of the marketing authorisation: new orphan medicinal products may have been authorised for the same condition in the meantime.

For the centralised procedure, the Agency will repeat its check for possibly similar orphan medicinal products before the Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion. Where additional possible similarity issues are identified, the applicant will be asked to submit further relevant documentation on similarity (and, if necessary, documentation to support that one of the derogations in Article 8(3) applies). The ‘procedural clock’ will be stopped until this documentation is submitted.

Should a new issue of possible similarity be identified during the procedure at the level of the European Commission, during the preparation of a marketing authorisation decision, the latter may refer the CHMP opinion back to the Agency for further evaluation.

3.5. Procedure for assessing similarity and for applying the derogation based on ‘clinical superiority’

Following identification of the relevant products to perform the product similarity check, the competent assessing body will initiate the procedure for assessing similarity and, if its opinion on similarity is positive, the procedure for assessing whether a derogation under Article 8(3) is fulfilled.

The competent assessing body should assess ‘similarity’ and, if applicable the fulfilment of the derogation ‘clinical superiority’ in parallel with the evaluation of the quality/safety/efficacy of the medicinal product.

Should the competent assessing body come, only during the quality/safety/efficacy evaluation, to the conclusion that there is similarity between the product under evaluation and an authorised orphan medicinal product, the applicant will be requested at that time to submit a justification that one of the derogations in Article 8(3) is fulfilled.

3.5.1. Centralised procedure

The CHMP opinion on ‘similarity’ and, where applicable on ‘clinical superiority’ will be part of the overall opinion on quality/safety/efficacy. Where clinical superiority is assessed, the basis for clinical superiority will be described in the European Public Assessment Report.

Re-examination of CHMP opinion

Once the CHMP has concluded its assessment of similarity and, if applicable, of the fulfilment of the criteria for the derogation ‘clinical superiority’, the applicant may ask for a re-examination of the CHMP Opinion according to the principles set out in Article 9(2) of Regulation (EC) No 726/2004.

Scientific advice or protocol assistance on similarity and clinical superiority

Applicants seeking to develop a product where an issue on similarity with an orphan medicinal product might arise can request Scientific Advice (or Protocol Assistance) from the CHMP. In its request for advice, the applicant will have to document its position regarding similarity and, if relevant, provide a justification for one of the derogations.

If the applicant intends to rely on the derogation of clinical superiority, Scientific Advice or Protocol Assistance can be requested, and is recommended, on the appropriateness of the study(ies) intending to demonstrate clinical superiority.

3.5.2. National, Mutual Recognition and Decentralised Procedures

It is highly recommended that the relevant national competent assessing body in a national, mutual recognition or decentralised procedure informs the Agency as soon as a potential similarity issue with an authorised orphan medicinal product is detected. In order to ensure consistency of the assessment of similarity and clinical superiority throughout the Community, it would be advisable to have a consultation process between the Agency's CHMP and the national authority.

In all cases, the Agency should be informed of the national authority's conclusions on similarity and, if applicable, clinical superiority.

3.6. Procedure for applying the derogation based on ‘inability to supply sufficient quantities’

For the derogation set out in Article 8(3)(b) of Regulation (EC) No 141/2000 — the holder of the marketing authorisation of the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product — the applicant of the second product will have to provide the competent assessing body with a report supporting this derogation (see above under 3.3 ‘information to be submitted by the applicant’).

The competent assessing body should circulate the applicant's report to (other) Member States for comments. The competent assessing body should also liaise with the marketing authorisation holder of the original product, inviting him to submit comments in writing. The competent assessing body should issue a position on the fulfilment of the criteria for derogation, taking into account the applicant's report as well as comments received from Member States and the marketing authorisation holder. If the derogation is assessed in the framework of the centralised procedure, this position shall be part of the CHMP opinion.

3.7. Parallel assessment of two applications for the same orphan condition

3.7.1. Centralised procedure

In case two procedures for granting marketing authorisations for possibly similar orphan medicinal products are running in parallel, having been received by the Agency at the same time, the following scenarios may arise:

In the very exceptional case where marketing authorisation applications for the same orphan indication are received at the same time and, being handled in accordance with the relevant provisions of the pharmaceutical legislation, the authorisation procedures remain in parallel, an opinion on similarity of the two products will not be necessary.

On the other hand, where for these simultaneous marketing authorisation applications, based on the examination of each application on its own merits, the two authorisation procedures do not remain in parallel, an opinion on similarity will be necessary: as soon as one of the products with orphan status obtains marketing authorisation, the applicant for the other (second) product will be informed that a marketing authorisation for a possibly similar orphan medicinal product has been granted. A report on ‘similarity’ and, if applicable a justification for one of the derogations in Article 8(3) will be requested from this applicant.

3.7.2 National, Mutual Recognition and Decentralised Procedures

In case a medicinal product has been designated as an orphan medicinal product and its marketing authorisation is under assessment, but has not yet been granted by the European Commission, a parallel assessment of a possibly similar (non-orphan (7)) medicinal product can occur by a national authority. As there is no authorised orphan medicinal product yet, the marketing authorisation may be granted (without an opinion of similarity).

(1) OJ C 178, 29.7.2003, p. 2.

(2) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1) provides that for medicinal products designated as orphan medicinal products, if specified criteria in the paediatric Regulation are met, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to twelve years (see Article 37 of that Regulation).

(3) IUPAC stands for International Union of Pure and Applied Chemistry.

(4) CAS stands for Chemical Abstracts Service, which is a division of the American Chemical Society.

(5) For example: atenolol and propranolol would be considered to have the same mechanism of action regarding their indication in hypertension, even if they have different selectivity and potency at β1-receptor and β2-receptor levels. On the other hand, for example carvedilol and metoprolol would not be considered to have the same mechanism: although they share β-receptor blocking activity, their mechanisms of action differ for the treatment of severe congestive heart failure due to the additional α-receptor blocking activity of carvedilol.

(6) As of 20 November 2005, designated orphan medicinal products may only be authorised via the centralised authorisation procedure (Article 3(1) of Regulation (EC) No 726/2004). Thus, a second product can only be authorised nationally, if it is not an orphan medicinal product.

(7) See under 3.1 above: since 20 November 2005, designated orphan medicinal products may only be authorised via the centralised authorisation procedure.

23.9.2008

Official Journal of the European Union

C 242/17

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 2204/2002 on the application of Articles 87 and 88 of the EC Treaty to State aid for employment

(Text with EEA relevance)

(2008/C 242/09)

Aid No

XE 26/08

Member State

Italy

Region

Calabria

Title of aid scheme

Incentivi alle imprese di grandi dimensioni per l'incremento occupazionale

Legal basis

Decreto dirigente generale dipartimento n. 10 Regione Calabria del 27 giugno 2008 pubblicato in data 30 giugno 2008 sul BURC — parte III — Avviso pubblico per la concessione di incentivi alle imprese di grandi dimensioni per l'incremento occupazionale e la formazione in azienda dei neoassunti. POR Calabria 2000/2006, Asse III Risorse umane (FSE). Misura 3.2 — Inserimento e reinserimento nel mercato del lavoro e Misura 3.4 Inserimento lavorativo e reinserimento di gruppi svantaggiati. POR Calabria FSE 2007/2013, Asse II Occupabilità, obiettivo operativo E. 1 Rafforzare l'inserimento (reinserimento lavorativo dei lavoratori adulti, dei disoccupati di lunga durata e dei bacini di precariato occupazionale attraverso percorsi integrati e incentivi

Budget

Annual budget: EUR 14 million

Maximum aid intensity

In conformity with Articles 4(2)-(5), 5 and 6 of the Regulation

Date of implementation

30.6.2008

Duration

31.12.2008

Objective

Art. 4: Creation of employment; Art. 5: Recruitment of disadvantaged and disabled workers; Art. 6: Employment of disabled workers

Economic sectors

All Community sectors (1) eligible for employment aid

Name and address of the granting authority

Regione Calabria — Dipartimento n. 10 lavoro, politiche della famiglia, formazione professionale, cooperazione e volontariato

Via Lucrezia della Valle

I-88100 Catanzaro

Aid No

XE 28/08

Member State

Italy

Region

Calabria

Title of aid scheme

Concessione di incentivi ai datori di lavoro per l'incremento occupazionale

Legal basis

Decreto dirigente generale dipartimento n. 10 Regione Calabria del 27 giugno 2008 — pubblicato in data 30 giugno 2008 sul BURC — parte III — Avviso pubblico per la concessione di incentivi ai datori di lavoro per l'incremento occupazionale e la concessione di una dote formativa come contributo all'adattamento delle competenze. POR Calabria 2000/2006, Asse III Risorse umane (FSE). Misura 3.2 Inserimento e reinserimento nel mercato del lavoro POR Calabria FSE 2007/2013, Asse II Occupabilità, obiettivo operativo E.1 Rafforzare l'inserimento (reinserimento lavorativo dei lavoratori adulti, dei disoccupati di lunga durata e dei bacini di precariato occupazionale attraverso percorsi integrati e incentivi)

Budget

Annual budget: EUR 7,6 million

Maximum aid intensity

In conformity with Articles 4(2)-(5), 5 and 6 of the Regulation

Date of implementation

30.6.2008

Duration

31.12.2008

Objective

Art. 4: Creation of employment; Art. 5: Recruitment of disadvantaged and disabled workers; Art. 6: Employment of disabled workers

Economic sectors

All Community sectors (2) eligible for employment aid

Name and address of the granting authority

Regione Calabria — Dipartimento n. 10 lavoro, politiche della famiglia, formazione professionale, cooperazione e volontariato

Via Lucrezia della Valle

I-88100 Catanzaro

Aid No

XE 32/08

Member State

Italy

Region

Campania

Title of aid scheme

Contratto di programma regionale

Legal basis

Legge regionale 12/07, regolamento 4/2007, disciplinare art. 16, delibera giunta regionale n. 514 del 21 marzo 2008.

Budget

Annual budget: EUR 10 million

Maximum aid intensity

In conformity with Articles 4(2)-(5), 5 and 6 of the Regulation

Date of implementation

19.6.2008

Duration

31.12.2013

Objective

Art. 4: Creation of employment; Art. 5: Recruitment of disadvantaged and disabled workers; Art. 6: Employment of disabled workers

Economic sectors

All manufacturing (3), All services (3)

Name and address of the granting authority

REGIONE CAMPANIA

AGC 12 Sviluppo economico

1.	Settore programmazione delle politiche per lo sviluppo economico Dirigente p.t. dott.sa Carolina Cortese

2.	Settore aiuti alle imprese e sviluppo insediamenti produttivi Dirigente p.t. dott. Filippo Diasco AGC 17 — Formazione Professionale

3.	Settore formazione professionale Coordinatore dott. F. Girardi

Centro direzionale Isola A/6

I-80143 Napoli

tél. (39) 081 796 75 43

e-mail: mc.cortese@maildip.regione.campania.it

Centro direzionale Isola A/6

I-80143 Napoli

Tel. (39) 081 796 68 65

e-mail: f.diasco@regione.campania.it

Centro direzionale Isola A/6

I-80143 Napoli

Tel. (39) 081 796 62 54

e-mail: f.girardi@regione.campania.it

Other information

The aid scheme is cofinanced under the ESF operating programme for 2007-2013 (see regional decree DGR No 514/2008)

Aid No

XE 33/08

Member State

Germany

Region

Freistaat Sachsen

Title of aid scheme

Gemeinsames Umsetzungsdokument zum Programm Ziel 3/Cíl 3 zur Förderung der grenzübergreifenden Zusammenarbeit 2007-2013 zwischen dem Freistaat Sachsen und der Tschechischen Republik im Rahmen des Ziels „Europäische territoriale Zusammenarbeit“

Legal basis

VO (EG) 1083/2006 (allg. Strukturfondsverordnung)

VO (EG) 1080/2006 (EFRE-Verordnung)

Gemeinsames Programmdokument (Operationelles Programm CCI-Code: 2007CB163PO017),

§§ 23 und 44 der Haushaltsordnung für den Freistaat Sachsen (Sächsische Haushaltsordnung — SäHO, SächsGVBl. 2001, S. 154) sowie der hierzu ergangenen Verwaltungsvorschriften des Sächsischen Staatsministeriums der Finanzen

Budget

Annual budget: EUR 0,85 million

Maximum aid intensity

In conformity with Articles 4(2)-(5), 5 and 6 of the Regulation

Date of implementation

1.1.2007

Duration

31.12.2015

Objective

Art. 5: Recruitment of disadvantaged and disabled workers; Art. 6: Employment of disabled workers

Economic sectors

All Community sectors (4) eligible for employment aid

Name and address of the granting authority

Sächsische Aufbaubank — Förderbank

Pirnaische Straße 9

D-01069 Dresden

(1) With the exception of the shipbuilding sector and other sectors subject to special rules in regulations and directives governing all State aid within the sector.

(2) With the exception of the shipbuilding sector and other sectors subject to special rules in regulations and directives governing all State aid within the sector.

(3) With the exception of the shipbuilding sector and other sectors subject to special rules in regulations and directives governing all State aid within the sector.

(4) With the exception of the shipbuilding sector and other sectors subject to special rules in regulations and directives governing all State aid within the sector.

23.9.2008

Official Journal of the European Union

C 242/20

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001

(2008/C 242/10)

Aid No: XA 422/07

Member State: Republic of Slovenia

Region: Območje občine Sveta Trojica v Slovenskih goricah

Title of aid scheme or name of company receiving individual aid: Podpora programom razvoja podeželja v občini Sveta Trojica v Slovenskih goricah 2007–2013

Legal basis: Pravilnik o dodeljevanju državnih pomoči za programe kmetijstva v občini Sveta Trojica v Slovenskih goricah (II. poglavje)

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company:

2007: EUR 14 000

2008: EUR 14 500

2009: EUR 15 500

2010: EUR 15 500

2011: EUR 15 500

2012: EUR 15 500

2013: EUR 15 500

Maximum aid intensity:

1. Aid for investment in agricultural holdings for primary production:

—	up to 50 % of eligible costs in less-favoured areas,

—	up to 40 % of eligible costs for investment in other areas.

The purpose of the aid is investment to restore farm features and to purchase equipment to be used for agricultural production, to invest in permanent crops and to manage pastures.

2. Aid for the conservation of traditional buildings:

—	up to 100 % of costs of investment to conserve non-productive heritage features located on farms,

—

up to 75 % of eligible costs in less-favoured areas or areas under Article 36(a)(i), (ii) and (iii) of Regulation (EC) No 1698/2005, defined as such by Member States in accordance with Articles 50 and 94 of that Regulation, and up to 60 % in other areas, provided that the investment does not entail any increase in the production capacity of the farm.

3. Aid for the payment of insurance premiums:

—

the amount of municipal support is the difference between the amount of co-financing of insurance premiums from the national budget and up to 50 % of eligible costs of insurance premiums for insuring crops and fruit against adverse weather conditions and insuring livestock against the risk of death due to disease.

4. Aid for land reparcelling:

—	up to 100 % of actual legal and administrative costs incurred.

5. Aid to encourage the production of quality agricultural products:

—

up to 100 % of the costs of market research activities, product conception and design, including aid granted for the preparation of applications for recognition of geographical indications, designations of origin or certificates of specific character in accordance with the relevant Community regulations. The aid is to be granted in the form of subsidised services and does not involve direct payments of money to producers.

6. Provision of technical support in the agricultural sector:

—

up to 100 % of costs concerning education and training of farmers, consultancy services and the organisation of forums, competitions, exhibitions, fairs, publications, catalogues and websites. The aid is to be granted in the form of subsidised services and does not involve direct payments of money to producers

Date of implementation: September 2007 (The aid will not be granted until a summary has been published on the European Commission's website)

Duration of scheme or individual aid award: Until 31 December 2013

Objective of the aid: To support SMEs

Reference to Articles of Regulation (EC) No 1857/2006 and eligible costs: Chapter II of the draft Rules on granting State aid for rural development programmes in the municipality of Sveta Trojica v Slovenskih goricah includes measures constituting State aid in accordance with the following Articles of Commission Regulation (EC) No 1857/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 (OJ L 358, 16.12.2006, p. 3):

Article 4: Investment in agricultural holdings,

Article 5: Conservation of traditional landscapes and buildings,

Article 12: Aid towards the payment of insurance premiums,

Article 13: Aid for land reparcelling,

Article 14: Aid to encourage the production of quality agricultural products,

Article 15: Provision of technical support in the agricultural sector

Economic sector(s) concerned: Agriculture

Name and address of granting authority:

Občina Sv. Trojica v Slov. goricah

Trg Osvoboditve 7

SLO-2235 Sv. Trojica v Slov. goricah

Website: http://www.izit.si/muv/index.php?action=showIzdaja&year=2007&izdajaID=417 (str. 358)

Other information: The measure for the payment of insurance premiums to insure crops and fruit includes the following adverse climatic events which can be assimilated to natural disasters: spring frost, hail, lightning, fire caused by lightning, storm and floods.

The municipality's Rules meet the requirements of Regulation (EC) No 1857/2006 concerning the measures to be adopted by the municipality and the general provisions applicable (steps preceding grant of aid, cumulation, transparency and monitoring of aid)

Mayor

Darko FRAS

Aid No: XA 429/07

Member State: Republic of Slovenia

Region: Območje občine Komen

Title of aid scheme or name of company receiving individual aid: Ukrepi za ohranjanje in razvoj kmetijstva ter podeželja v občini Komen 2007–2013

Legal basis: Pravilnik o dodeljevanju državnih pomoči za ohranjanje in razvoj kmetijstva ter podeželja v občini Komen

nnual expenditure planned under the scheme or overall amount of individual aid granted to the company:

2007: EUR 29 821

2008: EUR 30 000

2009: EUR 32 000

2010: EUR 34 000

2011: EUR 35 000

2012: EUR 36 000

2013: EUR 36 000

Maximum aid intensity:

1. Investment in agricultural holdings for primary production:

—	up to 50 % of eligible costs in less-favoured areas,

—	up to 40 % of eligible costs in other areas,

—	up to 60 % of eligible costs in less-favoured areas and up to 50 % of eligible costs in other areas, where the investment is made by young farmers within five years of setting up.

The purpose of the aid is to invest in the restoration of farm features, to purchase equipment to be used for agricultural production, to invest in permanent crops, to improve farmland and to manage pastures.

2. Conservation of traditional landscapes and buildings:

—	for non-productive features, up to 100 % of the real costs,

—	for productive assets on farms, up to 60 % of the real costs, or 75 % in less-favoured areas, provided that the investment does not entail any increase in the production capacity of the farm,

—	additional aid may be granted at a rate of up to 100 % to cover the extra costs incurred by using traditional materials necessary to preserve the heritage features of buildings.

3. Relocation of farm buildings:

—	up to 100 % of actual costs, provided that relocation involves only the dismantling, removal and re-erection of existing facilities,

—

where the relocation results in the farmer benefiting from more modern facilities, the farmer is to contribute at least 60 %, or 50 % in less-favoured areas, of the increase in the value of the facilities concerned after relocation. If the beneficiary is a young farmer, this contribution must be at least 55 % or 45 % respectively,

—

where the relocation results in an increase in production capacity, the contribution from the beneficiary must be at least 60 %, or 50 % in less-favoured areas, of the expenses relating to this increase. If the beneficiary is a young farmer, this contribution must be at least 55 % or 45 % respectively.

4. Aid towards the payment of insurance premiums:

—	the amount of municipal co-financing is the difference between the amount of co-financing of insurance premiums from the national budget and up to 50 % of eligible costs of insurance premiums for insuring crops and fruit and insuring livestock against disease.

5. Aid for land reparcelling:

—	up to 100 % of actual legal and administrative costs incurred.

6. Aid to encourage the production of quality agricultural products:

—	up to 100 % of actual costs incurred; this is to be provided in the form of subsidised services and does not involve direct payments of money to producers.

7. Provision of technical support:

—

up to 100 % of the eligible costs of education, consultancy services, the organisation of forums, competitions, exhibitions and fairs, the dissemination of scientific findings, publications, catalogues and websites. The aid is to be granted in the form of subsidised services and will not involve direct payments of money to producers

Date of implementation: October 2007 (No aid will be granted until the summary has been published on the European Commission's website)

Duration of scheme or individual aid award: Until 31 December 2013

Objective of the aid: To support SMEs

Reference to Articles of Regulation (EC) No 1857/2006 and eligible costs: The draft Rules on granting State aid for preserving and developing agriculture and rural areas in the municipality of Komen includes measures constituting State aid in accordance with the following articles of Commission Regulation (EC) No 1857/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 (OJ L 358, 16.12.2006, p. 3):

Article 4: Investment in agricultural holdings for primary production: modernisation,

Article 5: Conservation of traditional landscapes and buildings,

Article 6: Relocation of farm buildings in the public interest,

Article 12: Aid towards the payment of insurance premiums,

Article 13 of th: Aid for land reparcelling,

Article 14: Aid to encourage the production of quality agricultural products,

Article 15: Provision of technical support in the agricultural sector

Economic sector(s) concerned: Agriculture

Name and address of granting authority:

Občina Komen

Komen 86

SLO-6223 Komen

Website: http://www.uradni-list.si/1/ulonline.jsp?urlid=200792&dhid=91904

Uroš SLAMIČ

Mayor

Aid No: XA 430/07

Member State: Spain

Region: Spain

Title of aid scheme or name of company receiving individual aid: Ayudas para el fomento de la integración cooperativa de ámbito estatal

Legal basis: Orden APA/…/2007, de …, por la que se establecen las bases reguladoras para la concesión de subvenciones destinadas al fomento de la integración cooperativa de ámbito estatal

Annual expenditure planned: EUR 2,6 million in 2008

Maximum aid intensity: The maximum aid will be 100 % of the administration costs in the first year up to EUR 400 000, and 50 % of the integration costs up to EUR 100 000

Implementation date: From the date of publication of the order

Duration of scheme or individual aid award: From 2007 to 2013

Objective of aid: To promote co-operative integration of agricultural associations operating across more than one Autonomous Community, in order to improve their business size, efficiency and profitability.

Expenditure which is clearly an inherent part of the activity supported, and covering the following, will be eligible for aid:

1.	establishment;

audit;

3.	implementation;

4.	advice to decision-making and technical members;

5.	feasibility, marketing and financing studies;

tangible and/or intangible investments, excluding the purchase and renovation of buildings, expenditure on furniture, office equipment (other than computer equipment) and means of transport. Under this section, aid for investment may not exceed EUR 100 000, with a maximum of EUR 30 000 per integrated body;

2.	rental of appropriate premises for warehouses and offices, provided that they did not previously belong to the integrated body or its constituent parts. If premises are purchased, the eligible expenditure shall be limited to rental costs at market rates;

staff costs directly linked to the project. The maximum amount of investment will be that laid down in the exclusive collective agreement for persons employed by the General Government Administration in force. Staff costs may include training costs to facilitate adaptation to the new company structure;

4.	external assistance such as technical assistance, external consultancy costs, authorisation costs and services linked to the projects;

5.	inter-city travel and accommodation needed to carry out the project. The maximum amount will be that laid down for civil servants by the Ministry of Economy and Finance.

The aid scheme complies with Article 9 of Regulation (EC) No 1857/2006

Sector(s) concerned: Agriculture: crops and livestock sub-sectors

Name and address of the granting authority:

Ministerio de Agricultura, Pesca y Alimentación (MAPA)

Dirección General de Desarrollo Rural

C/ Alfonso XII, no 62-5a planta

E-28071 Madrid

Website: http://www.mapa.es/es/ministerio/pags/normas/normas.htm

Other information: —

Aid No: XA 128/08

Member State: Spain

Region: Castilla y León (provincia de Salamanca)

Title of aid scheme or name of company receiving an individual aid: subvenciones dirigidas a asociaciones y cooperativas de ganaderos para la financiación de programas de creación y mantenimiento de sistemas de control lechero, anualidad 2008

Legal basis: proyecto de bases reguladoras de la convocatoria de subvenciones dirigidas a asociaciones y cooperativas de ganaderos para la financiación de programas de creación y mantenimiento de sistemas de control lechero, anualidad 2008

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company: The expenditure planned under the aid scheme for 2008 is EUR 20 500 (twenty thousand five hundred euro), to include a loan facility, totalling EUR 12 000 (twelve thousand euro) for cooperatives and a loan facility totalling EUR 8 500 (eight thousand five hundred euro) for associations

Maximum aid intensity: The maximum amount of the grant may not exceed 50 % of the eligible expenditure or EUR 12 000 in the case of cooperatives or EUR 8 500 in the case of applicant associations

Date of implementation: From the day following the publication of the call for grant proposals in the Boletín Oficial de la Provincia de Salamanca (Official Gazette of the Province of Salamanca)

Duration of scheme or individual aid award: Until 31 December 2008

Objective of aid: The purpose of the aid is to help maintain and improve the genetic quality of the livestock population in Salamanca, through the monitoring of the quality levels of the milk from and the genetic quality of dairy breeds of cows, sheep and goats, conducted by livestock associations and cooperatives in the province of Salamanca.

The aid scheme falls within the scope of Article 16(1)(b) of Commission Regulation (EC) No 1857/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products.

Eligible costs are taken to mean current expenditure which has a clear and direct link to the subsidised activity (the implementation of programmes to establish the genetic quality or yield of livestock) and which concerns:

Indirect taxes will not be eligible

Sector(s) concerned: Livestock sector

Name and address of the granting authority:

Excma. Diputación Provincial de Salamanca

C/ Felipe Espino no 1

E-37002 Salamanca

Website: http://www.lasalina.es/areas/eh/Subvenciones2008/ProyectosConvocatorias/SubvControlLechero.pdf

Other information: The grant will be compatible with any other grant, aid, resource or revenue for the subsidised activity awarded by any public or private national or European Union administration or authority or international organisation, provided that it does not exceed the quantitative limits for aid set out in Article 16(1)(b) of Regulation (EC) No 1857/2006 (up to 70 % of the costs of the tests carried out).

If the applicant has been awarded another grant — for the same purpose — which is incompatible with that awarded by the Diputación, Article 33 of Spanish Royal Decree No 887/2006 of 21 July 2006 establishing the Rules implementing the General Law on Subsidies shall apply.

However, in no case may the amount of subsidies awarded by the Diputación be such that, on its own or together with other grants, aid, revenue or resource, it exceeds the cost of the subsidised activity.

Likewise, the grant will be incompatible with any other grant, aid, resource or revenue for the subsidised activity that is awarded by the Diputación de Salamanca — either by a direct award procedure or by a competitive procedure — covering the same eligible expenditure

		ISSN 1725-2423
Official Journal of the European Union		C 242

English edition	Information and Notices	Volume 51 23 September 2008

Notice No	Contents	page
	II Information
	INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2008/C 242/01	Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections ( 1 )	1

2008/C 242/02	Non-opposition to a notified concentration (Case COMP/M.5259 — Mitsui/Bamesa Celik/Bami/JV) ( 1 )	4

2008/C 242/03	Non-opposition to a notified concentration (Case COMP/M.5288 — GMR Infrastructure (Malta)/Ontario Teachers' Pension Plan/InterGen) ( 1 )	4

2008/C 242/04	Non-opposition to a notified concentration (Case COMP/M.5304 — Indaver/NEIF/JV) ( 1 )	5

	V Announcements
	PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY
	Commission
2008/C 242/11	Prior notification of a concentration (Case COMP/M.5312 — Dow/PIC/JV) — Candidate case for simplified procedure ( 1 )	25

2008/C 242/12	Prior notification of a concentration (Case COMP/M.5336 — Allianz/Generali/TopTorony and Shaza/JV) — Candidate case for simplified procedure ( 1 )	26

	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2008/C 242/05	Euro exchange rates	6

2008/C 242/06	Notice of publication of Special Report No 6/2008 European Commission Rehabilitation Aid following the Tsunami and Hurricane Mitch	7

2008/C 242/07	Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000 of the European Parliament and of the Council: Review of the period of market exclusivity of orphan medicinal products	8

2008/C 242/08	Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity	12

	NOTICES FROM MEMBER STATES
2008/C 242/09	Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 2204/2002 on the application of Articles 87 and 88 of the EC Treaty to State aid for employment ( 1 )	17

2008/C 242/10	Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001	20