Proposal for a Council Regulation (EC) amending Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (97/C 335/13) (Text with EEA relevance) COM(97) 489 final - 97/0255(CNS)

(Submitted by the Commission on 7 October 1997)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community and, in particular, Article 235 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Whereas, on 22 July 1993, the Council adopted Regulation (EEC) No 2309/93 (1) laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products ('the Agency`);

Whereas the Agency may not be regarded as a profit-making organization;

Whereas, since the Agency is a body governed by Community law, provision should be made for any resources remaining after the constitution, where appropriate, of a reserve to cover future expenditure and after any revision of the fees charged by the Agency to be paid into the general budget of the European Communities;

Whereas the entering of amounts in the said reserve should be made subject to the agreement of the Commission and whereas the Commission should inform the Council and Parliament of its decisions in this respect;

Whereas the financial provisions governing the decentralized agencies established by the Community should be harmonized, particularly in the matter of the controls to which the Agency is subject;

Whereas the Commission's Financial Controller is the person best placed to perform the tasks of Financial Controller of the Agency;

Whereas is it desirable to involve the European Parliament in the discharge procedure,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 57 of Regulation (EEC) No 2309/93

(a) The following paragraph 6a is inserted after paragraph 6:

'6a. Any revenue surplus to expenditure during a particular financial year shall, after account has been taken of the decrease in the Community subsidy, be entered in the general budget of the European Communities as miscellaneous revenue. However, the Budget Committee may authorize the establishment of a reserve to cover future expenditure. Amounts may be entered in the said reserve only with the agreement of the Commission, after Parliament has been consulted.`

(b) Paragraph 8 is replaced by the following:

'8. Control of commitment and payment of all expenditure and control of the establishment and recovery of all revenue of the Agency shall be carried out by the Commission's Financial Controller.`

(c) The second subparagraph of paragraph 9 is replaced by the following:

'The Court of Auditors shall examine the balance sheet in accordance with Article 188c of the Treaty.`

(d) Paragraph 10 is replaced by the following:

'10. The Management Board shall, on the recommendation of the European Parliament, give a discharge to the President of the Office in respect of the implementation of the budget.`

Article 2

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

(1) OJ L 214, 24. 8. 1993, p. 1.