Proposal for a Council Regulation amending Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (COM(97)0489 - C4-0603/97 - 97/0255(CNS))

The proposal was approved with the following amendments:

(Amendment 17)

Recital 2a (new)

>Original text>

>Text following EP vote>

Whereas, since the Agency may receive funding from the budget, all its revenues are to be budgetized and, as such, considered as preallocated resources of the Union;

(Amendment 18)

Recital 3

>Original text>

Whereas, since the Agency is a body governed by Community law, provision should be made for any resources remainingafter 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;

>Text following EP vote>

Whereas since the Agency is a body governed by Community law, provision should be made for

all resources received by the Agency in accordance with its finanical regulation to be entered into the general budget of the Union;

Whereas the Agency may constitute a reserve to cover future expenditure; whereas the fees charged by the Agency shall be subject to revision; whereas all surplus revenues shall be paid into the general budget of the Union;

(Amendment 19)

Recital 4

>Original text>

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

>Text following EP vote>

Whereas the entering of amounts in the said reserve should be made subject to the agreement of the Commission

pursuant to Article 28 of the Financial Regulation, and whereas the Commission should inform the Council and Parliament of its decisions in this respect;

(Amendment 20)

Recital 6

>Original text>

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

>Text following EP vote>

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

subject to the necessary practical arrangements being in place to ensure swift and effective processing of financial transactions and to prevent excessive recourse to the use of imprest accounts;

(Amendment 21)

Recital 7

>Original text>

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

>Text following EP vote>

Whereas

it is a prerequisite to involve the European Parliament in the discharge procedure, pursuant to Article 206 of the Treaty;

(Amendment 22)

ARTICLE 1(a)

Article 57(6a) (Regulation (EC) No. 2309/93)

>Original text>

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 miscelleaneous revenue. However, the Budget Committee may authorise 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.

>Text following EP vote>

6a. All revenues 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 Union as preallocated revenue. However, the Budget Committee may authorise the establishment of a reserve to cover future expenditure. Amounts may be entered in the said reserve and taken out of it only with the agreement of the Commission, after Parliament has been consulted.

>Original text>

>Text following EP vote>

After three years, the Commission shall evaluate the level of the fees received by the Agency which may be revised after consultation of Parliament.

(Amendment 23)

ARTICLE 1(b)

Article 57(8) (Regulation (EC) No. 2309/93)

>Original text>

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.

>Text following EP vote>

8. To ensure a maximum of transparency and harmonisation between the decentralised agencies, 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, who shall ensure that the necessary practical arrangements are in place to allow swift and effective processing of the Agency's financial transactions and to prevent excessive recourse to the use of imprest accounts.

(Amendment 24)

ARTICLE 1(d)

Article 57(10) (Regulation (EC) No. 2309/93)

>Original text>

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.

>Text following EP vote>

10.

The Management Board shall, subject to the recommendation of the European Parliament, give discharge to the President of the Office in respect of the implementation of the budget.

Legislative resolution embodying Parliament's opinion on the proposal for a Council Regulation amending Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (COM(97)0489 - C4-0603/97 - 97/0255(CNS))(Consultation procedure)

The European Parliament,

- having regard to the Commission proposal to the Council (COM(97)0489 - 97/0255(CNS)) ((OJ C 335, 6.11.1997, p.15.)),

- having been consulted by the Council pursuant to Article 235 of the EC Treaty (C4-0603/97),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Budgets (A4-0035/98),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to notify Parliament should it intend to depart from the text approved by Parliament;

4. Instructs its President to forward this opinion to the Council and the Commission.