A4-0338/98

Proposal for a Council Regulation amending Council Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (COM(98)0021 - C4-0284/98 - 98/0135(CNS))

The proposal was approved with the following amendments:

(Amendment 1)

Citation 1

>Original text>

Having regard to the Treaty establishing the European Community,

>Text following EP vote>

Having regard to the Treaty establishing the European Community

and in particular Article 235 thereof,

(Amendment 2)

Recital 1a (new)

>Original text>

>Text following EP vote>

Whereas Articles 1 and 19 of the Financial Regulation refer to the structure and the presentation of the Budget concerning revenue and expenditure;

(Amendment 3)

Recital 1b (new)

>Original text>

>Text following EP vote>

Whereas Article 57 of EC Council Regulation (EEC) No 2309/93 provides that the resources of the Agency consist in part of a contribution from the Community and whereas the level of the fees has a direct impact on the EU subsidy;

(Amendment 4)

ARTICLE 1(1)

Article 1, 2nd paragraph (Regulation (EC) No 297/95)

>Original text>

The amounts of these fees shall be laid down in ecus.

>Text following EP vote>

The amounts of these fees shall be laid down in

euros.

(This amendment to apply throughout the text)

(Amendment 5)

ARTICLE 1(1)

Article 1, 2nd paragraph a (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

The fees levied by the Agency are Community resources and as such shall be entered in the general budget as preallocated resources for the Agency.

(Amendment 6)

ARTICLE 1(1)

Article 1, 2nd paragraph b (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

The Budgetary Authority shall be consulted on the consequences for the EU subsidy of any change in the scale of fees.

(Amendment 7)

ARTICLE 1(1)

Article 1, 2nd paragraph c (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

The EU subsidy granted to the Agency during the annual budgetary procedure in accordance with Article 57 of Council Regulation (EEC) No 2309/93 may be adjusted to the other income resulting from the fees, with any surplus being returned to the budget of the Union.

(Amendment 8)

ARTICLE 1(2)

Article 3(1)(a), 3rd subparagraph a (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

However, the total amount of this fee may not exceed EUR 400 000 for applications submitted at the same time.

(Amendment 9)

ARTICLE 1(2)

Article 3(1)(b), 3rd subparagraph a (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

However, the total amount of this fee may not exceed EUR 200 000 for applications submitted at the same time.

(Amendment 10)

ARTICLE 1(2)

Article 3(2)(a), 2nd subparagraph (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

This fee shall cover all authorised strengths, pharmaceutical forms and presentations.

(Amendment 11)

ARTICLE 1(2)

Article 3(2)(b), 2nd subparagraph (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

This fee shall cover all authorised strengths, pharmaceutical forms and presentations.

(Amendment 12)

ARTICLE 1(2)

Article 6, 2nd paragraph (Regulation (EC) No 297/95)

>Original text>

The fee shall be increased by ECU 15 000 where the procedures laid down in Articles 19 and 20 of Directive 81/851/EEC are initiated at the instigation of the applicant for or holder of the marketing authorisation.

>Text following EP vote>

The fee shall be increased by

EUR 30 000 where the procedures laid down in Articles 19 and 20 of Directive 81/851/EEC are initiated at the instigation of the applicant for or holder of the marketing authorisation.

(Amendment 13)

ARTICLE 1(2)

Article 7(1), subparagraphs 1 and 2 (Regulation (EC) No 297/95)

>Original text>

A full MRL fee of ECU 50 000 shall be charged for an application to set an initial MRL for a given substance.

>Text following EP vote>

A full MRL fee of

EUR 50 000 shall be charged for an application to set an initial MRL for a given substance, and EUR 15 000 for each additional species.

>Original text>

An additional MRL fee of ECU 10 000 shall be payable for each application to amend or extend an existing MRL, including to cover new species.

>Text following EP vote>

An additional MRL fee of

EUR 15 000 shall be payable for each application to amend or extend an existing MRL, or to cover new species.

(Amendment 14)

ARTICLE 1(2)

Article 8(1) (Regulation (EC) No 297/95)

>Original text>

This fee shall be charged where an application is made for scientific or technical advice concerning a medicinal product before an application is submitted for authorisation to market it.

>Text following EP vote>

This fee shall be charged where an application is made for scientific or technical advice concerning a medicinal product before an application is submitted for authorisation to market it.

>Original text>

- For medicinal products for human use the fee is set at ECU 60 000

>Text following EP vote>

-

For medicinal products for human use the fee is set at EUR 30 000 or EUR 60 000 or EUR 90 000, depending on the complexity of the question raised.

>Original text>

- For medicinal products for veterinary use the fee is set at ECU 30 000.

>Text following EP vote>

-

For medicinal products for veterinary use the fee is set at EUR 20 000 or EUR 45 000 or EUR 70 000, depending on the complexity of the question raised.

>Original text>

>Text following EP vote>

The implementing rules for this Article shall be adopted under the procedure laid down in Article 11(2).

(Amendment 16)

ARTICLE 1(2)

Article 12, 3rd paragraph a (new) (Regulation (EC) No 297/95)

>Original text>

>Text following EP vote>

Future reviews of fees shall be based on a full evaluation of the costs of the Agency, including of the costs of Member States' rapporteurs

Legislative resolution embodying Parliament's opinion on the proposal for a Council Regulation amending Council Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (COM(98)0021 - C4-0284/98 - 98/0135(CNS))(Consultation procedure)

The European Parliament,

- having regard to the Commission proposal to the Council, COM(98)0021 - 98/0135(CNS),

- having been consulted by the Council (C4-0284/98),

- having regard to the report of the Committee on Budgets and the opinions of the Committee on the Environment, Public Health and Consumer Protection and the Committee on Budgetary Control (A4-0338/98),

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. Asks to be consulted again should the Council intend to make substantial modifications to the Commission proposal;

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