II
(Preparatory Acts)
COMMISSION
Amended proposal for a Council Regulation (EC) amending Regulation (EC) No 297/95 on
fees payable to the European Agency for the evaluation of medicinal productsØ (˛)
(1999/C 36/09)
COM(1998) 648 final - 98/0135(CNS)
(Submitted by the Commission pursuant to Article 189a(2) of the EC Treaty on 12 November
1998)
(˛)ÙOJ C 22, 27.1.1999, p. 11.
Following the opinion of the European Parliament of 7 October 1998, the initial Commissionproposal (COM(1998) 21 final) is hereby amended as follows:
ORIGINAL TEXT AMENDED TEXT
Article 1, point 2)
Article 3(2), point a), single subparagraph a) (new) (Regulation (EC) No 297/95)
In the event of the same amendment being introduced,
this fee shall cover all authorised strengths, pharmaÜ
ceutical forms and presentations.
Article 3(2), point b), single subparagraph a) (new) (Regulation (EC) No 297/95)
In the event of the same amendment being introduced,
this fee shall cover all authorised strengths, pharmaÜ
ceutical forms and presentations.
Article 5(2), point a), single subparagraph a) (new) (Regulation (EC) No 297/95)
In the event of the same amendment being introduced,
this fee shall cover all authorised strengths, pharmaÜceutical forms and presentations.
Article 5(2), point b), third subparagraph (new) (Regulation (EC) No 297/95)
In the event of the same amendment being introduced,
this fee shall cover all authorised strengths, pharmaÜ
ceutical forms and presentations.10.2.1999 C 36/17 Official Journal of the European Communities
EN
ORIGINAL TEXT AMENDED TEXT
Article 6, second subparagraph (Regulation (EC) No 297/95)
This fee shall be increased by ECU 15Ø000 where the
procedures laid down in Articles 19 and 20 of Directive
81/851/EEC are initiated at the instigation of theapplicant for or holder of the marketing authorisation.This fee shall be increased by ECU 20Ø000 where the
procedures laid down in Articles 19 and 20 of Directive
81/851/EEC are initiated at the instigation of theapplicant for or holder of the marketing authorisation.
Article 7(1), second subparagraph (Regulation (EC) No 297/95)
An additional MRL fee of ECU 10Ø000 shall be payable
for each application to amend or extend an existingMRL, including to cover new species.An additional MRL fee of ECU 15Ø000 shall be payable
for each application to amend or extend an existingMRL, or to cover new species.
Article 8, point 1 (Regulation (EC) No 297/95)
This fee shall be charged where an application is made
for scientific or technical advice concerning a medicinalproduct before an application is submitted for authoÜ
risation to market it.This fee shall be charged where an application is made
for scientific or technical advice concerning a medicinalproduct before an application is submitted for authoÜ
risation to market it.
-ÙFor medicinal products for human use the fee is set
at ECU 60Ø000.-ÙFor medicinal products for human use the maximum
fee is set at ECU 60Ø000.
-ÙFor medicinal products for veterinary use the fee is
set at ECU 30Ø000.-ÙFor medicinal products for veterinary use the
maximum fee is set at ECU 30Ø000.
The implementing rules for this Article shall be adopted
under the procedure laid down in Article 11(2).
Article 12, third subparagraph a) (new) (Regulation (EC) 297/95)
Future reviews of fees shall be based on a full cost
evaluation of the costs of the Agency, including expenÜditure relating to Member States’ rapporteurs.C 36/18 10.2.1999 Official Journal of the European Communities EN