PURPOSE: to amend Regulation (EC) No 726/2004 laying
down Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a
European Medicines Agency.
PROPOSED ACT: Regulation of the Council and the
European Parliament.
ROLE OF THE EUROPEAN PARLIAMENT: the European
Parliament decides in accordance with the ordinary legislative
procedure and on an equal footing with the Council.
BACKGROUND: Directive 2001/82/EC of the European
Parliament and of the Council and Regulation (EC)
726/2004 of the European Parliament and of the
Council constituted the Union regulatory framework for the
manufacture, authorisation and distribution of veterinary medicinal
products.
In the light of the experience acquired and following
the assessment by the Commission of the functioning of the internal
market for veterinary medicinal products, the Commission has
presented a proposal that will repeal and replace Directive
2001/82/EC on veterinary medicinal products. This
proposal lays down procedures for the authorisation and supervision
of medicinal products for human and veterinary use. It is therefore
necessary to amend Regulation (EC) No 726/2004 to take account
of the fact that centralised marketing authorisation for veterinary
products is being decoupled from that for medicines for
humans.
IMPACT ASSESSMENT: the consultation and a study, An
assessment of the impact of the revision of veterinary
pharmaceutical legislation, formed the basis of an impact assessment carried out
for the Commission between November 2009 and June 2011. The
Commissions Impact Assessment Board (IAB) released its final
opinion in September 2013.
CONTENT: the proposal seeks to amend Regulation (EC)
No 726/2004 so as to:
- delete from Regulation (EC) No 726/2004 the provisions
regarding granting and maintaining marketing authorisations for
veterinary medicinal products. The
rules on marketing authorisations valid in all EU Member States are
part of the proposal for a Regulation on veterinary medicinal
products. The new Regulation on veterinary medicinal products will
cover all routes granting marketing authorisations for veterinary
medicinal products in the Union both at centralised and
national level;
- establish certain principles applicable to fees
payable to the Agency, including the
need to take into account, as appropriate, the specific needs for
SMEs. The provisions regulating fees should be brought into line
with the Treaty of Lisbon;
- align the powers conferred on the
Commission under Regulation (EC) No
726/2004 to Articles 290 and 291 (delegated and implementing acts)
of the Treaty on the Functioning of the European Union.
BUDGETARY IMPLICATION: the costs for the EMA for
implementing and applying the new rules are entirely covered by
fees charged to industry. Therefore, the proposal is not
expected to have any financial impact on the budget of the
EU.
As set out in the legislative financial statement the
additional resource needs for EMA are approximately 8 staff plus
expenditure for meetings, translation, IT, etc. The level of fees,
their structure and modalities and exceptions will be set at a
later stage by the Commission by way of implementing
acts.
DELEGATED ACTS: the proposal contains provisions
empowering the Commission to adopt delegated acts in accordance
with Article 290 of the treaty on the Functioning of the European
Union.