Explanatory Memorandum to COM(2014)557 - Amending the regulation on Community procedures for authorisation and supervision of medicinal products for human and veterinary use and on a European Medicines Agency - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)557 - Amending the regulation on Community procedures for authorisation and supervision of medicinal products for human and ... |
|---|---|
| source | COM(2014)557  |
| date | 10-09-2014 |
Justification and objectives
Following the proposal that will repeal and replace Directive 2001/82/EC on veterinary medicinal products, 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 must be amended to take account of the fact that centralised marketing authorisation for veterinary products is being decoupled from that for medicines for humans.
Legal basis
The legal basis for legislative measures on animal health, which are essential to public and animal health, environmental protection, trade and single market policy are:
· Article 114 of the Treaty on the Functioning of the European Union (TFEU), which provides for the establishment and functioning of the internal market and the approximation of relevant legal, regulatory and administrative provisions; and
· Article 168(4)(c) TFEU, which covers measures setting high standards of quality and safety for medicinal products and devices for medical uses.
Contents
Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies, a public consultation on the key issues of the envisaged legal proposal, was launched on the Commission’s website on 13 April 2010 and was available through the interactive policy-making (IPM) tool until 15 July 2010.[1]
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.[2]
The Commission’s Impact Assessment Board (IAB) released its final opinion in September 2013.
Provisions regarding granting and maintaining marketing authorisations for veterinary medicinal products are deleted from Regulation (EC) No 726/2004. 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.
The costs of the procedures and services associated with the operation of this Regulation need to be recovered from those making medicinal products available on the market and from those seeking authorisation. Therefore, it is appropriate to 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.
As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex to technical and scientific progress, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.
The entry into force and application of this Regulation should be on the same date as of the new Regulation on veterinary medicinal products.
It is planned that 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. This holds not only for the fees for new tasks for the EMA set out in this proposal, but for all fees in general.
5. OPTIONAL ELEMENTS