PURPOSE: to amend Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products.
PROPOSED ACT: Directive of the European Parliament and of the Council.
CONTENT: within the European Community, medicinal products are regulated throughout their entire lifetime. Changes subsequent to their placing on the market, such as change in the production process, change in the packaging or change in the address of the manufacturer, are governed either by national provisions or by Community rules: Commission Regulations (EC) Nos 1084/2003 and 1085/2003 ("Variations Regulations"). These “Variation Regulations” are implementing measures adopted by the 'comitology' regulatory procedure.
However, the current Variations Regulations do not apply to changes to marketing authorisations for medicinal products which have been granted at a national level by a Member State competent authority under a national procedure. In the absence of Community harmonisation, changes affecting purely national authorisations are therefore subject to national rules. In some Member States, national requirements on changes to purely national authorisations nevertheless follow the Variations Regulations, by analogy. But in the majority of Member States there is no such alignment on Community legislation, which results in discrepancies between the rules of those Member States and may also have negative effects on public health, the administrative burden and the overall functioning of the internal market in pharmaceuticals.
The objective of this proposal is therefore to amend Directives 2001/82/EC and 2001/83/EC in order to empower the Commission to extend the scope of the corresponding Variations Regulation, namely Regulation (EC) No 1084/2003. The Commission may subsequently modify the scope of that Regulation by 'comitology' procedure. Enlarging the scope of Regulation (EC) No 1084/2003 will ensure that all medicinal products placed on the Community market -including those authorised at purely national level - are subject to the same criteria for the approval and administrative handling of changes, regardless of the procedure under which those medicines have been authorised.