Public Statement: Variation-Regulation
Commission Regulation (EC) No. 1234/2008 of Nov. 24, 2008, concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products (Variation-Regulation), governs variations to marketing authorizations for medicinal products for human use and veterinary medicinal products granted through a centralized (CP) or decentralized procedure (DCP) or a mutual recognition procedure (MRP).
The planned changes to the Variation Regulation primarily address the following issues:
- Expanding the scope of "variation regulation" to include approvals of human and veterinary drugs that have a purely national marketing authorization.
- Modification of some procedures regarding the concentration of resources on variations to marketing authorizations that have the greatest public health impact.
- Issues related to the practicality of the regulation's provisions.
- Procedures for approval of human influenza vaccines in the event of a pandemic.
The deadline for submitting comments is Oct. 21, 2011.
All stakeholders in the field of human and veterinary medicinal products, including those not based within the European Union, can participate in this consultation. In particular, small and medium-sized enterprises (SMEs) active in the pharmaceutical sector are invited to contribute their opinion on the planned amendment.
Comments should be sent to the European Commission by email maria-angeles.FIGUEROLA-SANTOS@ec.europa.eu.
The comments will be published on the Commission's website in the Pharmaceuticals section after the end of the consultation phase. If publication of the opinion is not desired, this must be announced as part of the opinion.
Further information:
