Renewal of an Authorisation
For the time being, an authorisation granted by both the European Commission and by the Member States is valid for five years. After these five years, the risk-benefit balance of the veterinary medicinal product will be reassessed.
For this purpose, the authorisation holder must submit an application for renewal of the approval to the competent licensing authority six months before the expiry of the validity period. If this application is not submitted by the deadline, the marketing authorisation expires automatically. After the renewal has been granted, the marketing authorisaiton is in general valid for an unlimited period of time.
However, the authorisation expires if the immunological veterinary medicinal product in question has not actually been placed on the market for three years. The regulatory authority may authorise derogations for reasons of public health protection or, by virtue of legislation governing measures to control specific animal diseases (e.g. swine fever, foot-and-mouth disease, Aujeszky's disease). Such exceptions must be reasonably justified.
Variations of Authorisation
If variations to an authorisation are planned resulting in changes to the documents submitted for the application for authorisation, those changes must be reported to the authority responsible for the authorisation. Depending on how significant these changes are, they are subject to the consent, i.e. the approval from the licensing authority.
For national authorisations (including authorisations granted in the MR procedure or in the decentralised procedure), pursuant to Section 29 of the Animal Vaccine Regulation in conjunction with the European Regulation (EC) No. 1234/2008 of 24 November 2008 ("Variation Regulation"), as amended by Commission Regulation (EU) No 712/2012 of 03/08/2012, a gradual distinction is made between
- minor changes (so-called Type IA and Type IB Variations) and
- major changes (so-called Type II Variations).
Certain changes to the approval (so-called extensions) require special assessment procedures. Authorisation extensions are those modifications which are listed in Annex I to the Regulation and which fulfill the conditions laid down therein.
In addition, European Regulation (EC) No 1234/2008 also allows:
- Grouping changes and
- submitting applications for changes in the so-called work-sharing procedure.
Variations to centralised authorisations are also governed by European Regulation (EC) No 1234/2008 of 24 November 2008 ("Variation Regulation"), as amended by Commission Regulation (EU) No 712/2012 of 03.08.2012.
Each marketing authorisation holder is required to collect and evaluate reports of adverse effects of veterinary medicinal products, and must notify the authorities as soon as possible or at specific time intervals with a collective report, depending on the severity of the event.
In relation to immunological veterinary medicinal products, in case of suspected serious adverse reactions in the animal or suspected adverse reactions in humans, the marketing authorisation holder must notify the Paul-Ehrlich-Institut (PEI) of this suspected case within 15 days after these adverse effects have become known to him. An adverse reaction should be considered serious if it is fatal or life threatening, results in significant disability, or produces persistent or long-lasting symptoms in the treated animals.
European drug regulatory agencies have a powerful data network (Eudravigilance Veterinary) for the registration, transmission and evaluation of suspected adverse drug reactions. The PEI is directly involved in the European pharmacovigilance network and thus actively contributes to improving the safety of veterinary medicines in Europe.