The renewal of a marketing authorisation is regulated by the directive 2001/83/EC (medicinal products intended for human use), and by Finnish Medicines Authority Fimea’s regulation Applying for and maintaining a marketing authorisation and registration for a medicinal product and by national Medicines act (395/1987) and Medicines degree (693/1987).
The marketing authorisation or registration is valid for five years from the date of issue, after which is must be renewed. The application for renewal of a marketing authorisation must be submitted to Fimea no later than nine months (medicinal products for human use) before the expiry of the marketing authorisation or registration of the product. If a renewal application is not submitted, the marketing authorisation or registration will expire.
All marketing authorisations and registrations for medicinal products must be renewed at least once, after which they will usually remain in force until further notice. However, for justifiable reasons relating to pharmacovigilance the first renewal may be limited to a fixed period of five years.
Application for renewal
The CMDh website contains a collection of instructions on the renewal of marketing authorisation. These instructions must be followed for products that have been granted a marketing authorisation or registration via a national procedure, mutual recognition procedure or decentralised procedure. The EMA website contains instructions for renewing the marketing authorisation of products that have received the marketing authorisation via the centralised procedure.
The renewal application uses an application form that is found on the NtA guidelines site, section 2B (medicinal products intended for human use).
The annual fee includes the costs of renewal application. A process fee is charged only when Finland acts as a reference member state.