Variation applications
Variation applications are regulated by the Variation Regulation (EC) No 1234/2008 and (EU) No 712/2012 and the directive 2001/83/EC (medicinal product intended for human use).
Changes to the national procedure are regulated by the Fimea regulation Applying for and maintaining a marketing authorisation and registration for a medicinal product.
A rather extensive guidance for variation procedures in mutual regocnition can be found on CMDh website. These guidelines are followed also with national procedures whenever applicable. Guidance for variation applications in centralised procedure can be found on EMA website.
Application types
Type IA/IAin, Type IB and Type II variations are classified following the guidelines of the European Commission. Article 5 updates to the classification guideline are published on the CMDh website.
Type IA/IAin variations
Type IA/IAin variations are minor notifications, processed in the mutual recognition procedure or national procedure within 30 says, and either approved or rejected without a chance for further clarifications. These applications are not subject to a variation application charge. When Finland acts as a Reference Member State in a mutual recognition procedure, Type IA and IAin applications are subject to a process fee. Type IA variations may be reported within a year of their implementations. Type IAin variations must be reported immediately after they have been implemented.
Type II variations
Type II variations are large, extensive variations that must be supported with accompanying documentation. The processing time for Type II variations varies depending on the nature of the change from 30 days (usually variations related to safety) to 90 days (extension of the therapeutic indication). This is followed by a national procedure that lasts for 30 days.
The variation handling fee depends on the content of the application.
Type IB variations
Changes that are not classified as Type IA/IAin or Type II variations are Type IB variations. By default, variations that are not classified in the European Commission guideline are Type IB variations (unclassified z variations).
The processing time for IB changes is 30 days. The variation handling fees are set in the Decree on fees.
Grouping and worksharing procedure of variation applications
Article 7 and Annex III of the variation regulation (EC) No 1234/2008 and (EU) No 712/2012 enable the collection of several variations into a single application.
Article 20 of the variation regulation (EC) No 1234/2008 and (EU) No 712/2012 describes the justifications for the worksharing procedure of applications.
Application
The variations are sought by the common EU Application form for variation to a marketing authorisation for medicinal products that must be accompanied with other documentation supporting the application.