Variation applications

Variation applications are regulated by the Variation Regulation (EC) No 1234/2008 and (EU) No 712/2012 and the directives 2001/83/EC (medicinal product intended for human use) and 2001/82/EC (veterinary medicines).

Changes to the national procedure are regulated by the Fimea regulation Applying for and maintaining a marketing authorisation and registration for a medicinal product (PDF).

Application types

Type IA/IAin, Type IB and Type II variations are classified following the guidelines (PDF) of the European Commission. Updates to the classification guideline are published on the coordination group (CMD(h)) site.

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 (PDF) 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 (PDF).

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.

For other instructions on the grouping of applications and the worksharing procedure, see the EMA CMD(h) website.

Application

The variations are sought by an EU Application form for variation to a marketing authorisation for medicinal products (human and veterinary) that must be accompanied with other documentation supporting the application.

The suggested SPC and package leaflet must also be submitted in an electronic format along with the application. The files must be created according to the instructions.