Applications for variations to marketing authorisations for veterinary medicines

Applications for variations are provided for in the Variations Regulation (EC) No. 1234/2008 and in the Directive on the Community code relating to veterinary medical products, 2001/82/EC.

Variations are provided for at the national level in administrative regulation 2/2013 of the Finnish Medicines Agency Fimea, Applying for and maintaining a marketing authorisation and registration for a medicinal product.

Types of application

Variations are classified according to the Commission guideline. Updates to the Commission guideline on the classification of variations may be found at the website of the Coordination Group (CMDh).

Type IA/IAin variations

Type IA/IAin variations involve minor changes that do not require prior approval and are reviewed via the mutual recognition procedure or national procedure within 30 days and are either approved or rejected without recourse to further explication. No fee is charged for these variations. Type IA variations may be submitted within 12 months of being implemented. Type IAin variations shall be submitted immediately after being implemented. The application form to use for submitting a variation application is the Application form for variation to a marketing authorisation for medicinal products (human and veterinary).

Type II variations

Type II variations are major variations which require supporting documentation.

Depending on the nature of the variation, the processing time for these variations ranges from 30 days (generally, changes related to product safety) to 90 days (broadening the therapeutic indication). This procedure is followed by the national procedure, which lasts 30 days in the mutual recognition procedure. The processing fee depends on the nature of the application.

The application form to use for submitting a variation application is the Application form for variation to a marketing authorisation for medicinal products (human and veterinary).

When submitting the application, the summary of product characteristics and package insert proposals must be appended also in electronic form. The files submitted must comply with the guidelines given.

Type IB

Variations not classified as type IA/IAin or type II are by default type IB variations. The processing time for these variations is 30 days.

The variation processing fees are determined separately in a Decree of the Ministry of Social Affairs and Health.

Grouping of variation applications and the worksharing procedure

The Variations Regulation (EC) No. 1234/2008 (Article 7 and Annex III) allows for the grouping of several variations in one application.

Article 20 of the Variations Regulation (EC) No. 1234/2008 provides for a worksharing procedure for applications.

Further instructions regarding the grouping of applications and for the worksharing procedure may be found on the EMA and CMD websites.

Transfer of marketing authorisations to a new holder

Applications for transferring a marketing authorisation to a new holder are national variation applications for which no application form is needed. The processing time for these applications is 120 days. There is a separate fee specified for transfers of marketing authorisations to a new holder.

Further information

  • Mustalammi Heidi
    Procedure Manager tel. +358295223329