New application forms for renewals and variations of marketing authorisation

17.06.2014.

New application forms for renewals and variations of marketing authorisation

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that new application forms have been introduced for renewals and variations of marketing authorisations (version June, 2014). When submitting applications for renewals and variations, please use the new application forms available on SAM website: Services > Human Medicines: Authorisation, Renewal, Variations > Application Forms.