• Marketing authorisations (registration)
  • Medicinal products authorised in Estonia (incl. product information)
  • Granting marketing authorisations
• Drug information
• Clinical trials
• European Pharmacopoeia
• Classification of medicinal products
• Pharmacovigilance and Adverse Drug Reactions
• Manufacture, distribution, pharmacy
• Drug statistics
• Travelling with medicines

02 February 11

Guidance to facilitate the submission of the documents concerning the applications for marketing authorisations to the State Agency of Medicines

Technical details of submissions of documentation concerning marketing authorisations are dealt by Ms. Killu Koll, Department of Human Medicines. It is necessary to appoint the time by telephone (+372 7 374140, secretary of the State Agency of Medicines) or by e-mail: Killu.Koll@ravimiamet.ee.

The documentation should be brought at the appointed time to the State Agency of Medicines at 1 Nooruse Street, Tartu or sent via courier.

If you need pre-submission consultation about the documentation requirements, you can communicate with the staff of Department of Human Medicines by e-mail:

Summary of product characteristics, patient information leaflet and labelling in Estonian should be sent electronically to Killu.Koll@ravimiamet.ee in the following cases: 

• submission of the application for marketing authorisation in national procedure; 
• submission of the application for variation to a marketing authorisation including the changes in summary of product characteristics in national procedure;
• submission of the application for renewal of the marketing authorisation in national procedure.
   

Summary of product characteristics, patient information leaflet and labelling in English should be sent electronically to Killu.Koll@ravimiamet.ee in the following cases: 

• submission of the application for marketing authorisation or the application for renewal of marketing authorisation in mutual recognition or decentralised procedure;
• submission of the application for variation to a marketing authorisation including the changes in summary of product characteristics in mutual recognition or decentralised procedure.

The electronic response documents and translations of final summary of product characteristic, patient information leaflet and labelling for mutual recognition and decentralised procedures (new, renewal, variations) should be sent to e-mail address mrp@ravimiamet.ee. The procedure number and product name should be indicated as a subject.

Check-in procedure of the documents presented to support the registration application encompasses the control of existence of the following data:
-application form signed by the authorised representative (Notice to Applicants forms are accepted);
-additional documentation in CTD format;
-Summary of product characteristics (SPC) and package information leaflet (PIL) electronically (national procedure - in Estonian, MRP/DCP - in English);
-a document confirming the payment of the state fee;
-one sample of the proprietary medicinal product.
 
State fees and payment information