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. Birgit Gitt, 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: Birgit.Gitt@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:
| Dr Katrin Kiisk Head of the department | clinical documentation, contoversial issues and disagreements, proposals for change of procedures | Katrin.Kiisk@ravimiamet.ee |
| Margit Plakso | regulatory advice concerning DCP and MRP, administrative and chemical-pharmaceutical documentation | Margit.Plakso@ravimiamet.ee |
| Margit Soots | DCP ja MRP correspondence | Margit.Soots@ravimiamet.ee |
| Birgit Gitt | technical details of submission of documentation, state fees | Birgit.Gitt@ravimiamet.ee |
| Aiki Rümmel | technical details of submission of documentation, state fees, expenses of expert examinations | Aiki.Rummel@ravimiamet.ee |
| Killu Koll | technical details of submission of documentation, state fees | Killu.Koll@ravimiamet.ee |
| Kaiti Lehiste | technical details of submission of documentation, state fees | Kaiti.Lehiste@ravimiamet.ee |
| Aet Viispert Head of the Bureau of Quality Assessment | administrative and chemical-pharmaceutical documentation | Aet.Viispert@ravimiamet.ee |
| Laivi Saaremäel Chief specialist | administrative and chemical-pharmaceutical documentation | Laivi.Saaremael@ravimiamet.ee |
| Evelin Saar | administrative and chemical-pharmaceutical documentation, categorisation of products | Evelin.Saar@ravimiamet.ee |
| Triin Mäesalu | administrative and chemical-pharmaceutical documentation | Triin.Maesalu@ravimiamet.ee |
| Kairi Rooma | administrative and chemical-pharmaceutical documentation | Kairi.Rooma@ravimiamet.ee |
| Maria Konsap | administrative and chemical-pharmaceutical documentation | Maria.Konsap@ravimiamet.ee |
| Heili Henning | administrative and chemical-pharmaceutical documentation | Heili.Henning@ravimiamet.ee |
| Kairi Kivil | administrative and chemical-pharmaceutical documentation | Kairi.Kivil@ravimiamet.ee |
| Hanna Laarin | administrative and chemical-pharmaceutical documentation | Hanna.Laarin@ravimiamet.ee |
| Ülle Toomiste Head of the bureau of clinical assessment and drug information | clinical documentation | Ulle.Toomiste@ravimiamet.ee |
| Liina Salur | summaries of product characteristics, package leaflets | Liina.Salur@ravimiamet.ee |
| Ene Kenkmann | summaries of product characteristics, package leaflets | Ene.Kenkmann@ravimiamet.ee |
| Riina Pettai | summaries of product characteristics, package leaflets | Riina.Pettai@ravimiamet.ee |
| Liilia Juhkason | package labelling | Liilia.Juhkason@ravimiamet.ee |
| Tiia Tooming | package labelling | Tiia.Tooming@ravimiamet.ee |
| Maia Uusküla Head of the bureau of pharmacovigilance | pharmacovigilance | Maia.Uuskula@ravimiamet.ee |
| Vivika Peets | pharmacovigilance | Vivika.Peets@ravimiamet.ee |
| Triin Leinemann | pharmacovigilance | Triin.Leinemann@ravimiamet.ee |
Summary of product characteristics, patient information leaflet and labelling in Estonian should be sent electronically to Birgit.Gitt@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 Birgit.Gitt@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;
-five samples of the proprietary medicinal product (in agreement with agency can be submitted fewer).
The state fee for marketing authorisation application and for renewal of marketing authorisation application is 500 kroons (31,96 EUR) per application for both national and mutual recognition procedure.
The state fee for application for variation both type I and II to a marketing authorisation is 250 kroons (15,98 EUR) per application for both national and mutual recognition procedure.
The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed. Please note that the bank charges should be paid by the applicant.
The state fee has to be paid to the Ministry of Finance (Rahandusministeerium)
Address: Suur-Ameerika 1, Tallinn 15006, ESTONIA
| IBAN: | EE932200221023778606 |
| SWIFT code: | HABAEE2X |
| Bank: | Swedbank |
| Address: | Liivalaia 8, 15040 Tallinn, ESTONIA |
The proof of payment should include at least the following data:
- the name of the product, pharmaceutical form and strength;
- the number and type of applications;
- reference number as follows:
| Application for marketing authorisation, renewal, variation application of human medicinal product and clinical trials applications: | 2900073517 |
| Application for marketing authorisation, renewal and variation application of veterinary medicinal product: | 2900073520 |
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