- Marketing authorisations (registration)
- Drug information
- Clinical trials
- European Pharmacopoeia
- Classification of medicinal products
- Pharmacovigilance and Adverse Drug Reactions
- Manufacture, distribution, pharmacy
- Drug statistics
- Travelling with medicines
Marketing authorisation of medicinal products
Procedure of marketing authorisation of medicinal products in Estonia is closely following the international guidelines and is generally similar to that of EU member states.
The requirements of quality, safety and efficacy are based upon the Medicinal Products Act of 2005 and respective regulations by the Minister of Social Affairs.
State fees and assessment fees
Power of Attorney
The State Agency of Medicines guidance paper has been prepared to facilitate the authorisation process and to give the necessary contact points for different questions.
eSubmissions
The requirements of patient information and labelling of package are similar in the three Baltic States and have been confirmed by the heads of drug regulatory authorities at first in November 1999 and updated in August, 2009.
Related information:
Results
State Agency of Medicines - Nooruse 1, 50411 Tartu, Estonia | Tel: +372 7374140 | Fax: +372 7374142 | info@ravimiamet.ee | Location map