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.
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.
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:
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