Licensing of Pharmaceutical Activity of Legal Entities (enterprises)

Licensing of Pharmaceutical Activity of Legal Entities (enterprises)

The State Medicines Control Agency under the Ministry of Health following the Law on Pharmacy, the Decision No 1191 (available only in Lithuanian language) of the Government of the Republic of Lithuania of 30 November 2006 "Regarding confirmation of the description of the licensing rules of pharmaceutical activity, requirements applied for qualified person responsible for manufacturing and (or) import, and confirmation licence forms of pharmaceutical activity", and following other legal acts regulating pharmaceutical activity grants, changes, issues duplicates of licences, rejects to issue or change licences, suspends validity of licences or revokes their validity, also revokes suspension of their validity for legal entities.

Types of Licences:

• Manufacturing licence;
• Wholesale distribution licence;
• Licence for the activity of pharmacy;
• Licence for the activity of production pharmacy;