Who can carry out wholesale trade with medicinal products? ⊶ A natural or legal person holding a permit for wholesale trade in medicinal products, issued by a regulatory authority in the relevant ⊶ EU member state and having storage facilities on the territory of the Republic of Bulgaria; ⊶ A natural or legal entity registered […]
Issuance of a wholesale trade permit for medical devices
A wholesale trade medical devices permit on the territory of the Republic of Bulgaria is carried out on the basis of Art. 78a of the Medical Devices Act. The procedure is regulated in Art. 77 et seq. and Art. 78a of the Law on medical devices /LOMD/. It is issued by the Medicines Executive Agency.
Wholesale trade permit The wholesale trade permit of medical devices in the country requires registration to competent authority. For this purpose, if you intend to develop such activity, you need to submit an application and any other documents in Bulgarian Drug Agency of the Ministry of Health. Required documents and fees: Application; List