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Administrative services

General administrative services delivered by the Bulgarian Drug Agency.

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List of articles in category Administrative services
Title
Report for the implementation of the goals for 2010 and ratified goals for 2011.
Charter and questionnaire form of the client
Issue of addendum to the Marketing Authorization for conduction of clinical trial of medicinal product in case of significant changes
Issue of Variation to a Marketing Authorization for wholesale of medicinal products
Issue of Marketing Authorization for wholesale of medical devices
Issue of Exemption Certificate of batch of pharmaceutical product under article 69 of the Law on Medicinal Products in Human Medicine (LMPHM)
Issue of Variation to a Certificate for registration of pharmacy
Issue of Registration Certificate for wholesale of medicinal products on the territory of the Republic of Bulgaria
Issue of Marketing Authorization for import of pharmaceutical products, active substances used as starting materials and medicinal products for clinical trial
Approval of non-interventional pharmaceutical clinical trial
Issue of Marketing Authorization for significant change in a pharmaceutical clinical trial under art. 109 item 2 of the Law on Medicinal Products in Human Medicine (LMPHM)
Issue of Marketing Authorization for pharmaceutical clinical trial under art. 109 item 2 of the Law on Medicinal Products in Human Medicine (LMPHM)
Issue of approval of pharmaceutical clinical trial
Issue of Variation to a Marketing Authorization Type II to the Marketing Authorization of pharmaceutical product
Issue of report for information received in BDA for adverse drug reactions (ADR) for a pharmaceutical product
Registration of medical devices
Issue of Variation to a Registration Certificate for wholesale of pharmaceutical products on the territory of the Republic of Bulgaria
Issue of Registration Certificate for wholesale of pharmaceutical products on the territory of the Republic of Bulgaria
Issue of registration certificate for homeopathic pharmaceutical product
Issue of Certificate for registration of pharmacy
Issue of Certificate for the origin of the pharmaceutical product
Issue of Exemption Certificate of batch of pharmaceutical product under article 70 of the Law on Medicinal Products in Human Medicine (LMPHM)
Issue of Certificate for pharmaceutical product
Issue of Marketing Authorization of pharmaceutical product via National Procedure
Issue of Marketing Authorization of pharmaceutical product via Mutual Recognition Procedure
Issue of Marketing Authorization of pharmaceutical product via Decentralized Procedure
Issue of Marketing Authorization for wholesale of pharmaceutical products
Issue of Variation to a Marketing Authorization for wholesale of pharmaceutical products
Issue of Marketing Authorization for production of pharmaceutical products, for active substances used as starting materials and for medicinal products for clinical trial
Issue of Marketing Authorization for conduction of clinical trial of medicinal product
Issue of Variation of Marketing Authorization of pharmaceutical product for transfer of the rights over an issued Marketing Authorization of medicinal product
Issue of Marketing Authorization for production of pharmaceutical products, active substances used as starting materials and medicinal products for clinical trial
Issue of Authorization for extension of the range of the issued Marketing Authorization of pharmaceutical product
Issue of Variation to a Registration Certificate for wholesale of pharmaceutical products on the territory of the Republic of Bulgaria