Governmental Decree No. 867 validating “Licensing procedures for the production of medicines, pharmacy practices, medical care and services, as well as curricula for secondary and higher medical education and approval of the form of licenses in the specified areas of professional activity”.

This Governmental Decree establishes “Licensing procedures for the production of medicines, pharmacy practices, medical care and services, as well as curricula for secondary and higher medical education and approval of the form of licenses in the specified areas of professional activity”. It defines the main technological processes for the manufacturing of high quality drugs, describes manufacturing technical equipment, sets forth the structure of manufacturing operational units and establishes guidelines for quality assessment of drugs. It also defines pharmacy and medical care practices applicable to humans and animals, and to research purposes, and imposes mandatory licensing of drug manufacturing. Serial drug production includes the following processes: (a) purchase of starting materials; (b) production technological processes; (c) quality assessment and control; (d) packaging (re-packaging); (e) labelling; and (f) storage. License shall be issued for at least one production processes, except for separate activities, such as purchase of starting materials, storage and quality assessment. License shall be issued by licensing authority within 30 days from the date of filing the application and it shall be based on expert opinion. The applicant must submit application in accordance with the forms contained in the Annexes 1 and 2, identification data for legal entities and individual entrepreneurs, information in accordance with the list contained in the Annex 3 and the list of available technical and technological equipment in accordance with the Annex 5. Drug manufacturers must use only authorized active pharmaceutical ingredients in accordance with applicable production rules. Manufactured drugs must comply with the established quality requirements, while non-complying drugs shall be subject to recycling and destruction.