Traditional medicinal products Manufacturing Certificate of Competence and Market Authorization Directive No. 957/2022.

This Directive is applicable to traditional medicinal products produced in the country at semi-industrial or industrial level according to good manufacturing practice, which have gone through pre-clinical research and clinical trial procedures. "Traditional medicinal product" means any finished, labeled traditional medicinal product, containing active ingredients from natural sources (plant, animal or mineral) applicable for the human health use. "Good production practice (GMP)" means a practice that is a part of the quality assurance system and ensures that the traditional medicinal product is manufactured in a consistent manner in accordance with the required quality standards and market licensing and product quality standards for the intended purpose
Any manufacturer of traditional medicinal products shall get a certificate of competence from the Authority and must produce traditional medicinal product following the good manufacturing practice. Part 2 provides for the discipline of application to get Certificate of Competence (request to submit to authorized Medicine Facility Inspection Directorate) and requirements including manufacturing premises, manufacturing plant water system, materials, documentation, professionals. The Part also disciplines complains, product recalls. Part 3 concerns application for registration of traditional medicinal products and clarifies conditions for registration, product packaging and labeling, quality testing, etc. Part 4 is clinical trials. Part 5 . Post approval inspection, storage, transportation and distribution. Part 6 revocation and suspension of licenses. Part 7 Advertising, Promotion and Sponsorship of Traditional medicinal products.