en
A new regulation has been established for the wholesale of medicines
A new regulation has been established for the wholesale of medicines
If a legal entity engaged in the import of medicinal products carries out the wholesale distribution of a medicinal product to pharmacy organizations within the country through another wholesale pharmaceutical enterprise, it shall pay up to 40% of the “Additional Amount for the Wholesale Pharmaceutical Enterprise” to the wholesale pharmaceutical enterprise that performs the direct wholesale distribution of the medicinal product to pharmacy organizations.
The Cabinet of Ministers has amended the "Regulations on the Pricing of State-Registered Medicinal Products and Control over Such Prices" accordingly.
The responsibilities of the relevant executive authority in the field of regulation of the circulation of medicinal products include the following:
- conducting simplified expert examinations of medicinal products;
- compiling a list of medicinal products manufactured in the Republic of Azerbaijan, publishing it on the official website for public awareness, and updating this list quarterly based on the information determined by the body (institution) designated by the relevant executive authority;
- preparing clinical protocols (a set of rules used by a doctor or paramedic when providing medical assistance in case of a disease or its symptoms, and approved by the body (institution) designated by the relevant executive authority), creating an electronic database for them, and publishing them on its official website;
- determining the requirements of Good Manufacturing Practice (a procedure for evaluating whether medicinal products are manufactured and tested in compliance with the requirements of technical regulatory legal acts, meet their intended use, conform to state registration documents, and the results of clinical trials conducted for the respective medicinal product).
If a legal entity engaged in the import of medicinal products carries out the wholesale distribution of a medicinal product to pharmacy organizations within the country through another wholesale pharmaceutical enterprise, it shall pay up to 40% of the “Additional Amount for the Wholesale Pharmaceutical Enterprise” to the wholesale pharmaceutical enterprise that performs the direct wholesale distribution of the medicinal product to pharmacy organizations.
The Cabinet of Ministers has amended the "Regulations on the Pricing of State-Registered Medicinal Products and Control over Such Prices" accordingly.
The responsibilities of the relevant executive authority in the field of regulation of the circulation of medicinal products include the following:
- conducting simplified expert examinations of medicinal products;
- compiling a list of medicinal products manufactured in the Republic of Azerbaijan, publishing it on the official website for public awareness, and updating this list quarterly based on the information determined by the body (institution) designated by the relevant executive authority;
- preparing clinical protocols (a set of rules used by a doctor or paramedic when providing medical assistance in case of a disease or its symptoms, and approved by the body (institution) designated by the relevant executive authority), creating an electronic database for them, and publishing them on its official website;
- determining the requirements of Good Manufacturing Practice (a procedure for evaluating whether medicinal products are manufactured and tested in compliance with the requirements of technical regulatory legal acts, meet their intended use, conform to state registration documents, and the results of clinical trials conducted for the respective medicinal product).