On July 14, 2023, significant amendments to the Law of the Republic of Azerbaijan “On Medicinal Products” were approved and came into effect on August 15, 2023. Among the most notable changes are:

• Gradual implementation of medicinal product serialization;
• Introduction of a simplified registration (recognition) procedure and approval of a list of reference countries and recognition organizations;
• Establishment of the foundation for the state registration of medical devices (currently, medical devices are not subject to state registration in Azerbaijan);
• Authorization for the sale and use of medicinal products introduced into circulation during the registration period, even after the registration period has expired;
• During state registration, packaging can be approved in Azerbaijani, Turkish, Russian, English, German, Spanish, Italian, French, and Hungarian languages;
• Clarification of the deadlines for the primary examination (15 working days) and specialized examination (90 calendar days) for new registrations and re-registrations;
• Stricter requirements for the advertising, storage, and sale of dietary supplements (biologically active food supplements) separately from medicinal products, with appropriate labeling.

Starting January 1, 2024, the first phase of medicinal product serialization for psychotropic and potent drugs will be implemented, followed by serialization for other medicinal products beginning June 1, 2024. An information system for tracking and monitoring medicinal products (DVTIS) has been developed, allowing electronic tracking of coded medicinal products according to the GS1 2D Datamatrix format. The system supports the importation of QR codes regulated by the European Union, the USA, India, and other countries. This system is intended for use by local manufacturers and importers, distributors, pharmacies, and medical institutions.

The recognition procedure involves submitting an application and a simplified registration dossier, including a notarized translation of the instructions into Azerbaijani and packaging layouts, which can be submitted in the language of the recognition country. The list of recognition countries was approved by Resolution No. 480 of the Cabinet of Ministers of the Republic of Azerbaijan on December 26, 2023. The list includes 38 countries, including the USA, Japan, EU countries, EFTA and EUCU countries, as well as WHO and EMA. Registration, including examination, is conducted within 9 working days from the date of application submission, not including the time for responses to comments, signing the contract, and payment for expert work and state fees. An important feature of the recognition procedure is the tight deadlines imposed not only on the regulatory body of Azerbaijan but also on the applicant: responses to comments must be addressed within 10 working days, and the signing of the contract with the regulatory body, payment for expert work, and payment of the state fee must be completed within 2 working days.

Cratia provides professional regulatory services on medicines in Azerbaijan and offers new registration, renewals, variations and pharmacovigilance. We have deep knowledge and expertise in local regulation, have necessary experience and resources. To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.