Azerbaijan introduces mandatory serialization of medicines.

From January 1, 2024, it will be compulsory to apply a 2D DataMatrix code to the packaging of imported psychotropic and potent drugs.

Serialization for all medicinal products will be implemented following the approval of legislation on the system for monitoring and tracking medicines (as of the end of May, it is in the approval stage in the Cabinet of Ministers).

It is expected that changes to registration documents will not be required if only the 2D code is added to the packaging. During renewal of registration, the 2D code will be mandatory on the packaging layout for the Azerbaijan market.

Based on the information we have gathered:

• An information system for tracking and monitoring medicinal products (DVTIS) has been developed, which allows for electronic tracking of coded medicinal products according to the GS1 2D Datamatrix format.
• Information on the system’s operation is available via video tutorials on the regulatory authority’s website: https://pharma.az/en/news/how-to-use-the-track-and-trace-system-of-medicines/
• The system allows for (1) the import of previously applied codes regulated by the European Union, the USA, India, and other countries; (2) the generation of codes for placement on packaging either directly during the production process or by stickering by the importer.
• When generating codes in Azerbaijan’s system, the minimum size of the Datamatrix code, along with the corresponding information, is 35×17 mm, and they are printed on stickers sized 40×20 mm.

Technical requirements can be provided upon your inquiry.

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.