LAW OF THE REPUBLIC OF AZERBAIJAN “On medicinal products”
Chapter 2 Article 11. Requirements for instructions on the use of medicines.
Instructions on the use of medicinal products, produced in or imported into the Republic of Azerbaijan, must contain the following information in the Azerbaijani language:
- Trade and unpatented name of the medicinal product;
- Name of the country, where the medicinal product was produced
- Name and legal address of the manufacturer of a medicinal product
- Date of preparation and serial number
- The rule of the appliance of a medicinal product, its dosage, form, number of doses per pack
- Expiry date
- Storage and dispensing conditions
- Precautionary measures while taking the medicinal product
- Information about components within the composition of the medicinal product
- The scope of application, contraindications, side effects, and interaction with other medicines
- Instructions on the use of medicinal products are confirmed by the relevant executive authority.
Azerbaijan declared the implementation of a Traceability system in 2024, yet without specifying the specific serialization requirements. The Ministry of Health of the Republic of Azerbaijan oversees the tracking of psychotropic drugs and potent medicines.
Additionally, starting from 1st June 2024 real-time monitoring of all other medications in the warehouses of domestic manufacturers, wholesale pharmaceutical enterprises, medical institutions, and pharmacies will commence.
The implementation of the "Drug Tracking and Monitoring System" (DTMS) will enable real-time monitoring throughout the entire pharmaceutical production and distribution process, ensuring that medications reach consumers safely and efficiently.
Initially, the focus will be on monitoring psychotropic and highly effective drugs from June 1, 2024, with other medications to follow. This monitoring will encompass domestic manufacturing facilities, wholesale pharmaceutical organizations, medical institutions, and pharmacies.
The system will utilize;
- Global Trade Item Number (GTIN),
- Serial Number,
- Expiration Date, and
- Batch/Lot Number for tracking purposes.
Current Scope is for the following participants;
- All domestic manufacturers
- Wholesale pharmaceutical enterprises
- Medical institutions
- Pharmacies
Compliance
Pharmaceutical companies need to work closely with their supply chain partners and technology vendors to ensure that their serialization solutions comply with Azerbaijan regulations and meet the required deadlines. Non-compliance with serialization requirements can result in penalties and delays in product registration and market access.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients manage end-to-end serialization projects and prepare them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Azerbaijan pharmaceutical serialization requirements.
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Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their interpretation before making business decisions. Please use the references below to follow the updates at the source.
