Biologically active supplements (BAS) are increasingly popular in Armenia, and understanding the regulatory framework is essential for manufacturers, distributors, and consumers. This guide answers the most pressing questions about BAS regulations in Armenia.
1. What is a Biologically Active Supplement According to Armenian Legislation?
According to the Law on Safety of Food of the Republic of Armenia (Law), a Biologically Active Supplement is defined as a concentrated unit of natural or nature-similar nutrients or other substances with a physiological effect. These supplements, either individually or in combination, are intended for use with or in combination with food and are marketed in small, fixed doses such as tablets, capsules, vials, or other small packaging.
It is important to note that BAS are classified as food products, not drugs. Consequently, food safety regulations apply to their production, distribution, and sale.
2. Shall Biologically Active Supplements Be Registered in Armenia?
Yes, biologically active supplements must be registered in Armenia. According to the Eurasian Economic Union (EEU) food safety regulation TR CU 021/2011, BAS fall under the category of specialized food products that require mandatory state registration. Without proper registration, BAS cannot be legally produced, stored, transported, or sold in Armenia.
3. What are the Registration Requirements for Biologically Active Supplements in Armenia?
To register a biologically active supplement, the following must be submitted:
- Results of studies or tests conducted in an accredited testing laboratory confirming the product’s compliance with technical regulations of the Customs Union.
- Information detailing the intended use of the BAS.
These ensure that the supplement meets safety and quality standards before it enters the market.
Working with a law firm familiar with EEU food safety regulations ensures the registration package is correctly prepared and submitted without triggering requests for additional documentation that delay market entry.
4. What are the Territory Requirements for the Production of Biologically Active Supplements in Armenia?
Production facilities for BAS in Armenia must comply with strict requirements under Article 14 of the EEU food safety regulations. Key requirements include:
- Facility Design: Layouts must ensure streamlined production processes to prevent cross-contamination and allow easy cleaning and disinfection.
- Ventilation and Lighting: Facilities must have adequate natural or mechanical ventilation and appropriate lighting to maintain hygiene standards.
- Hygiene Provisions: Handwashing stations with hot and cold water, soap, and drying devices must be available, along with separate restrooms that do not open into production areas.
- Surfaces and Materials: Floors, walls, and ceilings must be made of water-resistant, washable, and non-toxic materials to prevent contamination.
- Pest Control: Facilities must be designed to prevent the entry of insects and rodents.
Additionally, as per Armenian Government Decision No. 34-N (20.01.2011), production sites must include dressing rooms for personnel.
5. Why is Registration Important for Biologically Active Supplements?
Registration ensures that biologically active supplements meet the safety and quality standards established by Armenian and EEU regulations. It protects consumers from harmful or counterfeit products and helps maintain market transparency and trust. If you are also looking to distribute pharmaceuticals wholesale in Armenia, be aware that a separate licensing framework applies – read our guide to Starting a Wholesale Pharmaceutical Business in Armenia for a full breakdown.
Disclaimer: This article is provided for informational purposes only and does not constitute legal advice. It should not be relied upon as a substitute for specific legal counsel. For expert guidance on BAS registration, production facility compliance, and EEU food safety regulations in Armenia, our healthcare lawyers at Retrieve Legal & Tax can assist manufacturers and distributors through every stage of the regulatory process.