Registration of Food Supplement in Armenia

Regulatory Authority

Ministry of Health of the Republic of Armenia.

5 Years

• Along with Belarus, Kazakhstan, Kyrgyzstan, and Russia, Armenia has been a member of the Eurasian Economic Union (EAEU) since 2015. As a result of its Union membership, Armenia’s laws are always being updated to conform to those of the EAEU.
• The import and sale of special food items are permitted by local law following registration under the “centralized” EAEU procedure and the acquisition of a marketing license.
• The manufacturer or any other legal body, whether a resident or not, may apply for registration as the Marketing Authorization Holder.
• The State Service for Food Safety of the Republic of Armenia’s Ministry of Agriculture is responsible for registering unique food items.
• The dossier can be sent in in English, Russian, or Armenian. Administrative documents are sent as notarized copies or in their original, translated into Russian.
• The packaging labeling is filed in the language of the manufacturing nation, while the instruction is authorized in Russian. The sticker is approved in Russian.
• In addition to the samples of special food items, the documentation is presented in duplicate in compliance with the authorized list.

Stage 1: Preparation of the dossier and samples (1-12 months)

1.1 Receiving the samples and dossier from the Client

• Dossier according to requirements
  of CIS and EAEU
• Samples for sanitary- hygienic tests (150 g)
• Product ArtWorks in KZ/RU languages
• Draft instructions for use
• Certificates HACCP, ISO 13485, GMP
• Power of Attorney for Registration

1.2 Development of local documents

• • Translation of dossier into Russian
  • Notarization of documents
  • Development of bilingual ArtWorks
  • Development of instructions for use

Stage 2: Submission of the dossier and materials on registration (up to 1 week)

2.1 Submission of the dossier and samples to the Authority
2.2 Receive invoice for payment and conclusion of the contract with Authority

Stage 3: Food Supplement registration process and getting approval from Authority (up to 90 calendar days / 3 months)

3.1 Sanitary and hygienic trial:

• Composition analysis
• Analysis of physical-chemical indicators
• Determination of heavy metals, radionuclides, pesticides, microtoxins
• Microbiological tests
• Study of toxic effects on the body in acute trial on laboratory animals

3.2 Examination of the dossier

3.3 Assigning a registration number: Inclusion in the unified register of certificates on state registration of the EAC (Eurasian Economic Commission) or in CIS according to local legislation.

• The Drug and Medical Technology Agency’s expert judgments served as the basis for the resolution on the marketing authorization of dietary supplements. During the registration process, candidates need to send in an application file containing the following:

1. An application for dietary supplement registration,
2. A brief description of the product’s characteristics.
3. Information about ingredients’ safety and efficacy,
4. A brief description of the production process and a manufacturing license.
5. A Certificate of Analysis (including information on the composition of mula, shelf life, storage conditions, and test specifications), a GMP certificate, and a Free Sale Certificate from the nation of production.
6. An example of the consumer brochure and usage instructions.
7. Dietary supplement samples used in lab analyses.

1. Statement of identity,
2. Net quantity of contents,
3. Claim,
4. Directions for use
5. Supplement facts panel,
6. Other ingredients in descending order of performance,
7. Disclaimer “This product is not intended to diagnose, treat, cure, or prevent any dis- ease,”

Name and place of business of the manufacturer, packer, or distributor