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Registration of Food Supplement in Azerbaijan

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Registration of Food Supplement in Azerbaijan

Regulatory Authority

Analytical Expertise Center (the Center) of the Ministry of Health of the Republic of Azerbaijan

License Validity

Company receives an expert opinion valid for 1 year.

Registration Timeline

2 months

Introduction

  • According to state experts, state registration is required for the import and sale of specific food items, such as infant food, sports nutrition, nutritional supplements, and medical nutrition.
  • The Republic of Azerbaijan’s Ministry of Health’s Analytical Expertise Center (AEC) handles the registration of specialty food items. Consequently, the company obtains a 1-year valid expert opinion.
  • The procedure consists of two stages:
  1.  Expert evaluation of the dossier.
  2. Laboratory tests of the samples.
  • Registration documentation can be submitted in English, Russian, or Azerbaijani. Submission of a notarized translation into Azerbaijani is required for documents that is submitted in any other language.
  • Labeling may be done in Russian, English, Azerbaijani, or Turkish, but usage instructions must be provided in Azerbaijani.

Dietary Supplement Registration

  • A dietary supplement is defined as a product with a specific daily dosage of consumption, a biologically active substance of plant, animal, mineral, or chemical origin, and their complexes prepared in pharmaceutical form to enhance human nutrition.
  • The “Rules for the expertise of dietary supplements” were approved by the Azerbaijani Cabinet of Ministers.
  • To Submit Documents for dietary supplements registration in Azerbaijan, one must contact the Analytical Expertise Center (CAE) under the Ministry of Health of Azerbaijan.
  • The required documents should be sent directly to the Analytical Expertise Center tosubmit the application in both paper and digital (on a USB flash drive) formats.
  • After submitting the documents, an agreement is drawn up between the applicant and the AEC.

Documents Required for Registration of Dietary Supplements

1.  Manufacturer’s Information

•  Name, country, address, trademark of the dietary supplement manufacturer;
•  Trademark of dietary supplement and series.
•  Form of release of dietary supplement.
•  Dose of dietary supplement in the package.
• List of active ingredients and excipients in the dietary supplement composition, indicating the international name and quantitative composition.
• Storage conditions and shelf life of dietary supplements;

2. If this is an imported dietary supplement, he manufacturer’s HACCP, GMP, or ISO certificates in addition to certificates of origin and compliance should be shown.

3. Dietary supplement label and package styles that the applicant has authorized for sale within the borders of Azerbaijan;

4.  Consumer-oriented usage instructions for nutritional supplements written in Azerbaijani;

5. A manufacturer’s confirmation document confirming to the absence of genetically modified organisms (GMOs), nanomaterials, hormones, pesticides, narcotic medicines, psychotropic substances and their precursors, strong and poisonous compounds, and doping substances as listed on the World Anti-Doping Agency;

6. Protocols of relevant studies in which dietary supplements are recommended for use by children and pregnant women.

7. In relation to imported dietary supplements – a copy of invoice confirming the import of samples submitted for examination to the territory of Azerbaijan.

8.  Documents certifying information about a legal or physical person who imports dietary supplement to Azerbaijan.

9. Copies of the standards, specifications, technological guidelines, recipes, and documents confirming the creation of dietary supplements, together with the manufacturer’s authorization to produce such supplements.

Process of Food Supplement Registration in Azerbaijan

  1. Dietary supplement packaging is needed to ensure the product’s quality and safety.
  2. Materials used in packaging shouldn’t interfere with the dietary supplement itself.
  3. Inscriptions in a foreign language on the packaging of nutritional supplements must be duplicated in the Azerbaijani.
  4. A special label identifying the product as “dietary supplements” must be applied.
  5. The manufacturer’s indicated daily dosage, the quantity of active ingredients, the composition’s international names, and the protocol for using dietary supplements
    i) manufacturer’s name, country of location, address, trademark
    ii) release form
    iii) dose per package;
    iv) storage conditions;
    v) series;
    vi) expiration date and production date
    6. The words “Suitable for use by children aged 4 to 14 years” must be included with the trademark if the dietary supplement is meant for kids between the ages of 4 and 14. An image, design, or phrase indicating that the product is meant for children may not be present on packaging that isn’t meant for this age range.
    7. The words “Not a medicine” and “Keep out of the reach of children” must be indicated on the dietary supplement packaging in bold indelible type.

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