3. Procedure for the expertise of food supplements
Cabinet of Ministers of the Republic of Azerbaijan
By the Decision No. 287 of 10 July 2018
APPROVED
3.1. In accordance with the Law of the Republic of Azerbaijan “On Medicines”, the following food supplements are subject to expertise:
3.1.1.Food supplement produced in the territory of the Republic of Azerbaijan;
3.1.2. Imported to the Republic of Azerbaijan (excluding imported food supplement for personal use);
3.1.3. Food supplements with non valid expertise conclusions.
3.2. Relationships as a scope, duration and the value of the expertise between the manufacturer or his/her authorized representative(hereinafter referred to as the applicant) and the Analytical Expertise Center who conducts the expertise of food supplement, regulates by the agreement.
3.3. In the cases referred to in paragraphs 3.1.1 and 3.1.2 of this Regulation, the applicant shall provide a sample of the food supplement , as well as the following documents and information (hereinafter referred to as set of documents ) in accordance with paragraph 3.9 of this Regulation:
3.3.1. Manufacturer’s information about food supplement in Azerbaijan language:
1. Name of the manufacturer, country , address, trademark;
2. Trademark (patented) and serial number of food supplement;
3. Pharmaceutical form;
4. dosage of foo supplement in packaging;
5. A list of the active ingredients and excipients in the food supplement containing a list of international names and quantity composition;
6.Storage conditions and shelf life of food supplement
3.3.2. Regarding imported food supplement, Certificates of Origin and Conformity, HACCP or GMP provided by manufacturer
3.3.3.Mockups of labels and packagings of food supplements approved by applicant and intended for selling in territory of Azerbaijan Republic;
3.3.4. Copies of the instruction of use of food supplements for consumers in original and in Azerbaijan language;
3.3.5. Document that confirms of non-availability of genetically modified products and nanomaterials, hormones, pesticides, as well as narcotis, psychotropic substances and precursors, strongly influencing and toxic substances and doping agents identified by the International Anti-Doping Agency in the manufacturer’s food supplement ;
3.3.6. Relevant research protocols, if food supplements recommended for use by children and pregnant women,
3.3.7. a copy of the invoice confirming the importation of the samples submitted for the expertise in the territory of the Republic of Azerbaijan in relation to the imported food supplement;
3.3.8 In relation to the imported food supplement, information about legal or physical person imported the food supplement to the Republic of Azerbaijan;
3.3.9. Copies of the relevant documents (standards, technical specifications, technological instructions, specifications, references) on the production of the proposed food supplement, as well as copies of the manufacturer’s authorization for the production of the food supplement.
3.4. In the case referred to in Section 3.1.3 of this Regulation, the applicant shall apply to the Ministry for the re-expertise of the food supplement within one (1) month prior to the expiration of the previous expertise report and shall submit to the Ministry samples of food supplement,a copy of the set of documents and documents about non availability of any amendments in the documents of the food suppelemnt within one (1) year.
3.5. In the case referred to in paragraph 3.1.3 of this Regulation, the change in the collection of documents of the food supplement, the applicant shall submit the documents specified in subparagraphs 3.3.1-3.3.9 of this Regulation prior to its manufacture or import, for the purpose of re-examination of the food supplement; with an application, including a sample of food supplement in accordance with paragraph 3.9 of this Regulation.
3.6. Application and all documents attached to the application are provided in paper and electronic format.
3.7. If the documents mentioned in sub-clauses 3.3.2, 3.3.5, 3.3.6 and 3.3.9 of this Regulation are not in Azerbaijan, Russian or English languages, their notarized translation into Azerbaijan shall be submitted.
3.8. The documents specified in subparagraphs 3.3.2 and 3.3.7 of this Regulation shall not be required during the expertise of the food supplements in the Republic of Azerbaijan.
3.9. For the expertise, the applicant must submit 3 (three) samples of food supplement in the form intended for selling. Notwithstanding the results of the examination, the submitted documents and samples shall not be returned to the applicant.
3.10. The expertise of the food supplement shall be carried out within 15 (fifteen) working days, provided that the applicant’s complete submission of the documents specified in subparagraphs 3.3.1-3.3.8 of this Regulation, taking into account the requirements of the following documents approved by the Ministry:
3.10.1. A list of the biologically active substances containing the daily consumption value and energy value of added to the food supplement for adults over the age of 14;
3.10.2. List of vitamins, vitamins and minerals used in the production of food supplement;
3.10.3. narocits, psychotropic substances or their precursors that are prohibited during use in the manufacture of the food supplement, list of plants with strong or toxic substances and their processing products;
3.10.4. a list of plants and their processed products that are not allowed to be used in the composition of monocomponent food supplement;
3.10.5. The list of plant raw materials used for the production of food supplements for children aged 4-14;
3.10.6. List of plant raw materials used for the production of herbal teas for children up to 4 years;
3.10.7. a list of animal organs, tissues and their processing products considered to be hazardous to human organisms;
3.10.8. List of microorganisms that are not allowed to be used during the production of food supplements;
3.10.9. Requirements for the developing of instruction of use.
3.11. If the applicant fails to fully submit the documents referred to in paragraphs 3.3.1-3.3.8 of this Regulation, it shall be informed in writing within 3 (three) working days and the period specified in paragraph 3.10 of this Regulation shall be calculated after the full submission of the documents.
3.12. The Ministry refuses the expertise in the following cases:
3.12.1. within 10 (ten) business days, the applicant does not fully submit the documents referred to in paragraphs 3.3.1-3.3.8 of this Regulation, even though the applicant has received information that the documents are incomplete under Article 3.11 of this Regulation;
3.12.2. distorted or inaccurate information in the submitted documents.
3.13. The Ministry provides expert report about status of the product(medicine or not medicine)on the basis of the documents submitted for the expertise, as well as on the basis of the performed laboratory analyzes, in the form given in the Appendix to this Rule.
3.14. In case if in the expert report mentioned that it is medicine,requirements of a medicines are applied in accordance with the Law of the Republic of Azerbaijan “On Medicines” in respect of that food supplement.
3.15. Laboratory analyzes conducted for the purpose of expertise of the food supplement are carried out in the accredited laboratories pursuant to the Law of the Republic of Azerbaijan “On Compliance Assessment”.
3.16. The expertise report is valid within 1 (one) year, and also applies to other persons who import the a food supplement with the same name of the same manufacturer to the Republic of Azerbaijan.
3.17. After the expiry of the period specified in paragraph 3.16 of this Regulation, the food supplement shall be re-expertised in accordance with this Procedure.
3.18. Whenever there is a change in the documents and information submitted for the expertise of the food suplement during the validity of the expertise report, the applicant shall apply to the Ministry for the re-expertise of that food supplement in accordance with the requirements set out in this Regulation.
3.19. If the applicant does not agree with the expertise of the food supplement, he / she has the right to apply for the re-expertise of the Ministry within 5 (five) business days from the date of submission of the request.
3.20. Re-expertise is carried out within 5 (five) working days.
3.21. The expertise report of the Ministry, at least once a month, and the documents approved in accordance with paragraph 3.10 of this Regulation shall be placed on the official website of the Ministry and its subordinate “Analytical Expertise Center” Limited Liability Company.
3.22. Expertise report provided for in Article 3.21 of this Regulation shall be submitted to the State Customs Committee of the Republic of Azerbaijan and the Food Safety Agency of the Republic of Azerbaijan on paper and electronic carriers.