The procedure for state registration of special food products is regulated by the Law of the Republic of Mongolia “On medicinal products and medical devices” and Order No. 13 of the Ministry of Health of Mongolia dated January 15, 2015 “On approval of the provision on registration of biologically active products”.
Legislation of Mongolia determines that a biologically active product (BAP) is a product that facilitates the delivery of the necessary substances and/or calories to the human body, but is not intended for treatment. These products include classical dietary supplements (biological active supplements), as well as sport and medical nutrition.
The Application and a package of documents are to be submitted to carry out the registration procedure, as well as samples of the finished product.
Steps of the registration procedure:
- Submission of Application for registration, necessary documents and samples;
- Preliminary (primary) examination;
- Receipt of an invoice and payment of state fees;
- Performing of laboratory quality tests;
- Specialized examination and drawing up conclusions;
- Deciding on registration at the meeting of the Expert Council on biological products;
- Transfer of the decision on registration to the Applicant;
- Execution and issuance of the registration certificate;
- Adding of the medicinal product to Licemed’s database.
The registration certificate of the BAP is issued for a period of 5 years.
Labeling can be performed in Russian, English or Mongolian. Instructions for use shall be performed in Mongolian.
The application for renewal shall be submitted within 2 months till the end of the validity of the registration certificate.
Cratia provides professional services of state registration of food supplements in Mongolia. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.