As Turkmenistan’s healthcare sector continues to evolve, the country has established a regulatory framework for the registration of health supplements. For international regulatory managers seeking to introduce health supplements into the Turkmenistan market, understanding the registration process, requirements, and key considerations is essential.
Now we shall discuss the registration of health supplements in Turkmenistan, with a focus on the information most relevant to regulatory professionals.
Legislative Framework
The registration of health supplements in Turkmenistan is governed by the Law “On Ensuring Food Safety and Quality.” This law establishes the legal basis for the registration, production, import, and circulation of health supplements and other special food products in the country.
Mandatory State Registration
Turkmenistan requires state registration for all new types of health supplements and food packaging materials produced within the country, as well as imported food products and packaging materials. This mandatory registration process ensures that all health supplements entering the Turkmenistan market meet the necessary quality and safety standards.
Competent Authority
The Center for Registration and State Quality Control of Medicinal Products, operating under the Ministry of Health and Medical Industry of Turkmenistan, is the competent authority responsible for the state registration of health supplements. This center oversees the evaluation, approval, and monitoring of health supplements in the country.
Registration Process for Health Supplements in Turkmenistan
The state registration of health supplements in Turkmenistan involves the following key steps:
- Document examination: The State Center for Registration of Medicines and State Quality Control reviews the documents submitted by the manufacturer or supplier of the health supplement to ensure compliance with regulatory requirements, manufacturing conditions, and supply chain standards.
- Quality and safety testing: If deemed necessary, the competent authority may require quality and safety tests to be conducted on the health supplement. The results of these tests are reviewed as part of the registration process.
- Inclusion in the State Register: Upon successful completion of the document examination and any required testing, the approved health supplement and its manufacturer or supplier are included in the State Register of food products permitted for production or import in Turkmenistan.
- Certificate issuance: A certificate of state registration is issued for the health supplement, granting the right to produce or import the product for circulation in Turkmenistan.
Documentation Requirements for Health Supplements
For health supplements imported into Turkmenistan for the first time, the state registration is based on documents provided by the manufacturer and the government of the exporting country. These documents should verify the quality and safety of the products presented by the suppliers.
In cases where an examination of the health supplement is necessary, the supplier must submit the following:
- Samples of the health supplement
- Regulatory and technical documents
- Results of laboratory studies or tests, indicating the standards and actual content of substances
- Official confirmation from the manufacturer regarding the presence or absence of genetically modified sources or organisms
- Certificate of conformity from the country of origin
- Other necessary information as required by the competent authority
It is crucial for international regulatory managers to ensure that all required documentation is complete, accurate, and properly translated into Turkmen or Russian to facilitate the registration process.
Time to Register Health Supplements in Turkmenistan
The food supplement registration process in Turkmenistan requires a thorough understanding of the legislative framework, dossier requirements, and procedural steps. By carefully preparing the registration dossier, adhering to the established timelines, and maintaining open communication with the competent authority, regulatory affairs managers can successfully register their health supplements in Turkmenistan.
To streamline the registration process and ensure compliance with local regulations, consider partnering with experienced consultants or local representatives who have in-depth knowledge.
Delta Medical provides regulatory support for health supplements, medical devices and pharmaceutical registrations in Turkmenistan and Central Asia. Our experts can assist with product registration, licensing, compliance, and all documentation needed to meet local requirements. Contact Delta Medical today to learn more about bringing your healthcare products to new markets across the region.
