The main legislative act governing the registration and circulation of medicinal products (human drugs) is the Law of Turkmenistan “On Drug Provision”. Medicinal products, medical devices may be approved for use in Turkmenistan only after their state registration.
The competent authority for state registration of medicinal products is the State Registration Center for Medicinal Products of the Ministry of Health and Medical Industry of Turkmenistan.
The procedure for registration of medicinal products in Turkmenistan is approved by the Law of Turkmenistan “On Drug Provision” dated January 12, 2016.
The Applicant (Нolder) of the Мarketing Аuthorization can be both a resident and a non-resident of Turkmenistan. The Applicant must appoint (authorized) a local representative in Turkmenistan for regulatory purposes, which can be Cratia company.
Requirements to the Application
The registration dossier (registration file of the medicinal product) is provided in the national format. Submission of the dossier in CTD format or another format is possible only by prior approval from the competent authority.
The dossier is submitted in paper form, in two copies: the original and an identical copy, in different pieces/files. Part of the documentation (Power of Attorney, GMP certificate, CPP and/or certificate of registration of the medicinal product in the country of manufacture and other countries) is submitted in the form of the original or legalized copy.
Part of the documentation is submitted with translation into Russian:
- Application letter from the Applicant (Holder);
- Application for registration;
- CPP (Certificate of the Pharmaceutical Product) and/or certificate of registration of a medicinal product in the country of manufacture and other countries;
- GMP certificate;
- SmPC (Summary of Product’s Characteristics);
- Methods of quality control of the finished product.
Instructions for use and labeling of the package may be submitted in Turkmen and/or Russian, and/or English.
Samples of the finished medicinal product and working standards are submitted together with the registration dossier.
The registration procedure
The procedure for registration of the medicinal product in Turkmenistan can be presented in the following steps:
- Submission of the Application letter from the manufacturer, Application form for registration, registration dossier, samples and standards to the competent authority;
- Payment of the state fees;
- Expert evaluation of documentation;
- Laboratory analysis of the quality of the samples of the product;
- Inclusion of a medicinal product in the State Register of Medicinal Products permitted for production (manufacture) in Turkmenistan or import into Turkmenistan;
- Issue of a Marketing Authorization;
The inspection of the manufacturer is usually not required. However, that remains on the decision of the competent authority.
The duration of the registration procedure should not exceed 180 calendar days from the date of submission of the Application. This period does not include the time required for the Applicant to pay state fees, the duration of the laboratory analysis, and the time to answer questions (comments).
The validity of the Marketing Authorization (state registration certificate) is 5 years. Registered medicinal products are entered in the State Register of Medicinal Products.
Language and labeling
Both the dossier and the labeling of the medicinal product must be submitted in Russian, Turkmen and (or) English. Competent authority approves (registers) the instructions for use (package leaflet) and package labeling information.
Changes and variations
Marketing Authorization Holder must submit the Application for variations to the competent authority within 30 days from the date of approval of such changes in the MAH’s or manufacturer’s country, or as soon as MAH became aware of the necessity to implement such changes. The procedure of the assessment and approval of the suggested variations can take from 1 to 3 months from the date of submission of the Application and payment of the state fees.
The expert evaluation of the documentation on changes is carried out by the Pharmacopoeia Committee, which issues an opinion on the impact of the changes on the safety, quality and efficacy of the medicinal product.
Based on the results of the expert evaluation of the documentation, the Pharmacopoeia Committee draws up a protocol and makes a decision on the approval (rejection). The changes should not reduce the safety, quality or efficiency of the medicinal product.
Application for renewal of the registration should be submitted not later than 3 months before the expiry of the registration certificate.
The duration of the renewal procedure is 3-4 months. This period does not include the time required for the Applicant to pay state fees, and to reply to comments/questions of the state experts.
Renewal Application requires the submission of fewer registration materials than initial registration. The registration dossier is submitted in paper form plus one copy. Part of the documentation is submitted with translation into Russian.
Samples of the finished medicinal product and working standards should be submitted with Application.
For the renewal procedure, it is necessary to update the data on the quality of the registered product, provide the PSUR for the validity period of the Marketing Authorization.
As a result of the renewal procedure, a Marketing Authorization (registration certificate) is issued for the next 5 years.
Cratia provides professional services of state registration of medicines in Turkmenistan. We have an excellent knowledge of national legislation, necessary experience and resources.