Turkmenistan requires state registration of pharmaceuticals before they can be marketed and sold in the country. The registration process is governed by specific legislation and overseen by designated authorities.
Governing Legislation
The primary law governing the registration and circulation of medicines in Turkmenistan is:
- The Law of Turkmenistan “On Drug Provision” dated January 12, 2016.
Competent Authorities
The competent authorities responsible for the registration of medical devices and pharmaceuticals are:
- The Center for Registration and State Quality Control of Medicinal Products of the Ministry of Health and Medical Industry of Turkmenistan.
MAH Applicant Eligibility in Turkmenistan
Both Turkmenistani residents and non-residents can apply for registration as the Marketing Authorization Holder. However, non-resident applicants must appoint (authorize) a local representative in Turkmenistan for regulatory purposes.
Registration Timeline for Pharmaceuticals
The typical duration of the registration process is 4-6 months. This timeline does not include additional time required for:
- Paying state fees
- Completing laboratory analysis
- Responding to questions or comments from the authorities
Turkmenistan Registration Requirements for Medicines
The registration process for foreign medicines in Turkmenistan involves submitting a comprehensive dossier with specific documents and samples to the competent authority. Key requirements include:
- Application in the approved form.
- Copy of the Certificate of Pharmaceutical Product (CPP) issued according to WHO recommendations (original or certified/notarized copy), or a certificate of registration in the country of manufacture if CPP is not available.
- Copy of the Free Sale Certificate (original or certified/notarized copy).
- Manufacturer’s license for production (original or certified/notarized copy).
- Copy of agreement between manufacturing plant and registration documents owner retaining rights for production and quality decisions (if necessary).
- Certificate of Good Manufacturing Practice (GMP) for the manufacturing plant (original or certified/notarized copy).
- Copy of trademark registration certificate certified by relevant authorized body (if available).
- Information certified by relevant authorized body about medicine registration in other countries (countries registered, period, copies of certificates).
- Brief description of production process certified by manufacturing plant.
- Full description of quality control and quantitative analysis methods (references to standards, finished product specifications).
- Stability data confirming claimed shelf life, controlled in at least 3 batches, indicated on all primary packages.
- Information on preclinical, pharmacological, toxicological and clinical trial results:
- Report on preclinical and clinical trial results (if available)
- Literature review of preclinical and clinical trials
- For herbal medicines, review of scientific literature on medicinal plants
- For generic medicines, provide scientific publications and bioequivalence study report.
- Summary of Product Characteristics.
- Instructions for use.
- Colored mock-ups of primary and secondary packaging certified by manufacturer (all sizes/dosages).
- Samples of the finished product.
Documents must be submitted as originals or certified/notarized copies. Translations into Russian, Turkmen and/or English are required for the dossier and labeling.
Registration Procedure in Turkmenistan
The typical registration procedure involves:
- Submission of application letter, form, dossier, samples and standards to competent authority.
- Payment of state fees.
- Expert evaluation of documentation.
- Laboratory analysis of product samples.
- Inclusion in the State Register of Medicinal Products permitted for production/import.
- Issuance of Marketing Authorization.
An inspection of the manufacturing facilities is usually not required but remains at the discretion of the authorities. Medicines can only be approved for use in Turkmenistan after their registration, with some exceptions like samples for registration or clinical trials.
Marketing Authorization Validity and Renewal
The Marketing Authorization (state registration certificate) is valid for 5 years. Registered medicinal products are entered into the State Register.
To renew the registration, an application must be submitted 3 months before the certificate expires. The renewal procedure typically takes 3-4 months and requires updating the quality data of the registered product and providing the Periodic Safety Update Report (PSUR) for the validity period.
Upon successful renewal, a new Marketing Authorization is issued for the next 5-year period.
Variations and Changes of Pharmaceutical Registrations
The Marketing Authorization Holder must submit an Application for Variations to the competent authority within 30 days of approval in the country of origin or after becoming aware of the need for changes.
The proposed changes should not reduce the safety, quality, or efficacy of the medicinal product.
The duration of the variation procedure is 1-3 months from the date of submission and payment of state fees.
The Pharmacopoeia Committee conducts an expert evaluation of the documentation on changes and issues an opinion regarding the effects on the product’s safety, quality, and efficacy. Based on this evaluation, the committee decides on the approval or rejection of the proposed changes.
Re-Registration Requirements for Medicines in Turkmenistan
The re-registration process for foreign medicines in Turkmenistan involves submitting an updated dossier with specific documents and samples to the competent authority. Re-registration is required every 5 years. Key requirements include:
- Application for re-registration.
- Updated Summary of Product Characteristics.
- Updated Instructions for Use.
- Manufacturer’s license for production (original or certified/notarized copy).
- Certificate of Pharmaceutical Product (CPP) (original or certified/notarized copy), or a registration certificate from the country of manufacture if CPP is not available.
- GMP certificate for the manufacturing plant (original or certified/notarized copy).
- Free Sale Certificate (original or certified/notarized copy), indicating the trade name and composition of active substances.
- Full description of quantitative and qualitative control analysis methods (referencing industry standards and finished product specifications).
- Periodic Safety Update Report (PSUR) for the medicine.
- Colored mock-ups of primary and secondary packaging certified by the manufacturer (all sizes/dosages).
- Samples of the finished product.
Documents must be submitted as originals or certified/notarized copies. Translations into Russian, Turkmen and/or English may be required for the dossier and labeling.
Re-Registration Procedure in Turkmenistan
The typical re-registration procedure involves:
- Submission of the re-registration application, updated dossier, samples, and standards to the competent authority.
- Payment of state fees.
- Expert evaluation of the updated documentation.
- Laboratory analysis of product samples (if required).
- Renewal of the product’s inclusion in the State Register of Medicinal Products permitted for production/import.
- Issuance of the renewed Marketing Authorization.
An inspection of the manufacturing facilities is usually not required but remains at the discretion of the authorities.
Re-Registration Timeline
- The applicant may submit the re-registration application to the competent authority within 3 months before the expiry of the current registration certificate[3].
- The duration of the re-registration procedure is typically 3-4 months from the date of application submission. This period does not include:
- Time needed to pay state fees
- Time to respond to any queries or remarks from the authorities
- The registration certificate is valid for 5 years. After this period, the medicine must be re-registered to continue being marketed in Turkmenistan.
- Failure to re-register a medicine before the expiry of its current registration may result in the product being removed from the market until the re-registration is completed.
It’s important to note that the re-registration procedure is largely identical to the procedure for new registrations. The dossier requirements are somewhat reduced compared to a new registration, but the evaluation process and timelines are similar.
To ensure continuity of the marketing authorization, it is recommended to initiate the re-registration process well in advance of the expiry date, taking into account the 3-4 month timeline and any potential delays in addressing queries from the authorities or making necessary payments.
Packaging Requirements for Medicines in Turkmenistan
When a pharmaceutical product is registered by the state, the design of the packaging and the instructions for use (package insert) must be approved. Each medicine must be accompanied by instructions for use in the state language (Turkmen), Russian, and/or English, as well as other languages, which should include the following information:
- Name of the medicine
- General characteristics of the medicine (chemical name, main physico-chemical properties, composition)
- Information about the pharmacological properties of the medicine
- Indications and contraindications for use
- Interactions of the medicine with other drugs
- Methods of administration and dosage of the medicine
- Undesirable effects of the medicine
- Precautions when using the medicine
- Dosage forms of the medicine
- Storage conditions and shelf life of the medicine
- Conditions for dispensing the medicine (“without prescription” or “by prescription”)
- Other information about the clinical characteristics of the medicine
The labeling of the medicine packaging should be in the state language (Turkmen), Russian, and/or English, as well as other languages, and should contain the following information:
- Name of the medicine
- Address of the manufacturer of the medicine
- Batch (series) number of the medicine
- Date of manufacture of the medicine (for immunobiological medicines)
- Expiration date of the medicine
- Method of administration of the medicine
- Quantity or concentration of the medicine, volume, activity in units of action or number of doses
- Storage conditions of the medicine
- Precautions and storage conditions when using the medicine
The format and content of the instructions for use, as well as the design of the pharmaceutical packaging, must be approved by the Center (competent authority).
Key Points
- Packaging design and instructions for use must be approved during state registration
- Instructions for use must be provided in Turkmen, Russian, and/or English, and include specific details about the medicine
- Labeling on the packaging must also be in Turkmen, Russian, and/or English, and include key information about the medicine
- The format, content, and design of the instructions and packaging must be approved by the competent authority
It is crucial for regulatory affairs managers to ensure that the packaging and labeling of medicines comply with these requirements to facilitate successful registration and marketing of their products in Turkmenistan.
Have Plans to Register Medicines in Turkmenistan?
By understanding and adhering to these registration requirements and procedures, companies can manage the process of introducing pharmaceuticals into the Turkmenistan market successfully.
Delta Medical is ready to assist international pharmaceutical companies to obtain registrations in Turkmenistan. We have 25 years of extensive regulatory experience in Turkmenistan, Central Asia, the Caucasus, Ukraine and Belarus.
