The population of Turkmenistan is about 5.5 million people. Among the republics of the former Soviet Union, Turkmenistan has one of the highest GDP per capita. Import plays a significant role and makes up for more than 90% of pharmaceutical and medical market.
Import and sale of medicinal products are permitted after their registration only. To import medical devices and medical equipment, it is also required to obtain a registration certificate. This applies to medicinal teas, homeopathic medicinal products, hygiene products and disinfectants, including those used for the prevention of infectious diseases, medical cosmetic products, mineral water, mud and salt used for medical and preventive purposes.
The main legislative act regulating the registration and circulation of medicinal products is the Law of Turkmenistan “On Drug Provision”.
The competent authority responsible for the registration of medicinal products is the Ministry of Health and Medical Industry (website www.saglykhm.gov.tm). The authorized body that performs the examination of the documentation for the medicinal products is the State Registration Center for Medicinal Products of the Ministry of Health and Medical Industry of Turkmenistan.
To register a medicinal product, the manufacturer shall appoint a representative in Turkmenistan. Data on the representative shall be indicated in the Application for registration.
The registration dossier (registration file of the medicinal product) is provided in the national format. Submission of the file in CTD format or other format is possible only upon prior consent of the authorized body.
The dossier shall be submitted in paper form, in two copies: the original and the identical copy, in different folders. Part of documents (power of attorney, GMP certificate, CPP and/or certificate of registration of the medicinal product in the manufacturing country and other countries) is submitted in original or legalized copy.
Part of documents is submitted translated into Russian:
- Letter of appeal from the manufacturer;
- Application for registration;
- CPP (certificate for a pharmaceutical product) and/or certificate of registration of a medicinal product in the manufacturing country and other countries;
- GMP certificate;
- SmPC (a summary the product characteristics);
- Drug master file of the finished product.
An instruction for use and labeling of the packaging may be submitted in Turkmen, and/or Russian, and/or English, and other languages.
Samples of the finished medicinal product and working standards are submitted together with the registration dossier.
The registration procedure of the medicinal product in Turkmenistan may be described by the following stages:
- Submission of the Manufacturer’s letter of reference, the application for registration, the registration dossier, samples and standards.
- State fee payment.
- Examination of documents.
- Checking the reproducibility of the Drug master file methods for the medicinal product.
- Inclusion of the medicinal product into the State Register of medicinal products authorized for manufacture in Turkmenistan or importation into Turkmenistan.
- Issuance of registration certificate.
Usually, during the registration, inspection is not carried out. However, the state agency reserves the right to decide on sending its employees to the manufacturing site for inspection.
The duration of the registration procedure makes up 180 calendar days from the date of receipt of the Application. This period does not include the time necessary for the Applicant to pay state fees, the term of the laboratory analysis and the time for responding to remarks.
Registration certificate is valid during 5 years. Registered medicinal products are entered in the state register of medicinal products.
Introduction of variations
If there is a need to introduce variations and additions to the registration certificate and/or registration dossier, the Applicant shall submit the Application and relevant documents to the authorized body within thirty calendar days. Depending on the complexity, the procedure takes 1-3 months from the date of payment.
Documents examination on introduction of variations is carried out by the Pharmacopoeia Committee, which issues a conclusion on the impact of the introduced variations and additions to the safety, quality and efficacy of the medicinal product.
Following the results of documents examination the Pharmacopeia Committee draws up a protocol and decides on introducing such variations and/or additions. The variations and additions introduced should not reduce the safety, quality and efficacy of the medicinal product, medical devices.
In order to carry out renewal procedure of the medicinal product, the Applicant may submit an Application to the authorized body within three months before the Certificate validity expiration. Duration of the procedure is 3-4 months. This period does not include the time needed to pay state fees, and time to respond to remarks.
Together with the Application, registration documentation is submitted, in a smaller amount than for the new registration. The registration dossier shall be submitted in paper form in two copies. Part of the documentation is submitted translated into Russian.
The samples of the finished medicinal product and working standards are submitted together with the registration dossier.
The renewal procedure is identical to the procedure of new registration.
The legislation of Turkmenistan regarding pharmacovigilance is in the process of development. The Draft Order on monitoring the safety of medicinal products has been developed, but has not been formally approved.
The competent authority of the pharmacovigilance system is the Ministry of Health and Medical Industry of Turkmenistan.
In terms of legislation the applicant is not required to develop and maintain a pharmacovigilance system, appoint an authorized person responsible for pharmacovigilance.
Requirements for the submission of the Periodic Safety Update Report of the medicinal product (general data on side effects of the medicinal product – PSUR):
- once in 6 months – within 2 years after receiving the registration certificate;
- annually for the next 3 years;
- once in 5 years thereafter (in case of renewal of the product).
The main legislative act regulating the registration and circulation of medical devices is the Law of Turkmenistan “On Drug Provision”.
The competent authority responsible for the registration of medical devices is the Ministry of Health and Medical Industry (website www.saglykhm.gov.tm). The authorized body performing the examination of the documents for medical devices is the State Center for Registration of Medicinal Products and State Quality Control under the Ministry of Health and the Ministry of Manufacturing Industry of Turkmenistan (hereinafter – the Center).
The registration dossier is provided in the national format according to the approved list of documents. The file is submitted in two copies: the original and the identical copy.
Samples of the medical device are provided at the request of the Center.
Instruction for use and labeling of the packaging are submitted and approved in Turkmen, and/or Russian, and/or English, and other languages.
According to the effective law duration of the registration procedure must not exceed 180 calendar days from the moment of the Application reception.
The validity of the registration certificate is 5 years.
Renewal application shall be submitted within three months before the expiration of the validity of the Registration certificate.
The procedure takes 3-4 months.
Introduction of variations
From the moment of approval of variations and additions to the registration certificate and/or registration dossier in the country of the manufacturer, the Applicant shall, within thirty calendar days, apply to the authorized body with an Application and relevant documents. Introduction of variations procedure takes 1-3 months, depending on the complexity from the moment of payment.
Special food products
Special food products are registered in the Republic of Turkmenistan according to the Law “On Food Products Safety and Quality Assurance.”
The state registration is carried out by the State Center for Registration of Medicinal Products and State Quality Control under the Ministry of Health and Ministry of Manufacturing Industry of Turkmenistan.
The state registration of food products includes:
- examination of documents submitted by the manufacturer (supplier) of food products that confirm their compliance with the requirements of regulatory documents, manufacturing conditions or supply of food products;
- examination of the results of food quality and safety tests conducted if necessary;
- entering into the State Register of food products permitted for the manufacture in the territory of Turkmenistan or importation into the territory of Turkmenistan, as well as their manufacturers (suppliers);
- issuance to the applicant of the certificate of state registration of a food product granting the right to manufacture these products in the territory of Turkmenistan or import them into the territory of Turkmenistan for sales.
The state registration of food products, materials and products imported for the first time in the territory of Turkmenistan is carried out on the basis of the manufacturer’s documents and the authorized state body of the exporting country, confirming the quality and safety of these products, which are represented by their supplier.
In case it is necessary to carry out an appropriate examination of food products, materials and devices imported for the first time in the territory of Turkmenistan, the supplier shall provide their samples and regulatory documents, the results of laboratory investigations (tests), indicating the norms and the actual content of substances, an official manufacturer confirmation on the presence or absence of genetically modified sources (organisms), the certificate of conformity of the manufacturing country and other necessary information.
Medical cosmetic products, hygiene products, muds, salts that are used for medical and preventive purposes can be permitted for use in Turkmenistan only after their state registration.
The registration procedure is also carried out by the Center for Registration of Medicinal Products and State Quality Control under the Ministry of Health and Ministry of Manufacturing Industry of Turkmenistan.
The registration procedure is identical to the procedure for the medicinal products.
Company “Cratia” offers carrying out of state registration of medicinal products, registration of medical devices and medical equipment, special food products and cosmetic products in Turkmenistan.