Uzbekistan

The population of Uzbekistan is about 33 million. The volume of the Uzbek pharmaceutical market amounts to more than 1.3 billion US dollars, and the volume of the medical devices and in-vitro diagnostics market does to about 400 million US dollars. Import plays a very significant role and amounts to about 80% of the pharmaceutical and medical market.

Import and sale of medicinal products are authorized only after the state registration. To import medical devices and medical equipment, it is necessary to obtain a registration certificate. Import and manufacture of special food products and perfumes and cosmetics are carried out with the permission of the authorized body.

Medicinal products

Main legislative acts regulating the marketing authorization and circulation of medicinal products are the Law of Uzbekistan “On medicinal products and pharmaceutical activities” and Resolution as of the 23^rd of March, 2018 No. 213 “Provision on state registration procedure regarding medicinal products, medical devices and medical equipment and on issuance of the registration certificate.”

The State expertise and standardization center for medicinal products, medical devices and medical equipment of the Agency of development of pharmaceutical industry of the Ministry of Health (web-site http://www.uzpharm-control.uz/) performs documents evaluation, registration and issuance of the registration certificate on medicinal products.

Legal system describes various types of medicinal products, including originators and generics, medicinal immunobiological preparations, biosimilars, orphan products (orphans medicines), homeopathic preparations and herbal medicinal products.

Below mentioned products are subject to registration:

• medicinal products;
• new combinations of medicinal products registered in Uzbekistan;
• medicinal products previously registered in Uzbekistan, but manufactured in other dosage forms, potencies or by other manufacturer;
• medical devices;
• medical equipment.

The applicant (owner) of the registration can be a legal entity, both resident and non-resident of Uzbekistan. The name of such legal entity, in whose name the registration certificate is issued, is indicated in the certificate form.

The Applicant is not required to establish a representative office or company in Uzbekistan, but the Applicant shall develop and maintain a local pharmacovigilance system.

Instructions for medical use state the name and address of the organization accepting claims (proposals) on the quality of medicinal products in the territory of the Republic of Uzbekistan.

The registration dossier is submitted in the national format consisting of 4 modules drawn up based on the CTD format.

There are strict requirements for the registration dossier execution: materials are to be submitted in paper or electronic form, in two identical copies. The registration dossier shall have a table of contents and pagination, certain parts of the dossier shall be signed and sealed by the Applicant (or his by authorized representative).

It is necessary to submit samples of the finished medicinal product in the quantity sufficient for conducting triple tests, standard samples, and if necessary, related substances, control materials and specific reagents together with the registration dossier.

The registration dossier may be submitted in English with part of documents translated into Russian. Mock-ups, instruction for medical use, the drug master file (regulatory document) are to be translated into Uzbek and Russian.

The registration dossier is completed with a draft instruction for use in Uzbek and Russian, as well as color mock-ups.

CPP (a certificate of a pharmaceutical product) or other confirmation of the registration of the medicinal product shall be submitted as a part of the registration dossier, as well as evidence of the registration of the medicinal product in countries other than the manufacturing country. If the medicinal product is not registered in other countries, than during the registration procedure, clinical trials may be scheduled in the territory of Uzbekistan.

Registration procedure of the medicinal product in Uzbekistan can be briefly described by the following stages:

1. Submission of the Application for registration, copies of the certificate of state registration of the applying company, registration dossier and samples of the medicinal product.
2. Primary (preliminary) examination.
3. Signing of the Agreement between the Applicant and the State Center for Expertise and Standardization of Medicinal Products.
4. Receipt and payment of examination bills.
5. After payment is confirmed, registration materials and samples are sent for specialized expertise to the structural units of the State Center for Expertise and Standardization of Medicinal Products:
   1. laboratories;
   2. Pharmacological Committee;
   3. Pharmacopeia Committee;
   4. Committee on Narcotics Control (in the presence of narcotic substances in the product);
   5. Pharmaceutical inspection (if verification of manufacturing conditions is required).

1. During examinations and tests, questions and/or remarks may arise which the Applicant shall respond to in due time.
2. Produced positive conclusions are based on examinations and tests.
3. At the meeting of the Expert Council a decision to register the medicinal product is made.
4. The decision of the council and the materials are forwarded to the Head Department for Quality Control of Medicinal Products and Medical Equipment of the Ministry of Health for the publication of the Order related to the registration.
5. The registration certificate is produced and issued to the Applicant after the Order is signed.

During the examination of tests, questions and/or remarks may arise; the Applicant shall prepare responses (eliminate defects) within 45 working days.

During the registration procedure, inspection of the manufacturing site may be required. However, such a need arises quite rarely – in case the manufacturer does not have a GMP certificate, or when doubts related to manufacturing condition of medicinal products arise.

The total registration period of the medicinal product makes up 155 working days from the date of receipt of the application, and until the decision on registration. The deadline to respond to remarks is not included in the total registration period.

There is a peculiarity to provide Risk management system (RMS) on the registration stage.

The registration certificate is issued for 5 years.

Variations and additions

During the validity of the registration certificate, the Applicant may submit an Application for introduction variations to the registration certificate. Along with the Application relevant documents are submitted. If these variations relate to the quality of the medicinal product, samples and standards may be required.

The application and the package of documents are examined within 90 working days.

Renewal (re-registration)

To extend the validity of the registration certificate, and also if the Applicant is changed (transfer of rights for the certificate, or change of the name and/or location), the procedure of renewal is required.

The renewal application related to the extension of the registration certificate validity shall be submitted within three months before the expiry date. Requirements to the registration dossier, terms and stages of examination are consistent with the procedure of new registration. Term to perform such procedure takes 120 days and it does not include time for responses to remarks.

Pharmacovigilance

The competent authority that carries out pharmacovigilance activities in the territory of the Republic of Uzbekistan is the Ministry of Health. The legal framework for pharmacovigilance is approved in the Law of the Republic of Uzbekistan “On medicinal products and pharmaceutical activity”.

The applicant for the medicinal product registration shall develop and maintain a pharmacovigilance system in Uzbekistan. For such purpose he appoints a qualified person responsible for pharmacovigilance, collection and recording of adverse reactions. The data of a qualified person shall be submitted together with the Application for registration of the medicinal product.

Also, during the registration procedure, the Applicant will be required to submit a detailed description of the pharmacovigilance system and the risk management system.

Medical devices

The main legislative act regulating the procedure of state registration of medical devices is Resolution as of the 23^rd of March, 2018 No. 213 “Regulations on the procedure of the state registration of medicinal products, medical devices and medical equipment and the issue of a registration certificate”.

The State Examination and Standardization Center for Medicinal Products, Medical Devices and Medical Equipment of the Agency for Development of the Pharmaceutical Industry of the Ministry of Health (the website http: //www.uzpharm-control.uz/) examines documents, carries out registration and issues registration certificate for medical devices and medical equipment.

The applicant (owner) of the registration may be a legal entity, both resident and non-resident of Uzbekistan. The name and postal address of such legal entity, in whose name the registration certificate is issued, is indicated in the certificate form.

The registration documentation consists of an administrative part, a technical description and tests results, color advertising materials and graphic mock-ups.

In the registration application the trade name of the medical device, model and modifications, component parts are indicated.

A registration dossier can be submitted in English with the translation of a part of the documents into Russian.

The registration dossier is submitted with a draft instruction for use in Uzbek and Russian.

The registration procedure of a medical device in Uzbekistan can be briefly described in the following stages:

1. Submission of the Application for registration, copies of the certificate of state registration of the applying company, registration dossier, and a sample of the medical device, if necessary.
2. Primary (preliminary) examination.
3. Signing of the Agreement between the Applicant and the State Center for Expertise and Standardization of Medicinal Products.
4. Receipt and payment of examination bills.
5. After payment is confirmed, registration materials and samples are sent for specialized expertise to the structural units of the State Center for Expertise and Standardization of Medicinal Products:
   1. laboratories;
   2. New medical equipment committee;
   3. Pharmaceutical inspection (if verification of manufacturing conditions is required).
6. During examinations and tests, questions and/or remarks may arise which the Applicant shall respond to in due time.
7. Produced positive conclusions are based on examinations and tests.
8. At the meeting of the Expert Council a decision to register the medical device and to use it in the medical practice is made.
9. The decision of the council and the materials are forwarded to the Head Department for Quality Control of Medicinal Products and Medical Equipment of the Ministry of Health for the publication of the Order related to the registration.
10. The registration certificate is produced and issued to the Applicant after the Order is signed.

During the examination of tests, questions and/or remarks may arise. The Applicant shall prepare responses (eliminate defects) within 45 working days.

The total registration period of the medical device makes up 155 working days from the date of receipt of the application, and until the decision on registration. The deadline to respond to remarks is not included in the total registration period.

The registration certificate is issued for 5 years.

Variations and additions

During the validity of the registration certificate, the Applicant may submit an Application for introduction variations to the registration certificate for a medical device. Along with the Application relevant documents are submitted.

The application and the package of documents are examined within 90 working days.

Renewal (re-registration)

To extend the validity of the registration certificate, and also if the Applicant is changed (transfer of rights for the certificate, or change of the name and/or location), the procedure of renewal is required.

The renewal application related to the extension of the registration certificate validity shall be submitted within three months before the expiry date. Requirements to the registration dossier, terms and stages of examination are consistent with the procedure of new registration of medical devices and medical equipment.

Special food products

According to the law, import and manufacture of food supplements is carried out with the permission issued by the authorized body – the Head Department of Sanitary and Epidemiological Supervision of the Ministry of Health of the Republic of Uzbekistan (GUSEN). Such permission is placed in the register of issued permission on the website of the Ministry of Health of the Republic of Uzbekistan.

Both a legal entity and an individual may apply for entering the register, but de facto the registration owner is the manufacturer.

The manufacturer, authorized representative provides an application and documents, according to the requirements for special food products. The dossier is submitted in 2 copies.

Hygienic certification of imported to the Republic of Uzbekistan biologically active food supplements is made only after the manufacturer provides the authorization letter of the GUSEN of the Ministry of Health of the Republic of Uzbekistan, which confirms the examination of documents and the toxicological assessment of biomedical safety of biological active food supplements in order to avoid double registration of preparations, as a food supplement and as a medicinal product.

The authorized body considers the applicant’s application, issues permission within 45 working days from the date of receipt of the application, including the term for the toxicological and hygienic assessment.

The procedure of obtaining an import permission may take up to 4 months.

The permission is issued for 5 years.

Cosmetic products

According to the legislation import and manufacture of perfume and cosmetic products is carried out with the permission of the authorized body. Permissive requirements and conditions for importation, a list of necessary documents and samples, the terms of obtaining permission, the reissue of permission are indicated by the law.

The import of perfume and cosmetic products can be carried out by legal entities and individuals.

To obtain permission, the necessary documents and samples are to be submitted to the authorized body.

The authorized body considers the applicant’s application, issues a permission within a period of 120 working days from the date of receipt of the application, including the term for toxicological and hygienic assessment.

The permission is granted for an indefinite period.

Company “Cratia” offers carrying out of state registration of medicinal products, developing and maintaining of the pharmacovigilance system, registration of medical devices and medical equipment, special food products and cosmetic products in Uzbekistan.