The main legislative acts regulating the marketing authorization and circulation of medicinal products are the Law of Uzbekistan “On Medicines and Pharmaceutical Activity”, Decree of March 23, 2018 No. 213 “Regulation on the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a marketing authorization”, Resolution No. 862 of October 24, 2018 “On approval of the regulation on the procedure for recognition of the results of registration of medicines carried out outside the Republic of Uzbekistan.”
The competent authority responsible for expert evaluation of the registration materials, making the decision on the registration of the medicinal product and issue of the registration certificate is the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment of the Agency for the Development of the Pharmaceutical Industry of the Ministry of Health.
The legislation describes various types of Applications for registration of medicinal products, including originals and generics, medical immunobiological preparations, biosimilars, orphan products, homeopathic medicines and herbal medicines.
The following products are subject to registration:
- medicinal products;
- new combinations of medicinal products registered in Uzbekistan;
- medicinal products previously registered in Uzbekistan, but produced in other pharmaceutical forms, dosages, or by another manufacturer;
- medical devices;
- medical equipment.
The Applicant (Holder) of the Marketing Authorization can be a legal entity, both resident and non-resident of Uzbekistan. The name of the legal entity receiving the Marketing Authorization is indicated in the Marketing Authorization.
The Applicant is not required to establish a representative office or company in Uzbekistan, however, the Applicant must establish and maintain a local pharmacovigilance system.
The instructions for human use indicate the name and address of the organization accepting claims (proposals) on the quality of medicinal products in the territory of the Republic of Uzbekistan.
Establishment of registration
Since October 2018 there are two procedures for registering medicinal products:
- standard (full), in accordance with Resolution No. 213 dated March 23, 2018;
- recognition procedure (simplified/fast-track), in accordance with Resolution No. 862 dated October 24, 2018.
A simplified registration procedure implies recognition of the registration (marketing authorization) of medicinal products and substances registered by the competent authorities of countries with high regulatory standards. The simplified registration procedure is much faster, cheaper and requires the submission of an abridged package of documents compared to the standard procedure.
Simplified recognition procedure
On October 25, 2018, the Procedure for Recognizing the Results of Registration of Other Countries, approved by the Decree of the Cabinet of Ministers of the Republic of Uzbekistan No. 862 of October 24, 2018 “On approval of the regulation on the procedure for recognition of the results of registration of medicines carried out outside the Republic of Uzbekistan”, came into force.
The recognition procedure is provided for medicinal products and substances registered by the EMA and national competent authorities responsible for registration of medicines of the USA, Japan, Canada, Switzerland, Australia, Belgium, UK, Germany, Denmark, Ireland, Spain, Italy, the Netherlands, Norway, Slovenia, Finland, France, Sweden, Israel and Korea.
The assessment period under the recognition procedure should not exceed 15 working days. This period does not include the period for payment of the state fees (not more than 30 calendar days from the date of issue of the invoice for payment) and period required for answers on the deficiency letters.
The validity of the first recognition (marketing authorization) is 5 years. After the procedure for the extension of recognition results (renewal), the registration certificate is issued without expiry.
Standard (full) registration procedure
The registration dossier for the standard procedure is submitted in the national format, consisting of 4 Modules, created on the basis of the CTD format. No need to submit Module 2, the structure of the remaining Modules is similar to the ICH CTD format.
Module 1 is compiled according to national requirements. As part of the dossier, it is necessary to submit a Risk Management System (RMS), a document that identical to RMP (Risk Management Plan).
As part of the registration dossier, you must submit a CPP (certificate of pharmaceutical product) or other confirmation of registration of the medicinal product, as well as the availability of registration of the medicinal product in countries other than the country of origin. When registering medicinal products in Uzbekistan, the advantage is the availability of registration in other CIS countries, for example, in Kazakhstan, Belarus or Ukraine. If the medicinal product is not registered in other countries, then competent authority can inquire about abridged clinical studies to be performed in Uzbekistan.
There are strict requirements for registration dossier: materials are submitted in paper or electronic form, in two identical copies. The registration dossier should have a table of contents and pagination, certain parts of the dossier must be certified by the signature and seal of the Applicant (or it’s attorney).
Samples of the finished medicinal product, reference standards, and, if necessary, impurities, control materials and specific reagents in the quantity sufficient to perform full quality control according to the Specification should be submitted with the registration dossier.
It is allowed to submit the registration dossier in English with the translation of specific parts into Russian or Uzbek language. Instructions for use (package leaflet), package labeling information, control methods of the finished product (regulatory document) are translated into Uzbek and Russian.
Instructions for use (package leaflet) and color packaging layouts in Uzbek and Russian languages are submitted, assessed and approved within the registration process.
The standard procedure for registering a medicinal product in Uzbekistan can be summarized in the following steps:
- Submission of the Application for registration, registration dossier and product samples;
- Initial (preliminary) expert evaluation;
- Signing of an Agreement between the Applicant and the State Center for Expertise and Standardization of Medicines;
- Receipt and payment of Invoices for expert evaluation;
- After confirmation of payment, registration materials and samples are submitted for specialized expert evaluation to the structural units of the State Center for Expertise and Standardization of Medicines:
- Pharmacological Committee;
- Pharmacopoeia Committee;
- Drug Control Committee (if there are narcotic substances in the product);
- Pharmaceutical Inspection (if verification of manufacturing conditions is required).
- During the expert evaluations and tests, questions and/or comments may arise that the Applicant must answer within the established timeframe;
- Opinions and/or protocols are issued;
- A decision on the registration of the medicinal product is made at a meeting of the Expert Council;
- The decision of the Council and the materials are transferred to the Main Directorate for Quality Control of Medicines and Medical Equipment of the Ministry of Health for the publication of the Order on Registration.
- A Мarketing Аuthorization is issued to the Applicant after signing the Order.
Deficiency letters of the competent authority should be answered in a period not exceeding 45 working days.
During the registration process, it may be necessary to conduct a manufacturing site inspection. However competent authority makes such decisions not frequently, for example in the case of absence of a GMP certificate, or in case of serious doubts regarding the manufacturing conditions.
The total registration period of a medicinal product should not exceed 155 working days from the date of submission of the Application. The time required for the Applicant to answer on the deficiencies is not included in the total registration period.
The validity of the Marketing Authorization (state registration certificate) is 5 years.
Changes and variations
During the validity of the Marketing Authorization, the Applicant may submit an Application for changes. The Application must be amended with relevant documents, and in some cases related to changes in quality of the product, samples and standards can be required.
The Application and the registration materials are examined in a period of not more than 90 working days. The time required for the Applicant to answer on the deficiencies is not included in the total assessment period.
Renewal of registration is required to extend the validity of the certificate for the next 5 years, as well as for the change of the Marketing Authorization Holder (MAH transfer).
An Application in the case of renewal of the validity of the Marketing Authorization should be submitted not later than in three months before the expiry. The requirements for the content of the registration dossier, the timelines and steps of the expert evaluation are identical to the new registration procedure. The duration of the procedure is 120 days, which does not include the time to respond to the deficiencies.
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 Uzbekistan. We have an excellent knowledge of national legislation, necessary experience and resources.