Registration of medicines

"Regulations on the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a registration certificate", Resolution No. 862 of October 24, 2018 "On approval of the Regulations on the procedure for recognizing the results of registration of medicines carried out outside the Republic of Uzbekistan".

The procedure for examination of documentation, registration and issuance of a registration certificate for medicines is carried out by 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 (website http://www.uzpharm-control.uz/ ).

The legislation describes various types of medicines, including original and generic medicines, medical immunobiologicals, biosimilars, orphan products (orphan medicines), homeopathic medicines and herbal medicines.

Registration is subject to:

medicines;
new combinations of medicines registered in Uzbekistan;
medicines previously registered in Uzbekistan, but produced in other dosage forms, dosages or by another manufacturer;
medical products;
medical equipment.
The applicant (owner) of registration can be a legal entity, both a resident and a non-resident of Uzbekistan. The name of such legal entity, in whose name the registration certificate has been issued, is indicated on the form of the certificate.

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 medical use indicate the Name and address of the organization accepting claims (proposals) on the quality of medicines in the Republic of Uzbekistan.

New registration

Since October 2018, there are two procedures for registration of medicines:

standard (full), according to Decree No. 213 of March 23, 2018;
recognition procedure (simplified), in accordance with Decree No. 862 of 10/24/2018.
A simplified registration procedure implies the recognition of registration (marketing authorization) of medicines and substances registered by the competent authorities of countries with high regulatory standards. The simplified registration procedure is significantly faster, cheaper and involves the submission of a reduced 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 Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 862 dated October 24, 2018 "On approval of the Regulations on the procedure for recognizing 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 registration authorities of the USA, Japan, Canada, Switzerland, Australia, Belgium, Great Britain, Germany, Denmark, Ireland, Spain, Italy, the Netherlands, Norway, Slovenia, Finland, France, Sweden , Israel and Korea.

The official term for recognition of registration is no more than 15 working days. This period does not include the time to pay the fee for consideration of the procedure (no more than 30 calendar days from the date of issue of the invoice for payment).

Validity of the results of the first recognition (certificate of registration) is 5 years. After the procedure for extending the results of recognition (re-registration), the results of recognition are issued without limitation of their validity period.

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. It is not required to submit Module 2, the structure of other Modules is similar to the ICH CTD format.

Module 1 is compiled according to national requirements. As part of the dossier, you must submit the Risk Management System (RMS), a document that generally repeats the RMP (Risk Management Plan).

As part of the registration dossier, it is necessary to submit a CPP (certificate of a pharmaceutical product) or other confirmation of registration of a medicinal product, as well as the presence of registration of a medicinal product in countries other than the country of manufacture. An advantage when registering medicines in Uzbekistan is the presence of registration in other CIS countries, for example, in Kazakhstan, Belarus or Ukraine. If the medicinal product is not registered in other countries, then during the registration, clinical trials may be scheduled in the territory of Uzbekistan.

There are strict requirements for the registration dossier: materials are submitted in paper or electronic form, in two identical copies. The registration dossier must have a table of contents and page numbering, certain parts of the dossier must be certified by the signature and seal of the Applicant (or his authorized representative).

Together with the registration dossier, it is necessary to submit samples of the finished medicinal product in the amount necessary for conducting triple tests, standard samples, if necessary, impurities, control materials and specific reagents.

It is allowed to submit the registration dossier in English with the translation of part of the documentation into Russian. Packaging layouts, instructions for medical use, quality control methods (normative document) are translated into Uzbek and Russian.

As part of the registration dossier, a draft instruction for use in Uzbek and Russian is submitted, as well as color packaging layouts.

The standard procedure for registration of a medicinal product in Uzbekistan can be summarized as follows:

Submission of the Application for registration, copies of the certificate of state registration of the Applicant company, registration dossier and samples of the medicinal product;
Conducting a primary (preliminary) examination;
Signing of the Agreement between the Applicant and the State Center for Expertise and Standardization of Medicinal Products;
Receipt and payment of invoices for expertise;
After confirmation of payment, registration materials and samples are sent for specialized examination to the structural subdivisions of the State Center for Expertise and Standardization of Medicinal Products:
Laboratories;
Pharmacological Committee;
Pharmacopeia Committee;
Narcotics Control Board (in the presence of narcotic substances in the composition of the product);
Pharmaceutical Inspectorate (if it is necessary to check the production conditions).
During the examinations and tests, questions and / or comments may arise, to which the Applicant must respond within the prescribed time limits;
On the basis of examinations and tests, positive conclusions are drawn up;
At the meeting of the Expert Council, a decision is made on the registration of the medicinal product;
The Council's decision and materials are submitted to the General Directorate for Quality Control of Medicines and Medical Equipment of the Ministry of Health for issuing a Registration Order;
The registration certificate is drawn up and issued to the Applicant after signing the Order.
During examinations of tests, questions and/or comments may arise, to which the Applicant must prepare answers (eliminate deficiencies) within a period not exceeding 45 working days.

During the registration procedure, it may be necessary to inspect production. However, such a need arises quite rarely - if the manufacturer does not have a GMP certificate, or if there are doubts about the conditions for the production of medicines.

The total term for registration of a medicinal product is 155 working days from the date of receipt of the application, and until the decision on registration is made. The deadline for responses to comments is not included in the total registration period.

The registration certificate (certificate) is issued for a period of 5 years.

Changes and additions

During the validity of the registration certificate, the Applicant may submit an Application for amendments to the registration certificate. Relevant documents are submitted along with the Application, and in case of changes related to the quality of the medicinal product, samples and standards may also be required.

The application and the package of documentation are examined within a period of not more than 90 working days.

Re-registration (re-registration)

To extend the period of validity of the registration certificate, as well as - in case of a change in the Applicant (transfer of rights to the certificate, or change of name and / or location) - a reissuance procedure is carried out.

An application for reissuance in connection with the extension of the validity of the registration certificate is submitted within three months before the expiration of its validity. The requirements for the registration dossier, the terms and stages of the examination correspond to the procedure for a new registration. The duration of the procedure is 120 days, which does not include the time for responding to comments.

Upon completion of re-registration, a certificate is issued for the next 5 years.