Registration of pharmaceutical products

The primary role in this is assigned to the implemented system of registration of the medicinal product (hereinafter referred to as the drug) and the issuance of a registration certificate, which in Uzbekistan is the State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" (hereinafter referred to as SUE GCEISSLiMT ), which is a subdivision of the Ministry of Health of the Republic of Uzbekistan. Coordination of the activities of the General Directorate is carried out by four committees: pharmacopoeial, pharmacological, new medical equipment, drug control and the metrology department. Registration of drugs provides for the issuance of a registration certificate of drugs for a period of 5 years.

1. SUE "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" (SUE GCEISLsSiMT) (which is a subdivision of the Ministry of Health of the Republic of Uzbekistan), carries out the registration of drugs and the issuance of a registration certificate in Uzbekistan.

Registration Department - conducts an initial examination of the application and the samples and registration documents of medicinal products attached to it. Based on the positive results of the initial examination, it ensures the conclusion of an agreement between the State Center and the applicant; after the customer pays the amount of the fee, he transmits the application for registration of drugs and the samples and registration documents attached to it to the State Center for examination.

2. Laboratories of the State Center - evaluate regulatory documents, conduct tests to determine the compliance of samples of a medicinal product with the requirements of regulatory documents; transfer test reports, documents for drugs to the Pharmacopoeial, Pharmacological Committees or the Drug Control Committee.

3. Pharmacological Committee - conducts an examination of the administrative, pharmacological, toxicological and clinical parts of the registration documents of drugs; examination of drug documents with the involvement of independent experts; determines the types of clinical trials, the basis for their conduct, gives recommendations on the development of a clinical trial program; makes recommendations to the Expert Council on registration of medicinal products without clinical, or on the basis of clinical trials or refusal to register them; approves the instructions for use of medicines or changes made to them.

4. Pharmacopoeia Committee - requires the applicant to include alternative methods, additional indicators and methods of analysis in regulatory documents or replace them; sends samples and documents of the medicinal product to the relevant laboratories of the State Center for additional tests in cases of impossibility of reproducing the methods of analysis, their insufficient specificity, sensitivity and accuracy, as well as the introduction of changes in regulatory documents requiring testing of methodologies; approves regulatory documents of the drug; on the basis of the submitted documents and expert opinions, makes recommendations to the Expert Council on the registration of drugs or on the refusal to register them;

5. The Narcotics Control Committee - conducts an examination of the registration documents of medicines containing narcotic drugs, psychotropic substances and precursors; when conducting an examination of drugs containing narcotic drugs, psychotropic substances and precursors, considers the presence of these substances in the list of narcotic drugs, psychotropic substances and precursors under the state control, authorization for their medical use, as well as the need for prescription and makes proposals to the Pharmacological and Pharmacopoeial Committees;

6. Expert Council – makes a decision on the issuance or refusal of the Registration Certificate for a period of 5 years.

1. A foreign manufacturing company, which wants to register its products in Uzbekistan, sends a letter - submission in two copies to the SUE "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment (hereinafter REFERRED TO AS GCEISLSSIMT).

2. Depending on the medicinal product, the applicant firm submits documents (registration dossier of drugs) and samples to the State Unitary Enterprise GCEISLiMT.

3. After acceptance and a positive result of the initial examination of documents and samples, an agreement is concluded between the applicant's company and SUE GCEISSSiMT.

4. SUE GCEISLsSiMT sends documents: to the Pharmacological Committee, to the Pharmacopoeia Committee, to the Narcotics Control Committee, to the Laboratory of the State Center, to the Bureau for Registration of Medicines, Medicinal Products and Medical Equipment.

5. After carrying out the necessary procedures for checking documents and samples, a decision is made on the registration of drugs.

6. After that, the Registration Office, on the basis of the permission of the Expert Council, draws up an official registration certificate

The list of documents submitted for the registration of drugs increases over time, supplemented with new items. For example, in Uzbekistan, a mandatory requirement is the registration of a medicinal product in countries other than the manufacturing country; otherwise, clinical trials are scheduled to be conducted on the territory of Uzbekistan. It should also be noted such problematic issues of registration of medicinal products in Uzbekistan as, , the need to provide detailed information on the active substance when registering drugs. Not all manufacturers of substances, especially those that are expensive and purchased by the company in small quantities, agree to submit DMF free of charge. To obtain DMF, it is necessary to conclude a confidentiality agreement, which will lead to an increase in the cost of the substance and, accordingly, the drugs produced from it.

Undoubtedly, the registration process is very complicated, as it affects many bureaucratic instances and affects all committees of the General Directorate and requires certain and considerable resource and time spent time. As in the entire territory of the post-Soviet countries, in Uzbekistan the pharmaceutical market is regulated by a large number of legislative acts, resolutions, manuals and orders and, accordingly, require certain knowledge and practical skills of interaction with official authorities.

Moreover, if the registered drug is a product of foreign production, the above factors can be safely multiplied by two, since the foreign manufacturer, with self-registration, will incur additional financial (travel, transport) and temporary (frequent visits, preparation of required documents) costs.

In such cases, as a rule, foreign manufacturers, in order to optimize overhead and unforeseen financial expenses, as well as time costs, resort to the services of specialized consulting companies with experienced specialists and well-established business connections with official authorities in the country of registration. Undoubtedly, the services of professionals are due to a certain monetary reward, but as long-term practice shows, for foreign manufacturers the real way pays off many times, both in terms of finances and in terms of time and quality of work.

On guard of quality, proper classification and overcoming all such risks of counterfeiting, the legislative acts adopted in the Republic of Uzbekistan, the developed system of norms and rules for registration of drugs, medical devices and medical devices and Medical equipment. Registration of a medicinal product and medical devices, as well as the issuance of a registration certificate in Uzbekistan, is carried out by the State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment", equipment (hereinafter referred to as SUE GCEISSLiMT). Which is a subdivision of the Ministry of Health of the Republic of Uzbekistan. Coordination of the activities of the State Unitary Enterprise GCEISLsSiMT is carried out by four committees: pharmacopoeial, pharmacological, new medical equipment, drug control and the department of metrology. The document confirming the fact of registration of a medical device is a registration certificate valid for 5 years.

SUE "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" (SUE GCEISLsSiMT) (which is a subdivision of the Ministry of Health of the Republic of Uzbekistan), - registers a medical device and issues a registration certificate in Uzbekistan.

1. Registration Department - conducts an initial examination of the application and the samples and registration documents of medical devices attached to it. Based on the positive results of the initial examination, ensures the conclusion of a contract between the State Center and the applicant; after the customer pays the amount of the fee, he submits the application for registration of medical devices and the samples and registration samples attached to it. documents to the State Center, for examination.

2. Laboratories of the State Center - evaluate regulatory documents, conduct tests to determine the compliance of samples of a medicinal product or medical device with the requirements of regulatory documents; transfer test reports, documents for medical devices to the Committee on New Medical Equipment.

3. Committee on New Medical Equipment - conducts an examination of the administrative, chemical, biological, technical parts of registration documents, protocols of laboratory tests, as well as examination of clinical trial materials;

conducts examination and re-examination of registration documents of medical devices with the involvement of independent experts;

based on the specifics of the medical device, ensures testing in accredited laboratories or at the installation site of the medical device;

makes recommendations on the development of clinical trial programs and coordinates these programs;

determines the types of trials, approves the relevant clinical bases for conducting clinical trials;

supervises the conduct of clinical trials of medical devices;

approves the instructions for use and labeling of medical devices or amendments or additions to them;

prepares for approval or approval of normative documents of medical devices;

on the basis of the submitted documents and expert opinions, make recommendations to the Expert Council on the registration of medical devices without clinical or on the basis of clinical trials or on the refusal to register them;

4. Expert Council – decides on the issuance or refusal of the Registration Certificate for a period of 5 years.

1. A foreign manufacturing company, which wants to register its products in Uzbekistan, sends a letter - submission in two copies to the SUE "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" (hereinafter referred to as SUE GCEISSSiMT).

2. Depending on the Medical Device, the applicant company submits documents and samples to the State Unitary Enterprise GCEISSLiMT.

3. After receiving documents and samples, an agreement is concluded between the applicant firm and SUE GCEISLsSiMT. SUE GCEISLsSiMT sends documents to the Committee on New Medical Equipment, which conducts an examination of the administrative, chemical, biological, technical parts of registration documents, protocols of laboratory tests, as well as examination of clinical trial materials IMN, prepares for approval or approval of regulatory documents of imN; sends to clinical trials, on the basis of submitted documents and expert opinions makes recommendations to the Expert Council on the registration of medical devices without clinical, or on the basis of clinical trials / or on the refusal to register them.

4. After carrying out the necessary procedures for checking documents and samples, a decision is made on the registration of the Medical Device. The decision is made by the Expert Council of the State Unitary Enterprise GCEISSLiMT.

5. After that, in case of a positive decision, the Registration Bureau, on the basis of the decision of the Expert Council, draws up an official registration certificate.

Undoubtedly, the registration process is very complicated, as it affects many bureaucratic instances and affects all committees of the State Unitary Enterprise GCEISLsCiMT and requires certain and considerable resource and time-consuming time. And as throughout the territory of the post-Soviet countries, in Uzbekistan the pharmaceutical market is regulated by a large number of legislative acts, resolutions, frequently updated manuals and orders and, accordingly, require operational knowledge and practical skills of interaction with regulatory authorities.

In such cases, as a rule, foreign manufacturers, in order to optimize overhead and unforeseen financial expenses, as well as time costs, resort to the services of specialized consulting companies with experienced specialists and well-established business connections with official authorities in the country of registration. Undoubtedly, the services of professionals are due to a certain monetary reward, but as long-term practice shows, for foreign manufacturers the real way pays off many times, both in terms of finances and in terms of time and quality of work.

The growth rate of registration of dietary supplements in recent years is already comparable to the growth rate of registration of medicines. An increase in interest in dietary supplements is also observed among pharmaceutical manufacturers.

Accordingly, a fairly significant development of this segment of the pharmacological market requires to pay double attention to the issue of the quality of the products offered - it would be too self-confident to assert that only all dietary supplements, being a natural product, are of proper quality and are not subject to attempts at counterfeiting. On the contrary, today, like the most popular medicines, popular dietary supplements are the object of active counterfeiting. Moreover, some unscrupulous manufacturers, knowing that the registration of dietary supplements is the least expensive, both in terms of finances and the required time, are trying to issue medicines of dubious quality as dietary supplements, with all the ensuing consequences.

The legislative acts adopted in the Republic of Uzbekistan, the developed system of norms and rules for the registration of drugs, medical devices and medical equipment, as well as dietary supplements are designed to protect the quality, proper classification and overcoming all such risks of counterfeiting. SUE "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" (hereinafter referred to as SUE GCEISLsSiMT), which is a subdivision of the Ministry of Health of the Republic of Uzbekistan. Coordination of the activities of the Main Directorate is carried out by four committees: pharmacopoeial, pharmacological, new medical equipment, drug control and the department of metrology.

1. The applicant, in accordance with Appendix No. 4 to the Resolution of the Chief State Sanitary Doctor No. 1 of 04.02.09 "List of documents for biologically active food additives imported into the Republic of Uzbekistan", independently or through a specialized consulting company, shall provide a dossier (documents and materials) for dietary supplements to the Main Department of Sanitary and Epidemiological Surveillance of the Ministry of Health of the Republic of Uzbekistan (hereinafter referred to as the GUSEN).

2. THE GUSEN shall appoint an expert who is personally responsible for the accuracy of the submitted expert opinion and the storage of the documents submitted to the GUSEN.

3. The expert conducts an initial examination of the above-mentioned documents and materials, in accordance with Appendix No. 3 and if the result of the examination is positive, sends the customer (with a cover letter from the GUSEN) to the State Unitary Enterprise GCEISLsCiMT to obtain a status conclusion that the presented pharmaceutical product falls under the category of dietary supplements, and not drugs.

4. The customer submits the registration dossier and samples of dietary supplements to the State Unitary Enterprise GCEISLsCiMT of the Republic of Uzbekistan, which makes an official decision: whether the presented drug is a dietary supplement, or a drug, informing the GUSEN.

5. If a pharmaceutical product is recognized as a medicinal product, the documents on the drug shall be sent for registration to the State Unitary Enterprise GCEISLsCiMT of the Republic of Uzbekistan, for the subsequent passage of the established procedures for the registration of drugs.

6. When pharmaceutical products are recognized as dietary supplements, its registration dossier and samples are submitted to the GUSEN expert for the procedure for issuing an authorization letter from the GUSEN on inclusion in the register of food supplements for a period of 5 years.

7. Upon confirmation of the status of drugs for dietary supplements for food, toxicological studies are prescribed on the basis of the Research Institute of Sanitation and Hygiene and Occupational Diseases (SRI SGiPZ), tashkent Medical Academy (TMA) and other specialized scientific institutions of the Ministry of Health.
8. The conclusion on the results of toxicological studies of dietary supplements for food, approved by the head of the organization, shall be submitted to the GUSEN by the scientific institution that conducted them.

9. After conducting toxicological studies, if the expert has appointed studies to assess the effectiveness of the properties of dietary supplements to food declared by the manufacturer, he determines the list of these studies, which are conducted by the Research Institute of SGiPZ and TMA;
10. The conclusion on the results of the study on the evaluation of the effectiveness of dietary supplements for food is submitted to the GUSEN by the scientific institution that conducted them.

11. When an expert appoints clinical trials of dietary supplements for food, they are carried out in medical institutions specified in the order of the Ministry of Health of the Republic of Uzbekistan in accordance with the profile of studies.

12. The results of clinical trials of dietary supplements for food are submitted to the GUSEN by medical institutions.

13. Consideration of regulatory and technical documentation (technical specifications, standards of enterprises and technological instructions with recipes) shall be carried out by the expert who conducted the initial examination of the documents and submitted to him a conclusion on their coordination or existing comments in them;
14. Agency "Uzstandard" approves the regulatory and technical documentation and submits to GUSEN copies of the document with the seal of the agency. (For local manufacturers).

15. GUSEN issues a letter of authorization for inclusion in the register of dietary supplements for food for a period of 5 years.

In such cases, as a rule, foreign manufacturers, in order to optimize overhead and unforeseen financial expenses, as well as time costs, resort to the services of specialized consulting companies that have experienced specialists and well-established business relations with official authorities in the country of registration. Undoubtedly, the services of professionals are conditioned by a certain monetary reward, but as long-term practice shows, for foreign manufacturers, this path pays off many times over, both in terms of finances and in terms of time and quality of work.