As all around the world, over the last few years there has been quite dynamic development of the market of active additivesin Uzbekistan. BAA are rapidly filling the Uzbek pharmaceutical market, and increasingly competing with drugs. The growth rate of registration of BAAin recent years, is already comparable with the rate of growth of drug registration. Increasing interest in BAA observed among pharmaceutical manufacturers – about 20% of BAA manufacturers are producers of drugs.
According to some analytical agencies, in the structure of pharmaceutical sales BAA are on the second place after medical products.
Today, in Uzbek pharmacies more than 1000 trade units of dietary supplements are sold that represent more than 120 manufacturers.
Accordingly, quite a significant development of this segment of the pharmacological market requires to pay double attention to the quality of the products offered – it would be too self-confidently to declare that exclusively all the BAA, being a natural product, have proper quality and are not subject of counterfeiting attempts. On the contrary, today, as the most popular drugs, popular dietary supplements are subject of counterfeiting activities. Furthermore, some indecent manufacturers, being aware of the least costly registration of BAA , both in terms of finance and time required, try to issue medicines of dubious quality as a BAA, with all the ensuing consequences.
With the aim of the quality protection of proper classification and overcoming all these risks of counterfeiting, the legislation, designed system of norms and rules of registration of medicines, medical devices and medical equipment in Republic of Uzbekistan, as well as BAD, are adopted. Registration of medicines and medical products, as well as the issuance of the registration certificate in Uzbekistan is carried out by the General Directorate of Quality Control of Drugs and Medical Equipment, a division of the Ministry of Health of the Republic of Uzbekistan. Coordination of the Main Directorate of the activities is carried out by four committees: pharmacopoeia, pharmacological, new medical technology, medicine control and metrology department.
Here is the procedure for registration of BAA in the Republic of Uzbekistan carried out by PHARM GROUP.
Description of procedures:
- The client, according to the Annex №4 to the Decree of the Chief State Sanitary Doctor №1 from 04.02.09 “The documents on imported to the Republic of Uzbekistan of biologically active additives to food”, by itself or through a specialized consulting company, provides a file (documents and materials) for the BAA in the Main Department of sanitary – epidemiological inspection of Healthcare Ministry of the Republic of Uzbekistan (hereinafter – GUSEN).
- GUSEN appoints an expert, bearing personal responsibility for the fair presentation of expert opinion and storage of transmitted to GUSEN documents.
- The expert carries out the initial examination of the above documents and materials, according to №3 application and if the result of the examination is positive, leads the Customer (with a cover letter from GUSEN) in the Pharmacological Committee of the Republic of Uzbekistan for the receipt of the opinion that the presented pharmaceutical product falls under the category of BAA, not drugs.
- The customer sends the registration dossier and samples of BAA in the Pharmacological Committee of the Republic of Uzbekistan, which makes the formal decision: if represented product is supplements or drugs, informing GUSEN.
- If the pharmaceutical product is recognized medicament drug documents are sent for registration to the Pharmacological Committee of the Republic of Uzbekistan, for the subsequent passage of the established procedures for registration of drugs.
- With recognition of the pharmaceutical products as BAA – his registration dossier and samples are received by expert GUSEN for procedures of issuing permission letter GUSEN for inclusion in the register of food supplements for a period of 5 years.
- Upon confirmation of classifying preparations to food supplements, is assigned to conduct toxicological studies on the basis of Scientific Research Institute of sanitary and hygiene and occupational diseases (SGiPZ), Tashkent Medical Academy (TMA) and other specialized scientific institutions of the Ministry of health system.
- Report on the results of toxicological research to food supplements approved by the head of the organization is represented in GUSEN by scientific institution, held it.
- After conducting toxicological studies, if the study was appointed by an expert to assess the effectiveness of BAA claimed by the manufacturer to the properties of the food, it determines the list of these studies, which are conducted by SRI SGiPZ and TMA;
- Conclusion based on the results of a study to evaluate the effectiveness of food supplements is presented in GUSÈN scientific institution conducting them.
- With the appointment by an expert of clinical trials of BAA to food, they are carried out in health facilities identified by Ministry of Health in the Republic of Uzbekistan in accordance with the profile of research.
- The results of clinical trials of BAA to food, are presented in GUSEN by medical institutions.
- Consideration of the normative-technical documentation (technical conditions, standards of enterprises and technological instructions with recipes) is carried out by an expert who implements the initial examination of documents and submits the approval for their agreement or existing remarks in them;
- The Agency “Uzstandard” claims normative and technical documentation and submits in GUSEN the copy of the document with the seal of the agency.
- The Agency “Uzstandard” provides a health certificate in the prescribed manner;
- GUSEN gives permissive letter for inclusion of BAA in the register of food supplements for a period of 5 years.
Undoubtedly, the registration process is very complicated, because it affects the set of bureaucratic bodies and affects all the committees of the Main Office and requires specific and considerable resources, such as time, etc. And as within all the post-Soviet countries, pharmaceutical marke in Uzbekistan t is regulated by a large number of laws, regulations, frequently updated guidelines and orders and it requires operational knowledge and practical skills of interaction with the official authorities.
Furthermore, if the detected drug is a product of foreign production, previously mentioned factors can be easily multiplied by two, since the foreign manufacturer, at self-registration will bear the additional financial (travel, transport), and time (frequent visits, preparation of required documents) expenses.
In such cases, as a rule, foreign manufacturers to optimize overheads and unforeseen financial expenses and time costs, use the service of specialized consulting companies with experienced professionals and established business relations with official authorities in the country of registration. Undoubtedly, professional services are stipulated by definite monetary reward, but as a long-term practice shows, for foreign manufacturers it is compensated many times, both in the terms of finance, from the point of time and quality of work.
A proposed standard set of consulting companies service includes:
- Consulting on the process of registration or re-registration
- Development of normative documents
- Collecting and bundling regulated documentation
- Reports on the progress of the registration process
- Rapid response to innovations etc.
In the Republic of Uzbekistan there is a sufficient number of companies that offer services for the registration and re-registration of medicines, medical products, medical equipment and other products for Medical purposes at enough high quality level.
But separately in the company of consultants PHARM GROUP is allocated, which for more than 14 years, gives the tone and keeps the high level of quality services. Experts of PHARM GROUP, which is the most authorized specialized consulting companies in the field of complex services for registration of medicines, medical products, medical equipment, as well as BAA and cosmetic products in the Uzbek market, have in-depth subject knowledge and many years of experience in:
- analysis and preparation of documents for registration;
- representation the interests of producers in state bodies of registration / certification of medical use, dietary BAA , perfumery and cosmetic products;
- organization of clinical trials.
The apparent advantage of PHARM GROUP in comparison with the other consulting companies is that the specialists of the company implement the registration procedure really by turnkey, providing translation services for documents, filing records and a package of documents to regulatory authorities, the adoption and customs clearance of samples, constant updating in the registration process, and so on. d.
Regarding BAA, PHARM GROUP provides professional assistance to foreign companies in obtaining permissive letter GUSEN for inclusion of BAA in dietary supplements for 5 years for the registry entry into the Uzbek market.
KAMILOVA E.V., PhD of Agriculture
Registration ManagerPharm Group project – UBI Consulting LLC, Uzbekistan