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PHARM GROUP focused on acceleration the process of withdrawal the high quality, effective and safe products
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PHARM GROUP participated on Indian Pharmexcil's event in Uzbekistan on March 3-4 of 2016
PHARM GROUP had participated on Buyer Seller Meeting and Private meetings with members of Pharmexcil's at its EXPO-CUM-BSM. During the event PHARM GROUP met the following Indian companies

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Pharmaceutical market of Uzbekistan and the role of the consulting companies in the registration process
Currently, the pharmaceutical market in Uzbekistan is one of the fastest growing among the CIS countries (approximately 8-10% annual growth in 2011-2014, respectively). It depends almost 77% on imported medicines.

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PROCEDURE OF Registration of Biologically Active ADDITIVES IN Uzbekistan.
As all around the world, over the last few years there has been quite dynamic development of the market of active additives in Uzbekistan.

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Registration of medical products (MP) in Uzbekistan and the role of consulting companies in it
In 2003, the World Health Organization (WHO) has been developed and published guiding principles of regulation in the field of medical products (VTR №1, 2007 - Regulations for medical products, Review of international practices and guidelines), where the nomenclature has a fundamental role in international harmonization.

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How to Register Medicines in Uzbekistan
Registration is a key point in the system of finished pharmaceutical products circulation. In all the world countries registration allows to allocate medicine on pharmaceutical market of a certain country.

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Uzbekistan pharmaceutical market development prospects
Pharmaceutical market of Uzbekistan is a rapidly developing branch in the economics of Uzbekistan. For the last years pharmaceutical market rate growth was about 30%.

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Advantages of hiring consulting companies for registration (re-registration) of medicines of foreign countries in Uzbekistan
As in other countries, there are companies occupied with consulting on registration or re-registration of medicines, manufactured abroad, in Uzbekistan.

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PROCEDURE OF Registration of Biologically Active ADDITIVES IN Uzbekistan.


KAMILOVA e.V., PhD of Agriculture
Registration Manager, Pharm Group project - UBI Consulting LLC, Uzbekistan
pharm@ubi.uz , www.pharm.ubi.uz

As all around the world, over the last few years there has been quite dynamic development of the market of active additives in Uzbekistan. BAA are rapidly filling the Uzbek pharmaceutical market, and increasingly competing with drugs. The growth rate of registration of BAA in 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.

Fig.1 Registration diagram of  BAA 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.

Bibliography:

  • Ganiyeva Zilola "How to register medicines in Uzbekistan"
  • http://pharm.ubi.uz/
  • Decree of Public Health Ministry  №26 from 08.05.2009 "About the procedure of the assignment of studies for evaluation the efficacy and clinical trials of biologically active food additives"
Resolution of Chief State Sanitary Doctor №1 from 04.02.09 "The procedure for issuing a permissive letter for imported  biologically active food additives (BAA) in the Republic of Uzbekistan."

21.04.16





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