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. Currently, imported pharmaceuticals fill 60%-95% of the market in different segments. It is expected that in the next 5 years, the import of medicines will grow by about 8-12%. Now in Uzbekistan there has been an increase in demand for medicines, the pharmaceutical market in the coming years to reach $ 1.3 billion.
Mainly, Uzbekistan imports medicines from Ukraine, Russia, India, China, Hungary, Switzerland, France and Germany, etc., total-from 57 countries. So far, foreign producers dominate the pharmaceutical market. Products of such companies, as “Berlin Chemie/Menarine group” (Germany), “Novartis” (Switzerland), “Sanofi-Aventis” (France), Sandoz, Takeda (Japan), etc. are in great demand, as well as local manufacturers, such as MERRYMED, NOBEL, REKA-MED, NIKA PHARM, CODEPHARM, Uzfarmsanoat.
In Uzbekistan the production volume was 573.6 billion UZS (increase of 18.1%) for 2014.Amount of medical products was 425.4 billion UZS, medical products for the amount of 48.5 billion UZS, auxiliary materials – for the amount of 82.3 billion UZS (growth rate 196.5%) and other products for the amount of 17.3 billion UZS (growth rate 194.2%). Consumer goods were produced for the amount of 468.1 billion UZS (growth -14.9%). Production of medicines and medical products is carried out in accordance with 998 standards and normative-technical documents and 965 regulatory documents (FS, VFS, FSP, Nd) for the production of medicines; 23 (Tsh), 2-Kts, 8-State standards for medical products and hygiene items. 973 documents were harmonized with international counterparts.
A strict system of State Quality Control of medical and pharmaceutical products operates in the Republic of Uzbekistan, guaranteeing the population quality, efficiency, security and availability of medicines and medical equipment, medical products and in Vitro diagnostic facilities. The primary role of this is given to the embedded system of registration of pharmaceutical products (hereinafter referred to as medicines) and the issuance of registration certificate, which is controlled by the quality control of medicines and medical equipment in Uzbekistan (hereinafter GUKKLSiMT), which is department of the Public Health Ministry of the Republic of Uzbekistan. Coordination of the activity of the main Department is performed by four committees: Pharmacopoeia, pharmacological, new medical equipment, drug control and Metrology Department. Registration of medicines provides the issuance of medicines registration certificate for a period of 5 years.
The amount of medicines registered by the Public Health Ministry is amounted to 8270 preparations, 3371 of them are foreign, CIS-1738, domestic-1127; therapeutic and diagnostic tools (in vivo) 27, products of medical purpose and medical equipment – 1947 designations (including in vitro diagnostic tools).[i]
The procedure for registration of medicines in the Republic of Uzbekistan is represented below used by the consulting company “PHARM GROUP”.
- General Directorate of quality control of medicines and medical equipment (GUKKLSiMT) (a subdivision of the Public Health Ministry of the Republic of Uzbekistan), implements registration of medicines and the issuance of the registration certificate in Uzbekistan
Registration Department– carries out initial examination of the application and its annexed specimens and registration documents of medicines. Based on the positive results of the initial examination provides a contract between State Center and the applicant; After the payment of a fee by the customer sends the application for the registration of medicines and annexed samples and record documents to the State Center for examination.
- Laboratories of National Centre – assess regulatory documents, conduct tests to determine the conformity of samples of a medical product with the requirements of normative documents; pass test reports, documents on medicines in the Pharmacopeia, the Pharmacological Committee or committees for drug control.
- Pharmacological Committee- examines administrative, pharmacological, toxicological and clinical parts of registration documents of medicines; examination of the documents of drugs with the assistance of independent experts; defines the types of clinical trials, base for their conducting, makes recommendations on the elaboration of a program of clinical trials; passes on recommendations on the registration of medicines to the Expert Council without clinical or based on clinical trials or refusal of their registration; claims for instructions on the use of medicines or their modifications.
- Pharmacopeia Committee-requires from the claimant to include alternative methods, additional indicators and methods of analysis in regulatory documents or their replacement; sends the samples and documents for medicines in relevant laboratories of the State Center for additional tests in cases of the inability of reproduction of analysis methods, their lack of specificity, sensitivity and accuracy, as well as the amendment to normative documents requiring testing methodologies; approves regulatory documents for medicines; on the basis of the submitted documents and expert opinions passes to the Advisory Council recommendations on the registration of medicines or refusal of their registration
- Drug Control Committee– carries out an expertise of the registration documents of medicines containing narcotic drugs, psychotropic substances and precursors; during the examination of the composition of drugs, narcotics, psychotropic substances and precursors, considers the presence of these substances in the list of narcotic drugs, psychotropic substances and precursors under State control, permission for their medical use, as well as the need to leave a doctor’s prescription and makes proposals in Pharmacological and Pharmacopoeial committees;
- Advisory Council- issues the registration certificate for a period of 5 years, or refuses to register.
Registration procedure of HP:
- Foreign manufacturer which intends to register their products in Uzbekistan, sends a letter-representation in duplicate to the General Directorate for the control of quality of medicines and medical equipment (hereinafter referred to as the GUKKLSiMT).
- Depending on the medicine, company- applicant submits documents to GUKKLSiMT (HP registration dossier) and samples.
- After receiving the documents and samples the company-applicant and GUKKLSiMT will enter into contract.
- GUKKLSiMT sends documents to: the Pharmacological Committee, Pharmacopeia Committee, the Narcotics Control Committee, the State examination Center and standardization of medicines (hereinafter GCESLS), Office for registration of medicines, preventive, diagnostic products and medical equipment.
- After carrying out the necessary procedures for the verification of documents and samples, the decision on the registration of medicines will be made. Expert Council GUKKLSiMT makes a decision.
- Then, on the basis of the permission of Office management, Office for registration within 10 days formalizes the official registration certificate.
So far, requirements in Uzbekistan to the scope and content of the registration dossier are not so rigid as in Europe, but gradually they are tightening. List of documents submitted for registration of medicines increases over time, extended with new items. For example, in Uzbekistan it is mandatory to have registration of medicines in countries other than the country of manufacture; otherwise, it is assigned to conduct clinical trials on the territory of Uzbekistan.
It should also be noted that such issues of registration of medicines in Uzbekistan as the need to provide detailed information on the active substance at registration of medicine. Not all manufacturers of substances, especially expensive and procured by the company in small quantities, agree to submit a DMF for free. To obtain the DMF it is necessary to conclude the contract of confidentiality, which would lead to higher prices and, consequently, produced from substances medicines.
Certainly, the registration process is very complex, because it affects many bureaucratic levels and all of the Chief Directorate committees and requires certain and considerable resource and time expenses. As throughout the post-Soviet countries, the pharmaceutical market in Uzbekistan is regulated by a large number of legislative acts, regulations, guidelines and orders and consequently require specific knowledge and practical skills of interaction with government authorities.
Moreover, if the registered product is a product of foreign manufacture, these factors can be safely multiplied by two, since a self-registering foreign manufacturer will bear additional financial (travel, transportation) and temporary (frequent visits, preparation of required documents) expenses.
In such cases, as a rule, to optimize overhead and unexpected financial expenses, as well as temporary costs, foreign manufacturers employ the services of specialized consulting firms with experienced professionals and established business relations with the official authorities in the country of registration. Certainly, professional services determine certain monetary reward, but as long-term practice shows, for foreign producers current way is compensated many times, both in terms of finance and from the point of time and quality of work.
In this case, the logical and the most effective option for achieving the objectives (registration or re-registration of BAA) for manufacturers, can become addressing to aid of specialized consulting companies, which tend to offer a standard range of services of consulting companies, including:
- Consulting on the process of registration or re-registration
- Development of normative documentation
- Professional translation of documents (if necessary)
- Collecting and bundling of regulated documentation
- Reports about the registration process
- Rapid response to innovation
There are a sufficient amount of companies in the Republic of Uzbekistan that offer services on registration and re-registration of medicines, medical products, medical equipment and other medical products sufficiently for a high qualitative level.
But separately in the company of consultants “LLC PHARM GROUP” stands, which for over 14 years, sets the tone and keeps the high quality services. PHARM GROUP, is one of the most authorized specialized consulting firms in the field of multipurpose services for the registration of medicines, medical products, medical equipment, as well as BAA and cosmetic products in the market of Uzbekistan, will help You to conduct the registration process quickly, professionally and efficiently, avoiding many of the complexities connected with routine registration process. Our experts have deep substantive knowledge, and registration managers have years of experience in:
- analysis and preparation of documents for registration;
- representing the interests of producers in the bodies of State registration/certification of medical use, BAA, perfumery and cosmetic products;
- Organization of clinical trials.
Regarding medicines, PHARM GROUP assists to foreign companies in obtaining a registration certificate for a period of 5 years for entering the Uzbek market.
Of course, registration way, whether it is an independent (probably less expensive, but surely-long time) or with the assistance of specialized consulting firms, is a choice and the goodwill of the producer and depends on the prevailing circumstances at the time of the decision. But the obvious advantages of services of such companies as PHARM GROUP is difficult to challenge. And it is connected not only with the neutralization of “headaches walking on authorities”, but with that the rate of growth of volumes of the market of medical products and medical equipment in the Republic of Uzbekistan is undoubtedly high and demand considerably outruns supply. Niche is relatively empty …. currently is empty and the winner will be the one (ceteris paribus in quality and range) who is just more prompt and is able to make strategic decisions.
Pharm Group of UBI Consulting, Uzbekistan