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.
The range of medical products is widely used in solving various problems, including how development of regulatory documents and scientific research and monitoring activities, including – safety control.
From 1993 to 1996, the European and the International Organization for Standardization ISO and CEN, worked together, which led to the standardization of structure for nomenclature for medical products.
One of the main tasks of nomenclature development is identification of the products with the exchange of information, first of all – the safety of medical products.
In the modern classification of medical products (hereinafter MP), the most countries tend to apply the Global range of medical products (Global Medical Device Nomenclature, GMDN), in which besides the intended for the diagnosis in vitro, medical products are classified:
- On safety level:
- Class 1 – Medical products with a low degree of risk;
- Class 2a – Medical products with a medium level of risk;
- class 2b – Medical products with a high degree of risk;
- Class 3 – medical products with a high degree of risk.
- On the functional purpose, implying such criteria as:
- Duration of use;
- Way of interaction with the human body;
- Energy sources;
- Vital functions
Currently in Uzbekistan a large number of medical products are registrated, and in the future the need for it will grow. Therefore, it is important to further improve the classification of medical products in Uzbekistan, approaching international standards in this matter.
Every year in Uzbekistan the growth of the market of medical products for health care is observed , for use in medical practice more than 2 thousand medical products and medical equipment were registered and admitted (including in vitro diagnostics). The registration of medical products in the Republic of Uzbekistan is controlled by Public Health Ministry Decree from 22 March 2010, in which medical products are classified on a functional purpose. Accepted in the Republic of Uzbekistan legislation, developed system of norms and rules for the registration of medical products that prevent the penetration to the domestic market of low-quality medical products, the use of which may lead to irreparable consequences and may cause great harm to health. Resolution of the Cabinet of Uzbekistan №427 from 12.05.2002 has allowed to the Chief management to become a serious barrier to the penetration to the Republic of counterfeit and substandard medical products.
During the period of 2013-2014. the volume of imported into the Republic of Uzbekistan of medical equipment (M & E) and medical products (medical products) has increased more than three times. The most dynamic growth in imports was recorded in medical products, where the growth rate was 405.79%, while medical equipment – 78.87%. During the period from 2013 to 2014, exports of medical equipment and medical products increased in average by 68%. The volume of exports of medical products (99% of exports structure of medical product and medical equipment) showed a growth of 80%. Increased medical products export performance is mainly connected with the increment in exports of products of dental use, which was virtually zero. in 2013.
The share of domestic medical products and ME in the Uzbek market, as for 2014 was 6%, considering that production growth of medical products and ME amounted to more than 80% for 2013-2014.
Medical products must be registered in order to prevent low-quality products to the market. Also, registration helps to prevent unfair advertising of medical products, as the registration certificate contains all the detailed information about medical products. For the protection of the quality, proper classification and overcoming all these risks of counterfeiting adopted legislation in the Republic of Uzbekistan, developed system of norms and rules of registration of medicines, medical products and medical equipment is designed. 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 medicines and medical equipment (hereinafter – GUKKLSiMT), which is a division of the Ministry of Health of the Republic of Uzbekistan. Coordination of the activities of the Main Directorate is carried out by four committees: pharmacopoeia, pharmacological, new medical technology, drug control and metrology department. The document confirming the fact of registration of medical products, the registration certificate is valid for 5 years.
Here the procedure for registration of medical products is represented in the Republic of Uzbekistan used by the consulting company «PHARM GROUP».
Departments of the Public Health Ministry in the Republic of Uzbekistan, involved in the process of registration of medical devices:
- General Administration of Quality Control of Medicines and Medical Equipment (GUKKLSiMT) (a department of the Public Health Ministry in the Republic of Uzbekistan), – registers the medical devices and the issuance of the registration certificate in Uzbekistan.
Registration Division – conducts primary examination of the application and annexed samples and registration documents of medical products. Based on the positive results of primary expertise provides award of the agreement between the State Centre and the applicant; after payment by the customer contribution amount transmits an application for registration of medical products and the accompanying samples and registration documents to the State Center for examination.
- Laboratory of the State Centre make assessment of regulations, carry out tests to determine the compliance of medicine samples or medical products for regulatory requirements; transmit test reports, documents for medical products in the new Medical Technology Committee.
- The Committee on New Medical technology – examines administrative, chemical, biological, technical parts of the registration documents, lab protocols, as well as examination of clinical trial materials;
Conducts the examination and re-examination of the registration documents of medical products with the assistance of independent experts;
Based on the specifics of the medical products, provides testing in accredited laboratories or on-site medical products;
Provides recommendations for the development of clinical trials programs and coordinates these programs;
Defines the types of tests, approves the relevant clinical database for clinical trials;
Controls clinical trials of medical products;
Approves instructions for use and labeling of medical products or applied to them amendments or addendum;
Prepares for the agreement or approval the regulations of medical products;
On the basis of the presented documents and expert opinions shall submit recommendations to the Expert Council for the registration of medical products without clinical or on the basis of clinical trials or refusal to register them;
- The Council of Experts – provides registration certificate valid for 5 years, or refuses to register.
Description of the medical products registration procedure:
- Foreign manufacturer who wants to register its products in Uzbekistan, sends a letter – representation in two copies in the General Directorate for the Control and the Quality of Medicines and Medical Equipment (hereinafter GUKKLSiMT).
- Depending on the Medical Products the firm – applicant shall submit the documents and samples in GUKKLSiMT.
- Upon the receipt of documents and samples contract between the firm – applicant – and GUKKLSiMT is awarded. General Directorate sends the documents to the Committee on new medical technique that examines the administrative, chemical, biological, technical parts of the registration documents, lab protocols, as well as examination of clinical trial materials medical devices, preparing for agreement or approval the regulations of medical products; guides for clinical trials, on the basis of the presented documents and expert opinions shall submit to the Expert Council the recommendations for the registration of medical products without clinical or based on clinical trials / or refusal of their registration.
- After the necessary documents and samples inspection procedures, the decision on registration of medical products is The decision is made by GUKKLSiMT Expert Council.
- Then, in the case of a positive decision, Registration Bureau on basis of Directorate approval issues an official registration certificate within 10 days.
Undoubtedly, the registration process is very complex, because it affects the set of bureaucratic bodies and affects all the committees of the Main Directorate and requires specific and considerable time and other resources. And as on the whole territory of the former Soviet countries, Uzbekistan’s pharmaceutical market is regulated by a large number of laws, regulations, guidelines and frequently updated orders and therefore requires operational knowledge and practical skills of interaction with the official authorities.
Furthermore, if the registered medicine is a product of foreign production, the above mentioned factors can be easily multiplied by two, since the foreign manufacturer, for self-registration will bear the additional financial (travel, transport), and time (frequent visits, preparation of required documents) expenses
In such cases, as a rule, to optimize overheads and unforeseen financial expenses and time costs, foreign manufacturers use the services of specialized consulting companies with experienced professionals and established business relations with official authorities in the country of registration. Undoubtedly, certain professional services are stipulated by definite financial reward, but as a long-term practice shows, for foreign manufacturers is compensated many times, both in terms of finance, as well as from the standpoint of time and quality of work.
A proposed standard set of consulting companies service include:
- Consulting on the process of registration or re-registration
- Development of normative documents
- Collection and regulated documentation complete set
- Reports on the progress of the registration process
- Rapid response to innovations
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» LLC 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.
Regarding medical products PHARM GROUP provides professional assistance to foreign companies in the obtaining the registration certificate of GUKKLSiMT for a period of 5 years for entering the Uzbek market.
Of course, the method of registration, whether it is independent (possibly less expensive, but surely – long time ) or with the assistance of specialized consulting companies, is the choice and the goodwill of the producer and depends on the circumstances at the time of decision-making.
But it is hard to dispute. the evidence of the benefits of services by such company as PHARM GROUP And this is due not only to the neutralization of “headache because of tedious attending in state bodies” but also with the fact that the market volume growth rate of medical products and ME in the Republic of Uzbekistan, undoubtedly – is high, and demand far outruns supply. Niche is. relatively empty… currently is empty and the winner will be the one (on ceteris paribus basis for the quality and range) who is dexterous a little more and able to make strategic decisions.
KAMILOVA E.V., PhD
Pharm Group project – UBI Consulting LLC, Uzbekistan