Uzbekistan: Registration of Medicines Process

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. Main target of medicines registration in any country is provision of the population with production of high quality medicines. Medicines registration is a very complicated process and it requires certain period of time.

After iIndependence in 1991, radical changes occurred in all fields of activities in Uzbekistan, including pharmaceutics field.

According to the Decree of the Cabinet of Ministers in the Republic of Uzbekistan No. 181 dated 25 May, 1995, for purposes of regulating circulation of drugs and medical devices of Chief Directorate of medicines and medical equipment quality control, a subdivision of Ministry of Health in the Republic of Uzbekistan, was established.

Coordination of Chief Directorate’s activity is implemented by four committees: pharmacopoeial, pharmacological, committee of new medical equipment, drug control and by Metrology Department.

Analytics studied Uzbekistan pharmaceutical market capacity of Uzbekistan for recent years (2011-2012), evaluated it in the amount of USD 500 million; the market is characterized by high growing rates – 10% per year. Under these circumstances specialists expect that in the coming years the growth of the pharmaceutical market will reach 1 billion dollars.

Specialists forecast that rate of increase of productivity outputs in pharmaceutical field in this year will be 40%, in money terms medicines will be produced at the amount of 366 billion sums. In volume terms release of main types of production will be increased thrice and make up more than 720 million of conventional units. The share of national product in the general volume of pharmaceutical market will come near to 43%.

Following the results of first half-term of 2012, the production rate was 158.3 billion sum (up 21.5 % in comparison with analogical period of previous year). At that medicines were produced at the amount of 129.7 billion sum, medical devices - 16.9 billion sum, supplementary materials – at the amount of 7 billion sum and other production – 4.7 bullion sum (growth rate – 37.1%).

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. Main target of medicines registration in any country is provision of the population with production of high quality medicines. Medicines registration is a very complicated process and it requires certain period of time.

Process of medicines registration in Uzbekistan:

1. Foreign manufacturing-firm that wants to register its production in Uzbekistan sends a letter – presentation in 2 copies to the Chief Board of medicines and medical equipment quality control.

2. Manufacturing-firm submits documents and samples depending on the medicine.

3. After documents and samples submission, the applying firm and State Center of medicines expertise and standardization conclude a contract.

4. Chief Directorate sends documents to Pharmacological Committee, Pharmacopoeial Committee, Drugs Control Committee, State Center of medicines expertise and standardization, medical, prophylactic and diagnostic devices and medical equipment registration Bureau.

5. After implementation of necessary procedures on documents and samples checking, the decision on medicine registration is made. It is decided by the expert board of Chief Directorate on medicines and medical equipment quality control.

6. After that Registration Bureau on the base of permission of the Directorate finalizes official registration certificate within 10 days.

Time period, required for registration, depends on many factors, first of all – on the medicine class, but on the average it takes about a year for generic registration, registration of original drug may last several years because it requires clinical trials organization.

In many countries certificates of compliance with GMP requirements and clinical and/or preclinical trials reports are requested.

Regulatory requirement in Uzbekistan is availability of medicine’s registration in other countries of the world excluding manufacturing country; otherwise clinical trials on the territory of Uzbekistan are assigned.

For medicine registration in Uzbekistan the following documents are required:

1. Letter of application.The following documents are attached to the letter:

· Registration application in standard form– 2 (or 3) copies;

· Registration dossier – 2 (or 3) copies;

· Samples of medicine, at sufficient amount for 3-fold analysis by methods, described in regulative documents, substances (active agents);

· Reference-standards, standards samples of medicines, foreign impurities, and specific chemical agents, necessary for the analysis.

2. Translated documents of the manufacturer (producer) in foreign languages shall be legalized according to the legislation of Side, in which state registration is implemented.

Registration is valid within 5 years; upon the expiry of it the medicine shall be re-registered.

Many foreign manufacturing firms refer to distributors before registering their production. And in many cases distributors refuse aid. It is more profitable to promote domestic products for them. That’s why they do not admit products of foreign countries as possible. 75% of the pharmaceutical market of Uzbekistan depends on foreign countries manufacturing medicines.

Registration process is very complex and it takes definite time. If the medicine belongs to domestic manufacturer, in this case manufacturing companies usually have the specialist occupied in registration of medicinal products. If the medicine is produced by foreign firms, in this case manufacturing firm not always has an opportunity to send its specialist to the country where medicinal product registration is implemented. Especially when the amount of time needed for registration of a medicinal product is unknown. Regular visits, filling in documents, explanation of tangled procedures at various requests from the Chief Directorate take much time.

In such cases hiring registration specialist or consulting firm involved in registration of medicinal products becomes an advantage. This firm will be a mediator between you and regulatory body.

In such companies registration manager or specialist are in charge for work.

Undergoing registration or re-registration process mainly depends on the specialist of this company. His/her responsibilities include: consulting on registration or re-registration process, timely drawing of regulatory documents, professional translation of the documents, preparation and collection of necessary requested documents for the batch to be registered.