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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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Advantages of hiring consulting companies for registration (re-registration) of medicines of foreign countries in Uzbekistan

Ganieva Zilola
Registration Manager
Pharm-Group Uzbekistan
Ph.: +998-71-2457250
zilola@ubi.uz    www.pharm.ubi.uz

As in other countries, there are companies occupied with consulting on registration or re-registration of medicines, manufactured abroad, in Uzbekistan. The names of such consulting firms in Uzbekistan: Pharm Group (UBI Consulting), NEO PASS, Medreg.uz, Pharmregister, Pfarmconsult.uz, etc.

The companies of this kind are not occupied in registration only, but they also register biologically active addictives, cosmetics, equipment and medical devices.

To enter the market of Uzbekistan it is necessary to register the medicine in Uzbekistan. 
Here you can briefly acquaint with the market.

  1. Population  – 28 million
  2. Urban population – 62%
  3. More than 5184 medicines registered, including:
  4. Medicines of foreign manufacturers – more than 4400
  5. Medicines of manufacturers from CIS countries – more than 1900
  6. Medicines produced by domestic manufacturers – more than 700.
  7. Health clinics – 8350 units

In the following 5 years, every year approximately 615 thousand neonatal will be born. Forecasting in 2013-2020 years approximately 607.8 thousand people, and in 2020-2025 years – 596.7 people will be born. 
As on 2009 year:
The pharmaceutical industry produces 884 brands of medicines and their quantity for the last 3.5 years grew more than 27 percent up. 
Structure and growing rates of the pharmaceutical market of Uzbekistan in 2008.

External supplying: 85.1%  

Uzbek production    4,3%  Bactericides

                               2,5% .Others 
                                1,8%  Gastroenterology. Hepatology 
                                1,7%  Antiseptic agents 
                                1,1%  Anesthesiology. Accident and Emergency 
                                0,9% Analgesics 
                                0,7% anti-inflammatory agents 
                                0,5% Dermatology 
                                0,5% Cardiology. Angiologia 
                                0,4% Haematology

Pharmaceutical Market Volume

     2007 year - $ 447 million
      2008 year - $ 425.6 million
      2009 year - $ 420 million
      2010 year - $ 500 million
     2011 year - $ 700 million.

Investment projects 

  1. Reconstruction and equipping of cardiosurgical department Project: Total value of the project is 12, 93 USD million.
  2. Women and children’s health promotion project: Total value of the project is 40, 00 USD million.
  3. Equipping with medical devices of 171 departments of emergency medicine in central district and city hospitals Project:  Total value of the project is 20, 55 US million
  4. Health-2 project: Total value of the project is 40, 00 USD million.

Uzbekistan has the most developed bio-pharmaceutical industry among all the countries of Central Asia. Besides, the Republic is rich with raw material for pharmaceutical production and has serious research potential. We are the only country in Central Asia that has an Institute of vaccination and serum that apart from everything else has a collection of viral cultures.

Registration process is very complex and it requires certain amount of time. Many major producers already have their dealers or branch offices in Uzbekistan. In this case there is no need to hire consulting companies. But if your company doesn’t have dealers or branch offices in Uzbekistan, you may thoroughly think of hiring a consulting company that will be able to be busy with it on your part and spare your time and energy. If you decided to engage a company for your production registration in Uzbekistan, it is already a great virtue. This company will be negotiator between you and regulatory body. In such companies registration manager or registration specialist is in charge for this process. 
Undergoing registration or re-registration process mainly depends on the specialist of the company. His/her responsibilities include: consulting on registration or re-registration process, in-time development of legislative documentation, professional translation of the documents, preparation and collection of necessary and required documentation for the batch of the medicines to be registered. 
Approximate price-list for help in medicines registration may be seen in the following table.  


Quantity of registered products

Price at registration

1 drug formulation

$ 1500

1 medicinal dosage

$ 400

1 medical equipment

$ 1500

1 medical device

$ 800

1 biologically active additive

$ 700

1 cosmetic unit

$ 500

Registration process begins from submission of application to registration/re-registration. Registration dossier for the medicine is submitted together with the application. Then clinical trials are held. 
Registration certificate is valid for 5 years.

As we mentioned it beforethe process is very complex and long, it may take from 3 up to 6 months.  
We suppose that it is reasonable to engage company that is occupied in medicines registration. Not all the manufacturers can afford themselves opening a branch office or sending their specialist for 6 months to another country.

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