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Uzbekistan approves regulations on licensing of pharmaceutical activity

Business Materials 20 May 2010 13:01 (UTC +04:00)

Uzbekistan, Tashkent, May 20 / Trend, D.Azizov /

The Cabinet of Ministers has approved regulations according to which the term of license for pharmaceutical activity of legal and physical entities is limited to five years.

So far, licenses for pharmaceutical activity were issued without expiration date.

According to the document, licensing of pharmaceutical activity is conducted by the Ministry of Health.

Licensing is subjected to production of pharmaceuticals and medical products, manufacturing of pharmaceuticals and medical products, scientific research work on the creation of medicines and medical products, quality control of medicines and medical products, retail sales of pharmaceuticals and medical products, wholesale sales of pharmaceuticals and medical products, growing, gathering, harvesting, packing and wholesale of medicinal raw materials of plant, animal and mineral origin.

A license for production, manufacture, scientific research, quality control of medicines and harvesting medicinal plants are only issued to legal entities. Pharmaceutical institutions must license the activities of manufacturing medicines and medical products and their sale. The current document is adopted by the Government in accordance with President Islam Karimov's April decree on "Measures on streamlining licensing of pharmaceutical and medical activity".

Earlier, it was reported that Uzbekistan adopted a number of measures to strengthen control over the quality of medicines.

The Senate (Upper House of Parliament) of Uzbekistan approved the amendments to the Criminal Code, which envisages increasing punishment to 15 years imprisonment for the production and sale of counterfeit medicines in September of 2009.

In particular, for such offences the law imposes a fine worth 100-300 minimal salaries or imprisonment to three years. If the offense had been committed repeatedly by a group of persons, the punishment is increased to imprisonment for periods ranging from 7 to 15 years.

According to local experts, capacity of Uzbekistan's pharmaceutical market is about $500 million, while the share of counterfeit products is about 50 percent.

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