OREANDA-NEWS. November 15, 2011. The Government reinforces control over the quality of drugs, particularly imported. The Cabinet of Ministers has amended the Order of the state registration (re-registration) of medical products, having accepted the relevant resolution on November, 14th.

As noted Prime Minister Mykola Azarov, in particular when visiting the Pharmaceutical Firm Darnitsa, the manufacture of drugs should be under strict quality control. The Head of Government has set the task to take measures that the population of Ukraine to provide with qualitative, safe and effective medical products. Improving the system of registration of medicinal products, primarily, should protect consumers from unscrupulous suppliers of products for the pharmaceutical market.

Currently, worldwide more and more attention is paid to the observance of technological processes of manufacturing medicines. The quality needs be not to checked up in a preparation, and embed it in a product – it is such requirements of international standard quality drugs - so-called "Good Manufacturing Practices" (GMP).

However, till now, they acted only concerning domestic preparations, because keeping of demands GMP was a necessary condition of obtaining of the licence by the Ukrainian manufacturer. And as for imported drugs that are coming to Ukraine, the following requirements are not required at present. The situation was added when foreign vendors could enter the market of Ukraine after execution of one condition: implementation of the state registration of a medical product whereas the domestic producer should both register a medical product and obtain the licence.

Under the new order, monitoring behind quality of medicines is greatly enhanced. If earlier at carrying out of expertise of registration materials, the check of production of medical products was held only if necessary, the new procedure provides a check carrying out on compliance to requirements of a proper industrial practice, that is under monitoring, there will be a production of manufacture both domestic, and import medicines which get in the domestic market. The procedure of such check determines the Ministry of Health.

According to the document, the State registration (re-registration) of a medical product is carried by the Ministry of Health, on the basis of registration materials of such products and by results of monitoring of its quality, conducted by the State Expert Centre of the Ministry of Health.