Registration of medicines to replenish the budget

Legislation Rules igry29-01-2010 Location medications to replenish the budget in the State Duma on Friday approved the first reading of amendments to the Tax Code of fees for state registration of medicines. As stated in the explanatory note, the registration process involves the holding of examinations, which are now made on a contractual basis. Now proposed to include these services in the cost of official registration. "But nowhere in the press you will not find, what specifically will be charged this fee, and in what amounts. This is a contract concluded between the expert agency, which now operates in the market, and the manufacturer or the person who authorizes the manufacturer on the proper examination ", - said the head of Health Minister Tatyana Golikova, speaking on the current practice of treaty examinations at the plenary session of the State Duma. Under the new amendments, the fee for state registration of the drug will increase to 670 thousand rubles. This price will include an examination of documents to get approval for clinical research (25% of this amount), examination of the quality of the drug (75%), said Interfax. According to the Minister, currently the cost of a single registration for a foreign manufacturer is 1,2-1,3 million rubles for domestic producers - 400-600 thousand, wrote Finmarket. Also established board and for the conduct of other expert opinions. Examination to amend the instructions for the medical use of the drug will cost about 200 thousand rubles. Expert study on changes in the composition of the drug is estimated at 500 thousand rubles, the technological process of production - 300 thousand rubles. Obtaining documents for international study will cost 400 rubles. Another 200 thousand rubles. will have to pay for the examination of documents necessary for obtaining permission for post-registration clinical trial drugs. Drugs with the registration does not need to obtain additional approvals. According to the Minister, the introduction of new state duties in this area will bring the federal budget of 2 billion rubles. And all stages of the examination will be included in the procedure of state registration of medicines.