The Ministry of health proposed to change the procedure for the inclusion of medicines in the list of drugs that can purchase medical facilities under trade names, writes “Kommersant”.
The Department has prepared a draft of new rules of procurement of drugs on behalf of Prime Minister Mikhail mishustina: in February of this year in the government discussed how to resolve the problems of drug supply as preferential recipients of drugs and regular patients.
According to the text of the draft resolution, as before, to the specific drug in the list purchased by brand name, manufacturer, or patient organization needs to submit an application to the Ministry of health.
The only way of statement and response agencies will now be electronic. The package of documents for the approval now in addition to the data on the bioequivalence of the drug and examination of the balance of risks and benefits of its application must include the results of pharmacovigilance, including data about efficacy and safety when changing products with different trade names within the same international nonproprietary names, as well as medical care standards and clinical guidelines supporting the need for its application.
The examination of the application will not only engage members, but at least two of the main freelance specialist of Ministry of health, which specializiruetsya in the area of the drug. They, in turn, will have the right to collect expert opinions from the medical and pharmaceutical communities.