December 1, 1998 were approved by the rules of state registration of medicines.These rules provide for a uniform procedure for organizing and conducting the state registration, for both domestic and foreign medicines, including here and homeopathic preparations.According to these regulations, manufacturers of drugs for registration must prepare documentation materials pharmacological, toxicological studies, instructions for medical use, as well as other data on manufactured drugs, according medlinks.ru.
Now, with the law, the Ministry of Health considers unacceptable the current practice when the same drug is available on a pharmacopeia article several enterprises.The issue of overcoming the "double standards" in relation to the scheme of registration of domestic and foreign medicines rises in the Federal Law "On Medicines", since all companies use different substances, aids and technology, despite the commonality of pharmaceutical articles.
addition, differ as labeling and packaging and dosage forms o
introduction of a new scheme of registration of medicines, according to the Department, will only lead to positive consequences.Now, each company will be responsible only for himself, will operate and maintain the documentation, without looking at it on someone else.
will also be set fairly stringent time frame in which it will be necessary to update the documentation as well as the fulfillment of the Law "On Medicines" would be possible.Only after re-registration of drugs 1950-60s.