Government approves simplification of drug registration
Kyiv • UNN
The Cabinet of ministers approved a draft law on simplifying the registration of medicines purchased by the state enterprise "Medical procurement of Ukraine". The changes will expand access to new drugs and vaccines purchased from the state budget.
The Cabinet of Ministers of Ukraine has approved a draft law that simplifies the procedure for registering medicines purchased by the state enterprise "medical procurement of Ukraine". About it UNN reports with reference to the Ministry of Health.
Details
"Recently, the government approved a draft law that simplifies the procedure for registering medicines purchased by the state enterprise "medical procurement of Ukraine" (mzu). Relevant amendments are planned to be made to the law of Ukraine "On medicines"," the report says.
It is reported that the main goal is to expand patients ' access to new medicines and vaccines that can be purchased by the Ministry of Health at the expense of the state budget.
In particular, we are talking about the registration of medicines included in the list of WHO prequalified medicines, vaccines and medicines included in the database of medicines that can be purchased under the President's emergency plan for assistance in the fight against HIV (PEPFAR).
Currently, the law on medicines provides for a simplified procedure for registration of medicines purchased by an authorized person for medicines registered by the Competent Authority of the United States, Switzerland, Japan, Australia, Canada, and applied in the territory of these countries or by the competent authority of the European Union under a centralized procedure and applied in the territory of EU member states, the Ministry of Health informs.
It is noted that this list also provides for changes in the new draft law. We are talking, as indicated, about medicines registered in the UK, as well as in EU member states under a decentralized procedure.
"Now suppliers can register medicines within one month for delivery to the Ministry of health, but the state expert center of the Ministry of health of Ukraine conducts an expert examination of materials during the full registration procedure within 7 months," the report says.
It is reported that the applicant is issued a certificate indicating the validity period during which the drug is allowed for use on the territory of Ukraine. Such a drug can be used in Ukraine for 5 years from the date of its state registration. After this period, its further application is possible, subject to re-registration.
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