GEC, Ministry of health will increase the price of carrying out examination of materials for state registration of pharmaceuticals
State expert center (SEC) of the Ministry of health of Ukraine plans to increase the cost of examination materials for medicinal products submitted for state registration on February 15, reported the press service of the Ministry.
The change in the cost of services associated with an increase in the minimum wage to 3, 2 thousand UAH, the improvement of expert work of the centre, the alignment of the registration procedure of medicines in Ukraine legislation and standards of the European Union.
The cost increase also would apply to the services for conducting expert evaluation of materials about introduction of changes to registration materials during the validity period of registration certificate.
The report did not specify how much will be increased prices for services.
Currently, according to the order GEC No . 139 “About approval of cost of services of the State expert center of the Ministry of health” on 17 November 2015, the minimum cost of examination of materials of drugs for state registration equal to 7.5 thousand UAH – check of documents for registration of medicines for tuberculosis, HIV / AIDS, viral hepatitis, cancer and orphan diseases registered by the competent authorities of the United States, Switzerland, Japan, Australia, Canada or the European Union. The maximum price set for a product registration with a full dossier biotechnological, medical immunobiological preparations – 75,1 thousand UAH
Services examination for changes range from 900 UAH (technical error) to 41.3 thousand UAH (changes requiring a new registration).