Thanks to the joint efforts of the Cabinet of Ministers of Ukraine, Ministry of Health of Ukraine (MOH), the State Expert Center (SEC) and the Association’s Health Care Committee (EBA HCC) leading experts the amendments to the MOH Order No.1245, which are to contribute to the successful functioning of the simplified procedure of state registration of medical drugs, were elaborated and are now adopted.
In 2016, the EBA HCC supported the initiative of the Government of Ukraine to simplify the procedure of drugs’ registration, in particular, for those drugs registered via the EMA centralized procedure. The initiative was intended to open access to Ukraine for safety, quality and effective drugs applied throughout the EU member-states.
On December 30th, 2016, the MOH Order No. 1245 adopted to implement the simplified registration came into force. However, it raised a number of practical issues from both SEC and pharmaceutical companies. It required revision of a number of provisions to get their successful implementation.
Now the amendments to the simplified registration procedure include necessary clarifications and remove ambiguous provisions that did not allow SEC experts to provide reliable information during consultations to applicants prior to the submission of registration materials’ package. Inter alia, the following procedural improvements can be highlighted:
- providing the SEC experts with the possibility to request additional information, which is essential for further consideration of materials;
- clarification as regards the “discrepancy in manufacturer’s name and address”;
- сlarification as regards the variations that applicants have to add to the registration materials, according to their types in those countries where a relevant medical drug was registered;
- providing applicants with the possibility to attach the variations to the dossier as well as in the form of the already updated dossier with variations included.
The Association welcomes the adoption of the amendments to the MOH Order No. 1245. They shall allow companies to register the appropriate medicines much faster. It is essential to open the way for the necessary medicines to the patients of Ukraine as there is such a demand. We also hope for further implementation of deregulation measures in the pharmaceutical sphere, in particular, during importation of medical drugs for further circulation in Ukraine. They are sure to foster avoidance of duplications, optimization of relevant procedures and timely supply of medical drugs required for Ukrainian patients.