The system of state regulation of registration of medicines in Ukraine
The procedure of registration, re-registration of medicines, as well as amendments to the registration dossier in Ukraine is somewhat different from the Russian procedures. For example, in Ukraine it is mandatory to comply with the IFU for a drug with the instructions of the reference European state (if the drug is registered in the EU), the national expert center of Ukraine has a more complex structure, and the documents for registration are submitted simultaneously to the Ministry of Health of Ukraine and the expert center. In this regard, it is necessary to clearly present which institutions of the state apparatus are involved in the procedure of registration of medicines.
1.Ministry of Health of Ukraine (MOH).
As in Russia, the Ministry of Health of Ukraine is responsible for making decisions regarding registration of medicines. The structure of the Ministry of Health of Ukraine includes 26 subdivisions, including the Administration of Pharmaceutical Activity and Quality of Pharmaceutical Products, which includes the Department of State Registration of Medicinal Products and immunobiological agents. The functions of this department include: consideration of the application for registration of the medicinal product, interaction with the expert organization, as well as making a decision on registration of the medicinal product on the basis of the expert center opinion.
2.State Expert Center of the Ministry of Health of Ukraine (Center).
Examination of the drug at its primary registration in Ukraine is carried out in two stages: Completeness check and specialized expertise. Specialized expertise shall be carried out in the relevant department (s). In total, there are 6 such units in the Center:
– Department of examination of instructions and nomenclature;
– Department of examination of vaccines and immunobiological preparations;
– Department of examination of materials on bioequivalence;
– Department of expert work;
– Department of expertise on preclinical and clinical trials;
Department of Pharmacovigilance;
If the drug passes secondary registration (after the expiry of the initial registration certificate issued for a period of 5 years), most often the examination includes the Department of Expertise instructions and nomenclatures and the Department of Pharmacovigilance. At the same time, if comments are received from only one of the units, both of them need to be informed. For example, when making amendments to the instruction on the basis of a request from the Department of Pharmacovigilance, the Applicant or authorized person must inform the Department of Expertise of the instructions and nomenclature with a separate letter.
3.State Service of Ukraine for Medicines and Drug Control (GosLekService).
The functions of the GosLekService of Ukraine include control and supervision measures for the circulation of medicines, as well as organization of GMP certification of manufacturers and maintenance of registers.