Registration of pharmaceuticals for human use in Ukraine

The procedure for registration of medicines in Ukraine is in the stage of harmonization with the registration in the European Union, which leads to regular updating of the regulatory framework and some changes in the organization of work on registration. However, the new registration of pharmaceuticals for human use now includes three main stages: preparatory step, registration process and fulfillment of post – registration obligations.

* The main state bodies involved in the registration process can be found in the article: “The system of drug registration state regulation in Ukraine”.

1 – Preparatory stage

The applicant and holder of the registration certificate can be both resident and non-resident of Ukraine. However, it is necessary to have two local representatives:

  • The person responsible for the system of Pharmacovigilance in Ukraine;
  • The person responsible for the quality management system of drugs in Ukraine;

It is important that the Applicant may delegate the performance of quality management, pharmacovigilance system and registration obligations to a third party. To do this, it is necessary to properly execute the Contract and the Power of Attorney.

2 – Registration process

State registration is carried out by the Ministry of Health of Ukraine (https://moz.gov.ua/) and its subordinate expert center (https://dec.gov.ua/).

At the first stage, it is necessary to submit the Power of Attorney to the expert center and conclude the Contract for carrying out expert works;

At the 2nd stage, the application for registration is submitted to the Ministry of Health of Ukraine, and the registration form is submitted to the expert center (Appendix to the application);

At the 3rd stage, in case of a positive conclusion of the Ministry of Health of Ukraine and the Expert Center, invoices for payment of state duties and expert works are sent. Submission of the dossier to the expert center is possible only after payment;

At the stage 4, the completeness of the materials of the registration dossier according to the type of Application is checked;

At the stage 5, in case of receiving a positive conclusion at the stage 4, the dossier is transferred to expert committees (EC) for specialized expertise. In total, 6 EC operates in Ukraine. The number of necessary examinations depends on the drug;

At the 6th stage it makes sense to include comments from the expert center, which can be discussed with the expert in personal communication (if necessary). After that – the correction of these comments;

At the 7th stage, the quality control of the drug is carried out in the authorized laboratory;

At the 8th stage, with the recommendation of the drug for registration, approval of the draft registration certificate, the text of the labelling and the instruction for use with the subsequent transfer of the package of documentation to the Ministry of Health is carried out;

At the 9th stage, the Order on registration is formed, the drugs are entered into the State Register of drugs of Ukraine (http://www.drlz.com.ua/) and the original of Registration Certificate, as well as its annexes are issued.

3 – Post-registration obligations

After receiving the recommendations of the expert center regarding the instructions and layouts of the packaging, it is necessary to make appropriate changes, as well as register the layouts of the primary and secondary packaging in the Unified Automated Information System (EAIS) of the State Service of Ukraine for Medicines and Drug Control (GosLekService).

Important: in parallel with the procedure of drug registration, it is necessary to organize the receipt of the GMP certificate. The authorized body of Ukraine responsible for this procedure is the GosLekService.

References:

1 – https://moz.gov.ua/

2 – https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80?lang=ru

3 – https://zakon.rada.gov.ua/laws/show/ru/z1069-05

4 – https://zakon.rada.gov.ua/laws/show/ru/376-2005-%D0%BF

5 – https://dec.gov.ua/

6 – http://www.drlz.com.ua/