The pharmacovigilance procedure in Ukraine is regulated by Order No. 898 of the Ministry of Health of Ukraine dated December 27, 2006, “The Procedure for Pharmacovigilance”, developed on the basis of international standards, including EU Directive 2001/83 and EU Council Regulation 2309/93.

Pharmacovigilance of adverse reactions of medicinal products by the state is carried out by the State Expert Center of the Ministry of Health of Ukraine (hereinafter – the SEC). In turn, the SEC organizes the work of physicians of all healthcare facilities of all forms of ownership, and the work of all Applicants/Holders of Marketing Authorizations for medicinal products approved for use in Ukraine.

The obligation to establish and maintain a pharmacovigilance system is applicable to all medicinal products registered in Ukraine from the moment of their state registration, regardless of the chosen procedure.

It is the responsibility of an Applicant/Holder of Marketing Authorization to create and maintain a pharmacovigilance system. A non-resident applicant is required to appoint a LCP (Local Contact Person) – a contact person responsible for pharmacovigilance in Ukraine. Such a person must have a higher medical/pharmaceutical education (pharmacist, clinical pharmacist) and the necessary training.

Name, contact details and CV of the LCP are submitted as part of the Application and dossier for registration/renewal. Change of the LCP is carried out as type IA variations.

Routine pharmacovigilance must be organized by the Applicant/Holder of the Marketing Authorization. Routine pharmacovigilance includes the following actions by the Applicant or the Representative of the Applicant:

• Description of the pharmacovigilance system: availability, contact details and CV of the LCP, information on the master file, the Applicant’s assurance letter on the availability of the necessary resources to carry out pharmacovigilance in Ukraine;
• Obtaining timely information from the SEC regarding all serious adverse events (hereinafter referred to as “AEs”) of the medicinal product (disability, death, and other serious AEs). This information can lead to the initiation of risk minimisation measures (for example, amending the instructions for human use), therefore, in accordance with international legislation, it should be distributed among the regulatory authorities of other countries;
• Obtaining retrospective information from the SEC to form a registration dossier for registration/renewal of the medicinal product in other countries;
• Providing timely information to the SEC regarding all serious AEs of the medicinal product that have been reported in Ukraine (for example, information from medical representatives, direct requests from physicians and patients, information about AEs from other sources);
• Providing timely information to the SEC regarding all serious AEs that led to the death or patients life threatening in other countries;
• Providing timely information to the SEC regarding the lack of efficacy of the medicinal product in the treatment of life-threatening conditions, emergency conditions and conditions in which the absence of effect can threaten the patient’s life;
• Providing timely summary information (including detailed information, methods for correcting AEs) about all side effects and/or about all cases of lack of efficacy of the medicinal product at the request of the SEC;
• Preparation and submission of consolidated information on safety of human use of a medicinal product in Ukraine for renewal procedure (drafting a “local” PSUR);
• Participation in cooperation with the SEC and all other pharmacovigilance entities on other aspects;
• Periodic submission of PSUR according to the set frequency;
• Submission of RMP (Risk Management Plan) during registration/renewal of medicinal products, in the case of changes requiring a new registration, in the case of emergence/identification of new risks, at the request of the regulatory body;
• Submission of CRM during marketing authorization renewal of medicinal products.

There are applicable national requirements for the submission of PSUR, RMP, CRM: documents must have an established structure, certain sections must be submitted in Ukrainian translation, they must be accompanied with letters and forms in prescribed formats.

Cratia provides professional services on establishment and maintenance of the pharmacovigilance system in Ukraine. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.