New Procedure for Pharmacovigilance

A new Procedure for Pharmacovigilance approved by Order of the Ministry of Health of Ukraine No. 898 as of December 27th, 2006 (hereinafter - the Procedure) entered into effect on January 6th, 2017.

In addition to significant additions and changes to the terminology, the new Procedure also specifies new requirements to the applicant's pharmacovigilance system, without which circulation of medicinal products, vaccines and tuberculin is not permitted in Ukraine. Thus, the applicant must establish and manage at least one pharmacovigilance system, which consists of elements allowing for the monitoring of safety of medicinal products, vaccines and tuberculin and determining any changes in benefit / risk ratio, namely:

• that the applicant (permanently and continuously) has at least one qualified authorized person responsible for pharmacovigilance. Depending on whether the applicant is in Ukraine or not, the authorized person must be either an employee of the applicant (for applicants who are residents), or a contact person should be designated on the territory of Ukraine and be subordinated to the applicant’s authorized person (for non-resident applicants). These persons must have higher medical or pharmaceutical education (pharmacist, clinical pharmacist). If necessary, the authorized person must be able to appeal to a person who has a medical degree. Also, the contact person should have an appropriate document confirming his / her powers. Data about the authorized person / contact person must be contained in a master file of pharmacovigilance system. If there is no authorized person / contact person replacement procedure, one should be created;

• a structured system of organization of pharmacovigilance, its update and support;
• documentation of all procedure processes;
• creation and maintenance of databases used by the applicant for pharmacovigilance;
• involvement (if needed) of other legal and / or natural persons and enterprises, institutions and organizations into pharmacovigilance by entering into contractual relationships;
• providing training of personnel of the applicant to carry out activities related to pharmacovigilance;
• creation of pharmacovigilance quality system;
• pharmacovigilance documentation processing, including its storage and archiving;
• creation and support of the risk management system.

The Procedure also establishes new requirements to the applicant in the context of the effective functioning of the system of pharmacovigilance, including the requirement to monitor the results of events aimed at minimizing the risks; update regularly the risk management system; and carry out regular audit of its pharmacovigilance system (s).

In this case, just like before, pharmacovigilance over side reactions of medicinal products permitted for medical use rests with the State Expert Centre of the Ministry of Health of Ukraine. Furthermore, it is the Centre where the applicant must provide information specified by the Procedure on the authorized person / contact person.