Procedure for the Conduct of Pharmacovigilance - In Anticipation of Changes

On the 10th of February this year, The Ministry of Health of Ukraine published on its website the draft decree "On Amendments to Some Decrees of the Ministry of Health of Ukraine" (hereinafter - the draft decree), which proposes a number of changes in the relevant Ministry regulations.

The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree № 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure). Thus, the new procedure provides a number of new features, the most interesting of which relate to the applicant.

Thus, the new procedure determines that the applicant may have more than one system of pharmacovigilance, for example, specific systems for different types of medicines (vaccines, OTC drugs, etc.). At the same time, each applicant's pharmacovigilance system can have only one authorized person responsible for the pharmacovigilance (hereinafter – authorized person).

With regards to the authorized person, the new order establishes that in the case of the applicant, who is located in Ukraine, the authorized person must be part of the applicant's personnel. Should the applicant not be located in Ukraine, then a contact person for pharmacovigilance in Ukraine, who is a subordinate of the applicant's authorized person, must be assigned on the territory of Ukraine.

The new procedure defines the document with a detailed description of the pharmacovigilance system as a Pharmacovigilance System Master File (PSMF). In comparison with the current procedure, the new procedure establishes simultaneously a clear framework for such PSMFs with the requirements for information that must be contained in it.

An important achievement of the new procedure is to establish the requirements for the system of risk management in pharmacovigilance. It should be noted that the current procedure contains a provision, according to which the applicant creates a pharmacovigilance risk management plan, i.e. it provides the applicant's right to create the relevant plan.

In contrast to the existing rules, the new procedure provides for the obligation of creating a risk management plan.

For example, starting from 30th October 2017, a pharmacovigilance risk management plan will be mandatory for the submission of all new applications for registration of medicines, including generic medicines (except herbal remedies and homeopathic medicinal products registered under the simplified procedure) vaccines and tuberculin.

In addition, the applicant shall create and/or provide the risk management plans for pharmacovigilance:

• when changes occur requiring new registration, in particular, the new medicinal form, new route of administration, other significant changes in the usage, etc.;

• when new data arises affecting the benefit/risk ratio of the drug, vaccine, tuberculin, the current specification, the pharmacovigilance plan, measures to minimize the risks or effectiveness, or if it arises within 60 days after reaching important results concerning pharmacovigilance or risk minimization ;

• at the request of the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" (hereinafter - the Center) within 60 days after filing the request.

In concern with medicinal products that do not require the creation of risk management plans, the applicant must support the specification file of important identified risks and important potential risks with the aim of preparing regular reports.

Also, the new procedure regulates relations between the Center and the applicant relating to the implementation of non-interventional trials on the safety of medicines, vaccines and tuberculin, which may be carried out based on the initiative of the applicant or the obligations as established by the Ministry of Health and / or the Center.

In terms of other amendments foreseen by the new procedure, emphasis should be given to the advanced categorical apparatus and a new player in the field of pharmacovigilance - rapid response groups of relevant departments of Health, which are responsible for investigating all serious adverse events after immunization and some others.

In general, the framework of the project of the New Order was based on European experience and the provisions of the Directive 2001/83/EU of the European Parliament and Council and Regulation (EU) № 726/2004 of the European Parliament and Council as well as the WHO recommendations on the implementation of pharmacovigilance.

Therefore, the adoption of the new order will contribute to the harmonization of national legislation with the European legislation.in the field of pharmacovigilance.