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Pharmacological vigilance

Pharmacological vigilance – is a scope of work of vigilance, analysis of information and respective reactions on side effects of medicinal products. Aim of pharmacovigilance is minimization of risks of side effects of medicinal products.

Term “pharmacological vigilance” was introduced in Ukraine at the beginning of 2007 by Order of Ministry of Health of Ukraine No 898. Legislation in pharmacological vigilance in Ukraine is harmonized with international standards, including Directive EC 2001/83 and Council directive EC 2309/93.

Ukraine has completely independent system of pharmacological vigilance (hereinafter - PV). It is required to establish and maintain local PV system by assigning a qualified person physically located in Ukraine that will be responsible for further actions, communication with state authorities etc. Establishment and maintenance of pharmacological vigilance is obligatory requirement for Applicant of any medicinal product that obtained marketing authorization in Ukraine.

 Pharmacological vigilance | Cratia

Central state authority responsible for pharmacological vigilance of medicinal products in Ukraine is State Expert Center of Ministry of Health of Ukraine. State Expert Center organizes vigilance work of all doctors of all medical institutions and work of all Applicants (owners) of registration certificates (marketing authorizations) of all medicinal products adopted for use in Ukraine.

Activities of pharmacological vigilance of Applicants can be divided into two groups:  

  • Routine vigilance of adverse events (AE);
  • Periodical submission of safety update reports of use of medicinal products (PSUR);

Periodical submission of safety reportsis mainly relates to companies-innovators (originators). Starting from international birth date (IBD), and after state registration of medicinal product in Ukraine the consolidated PSUR must be submitted within following time frames:

  • once per 6 months – during first 2 years from the moment of issue of marketing authorization (registration certificate);
  • one a year – during following 3 years;
  • afterwards – once per 5 years (usually is submitted during renewal of registration);

Specific requirements are applied to PSUR: report must comply with approved structure, specific parts of PSUR should be submitted in Ukrainian language, PSUR must be submitted with specific cover letters and specific forms.

Routine pharmacological vigilance must be managed by Applicant of registration certificate.  Routine pharmacovigilance require following actions from Applicant’s side (or from representative of Applicant):

  • receipt of operative information from State Expert Center regarding all serious side effects of medicinal product (physical inability, death and other serious SE); that information, in accordance with international legislation, must be distributed between regulatory authorities of other countries; additionally information on side effects can cause number of correcting activities (for examples – changes in instruction (SmPC) for medicinal use of the product); 
  • receipt of summarizing retrospective information on adverse events from State Expert Center for preparation of registration dossier for registration/renewal of registration in other countries;
  • submission of urgent information to State Expert Center regarding all serious side effects of medicinal product (for example – information from medical reps, direct calls of doctors or complaints of patients, information on AE from other sources);
  • submission of urgent information to State Expert Center regarding all serious side effects that caused death or life threat of patients on territories of other countries;
  • submission of urgent information to State Expert Center regarding ineffectiveness of medicinal product during treatment of serious diseases, urgent conditions or conditions when ineffectiveness of medicinal product make treat to life of patient;
  • submission of urgent consolidated information (including detailed information, methods of corrections of AEs) on all side effects and/or all cases of ineffectiveness of medicinal product upon request of State Expert Center;
  • preparation and submission of consolidated information regarding safety of medicinal product in Ukraine during renewal of registration (in other words – preparation of “local” PSUR); 
  • participation in other aspects of cooperation with State Expert Centerand other subjects of pharmacological vigilance (doctors etc.);
Pharmacological vigilance | Cratia 2 Cratia Ltd. can provide you with professional services in establishment and maintenance of pharmacological vigilance system in Ukraine. We have all necessary resources, specialists with respective knowledge and experience in the field of pharmacovigilance. Additionally we train your staff and/or write standard procedures for PV. 

 

 

It is obvious that all preliminary advices and consulting are free of charge. 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.