1. General information about pharmacovigilance in Ukraine.
2. Requirements to pharmacovigilance.
3. Services of Cratia Ltd. in the field of pharmacological vigilance.
4. Legislation.
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 to healthcare of people.
Term “pharmacological vigilance” was implemented in Ukraine is very young: at the beginning of 2007 and Order of Ministry of Health of Ukraine No 898 as of 27.12.2006 “Procedure of pharmacological vigilance of side effects of medicinal products, adopted for use in Ukraine” has came into force (hereinafter – Order). Order on pharmacovigilance is harmonized with international standards, including Directive EC 2001/83 and Council directive EC 2309/93.
After the Order has came into force, requirements to pharmacological vigilance were also adopted by other legal acts of Ukraine, including central law regarding registration of medicinal products – Order of Ministry of Health of Ukraine No 426 as of 26.08.2005. Requirement (obligation) of pharmacological vigilance is applied to all medicinal products that obtained marketing authorization in Ukraine, starting from the moment of it’s state registration in Ukraine or starting from the moment of coming into force of mentioned above Order.
Central state authority responsible for pharmacological vigilance of medicinal products in Ukraine is State Pharmacological Center of Ministry of Health of Ukraine (hereinafter – SPhC). Thus SPhC manage 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 side effects (SE);
- Periodical submission of safety update reports of use of medicinal products (PSUR);
Periodical submission of safety reports is 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 Russian or Ukrainian language, PSUR must be accompanied 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 SPhC 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 retrospective information from SPhC for preparation of registration dossier for registration/renewal of registration in other countries;
- submission of operative information to SPhC regarding all serious side effects of medicinal product, that were registered in Ukraine (for example – information from medical reps, direct calls of doctors or complaints of patients, information on SE from other sources);
- submission of operative information to SPhC regarding all serious side effects that lead to death or life threat of patients on territories of other countries;
- submission of operative information to SPhC 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 operative consolidated information (including detailed information, methods of corrections of SE) on all side effects and/or all cases of ineffectiveness of medicinal product upon request of SPhC;
- 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 SPhC and other subjects of pharmacological vigilance (doctors etc.);
Cratia Ltd. can provide you with professional services of partial management or total management of entire system of pharmacological vigilance of your company in Ukraine. Cratia Ltd. has all required specialists with respective knowledge and experience in the field of pharmacovigilance.
Due to specific of he service we prefer to discuss all terms and conditions of possible cooperation during meeting
Tel.: +38 044 332 42 94
Tel/Fax: +38 044 425 32 86
E-mail: info@cratia.com.ua
As mentioned above, system of pharmacological vigilance in Ukraine is mainly regulated by Order of Ministry of Health of Ukraine No 898 as of 27.12.2006 “Procedure of pharmacological vigilance of side effects of medicinal products, adopted for use in Ukraine” and Annexes:
- Procedure of pharmacological vigilance of side effects of medicinal products, adopted for use in Ukraine [available in English language]
- Annex 1: Form of notification regarding side effect (SE) or regarding ineffectiveness of medicinal product during it’s medical use (filled by doctor);
- Annex 2: Requirements for filling of form of notification regarding SE or regarding ineffectiveness of medicinal product during it’s medical use (filled by doctor);
- Annex 3: Report regarding cases of side effects during medicinal use of pharma products in healthcare institutions.
- Annex 4: Requirements for filling the report regarding cases of side effects during medicinal use of pharma products in healthcare institutions.
- Annex 5: Form of notification regarding SE or regarding ineffectiveness of medicinal product during it’s medical use (filled by Applicant or it’s representative);
- Annex 6: Requirements for filling of form of notification regarding side effect or regarding ineffectiveness of medicinal product during it’s medical use (filled by Applicant or it’s representative);
- Annex 7: Structure of periodical safety update report of medicinal product adopted for use in Ukraine (structure of PSUR);
- Annex 8: Form of submission of consolidated data by manufacturer / Applicant (or it’s representative) regarding safety of medicinal product in Ukraine during period of validity of marketing authorization (registration certificate);
- Annex 9: Structure of protocol of study of safety of medicinal product adopted for medical use in Ukraine.
- Annex 10: Notification on start of study of safety of medicinal product adopted for medical use in Ukraine.
- Annex 11: Notification on finish (end) or temporary pause of study of safety of medicinal product adopted for medical use in Ukraine.
- Annex 12: Structure of report of study of safety of medicinal product adopted for medical use in Ukraine.
If you are interested with services of our company in the field of pharmacological vigilance in Ukraine or if you have any questions – please contact us.
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