Pharmacovigilance is defined as activities relating to the detection, collection, assessment, understanding and prevention of adverse drug reactions (ADRs) and other issues relating to the safety and efficacy of medicinal products.
The procedure for conducting pharmacovigilance in Ukraine is governed by MoH of Ukraine Order of 27.12.2006 No. 898 "About the Approval of Pharmacovigilance Procedure" (as amended by MoH of Ukraine Order of 26.09.2016 No. 996), which is harmonized with the international standards, including Directive 2001/83/EC and Council Regulation No. 2309/93.
The obligation to conduct pharmacovigilance activities is applicable to all medicinal products approved in Ukraine from the moment of their state registration. The responsibility for establishing and maintaining the pharmacovigilance system lies with the Applicant/ marketing authorisation holder. The Applicant must appoint a qualified person responsible for pharmacovigilance (QPPV) in Ukraine. The QPPV must have a higher medical or pharmaceutical education (pharmacist, clinical pharmacist) and be appropriately trained.
On the part of the state, pharmacovigilance activities for adverse drug reactions is carried out by the State Expert Center of the MoH of Ukraine (SEC). The SEC, in its turn, organizes the work of doctors at all health facilities regardless of types of ownership and the work of all Applicants/ marketing authorisation holders of the medicinal products permitted for medical use in Ukraine.
Pharmacovigilance activities can be divided into two levels:
* RMP – Risk Management Plan, PSUR – Periodic Safety Update Report, ACO – Addendum to the Clinical Overview.
Routine pharmacovigilance activities must be managed by the Applicant/ marketing authorisation holder. It includes the following activities on the part of the Applicant (or the Applicant's representative):
- Preparing a description of the pharmacovigilance system: availability, the contact details and the CV of the QPPV, information on the master-file, a letter from the Applicant guaranteeing the availability of necessary resources for maintenance of pharmacovigilance in Ukraine;
- Receiving operative information from the SEC regarding all serious adverse events (SAEs) associated with the medicinal product (disability, death, other SAEs). This information may trigger measures of risk minimization (e.g. changes to the instruction for medical use – SmPC), therefore, in accordance with the international legislation, it must be shared with regulatory authorities of other countries;
- Receiving retrospective information from the SEC to compile the application dossier for product registration/ renewal of registration in other countries;
- Providing the SEC with the urgent information regarding all serious ADRs reported in Ukraine (e.g. information from medical representatives, direct communications from doctors or patients, AE reports from other sources);
- Providing the SEC with the urgent information regarding all SAEs that have caused death or life threat of patients in other countries;
- Providing the SEC with the urgent information on the lack of efficacy of medicinal products in treatment of life-threatening conditions, emergencies, or states in which a lack of efficacy may pose a threat to the patient’s life;
- Providing the SEC, upon request, with the urgent consolidated information (including detailed information, methods of AE correction) on all adverse events and/or lack of efficacy cases;
- Preparing and submitting consolidated information regarding safety of medicinal product in Ukraine for renewal of registration (preparing ‘local’ PSURs);
- Taking part in other aspects of cooperation with the SEC and the other pharmacovigilance subjects;
- Periodically submitting of PSURs. From the international birth date of a medicinal product and after its registration in Ukraine, PSURs must be submitted at the following intervals:
For newly registered medicinal products:
- every 6 moths (for 2 years),
- annually (for 2 years),
- every 3 years (starting from the date of registration), or
- in accordance with the EMA timelines, or
- in accordance with the timelines specified in the registration certificate,
- upon request of regulatory authorities.
The RMP is submitted:
- when the medicinal product is registered/ renewal of registration;
- when there are changes requiring new registration (a new dosage form, a new route of administration, a new manufacturing process for biotechnological medicinal product, pediatric indications, substantial changes in indications);
- in the case of obtaining/ detecting new risks (changes in the specification, the pharmacovigilance plan, the risk minimization measures, the benefit/risk balance);
- upon request of regulatory authorities.
- The АСО is submitted: in the event of renewal of registration of the medicinal product.
There are specific requirements for the submission of PSURs, RMPs, АСОs: the documents must conform to the established structure, certain sections must be translated into Ukrainian and be accompanied by letters and standard forms (comparative description of three documents.PDF).
Cratia Ltd. is ready to offer its services in conducting some or all pharmacovigilance activities for your company in Ukraine. We have appropriately qualified specialists equipped with the necessary knowledge, experience and skills. We would be glad to offer you the following services:
- full performance of the tasks of establishing and maintenance pharmacovigilance, appointment of our employee as the person responsible for pharmacovigilance for your company's medicinal products;
- monitoring, analysis, processing and submission of SAE reports from other countries (CIOMS or MedWatch);
- training of your employee, writing of SOPs for pharmacovigilance;
- provision of trainings to the employees of your company;
- medicinal product-specific media monitoring;
- development (writing) or improvement of Risk Management Plans, Periodic Safety Update Reports, Addendum to the Clinical Overview.