Pharmacovigilance

Cratia provides professional pharmacovigilance and medicines registration services in 12 countries and the Eurasian Economic Union (EAEU):

Azerbaijan Georgia Moldova Turkmenistan
Armenia Kazakhstan Mongolia Uzbekistan
Belarus Kyrgyzstan Tajikistan Ukraine

For some countries, the establishment and maintenance of a local pharmacovigilance system is an obligatory requirement for establishment and maintenance of the medicinal product registration. Some other countries have not yet included such requirements in national legislation, and the local pharmacovigilance system can operate voluntarily.

In those countries where pharmacovigilance is a mandatory part of the regulatory system, we have our own internally trained local employees with high professional skills, experience, knowledge of the national legislation and language. All activities are coordinated by our Head office, whose specialists control the quality and timescales of work.

The Head office is located in Ukraine, the country with the most developed and high regulatory requirements. Since 2005 Ukrainian drug regulatory legislation has been actively harmonized with European legislation, and since 2006 national pharmacovigilance legislation has been based on Directive 2001/83/EC of the European Parliament and Council, EU Council Regulation 2309/93 and Guidelines of Good Pharmacovigilance Practice (GVP). We have successfully applied the many years of experience and knowledge gained on the national market to scale services in other countries. Our experts have deep knowledge of the national legislation of each country, specific requirements for registration materials and approval procedures, use professional terminology and monitor all changes.

In addition to coordinating the work, the Head office specialists develop documentation in the pharmacovigilance system, such as the Risk Management Plan (RMP), the Addendum to the Clinical Overview (ACO), the Periodic Safety Update Report (PSUR), the Pharmacovigilance System Master File, SOPs, etc.

Establishment and maintenance of the local pharmacovigilance system includes:

  • designation of a local contact person (LCP or CPRP) responsible for pharmacovigilance, meeting  education and qualification requirements;
  • submission of the information on the LCP to the competent authority, applying for variations if required;
  • development or localization of SOPs on pharmacovigilance for a specific country;
  • preparation of a summary of the local pharmacovigilance system: contact details and curriculum vitae of the LCP, information on the master file and SOP, letters of guarantee, etc.;
  • training of the LCP and other employees of the Representative Office, if applicable;
  • SDEA signing with importers/distributors;
  • creation of a local database containing information on all events in the pharmacovigilance system;
  • registration of all events related to the pharmacovigilance system in a local database;
  • receiving and analyzing reports of adverse events (AEs) around the world, if necessary, submitting them to the competent authority;
  • collection, assessment and submission of reports about AEs that have occurred in the country (distributors, external service, etc.);
  • monthly monitoring of specialized periodicals, preparation of reports;
  • creation and approval of a PSUR/PBRER submission schedule, submission of duly executed reports (including translation of certain parts) to the competent authority;
  • monthly reconciliation for all events in the pharmacovigilance system;
  • proper storage, archiving, backing up documentation and databases;
  • interaction with competent authorities, physicians and patients in case of their requests;
  • creation of a quality system: periodic internal audits of the pharmacovigilance system.

We are also ready to conduct an independent audit of the pharmacovigilance system of your company or representative office.

National requirements in brief:

Azerbaijan  The Applicant is not required to establish and maintain a pharmacovigilance system, but the Applicant is required to submit information on adverse events that meet certain criteria, including all adverse events during the first 5 years after registration, as well as all serious adverse events, to the competent authority. Information on all serious and unexpected adverse events of the medicinal product should be sent to the competent authority as soon as possible, but not later than 3 days.
Armenia The pharmacovigilance system of Armenia based on the Good Pharmacovigilance Practices of the Eurasian Economic Union, which require the appointment of a pharmacovigilance contact person at the national level. The Applicant is required to appoint a contact person responsible for pharmacovigilance in Armenia. The responsibilities of the contact person include the development of a risk management plan (RMP), the collection, analysis and submission of information on adverse events to the competent authority, screening of literature, the submission of periodic safety reports, etc. The competent authority has the right to inspect the pharmacovigilance system.
Belarus The Guidelines (Technical Code of Common Practice) on Pharmacovigilance in Belarus are based on the EU Directive 2012/26/EU, Regulation of the European Parliament and the Council of Europe No. 1027/2012 and Regulation of the European Commission No. 520/2012. To ensure the functioning of the pharmacovigilance system the manufacturer of medicinal products appoints an authorized pharmacovigilance person in Belarus. The manufacturer’s pharmacovigilance system is subject to control by the competent authority.
Georgia The Applicant has no obligation to create and maintain a local pharmacovigilance system. Information about adverse events is submitted to the competent authority in paper form with a signature and seal; information about unexpected serious adverse events is submitted within 2 days; in other cases – within 30 days.
Kazakhstan Monitoring of adverse events of medicinal products has been introduced since 2005. In 2015, the Standard of Good Pharmacovigilance Practice (GVP) was adopted. The Applicant (holder) of the marketing authorization is obliged to create and maintain a pharmacovigilance system in Kazakhstan, including appointing a contact person for pharmacovigilance (LCP) within the territory of the Republic of Kazakhstan, submit reports about adverse events on scheduled time, maintain a database, and annually submit to the competent authority information about any prohibitions or restrictions on use and data for assessing the benefit-risk ratio. During registration (renewal), a description of the pharmacological safety control system and the risk management system is provided (corresponds to Section 1.8.1. “Pharmacovigilance system”). The competent authority has the right to conduct an inspection of the pharmacovigilance system, both locally and globally.
Kyrgyzstan The Applicant is obliged to create and maintain a pharmacovigilance system in Kyrgyzstan, for which an authorized person on pharmacovigilance in Kyrgyzstan is appointed. The responsibilities of the contact person include the collection, analysis and submission of information about adverse events to the competent authority, screening of literature, the submission of periodic safety reports, etc. The pharmacovigilance system is subject to control by the competent authority.
Moldova The pharmacovigilance system in Moldova is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Directive of the Council of the European Economic Community on Pharmacovigilance No. 75/319. The Applicant is obliged to create and maintain a pharmacovigilance system in Moldova, therefore he/she appoints an Authorized Person in the Republic of Moldova to conduct pharmacovigilance. Within the first 5 years after marketing authorization the Applicant is obliged to submit to the competent authority information about any adverse events; the deadline for reporting about unexpected serious adverse events is up to 15 days. The pharmacovigilance system is subject to control by the competent authority.
Mongolia  The Applicant has no obligation to create and maintain a local pharmacovigilance system. Distributors and manufacturers are required to submit a Periodic Safety Update Report (PSUR) to the competent authority of Mongolia on scheduled time.
Tajikistan The Applicant has no obligation to create and maintain a local pharmacovigilance system, as well as no obligation to provide information on drug adverse events (adverse reactions).
Turkmenistan The Applicant has no obligation to create and maintain a local pharmacovigilance system, however, there is an obligation to submit a Periodic Safety Update Report (PSUR) to the competent authority timely.
Uzbekistan  The Applicant must create and maintain a pharmacovigilance system in Uzbekistan, therefore he/she appoints a local contact person, information about whom is submitted to the competent authority. As part of the registration dossier, the Applicant also submits a description of the pharmacovigilance system and the risk management system (analogous to RMP), the Pharmacovigilance System Master File (PSMF), PSUR. Inspection of the pharmacovigilance system is not described in local legislation.
Ukraine The national pharmacovigilance legislation is based on Directive 2001/83/EC of the European Parliament and of the Council, EU Council Regulation 2309/93 and Guidelines of Good Pharmacovigilance Practice (GVP). The Applicant is obliged to create and maintain a pharmacovigilance system in Ukraine, for which purpose a contact person responsible for pharmacovigilance in Ukraine (CPRP/LCP) is appointed to collect and submit reports of adverse events on time, maintain a database, monitor literature, etc. Pharmacovigilance system is subject to control by the competent authority.
Eurasian Economic Union The Applicant is obliged to create and maintain a pharmacovigilance system in the EAEU, for which purpose he/she appoints a contact person responsible for pharmacovigilance in the EAEU. The responsibilities of the contact person include the development of a risk management plan (RMP), the collection, analysis and submission of information on adverse events to the competent authority, screening of literature, the submission of periodic safety reports, etc. The competent authority has the right to inspect the pharmacovigilance system.

Cratia offers professional services on establishment and maintenance of a pharmacovigilance system in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources to carry out the work.

To start cooperation or get advice, please contact us by phone: +38 044 361-48-28, +38 044 221-71-29, by e-mail: info@cratia.ua, or visit our office

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