Requirements for nomination of a pharmacovigilance (PV) contact person at national level in Lithuania, Latvia, Estonia
As part of the EU pharmacovigilance system, MAHs are required to have an appropriately qualified person responsible for pharmacovigilance (QPPV) permanently and continuously at their disposal within the EU. Furthermore the amendments in EU pharmacovigilance framework gave the National Competent Authorities (NCA) of EU the opportunity to request the nomination of a contact person for pharmacovigilance issues at national level.
Such individuals are typically required to speak local language and to reside within the given Member State and should have a direct reporting link to the European Qualified Person for Pharmacovigilance (EU-QPPV). The requirement for local person for PV varies between Member States, ranging from nominating simply a local contact person for PV (LCPPV, LPPV) to more stick requirements, where a local person holds legal responsibilities and has more influence on the Marketing Authorization Holder’s (MAH) pharmacovigilance system (local QPPV, GPO).
Baltic countries are no exception and have local requirements regarding nomination of PV contact persons at national level. Therefore we believe it is necessary to summarize what these requirements are.
|Latvia||MAH must provide LCPPV contact details in cases where QPPV does not work and reside in Latvia. LCPPV details must be provided to the State Agency of Medicines in Latvia by each MAH during the Marketing Authorization Application review or as soon as the approval is granted.||Regulation No. 47 of the Cabinet of Ministers of the Republic of Latvia “Pharmacovigilance Procedures”, Chapter III. Responsibilities of the Marketing Authorisation Holder of the Medicinal Product, paragraph 15 section 4.|
|Lithuania||The State Medicines Control Agency of Lithuania may request MAH to nominate a LCPPV in Lithuania who would have a direct reporting line to the EU-QPPV.||Pharmaceutical Law of the Republic of Lithuania No. X-709, Chapter 11 – Pharmacovigilance, Article 53 – Pharmacovigilance system and practice used by the MAH, paragraph 2 section 2.|
|Estonia||Estonian speaking contact person is required for the cases where the prescribers of the medicinal products have to be informed about any safety risks associated with the use of medicines, i.e. cases of Direct Healthcare Professional Communication (DHPC) and distribution of materials associated with additional risk minimisation measures (Educational Materials).||Medicinal Products Act, paragraph 783 section 3.
Minister of Social Affairs Regulation No. 26 “Procedure for providing safety information about a medicinal product and the calculation of fee payable for safety and quality surveillance of a medicinal product” paragraph § 4 section 4.4.