Information on the national level contact person regarding pharmacovigilance issues
The marketing authorisation holder (hereinafter - MAH) must ensure effective communication with national competent authorities and the European Medicines Agency regarding:
- new or identified risks;
- key information on the pharmacovigilance system;
- risk management systems;
- risk minimisation measures;
- periodic safety update reports;
- corrective and preventive actions;
- post-authorisation studies, etc.
Furthermore, essential safety information must also be provided to healthcare professionals and patients in a timely and understandable manner. To ensure effective communication in Latvian with authorities, patients, and healthcare professionals, national legislation sets additional requirements. Subparagraph 15.3 of Cabinet Regulation No. 47 of 22 January 2013 “Pharmacovigilance Procedures” (hereinafter – Regulation No. 47) stipulates that the MAH shall permanently employ a qualified person responsible for pharmacovigilance (hereinafter - QPPV), who lives and works in the European Union and is responsible for establishing and maintaining the pharmacovigilance system.
If the QPPV is not located in Latvia, then, in accordance with Subparagraph 15.4 of Regulation No. 47, the MAH shall appoint a national-level contact person (hereinafter - NLCP) for pharmacovigilance matters, who lives and works in Latvia and shall submit the NLCP’s contact information, as well as any changes to it, to the State Agency of Medicines of Latvia (hereinafter - the Agency).
Meanwhile, a parallel importer or parallel distributor, in accordance with Subparagraph 20.3 of Regulation No. 47, appoints a coordinator responsible for fulfilling the requirements referred to in Subparagraph 20.1 and 20.2 of this regulation with regard to the distributed medicinal products, and submits the coordinator’s contact information to the Agency.
Notification of the national-level contact person in the field of pharmacovigilance
The Agency has developed an online notification form to facilitate and expedite the notification of a NLCP. To ensure the availability of up-to-date information, MAHs are invited to complete the online notification form:
The form must be completed in the following cases:
- the QPPV does not live and work in Latvia and an NLCP is nominated;
- the QPPV appoints a new NLCP;
- the contact information of the NLCP for pharmacovigilance matters changes;
- the marketing authorisation holder changes;
- the name or address of the MAH changes;
- the parallel importer or parallel distributor of medicinal products appoints a coordinator or the coordinator’s contact details change.
MAHs are encouraged to use this form both for initial notification and for updates.
Additional information
Cabinet Regulation No. 47 of 22 January 2013 “Pharmacovigilance Procedures”
Information on the European Medicines Agency website on the guidelines “Good Pharmacovigilance Practices” (GVP)
Frequently Asked Questions
Frequently Asked Questions
Must the MAH notify the Agency about a change of QPPV?
A change of QPPV, including changes to contact details, must be reported in the Article 57 database of the European Medicines Agency. It is not necessary to inform the Agency separately.
When must the MAH nominate a NLCP for pharmacovigilance to the Agency?
According to the requirements set out in the Good Pharmacovigilance Practices (GVP Module VI) guidelines, the MAH must ensure certain pharmacovigilance activities for all products regardless of their marketing status.This requirement applies to all medicinal products authorised in the European Union, regardless of their indications, marketing status, or procedure.
If a medicinal product is authorised with conditions for safe and effective use that must be implemented before distribution begins, the MAH shall appoint a NLCP, who submits risk minimisation measures to the Agency for approval and ensures effective communication and coordination of matters related to educational materials.
Must medicinal products authorised through the centralised procedure have a NLCP nominated?
Yes, the nomination must be made by completing the online notification form: Notification of nomination of a contact person for pharmacovigilance issues at national level (NLCP)
Must the MAH submit information to the Agency about a deputy/substitute of NLCP?
The Agency does not require submission of information, including contact details about a deputy. Information on substitution arrangements must be included in the Pharmacovigilance System Master File (PSMF).
Must the NLCP be reachable outside working hours?
To ensure continuous monitoring of medicinal product safety data, the NLCP’s contact information for communication outside working hours must be submitted to the Agency.
When should local literature monitoring be initiated?
Literature monitoring must be carried out for all authorised medicinal products regardless of their distribution status, in accordance with the requirements set out in the Good Pharmacovigilance Practices guidelines regarding the identification of new safety signals (GVP Module VI.C.2.2.6 and GVP Module IX) and the preparation of periodic safety update reports (GVP Module VII).
Is there a defined set of periodicals in Latvia that the MAH should monitor?
The MAH determines appropriate literature sources for each product in accordance with the GVP guidelines (Module VI, Appendix 2.2). The Agency does not publish a list of recommended publications.
Must the NLCP be proficient in the official language?
The MAH must ensure effective communication with authorities, patients, and healthcare professionals in Latvia. To achieve this, the NLCP must be proficient in the official language.
