Information on the national level contact person regarding pharmacovigilance issues
Considering the enquires the State Agency of Medicines of Latvia has received on the national level contact person regarding pharmacovigilance issues stated in paragraph 15.4 of the Cabinet of Ministers Regulation No. 47 “Procedure for Pharmacovigilance” please be informed of the following explanation.
Article 11, Point 1(e) and 1(g) of the 19th June 2012 Commission Implementing Regulation (EU) No. 520/2012 regarding the performance of pharmacovigilance activities determined by Regulation (EC) No. 726/2004 of the European Parliament and of the Council and Directive No. 2001/83/EC of the European Parliament and of the Council states that the marketing authorisation holder shall effectively communicate with the competent State institutions and the European Medicines Agency, including communication regarding new or changed risks, pharmacovigilance system master file, risk management systems, risk minimisation measures, periodic safety update reports, corrective and preventive measures and post-authorisation studies, and shall appropriately provide relevant safety information to healthcare professionals and patients.
In accordance with Point 15.3 of 22nd January 2013 Cabinet of Ministers Regulation No. 47 “Procedure for Pharmacovigilance” (hereinafter - Regulation) the marketing authorisation holder shall constantly and continuously employ a responsible Qualified Person who lives and works within the European Union and is responsible for the development and maintenance of a pharmacovigilance system. In accordance with Point 15.4 of this Regulation the marketing authorisation holder shall appoint a national level contact person regarding pharmacovigilance issues, if the responsible person does not live and work in Latvia. The contact information or changes in the contact information (if any) of the national level contact person shall be immediately submitted to the State Agency of Medicines.
The Regulation states that the Qualified Person responsible for pharmacovigilance shall live and work within the European Union. At the same time the marketing authorisation holder shall ensure effective and appropriate communication with agencies, patients and healthcare professionals on a national level. Taking into account the aforementioned information, the national level contact person should have thorough knowledge of the State language to ensure effective and appropriate communication.
A new online notification form for appointment of a contact person for pharmacovigilance issues at national level – starting from 1 May, 2024
The State Agency of Medicines has developed an online form for notification of contact details of the national level contact person for pharmacovigilance issues to speed up and facilitate this process for marketing authorisation holders (or their authorised persons).
According to the Cabinet of Ministers Regulation No. 47 of January 22, 2013 "Procedure for Pharmacovigilance" subsection 15.4, the marketing authorisation holder of a medicinal product shall appoint a national level contact person for pharmacovigilance issues who resides and works in Latvia, if the qualified person responsible for pharmacovigilance (QPPV) does not reside and work in Latvia.
According to subsection 21.9 of this Regulation, the State Agency of Medicines shall maintain and update the list of contact information provided by marketing authorisation holders about the national level contact persons for pharmacovigilance issues.Considering the above, the State Agency of Medicines has developed an online notification form to facilitate the notification process of a contact person for pharmacovigilance issues at national level for marketing authorisation holders (or their authorised persons) and to ensure compliance with the Regulation on maintaining up-to-date information.
The State Agency of Medicines invite all marketing authorisation holders, whose QPPV does not reside and work in Latvia, to fill out the online notification form.
If it is necessary to make changes to the previously provided information about the contact person for pharmacovigilance issues at national level (incl. transfer of marketing authorisation holder), we invite you to use this online notification form in the future as well.
