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.
