From 1 February 2016 companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance

From 1 February 2016 companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that as of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit to EU regulatory institutions the type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF).

Information mentioned above from 1 February 2016 will be required to submit only in the Article 57 database.

For further information, please, visit the website of the European Medicines Agency.

In addition, the State Agency of Medicines reminds that according to the amendments to the Regulation No. 47 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Pharmacovigilance" adopted on 22 January 2013 (the amendments came into force on 4 October 2014) marketing authorisation holders should nominate a contact person for pharmacovigilance issues at national level and submit the contact details of the contact person for pharmacovigilance issues to the State Agency of Medicines.