From 1 July 2015 a contact person for pharmacovigilance issues at national level is required

From 1 July 2015 a contact person for pharmacovigilance issues at national level is required

The State Agency of Medicines (SAM) reminds marketing authorisation holders that amendments to the Regulation No. 47 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Pharmacovigilance" adopted on 22 January 2013 came into force on 4 October 2014 laying down the requirement for nomination of a contact person for pharmacovigilance issues at national level starting from 1 July 2015. The national level contact person needs to reside and work in Latvia.

In accordance with Article 15.4 of the amendments ”The marketing authorisation holder shall nominate a contact person for pharmacovigilance issues at national level (hereinafter - national level contact person), who resides and works in Latvia, if the responsible person does not reside and work in Latvia. Shall immediately submit the contact details of the national level contact person - given name, surname, address of site of operation, electronic mail address, phone number and fax number (if such exists), also for communication outside of working hours, as well as changes in the contact details (if any) to the State Agency of Medicines”.

The contact person may be nominated by sending an application with the signature to the State Agency of Medicines via post (address: Jersikas street 15, Riga, LV-1003) or via e-mail info@zva.gov.lv (with the secure electronic signature). The list of medicines, for which the contact person is responsible, should also be included in the application. Additional information is available via telephone: 67078438.

The amended Regulation No. 47 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Pharmacovigilance" adopted on 22 January is available in the section "Legislation" of the SAM website and on the website for legal acts in Latvia www.likumi.lv.