Submission and approval of risk minimisation measures: updated versions of documents are published

Submission and approval of risk minimisation measures: updated versions of documents are published

The State Agency of Medicines (SAM) informs that updated information is published on the SAM website regarding the submission and approval of Educational Materials (EMs) and Direct Healthcare Professional Communications (DHPCs) laid down in the risk management plan of medicinal products. The previous versions of the documents, dated 27 May 2016, have been replaced with updated versions of 20 February 2017, and a new document “DHPC sample form - Annex 2” has also been published.

Several changes have been made to the aforementioned documents, including the additional information that the approved versions of EMs and DHPCs are added to the respective medicinal product in the public Medicinal Product Register of Latvia, that is available in the “Register” section of the SAM website. Upon drafting DHPCs, it is recommended to use the sample form (Annex 2), which is a new document.

The documents are intended for marketing authorisation holders’ responsible persons, especially national level contact persons for pharmacovigilance issues. The updated versions of the documents are available on the SAM website (section “Services > Pharmacovigilance > Information to marketing authorisation holders > Submission and approval of risk minimisation measures”).