Updated information on approval of educational materials and direct healthcare professional communication

Updated information on approval of educational materials and direct healthcare professional communication

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that on 27 May 2016 updated information on submission and approval of educational materials (EM) included in the risk management plan for medicines and direct healthcare professional communication (DHPC) was published on SAM website.

Important updates:

• A new single e-mail address em_dhpc@zva.gov.lv has been established for submission of both types of documents (EM and DHPC).
• Updated information regarding the approval procedure for EM and DHPC.
• Updated standard text that regards reporting of adverse drug reactions, including the SAM phone number in cases where it is necessary for a healthcare professional to contact SAM experts, and the supplementary text that should be added in case of biological medicinal products.
• The information regarding the EM content and format has been updated in accordance with the Guideline on Good Pharmacovigilance Practices, Module XVI, Addendum 1 "Educational Materials".
• In order to facilitate the preparation of documents for submission of EM SAM recommends that marketing authorisation holders (MAHs) use a checklist (Annex 1) indicating all documents that need to be submitted within EM approval procedure.

We invite the responsible MAHs’ persons, especially national level contact persons for pharmacovigilance issues, to use the updated information. This information is available on SAM website, section "Services > Pharmacovigilance > Information for marketing authorisation holders > Submission and approval of risk minimisation measures".