The Icelandic Medicines Agency has now published the following updated Icelandic instructions on Safety Advice Tools, previously called educational materials:
- Instructions for preparing and submitting Safety Advice Tools
- Instructions for publishing and removal of Safety Advice Tools
- Application form for the assessment of the Safety Advice Tools
The Icelandic Medicines Agency reminds that all requirements for Safety Advice Tools are detailed in GVP Module XVI. The Agency's instructions on creating these tools do not replace GVP and do not cover all its requirements. Their primary purpose is to outline the specific requirements for assessment requests and how the Agency conducts these evaluations.
The guidelines
Efforts were made to simplify the guidelines and make them as instructive as possible and to promote the harmonization of the Safety Advice Tools and their dissemination. However, the Icelandic Medicines Agency emphasizes that the final decision on the approval of the Safety Advice Tools and its dissemination is made on a case-by-case basis, with patient safety as the guiding principle.
A dissemination plan is essential
This update of the instructions was extensive, and therefore it is not possible to list all the changes made, but the main ones are:
- Change in terminology: Safety Advice Tools used instead of educational materials
- New sections added: User-testing and dissemination plan
- The application form has been updated to now include a section for the dissemination plan. An application for the evaluation of Safety Advice Tools is not considered valid unless a satisfactory dissemination plan accompanies the application
- The section on the dissemination of Safety Advice Tools has been updated
- Requirements for the cover letter to HCPs have been slightly reduced
- The standardized sentence on adverse reaction reporting has been modified
- Change in the publication of updated Safety Advice Tools in Sérlyfjaskrá: Generally published every working Monday
The Icelandic Medicines Agency continues to strive to respond to applications for the assessment of Safety Advice Tool within 60 days.
The Icelandic Medicines Agency finds it necessary to emphasize that applications that do not comply with the guidelines of the Icelandic Medicines Agency will be returned.