19.06.2020.
In order to facilitate productive cooperation and shorten the harmonization process, pharmacovigilance experts from the State Agency of Medicines have prepared updated information to marketing authorization holders on the procedure for submitting educational materials (EM) developed by marketing authorization holders (MAH) for approval. For the convenience of MAHs, a checklist for EM submission is also available (Appendix 1).
Please be informed that document “Submission of educational materials laid down in the risk management plan to the State Agency of Medicines and their agreement” has been updated on 11 June 2020.
The documents are available HERE.
