Requirements for Submissions of PSURs to HALMED
In accordance with the notice published on the European Medicines Agency's (EMA) website, the Agency for Medicinal Products and Medical Devices informs hereby that the marketing authorisation holders shall submit the periodic safety update reports to all member States in which the medicinal products has been authorised until the EMA has established the functionality of the repository for central submission. For medicinal products authorised in the Republic of Croatia, the marketing authorisation holder shall submit their PSURs to HALMED.
These requirements shall be in effect 12 months after the centralised repository has been established.
Detailed information for Periodic Safety Update Reports submission to HALMED, are accessible here. This table shall soon be included in the document with detailed information on the requirements for PSUR submission to national competent authorities and EMA, which is available on the EMA website, or here.