Recommendations for reporting variations in documentation based on the signal safety review from the PRAC March 2015 meeting available now
The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages recommendations for reporting variations in documentation based on the safety signal review from the March 2015 meeting of the European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC). Recommendations concern the active substance aripiprazole and the text of recommendation is accessible in English here.
The obligation of reporting variations in documentation to HALMED refers to medicines authorised via national procedure in the Republic of Croatia, for active substances for which the adopted PRAC recommendation includes changes in product information. The deadline for submitting variations is indicated in the PRAC recommendation. Marketing authorisation holders are obliged to use the Croatian translation when reporting variations in documentation. The Croatian translation of recommendations is expected to be published in the second half of March 2015 on the HALMED webpages. When the translation is published, Newsletter is not being sent, so we would kindly ask users to follow regularly releases in this section of our webpages.
When submitting an application, the marketing authorisation holder is obliged to indicate the adequate EPITT number as a procedure code.