Recommendations for reporting variations based on the safety review from the February 2015 PRAC meeting available now
The Agency for Medicinal Products and Medical Devices (HALMED) has made available on its webpages the recommendations for reporting variations based on the signal safety review adopted in the February 2015 meeting of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC). The recommendations concern the active substances amiodarone and aripiprazole and recommendations texts in English are available in the table accessible in the Medicinal Products/Instructions for Applicants/Variation Applications for Updates of Product Information Following PRAC Recommendations on Safety Signals Section of the website.
The obligation of reporting to HALMED variations to the medicinal product documentation concerns medicinal products authorise via national procedure in the Republic of Croatia and containing active substances encompassed by the PRAC recommendations involving a change in product information. the deadline for submitting variation applications is indicated in the PRAC recommendation. Marketing authorisation holders are obliged to use the adopted Croatian translation when submitting variation applications. The Croatian translation of the PRAC recommendations is expected to be published on the HALMED webpages by the mid of March 2015, in the table accessible in the Medicinal Products/Instructions for Applicants/Variation Applications for Updates of Product Information Following PRAC Recommendations on Safety Signals Section of the website. When these texts are published, no Newsletter will be distributed, therefore we would kindly advise our users to regularly follow posts in this section of the HALMED webpages.
When submitting variation applications, marketing authorisation holders are obliged to indicate the corresponding EPITT number.