Recommendations for variation application based on the signal safety assessment from the PRAC May 2015 meeting
The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages recommendations for variation application based on the safety signal assessment adopted at the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) May 2015 meeting, as well as Croatian translations of these recommendations. The concerned active substances are fingolimod, latanoprost (Xalatan), leflunomid and natalizumab. The recommendations are available here.
From May 2015 the EMA has started with a simultaneous publication of recommendations in English and their translations in all official languages of the EU member states. Recommendations and translations are published by the EMA approximately three weeks after the PRAC meeting. The Croatian translation, beginning from the PRAC May 2015 meeting will be published on the HALMED webpages simultaneously with recommendations in English and Newsletter will also be sent to users.
The obligation of reporting variations to HALMED concerns all nationally authorised medicinal products in Croatia containing active substances and/or excipients for which the adopted PRAC decision involves a change in product information. When reporting a variation, marketing authorisation holders are always obliged to use the adopted Croatian translation when available and in that case classify the variation as IAIN C.I.z. Only in the case when the Croatian translation for a certain signal is not published on the EMA webpages (signals before the PRAC January 2015 meeting), holders are obliged to translate the text from English into Croatian.
When submitting a variation application, marketing authorisation holders are obliged to indicate the adequate EPITT number as a procedure code.