Recommendations for reporting variations in the medicine documentation based on the signal safety review from the PRAC September 2015 Meeting available now
The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages the recommendations for reporting variations in the medicine documentation based on the safety signal review adopted on the September 2015 Meeting of the European Medicines Agency’s (EMA’s) Pharmacovigilance and Risk Assessment Committee (PRAC) as well as Croatian translations of these recommendations. The recommendations concern the following active substances: alendronic acid, cholecalciferol, clodronic acid, etidronicl acid, ibandronic acid, neridronic acid, palmidronic acid, risedronic acid, tiludronic acid, zoledronic acid, leflunomide, thioctic acid and trabectedin. The recommendations are available here.
The obligation for reporting variations in the medicine documentation to HALMED concerns all nationally authorised medicines in the Republic of Croatia containing active substances and/or excipients for which the adopted PRAC recommendation includes changes in the product information. When reporting a variation, marketing authorisation holders are obliged to use the adopted Croatian translation, whenever it is available and in this case, classify the variation as IAIN C.I.z. Only in the case when the translation is not available on the EMA webpages (signals before the PRAC January 2015 Meeting), marketing authorisation holders are obliged to translate the text from English into Croatian.
When submitting an application for variation, the marketing authorisation holder is obliged to quote the corresponding EPITT number as a procedure code.