Recommendations for reporting variations in medicinal product documentation based on the signal safety review from the PRAC December 2015 meeting
The Agency for Medicinal Products and Medical Devices (HALMED) has made publically available on its webpages the recommendations for reporting variations in medicinal product documentation based on the safety signal review adopted on the December 2015 meeting of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) as well as Croatian translations of these recommendations. The recommendations concern hormone replacement therapy (HRT) medicinal products, which are not pharmaceutical forms for vaginal use, containing oestrogens or combined oestrogens-progestagens. The recommendations are available here.
The obligation of reporting variations in medicinal product documentation to HALMED concerns all nationally authorised medicinal products in the Republic of Croatia containing active substances and/or excipients for which the adopted PRAC recommendation includes changes in 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 EMA's webpages (signals before the PRAC January 2015 meeting), marketing authorisation holders are obliged to translate the text from English to Croatian.
When submitting an application for variation, marketing authorisation holder is obliged to quote the corresponding EPITT number as a procedure code.