Recommendations for reporting variations in medicinal product documentation based on the safety signal review from the PRAC August 2016 meeting
The Agency for Medicinal Products and Medical Devices (HALMED) has published on its website the recommendations for reporting variations in medicinal product documentation based on the safety signal review adopted at the meeting of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) held at the end of August and the beginning of September 2016 as well as Croatian translations of these recommendations. The recommendations concern the following active substances: agomelatine (urinary retention), boceprevir, daclatasvir, dasabuvir, elbasvir/grazoprevir, ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir, simeprevir, sofosbuvir, sofosbuvir/velpatasvir (drug interaction between direct-acting antivirals (DAAV) and vitamin K antagonists leading to a reduced international normalised ratio (INR)), iomeprol (haemolysis) and cobicistat containing products: cobicistat, cobicistat/atazanavir sulfate, cobicistat/darunavir, cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide, cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (drug interaction with corticosteroids leading to adrenal suppression). 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 cases when translations are not available on EMA's website (signals before the January 2015 PRAC 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.