New instructions to marketing authorisation holders for variations applications based on the PRAC recommendations following a signal safety review
Following the Pharmacovigilance Risk Assessment Committee (PRAC) January 2015 meeting, the European Medicines Agency (EMA) is publishing on its webpages translations of all texts in the EU official languages that should be included in the product information and that are related to medicines authorised via national or centralised procedure. When applying for a variation, marketing authorisation holders are obliged to use the adopted Croatian translation. Only in the case when no Croatian translation for certain signal is published on the EMA’s webpages (signals before the PRAC January 2015 meeting), marketing authorisation holders are obliged to translate the text from English in Croatian. The deadline for submitting a variation in documentation is indicated in the PRAC’s recommendation. When applying for a variation, marketing authorisation holders are obliged to indicate as a procedure code the corresponding EPITT number.
In the week after CHMP/CMDh meetings where recommendations are endorsed, HALMED will publish on its webpages links to the PRAC recommendations and deliver Newsletter with a brief summary of the most important information. The EMA will publish the translation of PRAC recommendation in the third week after CHMP/CMDh meetings where recommendations are endorsed. In this week, HALMED will publish a link to the Croatian translations of the PRAC recommendations, and Newsletter will in this case not be sent to recipients.
More information, including an instruction for variation classification, list of active substances authorised in the Republic of Croatia to which the PRAC recommendations relate and corresponding EPITT numbers, is available on the HALMED’s webpages, or here.