Instructions for marketing authorisation holders regarding variation applications for updates of product information following PRAC recommendations on safety signals available now
The Agency for Medicinal Products and Medical devices (HALMED) has published on its web pages recommendations for reporting variations in documentation based on signal safety reviews endorsed at the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) meeting in April 2015. Recommendations concern the active substances daclatazvir, sofosbuvir, sofosbuvir+ledipasvir, interferon alpha-2a, interferon alpha-2b, interferon beta-1, interferon beta-1b, peginterferon alpha-2a, peginterferon alpha-2b, peginterferon beta-1a and trabectedin and are available in English here.
We would like to emphasize that these recommendations include recommendations for sodium-containing oral suspension, oral solution and effervescent forms, which translation is not expected to be at the same time with publication of other recommendations that were endorsed at the PRAC April 2015 meeting. The information on recommendation implementation for these sodium-containing medicines, will be published retrospectively on the HALMED’s web pages, as soon as the EMA’s renewed guideline "Excipients in the label and package leaflet of medicinal products for human use” has been published. The renewed guideline will contain the text that should be implemented for sodium-containing medicinal products as active substance or excipient and that should replace the existing text that has been included in the product information based on the current version of the guideline. On this occasion, Newsletter will be sent to users.
The obligation of reporting variations to HALMED concerns medicinal products authorised via national procedure in the Republic of Croatia, containing active substances and or excipients for which the PRAC recommendations are endorsed, includes a change in the product information. The deadline for reporting variations is indicated in the PRAC recommendation. When reporting a variation, marketing authorisation holders are obliged to use the endorsed Croatian translation. The Croatian translation of recommendations from the PRAC April 2015 meeting, except for recommendations for sodium-containing medicinal products for oral suspension, oral solution and effervescent forms, is expected to be publically available on the HALMED’s webpages in the second half of May 2015. Newsletter will not be sent at the moment of publication, therefore, we would kindly ask our users to regularly follow publications in this section of the HALMED’s webpages.
When reporting a variation, the marketing authorisation holder is obliged to indicate the corresponding EPITT number as a procedure code.