Instructions for reporting variations in the documentation for medicine resulting from PRAC recommendations based on the safety signals assessment
The European Medicines Agency (EMA) monthly publishes recommendations of the Pharmacovigilance Risk Assessment Committee adopted based on the safety signal assessment. The list of all published PRAC recommendations based on the safety signal assessment is accessible on the European Medicines Agency’s (EMA) webpages and on the webpages of the Agency for Medicinal Products and Medical Devices (HALMED) in the Medicinal Products/Instructions for Applicants/Variation Applications for Updates of Product Information Following PRAC Recommendations on Safety Signals section.
Under Article 16(3) of Regulation 726/2004/EC and Article 23(3) of Directive 2001/83/EC marketing authorisation holders for medicines containing active substances that are subject to adopted recommendations are required to undertake respective measures in accordance with these recommendations. In cases where PRAC recommendations include a regulatory procedure, like introducing new information in the summary of product characteristics (SPC) and package leaflet (PIL), marketing authorisation holders are required to submit an application for variation. The obligation of variation reporting to HALMED refers to medicines authorised via national procedure in the Republic of Croatia, containing active substances for which the adopted PRAC recommendation includes a modification in medicine’s information.
The deadline for submitting applications for variation in the documentation is indicated in the PRAC recommendation and it is calculated from the release of recommendation on the European Medicines Agency’s (EMA) webpages.
HALMED is reminding marketing authorisation holders about the importance regular PRAC recommendations monitoring to promptly inform about the recommendations for authorised medicines and to act accordingly.
Pursuant to recommendations of the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for human medicines (CMDh): Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008, the variation in the medicine’s documentation should be classified as type IB C.I.z (in the case of including the agreed text indicated in the PRAC recommendation) or as type II C.I.z (when additional data are to be included in addition to the agreed text). It is not possible to classify the variation as type IA C.I.z., because national translations of the texts that should be included in the summary of product characteristics and/or package leaflet in Croatian are not available. Texts to be included in the summary of product characteristics and/or package leaflet are contained in the PRAC recommendation.
Detailed information on the procedure of assessment, scientific conclusions and summary of PRAC recommendations for every safety signal is available on the EMA webpages, in the PRAC Minutes section.
For including the PRAC recommendations adopted based on the safety signal assessment after 1 July 2013, it is necessary to report the variation in the medicine’s documentation for all medicines authorised via national procedure in the Republic of Croatia containing the substances that are subject to PRAC recommendations, regardless from other pending regulatory requirements (renewal, documentation upgrading or variation) or their submission is foreseen.
The including of PRAC recommendations adopted before 1 July 2013 may be carried out within the application for dossier upgrading.
Instructions for reporting variations in the dossier resulting from PRAC recommendations are available on the HALMED webpages in the Medicinal Products/Instructions for Applicants/Variation Applications for Updates of Product Information Following PRAC Recommendations on Safety Signals