Notice on the new version of Appndix V. QRD template and procedure for indicating information on the national system of reporting undesirable effects in the summary of product Characteristics and Package Leaflet
We hereby inform marketing authorisation applicants/holders that the information on the reporting system in the Republic of Croatia in the Summary of Product Characteristics and Package Leaflet should be indicated according to instructions for preparing product information available on the EMA’s webpages Quality review of Documents human-product information annotated template (English) version 9, or on the webpages of the Co-Ordination Group for MRP and DCP (CMD(h)) CMDh QRD annotated template for MRP/DCP.
This concerns also marketing authorisations granted via national procedure and involves the following:
1 Applicants in text proposals, as well as HALMED in approved texts of summary of product characteristics and package leaflet, do not enter concrete HALMED contact details, but rather only a link to Appendix V. of QRD as follows:
- In the summary, section 4.8:
"Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.”
- In the leaflet, section 4:
"Reporting of adverse reactions
If you discover any adverse reaction, you should report it to your ˂ doctor ˃ ˂ , ˃ ˂ or ˃ ˂ pharmacist ˃ ˂ or nurse ˃. This includes every possible adverse reaction that is not indicated in this package leaflet. Adverse reactions may be reported directly via national reporting system indicated in Appendix V. By reporting adverse reactions, you may contribute to the safety review of this medicine.”
The Summary of Product Characteristics and Package Leaflet published on the HALMED webpages contain the link on Appendix V.
2 Marketing authorisation holders in printed and electronic version of the Summary of Product Characteristics and package Leaflet instead of the link to Appendix V must indicate concrete information on the national reporting system in the Republic of Croatia, according to data indicated in Appendix V., or exactly in the following way:
Agency for medicinal Products and Medical Devices (HALMED) Department for Pharmacovigilance Ksaverska cesta 4 10000 Zagreb
Republic of Croatia Fax: +385 (0) 1 4884 110
website: www.halmed.hr e-mail: firstname.lastname@example.org
Note: Taking account of the beginning of the HALMED Registry Office on one location in Ksaverska cesta 4 only, Appendix V. of the QRD template has been modified (version 10 from 1 April 2015) in a way that the contact address Ksaverska cesta 4 and the corresponding fax number should be indicated instead of the previously indicated data for Sky Office.
By the procedure described above, the necessity for reporting variations in the summary of product characteristics and package leaflet is being avoided in the case of a change of contact details of competent authorities.
In the case when HALMED has approved texts of summary of product characteristics and package leaflet with these concrete HALMED’s contact details, marketing authorisation holders are advised of the following:
The contact address and HALMED’s fax number should be changed in a printed or electronic version of the summary of product characteristics and package leaflet as indicated under 2 of this notice. This change in contact data, marketing authorisation holders should implement in a printed or electronic version of the summary of product characteristics and package leaflet as soon as possible, preferably by the next print of product information. Due to specificities of the existing circumstances, this change in contact details may be implemented without a separate submission of application to HALMED.
The transfer to indicating the link to appendix V., instead of indicating the concrete data on the national system for reporting adverse reactions in the Republic of Croatia in the version of the summary of product characteristics and package leaflet that will be approved by HALMED (the procedure described under 1 of this Notice) may be carried out within any other variation that changes the summary of product characteristics and package leaflet (it is not necessary to submit a separate application for variation), within a renewal, documentation upgrading or marketing authorisation transfer.
For pending applications with HALMED, HALMED will rectify the data on the reporting system in the Republic of Croatia as described under 1 of this notice to avoid a retrospective need for transfer to indicating the link to Appendix V.