Summary of product characteristics and package leaflet to be updated after the establishment of DKMA
Following the establishment of the Danish Medicines Agency (DKMA) on 8 October 2015, the section on the reporting of side effects must be updated in the summary of product characteristics (section 4.8) and the package leaflet (section 4) so that it says the Danish Medicines Agency and firstname.lastname@example.org in the section about reporting of side effects. This applies to human medicinal products.
As regards submitted applications concerning changes to section 4 and/or 5 of the summary of product characteristics, we will change the above information about name and email in the summary of product characteristics in connection with the authorisation of the changes applied for.
We have fixed a transitional period of 3 years from 8 October 2015.We encourage marketing authorisation holders (MAH) to include the change when applying for other changes to the product information, but if the change is not included in the variation application, we will make sure that the information is updated in the summary of product characteristics.
Alternatively, you can apply for the change as a C.I.Z, type IA variation.The MAH can make the change to the package leaflet in connection with the next or a future revision of the package leaflet. However, it is important that patients are familiar with the methods for and the correct way of reporting suspected adverse reactions.
Section 4.8 of the summary of product characteristics
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. Doctors and healthcare professionals are asked to report any suspected adverse reactions via:
Section 4 of the package leaflet
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacy. This includes any possible side effects not listed in the package leaflet. You or your relatives can also report side effects directly to the Danish Medicines Agency via the below information.
By reporting side effects, you contribute to providing more information about the safety of this medicinal product.