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 dkma@dkma.dk in the section about reporting of side effects.
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. This means that the changes must be implemented by 8 October 2018 when the medicinal product is supplied to the wholesaler. We encourage marketing authorisation holders (MAH) to include the change when applying for other changes to the product information.
We recommend that you apply for the change in connection with another regulatory procedure concerning the product information. Alternatively, you can apply for the change as a C.I.Z, type IA variation.
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:
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Website: www.meldenbivirkning.dk
Email: dkma@dkma.dk
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 this leaflet. You or your relatives can also report side effects directly to the Danish Medicines Agency via the below information.
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Website: www.meldenbivirkning.dk
Email: dkma@dkma.dk
By reporting side effects, you contribute to providing more information about the safety of this medicinal product.