Summaries of product characteristics, package leaflets and labelling
The Danish Medicines Agency or the European Commission must authorise medicines before they can be sold in Denmark to guarantee its safety and efficacy. This includes also herbal medicines and strong vitamins and minerals.
Once the products have been authorised, their product information must also be approved. The product information consists of a
- summary of product characteristics (SPC) for healthcare professionals,
- package leaflet for medicine users or those close to them,
- labelling (the product details to be placed on the medicine pack).
Summaries of product characteristics for nationally authorised medicines
The Danish Medicines Agency approves summaries (SPCs) of product characteristics for the medicines it has authorised (nationally) and is also responsible for publishing the SPCs at www.produktresume.dk (the website contains SPCs in Danish only).
Package leaflets for nationally authorised medicines
The pharmaceutical companies are responsible for ensuring that the package leaflets follow the information approved in the summaries of product characteristics. Companies upload their package leaflets to www.indlaegsseddel.dk, which contains the most recent package leaflets (the website contains package leaflets in Danish only).
Product information for medicines authorised in the EU
At www.ema.europa.eu/en/medicines, you can find the product information for medicines authorised by the European Commission via the so-called centralised procedure.
Below we have compiled several guidelines for companies which detail how to write and translate summaries of product characteristics and package leaflets and how the labelling on the packages should be designed. Some information is only available in Danish.
At the bottom, you can find templates for summary of product characteristics, package leaflets and labelling.
Updating of summary of product characteristics and package leaflet regarding the reporting of adverse reactions
The reporting of adverse reactions of human medicines to the Danish Medicines Agency must now only be done at www.meldenbivirkning.dk.
For human medicines this means that the section on the reporting of adverse reactions must be updated in both the summary of product characteristics (section 4.8) and the package leaflet (section 4) so that the Danish Medicines Agency email address is removed from the section on the reporting of adverse reactions. The change must be made in conjunction with the next variation application, and we encourage applicants to do it in connection with another change to the product information.
If an application concerning changes to the product information is being processed by us already, we will change the above-mentioned email information in the summary of product characteristics in connection with the approval of the changes applied for.
The marketing authorisation holder can implement the change in the package leaflet in connection with the next review of the package leaflet. We stress the importance that patients also know of the methods and correct communication routes to use to report 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. Healthcare professionals are asked to report any suspected adverse reactions via the:
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Website: www.meldenbivirkning.dk
Section 4 of the package leaflet – Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Website: www.meldenbivirkning.dk
By reporting side effects, you can help provide more information on the safety of this medicines.
Guidelines
Updating of product information to marketing authorisation holders of authorised medicinal products
Guidance on declaration of herbal medicinal products
Danish requirements for "Blue box" and package leaflets
Preparation of product information
Send Danish package leaflet when applying for changes to product information
Guidance on package leaflets and labelling when applying for a parallel import licence
Vejledning vedrørende udarbejdelse af produktresuméer for farmaceutiske specialiteter til human brug (in Danish)
Translations of product information
Guidelines for translating product information
Danish translations of product information
Danish translations of the CMDv recommendations
Danish translations of the PhVWP recommendations for the wording of product information
QRD-kontrol af oversættelser på den centrale procedure - variationsansøgninger (in Danish)
Labelling
Medicines with multilingual packages
If a medicine has a multilingual package, such as a Nordic package, the applicant is requested to indicate this in the covering letter of all types of applications, i.e. applications for MAs, renewals and variations.
Guidance on Nordic packages
The documents 'Guideline on Nordic packages' and 'Questions & Answers' have been prepared in order to facilitate the regulatory work when making common Nordic medicinal packages.
These documents apply to medicinal products for both human and veterinary use. The 'Guideline on Nordic Packages' contains general information on Nordic packages, whereas the 'Questions & Answers' gives detailed advice on different package issues.
Marketing authorisation holders may submit questions regarding issues relating to Nordic packages. For this purpose a specific form, Question to the Nordic package group, should be used. The documents are prepared in cooperation between the medicines agencies in Denmark, Finland, Iceland, Norway, and Sweden.
You can find the documents on the Swedish Medical Products Agency's (MPA) website
Other links related to labelling
Vejledning til bekendtgørelse om mærkning m.m. af lægemidler (in Danish)
Special warning on the labelling of pain relievers
Guidance on exemption from the Danish executive order on labelling pursuant to section 38
Labelling of unit-dose blisters
Language and harmonisation
Danish translations of the PhVWP recommendations for the wording of product information
Linguistic proofreading of product information for centrally authorised medicinal products
Harmonisation of package leaflets and summaries of product characteristics