Procedures for summaries of product characteristics, package leaflets and labelling

Updated 01 March 2016

Guidelines

Updating of product information to marketing authorisation holders of authorised medicinal products

Guideline on the use of QRD templates for summaries of product characteristics, package leaflets and labelling of human medicinal products

Guidance on declaration of herbal medicinal products

Danish requirements for "Blue box" and package leaflets

Vejledning om mærkning af lægemidler som er optaget på listen over lægemidler underlagt supplerende overvågning i EU (in Danish)

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)

Indication of medicinal product names nationally authorised in other EEA countries as well as the date of the most recent revision/change of the package leaflet

Translations of product information

Guidelines for translating product information

Danish translations of product information

Danish translations of the PhVWP recommendations for the wording of product information

QRD-kontrol af oversættelser på den centrale procedure - variationsansøgninger (in Danish)

Labelling

The Nordic medicinal agencies release Guidance on Nordic packages

The new documents 'Guideline on Nordic packages' and 'Frequently Asked Questions' 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 'Frequently Asked Questions' 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

Language and harmonisation

Danish translations of the PhVWP recommendations for the wording of product information

Linguistic proofreading of product information of centrally authorised medicinal products

Harmonisation of package leaflets and summaries of product characteristics

Forms

Adapted QRD templates and guideline for Danish product information for veterinary medicines