Printed 18/06/2013

Url http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/summaries-of-product-characteristics,-pa---labelling

MEDICINES HEALTH Shortcuts to sst.dk

Authorisation and supervision

Procedures for summaries of product characteristics, package leaflets and labelling

Guidelines

Guidance on package leaflets and labelling when applying for a parallel import licence

Guidelines for translating product information

Vejledning vedrørende udarbejdelse af produktresuméer for farmaceutiske specialiteter til human brug (in Danish only)

Guideline no. 31 of 13 May 2005 on labelling of and package leaflets for medicinal products

Guidance on declaration of herbal medicinal products

Requirements for "Blue box" and package leaflets

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

Forms

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

Translations of product information

Danish translations of product information

Changed practice on authorisation and implementation of name changes of medicinal products with generic terms

Guidance to manufacturers outside the EU/EEA area

Updated 03 April 2013

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About clinical trials

About counterfeit medicines

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Danish Health and Medicines Authority
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2300 Copenhagen S, Denmark

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