Authorisation and quality control

• Company authorisations
• Authorisation of medicinal products
• Marketing authorisation
• Procedures for summaries of product characteristics, package leaflets and labelling
• Application for parallel import

• Application for variations
• Fees payable for medicinal products and companies
• Inspection of authorised pharmaceutical companies
• Companies' name and address changes

Side effects and trials

• Companies' reporting of side effects
• EudraVigilance

• Safety updates
• Clinical trials

Retail and online sale

• Pharmaceutical companies’ reporting of discovery of counterfeit medicines

Statistics, prices and reimbursement

• Medicine Prices for companies
• Notification of prices and range via DKMAnet

• Application for general reimbursement

Legislation

• The Danish Medicines Act
• The Danish Health Act

• Companies’ notification of collaboration with doctors, dentists and pharmacies