Forms

Updated 06 December 2016

Marketing authorisation

Application for marketing authorisation

Notification about initiation or cessation of marketing of medicinal products (Sunset Clause)

Renewal of marketing authorisation

Application for renewal of marketing authorisation

Parallel import

Application for parallel import

Variations

Application for variations

Compassionate use

Application for compassionate use permits for human use

Application for compassionate use permits for veterinary use


Company authorisations and registrations

Company authorisations in general

Company registrations in general

Manufacture and import of medicines and intermediates

Application for authorisation to manufacture and import medicines and intermediates

Wholesale distribution

Application for wholesale distribution of medicines within the EU/EEA

Distribution of medicines outside pharmacies

Distribution of medicines outside pharmacies

Application for authorisation to sell medicinal gasses by retail (in Danish)

Euphoriant substances

Euphoriant substances

Application for authorisation of activities with euphoriant substances

Radiopharmaceuticals

Application for handling radiopharmaceuticals in hospitals (in Danish)

Toxicological and pharmacological trials

Application for the conduct of toxicological and pharmacological trials (non-clinical trials)


Magistral medicinal products

Application for permission to prepare magistral medicinal products (for doctors)


Side effects and incidents

Report side effects in humans

Report side effects in animals

Adverse reactions in clinical trials

Clinical trials

Trials in humans

Application for clinical trials in humans

Trials in animals

Application for clinical trials in animals


Sale of medicine outside pharmacies

Application for authorisation to sell over-the-counter medicines and V-marked medicines

Application for authorisation to sell medicines for production animals

Import of medicines into Denmark

Ask us about import

Falsified medicines

Pharmaceutical companies’ reporting of discovery of counterfeit medicines


Prices of medicines

Notification of prices and range via DKMAnet

Emergency forms for notification of prices and product range


Reimbursement of medicines

Medicines bought in another EU/EEA country

General reimbursement

Application for general reimbursement


About DKMAnet

About DKMAnet

Appointment of Security Administrator (SA)


Legislation

Report suspected illegal activities with medicines

Did you get answers to your questions?

Please tell us how we can improve our website?