On this page, you can find guidelines and forms for the renewal of marketing authorisations for human and veterinary medicines and parallel import of medicines.
A marketing authorisation for a medicine is generally valid for five years. The marketing authorisation holder must apply for a renewal no later than six months before the expiry of the authorisation.
Guidelines
Centralised procedure
Human medicines
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Veterinary medicines
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Mutual recognition and decentralised procedure
Human medicines
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Veterinary medicines
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National procedure
Human medicines
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Veterinary medicines
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Parallel import
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Application forms
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Application for renewal of marketing authorisation for parallel import of an already approved medicine (e-form in Danish only)
Human medicines
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Veterinary medicines
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