EN

Marketing authorisation

Appeared: 2008.08.06 15:01, Last modified: 2019.02.19 10:38

Drug registration process means not only "putting something into the register" after evaluation, but every regulatory step that happens from the first application up to the cancellation of the drug from register.



Process of Marketing Authorisation

Variation of marketing authorisation

The Process of National Marketing Authorisation Renewal

Transfer of the marketing authorisation to a new holder ("MAH transfer")

Naming of Medicinal Products

Withdrawal of Marketing Authorisation (Cancellation)

Herbal Medicines

Allowed differences from the Marketing Authorisation (formal defect)

Homeopathic Medicinal Products

eCTD/baseline submission

Quality Review of Documents

Assessment of product information

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