Documents - Marketing authorisation medicines for human use
49 documents Marketing authorisation medicines for human use
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Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)
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MEB 44: Direct Healthcare Professional Communications (DHPCs)
This document is based on the Guideline on Good Pharmacovigilance Practices (GVP) Module XV – Safety communication, and is aimed ...
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MEB 37: Legal status of supply
This document describes the policy of the Medicines Evaluation Board for awarding a legal status of supply.
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MEB 14: Parallel importation: marketing authorisation and maintenance
Parallel import is the importation – and subsequent marketing in the Netherlands – of a medicinal product authorised elsewhere in ...
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Parallel import comparison form
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MEB 39: Policy for assigning RVG numbers
This document describes the Medicines Evaluation Board policy for assigning RVG numbers. This policy is based on the definitions ...
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Terms and conditions for package fee and reduced fee for copy DCP application - human products
The term package fee entails that a group of products (each with an individual RVG number) is only billed once at the tariff ...
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GS-list 21
The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 20 October ...
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MEB 42: Renewal of medicinal products for human use authorised through the national procedure
The MEB decides whether to renew the marketing authorisation for each product authorised through the national procedure.
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MEB 45: National implementation of additional risk minimisation measures
An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the ...