Documents - Marketing authorisation medicines for human use

50 documents Marketing authorisation medicines for human use

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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 ...

Policy document | 02-10-2023
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.

Policy document | 03-08-2022
Withdrawal of marketing authorisation at the request of the marketing authorisation holder

A marketing authorisation holder may decide to have their marketing authorisation withdrawn for various reasons. After completing ...

Form | 01-01-2022
MEB 43: Two-round assessment policy for national procedures

Limiting the number of assessment rounds ensures that the (legally) stipulated time within which the MEB must make a decision ...

Policy document | 01-08-2020
Declaration for the package leaflet of parallel imported products

Form | 01-01-2020
Explanation of the Interest Form - MEB-ZIN Parallel Procedures pilot

Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...

Publication | 10-07-2019
List of patient-friendly terms for the package leaflet

In order to optimise the readability of the package leaflet, the MEB has revised the list of patient-friendly terms. The list has ...

Policy document | 28-06-2019
Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications

Form | 01-05-2019
Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU

The delegated Regulation on the characteristics of the safety features and the new medicine verification system will apply as of ...

Publication | 01-10-2018
MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

Policy document | 11-09-2018

Documents - Marketing authorisation medicines for human use

50 documents Marketing authorisation medicines for human use

MEB 39: Policy for assigning RVG numbers

MEB 42: Renewal of medicinal products for human use authorised through the national procedure

Withdrawal of marketing authorisation at the request of the marketing authorisation holder

MEB 43: Two-round assessment policy for national procedures

Declaration for the package leaflet of parallel imported products

Explanation of the Interest Form - MEB-ZIN Parallel Procedures pilot

List of patient-friendly terms for the package leaflet

Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications

Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU

MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

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