Documents - Marketing authorisation medicines for human use

47 documents Marketing authorisation medicines for human use

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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 ...

Publication | 01-09-2020

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

MEB 13: Nomenclature of pharmaceutical products

This document describes the requirements which the marketing authorisation holder has to fulfil when submitting a proposal for a ...

Policy document | 23-03-2020

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

MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging

Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...

Policy document | 10-05-2019

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