Documents - Marketing authorisation medicines for human use
45 documents Marketing authorisation medicines for human use
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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 ...
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 ...
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 ...
Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications
Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)
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 ...
MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions
MEB 16: Duplex marketing authorisation
A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a ...