Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
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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 ...
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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 ...
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Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications
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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 ...
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MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products 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 48: National informed consent application
An Article 10c 'Informed Consent' application ( article 10c of Directive 2001/83/EC) is an application for marketing ...
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Previous versions of the Dutch QRD-template
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Parallel import dossier structure
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Declaration regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use