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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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The MEB: Good medicines used better (short version)
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The MEB: Good medicines used better (long version)
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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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Request form for permission to carry out tests with additives for animal feed
If you want to put animal feed on the market with an additive that has not (yet) been licensed, the additive has to be examined ...
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Declaration regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use
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Application for the inclusion of QR code in national procedures