CRED SMPC 2024

17/09/2024

Labels, Mock-ups and Specimens

MOCK-UP A copy of the flat artwork design in full colour (a replica of both the outer and immediate packaging) so that the three dimensional presentation of the label text is clear

LABEL TEXT A word document which specifies all the contents of the label as per QRD template

SPECIMEN Samples of the actual printed outer and immediate packaging materials and package leaflet, i.e. the 'sales presentation’

The Organisation for Professionals in Regulatory Affairs

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Translations

CMDh Best practice guide on the submission of high-quality national translations

All in QRD template

Faithful (not word-for word) translations of the common English text

CP: All languages (including Icelandic and Norweigan) Procedural guidance for all community procedures states when translations are required to be submitted CP: Linguistic review procedure ensures member states agree with the translations. Usually occurs after CHMP opinion MRP/DCP: Individual local language text, specific per country, even if the same language is an official language in several countries

The Organisation for Professionals in Regulatory Affairs

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