CRED SMPC 2024

17/09/2024

EU CP vs. MRP/DCP - Differences

Invented name

Pack design

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CP: Identical across all EU member states

CP: Identical design. Pack sizes as registered. Multilingual packs if more than one official language or to facilitate pack sharing MRP/DCP: Outer and immediate packaging may look different Leaflet design consistent with user tested format and layout

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MRP/DCP: Different trade names possible in EU member states. Names listed at end of leaflet

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National requirements

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Additional statements, overdose help-line numbers etc

The Organisation for Professionals in Regulatory Affairs

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Blue Box

Directive 2001/83/EEC, Article 57

Member states may require the use of certain forms of labelling of the medicinal product making it possible to ascertain

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price of the medicinal product

– reimbursement conditions of social security organisations

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legal status for supply to the patient

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authenticity and identification

Readability guideline All outer packaging must include space for the prescribed dose to be indicated and/or ‘blue - box’ information as required by member states

The Organisation for Professionals in Regulatory Affairs

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