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EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP

Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of mock-ups and specimens of outer/immediate labelling and package leaflets of human medicinal products in the centralised procedure".


The purpose of this guideline is to present the proposed revision of the current process of checking human medicinal products, along with a discussion of how to practically implement it.

This guideline is been updated:

• to reflect the implementation of safety features (section 2.1, section 2.4 and Annex 2),

• to include the shipping address for the submission of specimens (section 2.4),

• to specify the submission of a declaration, in addition to the mock-ups, for transfers only affecting the MAH details without any impact on the overall design (section 3 and Annex 3) and

• to include information regarding the dispatchment of specimens from outside the EU (Annex 2).


A ‘mock-up’ is a copy of the flat artwork design in full colour, presented so that, following cutting and folding where necessary, it provides a replica of both the outer and immediate packaging so that the three dimensional presentation of the label text is clear.


A ‘specimen’ is a sample of the actual printed outer and immediate packaging materials and package leaflet (i.e. the sales presentation).


Title V of Directive 2001/83/EC defines the particulars to be included on the outer/immediate labelling and in the package leaflet. Also, templates are provided in all EEA languages on the EMA website, which reflect the items which must appear on the labelling and package leaflet of medicinal products according to the Directive.


Similarly, the Guideline on the readability of the label and package leaflet of medicinal products for human use , details the presentation of the content of the labelling and package leaflet and on the design and layout concepts which will aid the production of high-quality information.


Click this LINK to know more about this guideline.



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