Mock-ups and specimens

The European Medicines Agency operates a checking process of the printed materials used in the packaging and labelling of centrally authorised medicines.

The aim of this checking process is to improve the quality of the printed materials that patients and healthcare workers receive with a medicine. This includes the outer and inner packaging of the medicine, and the printed package leaflet.

The Agency reviews mock-ups and specimens of the packaging and labelling of medicines authorised via the centralised procedure, both before the medicine is marketed and following certain changes to the medicine's authorisation:

  • Mock-ups are copies 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.
  • Specimens are samples of the actual printed outer and immediate packaging materials and package leaflet, i.e. the 'sales presentation'.

The QRD group has agreed on a contact point list for any request to place the unique identifier, as required by the Falsified Medicines Directive, via a sticker. Applicants/MAHs should contact directly Member States who will then communicate their decision to the requester as well as inform EMA of the outcome.

Related information: Commission Delegated Regulation (EU) 2016/161 and Safety features for medicinal products for human use questions and answers (Q.2.21).


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