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'.

Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

Reference Number: EMA/305821/2006 Rev. 4 Summary:

Since February 2007 the European Medicines Agency (EMA) has been operating an extensive checking process of the marketing-authorisation holder’s (MAH) printed packaging materials for outer and immediate labelling of centrally authorised medicinal products as well as of the printed package leaflet (‘mock-ups and specimens’).

Mock-ups and specimens: Response form

Specimen submission form

Standard operating procedure for checking of mock-ups and specimens for new applications and extensions

Adopted Reference Number: SOP/H/3013 Legal effective date: 17/12/2010

Standard operating procedure for checking of mock-ups and specimens for renewals

Adopted Reference Number: SOP/H/3217 Legal effective date: 17/12/2010

Standard operating procedure for checking of mock-ups and specimens for transfer of marketing authorisation

Adopted Reference Number: SOP/H/3218 Legal effective date: 17/12/2010

Standard operating procedure for checking of mock-ups and specimens for all post-authorisation procedures other than new applications, line extensions, renewals and transfers

Adopted Reference Number: SOP/H/3219 Legal effective date: 17/12/2010