The mock-up of medicinal product packaging
Instructions for preparing a mock-up of the packaging of the medicinal product
Instructions for preparing a mock-up of the packaging of the medicinal product (version 1.2, January 2019) are available here.
These instructions are intended for applicants/marketing authorisation as a guide when producing a mock-up of medicinal product packaging, so as to best utilise the packaging surface area at their disposal for designating the stipulated mandatory information for the purpose of unambiguous identification of medicinal products and their safe administering.
The instructions explain the provisions of current laws that refer to the labelling of medicinal products and provides more detailed recommendations for producing high-quality and consistent presentation of information on the mock-ups of medicinal product packaging, which must be clear and legible in order to avoid confusing healthcare workers/users of medicinal products and the possibility of wrongly administering medicinal products.