CMDh Update For New Applications

Mock-ups, specimens and samples required for New applications

15th April 2016

In accordance with Article 8 of Directive 2001/83/EC, a mock-up of the sales presentation of the medicinal product, together with the proposed package leaflet should be included with the application. In addition, Member States may require specimens of the sales presentation of the medicinal product to be submitted, in order to check compliance with the relevant articles in Title V of Directive 2001/83/EC.

A "mock-up" is a copy of the flat artwork design in full colour (incl. Braille if applicable), 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 labelling text of the medicinal product is clear. It is generally referred to as a "paper copy" or "computer generated version".

A "specimen" should be interpreted as referring to a sample of the actual printed outer and inner packaging materials and package leaflet (i.e. the sales presentation).

Sample requirements in National, Decentralised and Mutual Recognition (new applications):

For the purposes of implementing Article 10 of Directive 2001/83/EC, samples of the (non-) active substances and of the finished medicinal product should be supplied.

An overview of the requirements by Member States could be found in the published document .

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