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Guide to labels and leaflets of human medicines

09 December 2013

The guidance in this document applies to the label and package leaflets of medicinal products for human use, authorised nationally, through mutual-recognition or through the decentralised procedure. The guidance does not apply to medicinal products authorised through the centralised procedure. A link to the Braille declaration form can also be found below.

Click on the link below to read the full Guide to labels and leaflets for Human Medicines:
Guide to Labels and Leaflets of Human Medicines

For details of the most recent changes in the guide, click on the link below:
Guide to Labels and Leaflets of Human Medicines - with changes tracked

Click on the link below to view the Braille declaration form:
Braille declaration form





Date Printed: 25 April 2014

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