On 1 March 2018, the Federal Agency for Medicines and Health Products (FAMHP) published amended guidelines on the labelling of medicines within the context of new marketing authorisations, renewals or variations for medicines for human use. Pharmaceutical companies should comply with these guidelines, which stipulate specific requirements for the packaging and labelling of medicines.

The guidelines have been amended to meet European guidelines and other national and international agreements. The main changes include amendments to, inter alia:

  • The definition of small packages and mock-ups.
  • The use of trademarks and logos.
  • The labelling of combination packs.
  • Sections 16-19 of the guidelines in accordance with the European Quality Review of Documents template.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2018 issue (Thomson Reuters).