18 May 2020 - Authored by:Tine Carmeliet
On 3 April 2020, the Federal Agency for Medicines and Health Products (FAMHP) updated its guidelines on the labelling of medicinal products. The FAMHP stated in a communication that the update brought the guidelines in line with EU legislation and other national and international agreements. For example, to avoid medication errors, the guidance now includes clarification on the requirements concerning mock-ups, which are the “two-dimensional draft design, in colour and employing the final font and character size, which gives a clear image of the three-dimensional presentation of the packaging”.
Marketing authorisation holders of medicinal products for human use are required to comply with these guidelines.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, May 2020 Issue (Thomson Reuters)