Package insert for medicinal products used by professionals

Requirements for product information for human medicinal product information in dispensing categories A and B

According to Chapter of the WL Guidance document Formal requirements, no patient information is required for certain types of human medicinal products in dispensing categories A and B which in accordance with Art. 14 Para. 2 TPO (Therapeutic Products Ordinance - In German only) are used exclusively by physicians or dentists (e.g. injectables, infusions). Theoretically, however, it is possible to provide patient information in this case. The patient information can then be used as a package insert (in 3 languages) instead of the Information for healthcare Professionals. Otherwise, the Information for healthcare Professionals is used as a package leaflet in accordance with the information in the Guidance document Packaging for human medicinal products, i.e. in two languages.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director

Send email


You might also find this interesting

We also pass on our knowledge at events:
Decades of experience and knowledge – these are our employees:
We have been committed to serving our clients enthusiastically and cooperatively for 25 years: