Function as information officer
How far are pharmaceutical companies allowed to go when advertising medicinal products? What must and what may a summary of product characteristics contain?
Diapharm is fully acquainted with these issues – and also takes responsibility for them: as the information officer in accordance with EU Directive 2001/83/EC, we provide expert and reliable assistance regarding questions relating to drug information.
With Diapharm’s help, pharmaceutical companies are able to fulfil legal requirements without having to tie up their experts with additional responsibilities. On our clients’ behalf, we check whether they comply with the requirements set forth in the AMG and laws regarding healthcare advertising (e.g., HWG) regarding
- Patient Information Leaflets (PIL)
- Summary of Product Characteristics (SmPC)
- Advertising materials (adverts, brochures, displays, etc.) and materials for field representatives
In addition to the pure review of provided texts by an information officer in accordance with sect. 74a of the AMG, our qualified experts also offer medical writing services for such technical information texts with the expertise necessary for this job.