Scientific information on your medicinal products must be checked with respect to specific guidelines. We provide an Information Officer for this task according to your needs.
Different markets do not only have different regulations, but sometimes also special positions that must be filled. One of these is the Information Officer, who plays an important role for the German and Austrian markets in particular.
In German pharmaceutical law, the Information Officer is responsible under §74a AMG (Medicinal Products Act) for ensuring that scientific information on offered medicinal products is correctly provided, for example in mandatory statements or in advertising, and is personally liable for this. Austria has a similar regulation according to §56 AMG.
Whether for a new product, certain sections or as a complete service – we provide you with an experienced Information Officer with the required expertise, depending on your needs. In this function, we...
- ...review the labelling of finished dosage forms and can thus properly release packaging materials.
- ...support you in the preparation and approval of package leaflets, expert information, and other mandatory texts so that their contents not only comply with the marketing authorization or registration, but also take all current national and EU-wide requirements into account.
- ...check advertising materials for compliance with the marketing authorization or registration documents and ensure that all relevant laws, in particular the Medicinal Products Act (AMG), the Health Services and Products Advertising Act (HWG), and the Act against Unfair Competition (UWG), are considered accordingly.
- ...assess whether any misleading names, specifications or presentations are used regarding the effect, guarantee of success, harmful effects, and quality of the products – and thus ensure that the prohibitions to prevent deception (AMG §8) are complied with.
- ...in addition to legal requirements, take care that all scientific information mentioned complies with your company's specific internal policies and SOPs.