DE Deutschland

Medicinal products

Second Regulation amending the AMG Civil Protection Exemption Regulation

The draft Regulation complements the existing exceptions to pharmaceutical legislation for the procurement, storage, manufacture and placing on the market of medicinal products in certain crisis situations. 

The draft Regulation essentially lays down the following rules: In particular, for reasons of drug safety, the supply of an unauthorised medicinal product is made conditional on the positive assessment of the competent federal superior authority on the expected benefit-risk balance. In crisis situations, disparate distribution channels may be required to control the supply of medicines to the population. The corresponding exceptions to the pharmaceutical legislation will be supplemented for such cases. 

In addition, the exceptions to the labelling requirements will be supplemented to allow for a timely and flexible 

marketing of medicinal products in crisis situations. 

In addition, there is a supplement for the production of medicinal products. It is possible to deviate from various
regulations in the field of the manufacture of medicinal products after permission from the competent state
authority and positive evaluation by the competent federal authority. 

In addition, there is a restructuring and complementarity in the area of liability rules. The restructuring aims to
harmonise the requirements in the area of liability for all liability bases.