§ 28 of the Medicine Act

Authority to impose conditions on producers

 

(1) The Supreme Federal Authority in charge can combine the admission of medical products with strict conditions. these conditions can also be ordered after the admission.

 

Concerning conditions under paragraphs 2-3c ("protection of the enviroment"), the Supreme Federal Authority in charge will decide in agreement with the Federal Enviroment Agency, if repercusussions on the enviroment have to taken into consideration.

 

In this case the Supreme Federal Authority will deliver all necessary data and documents to the Federal Enviroment Agency.

 

(2) Conditions can be imposed on producers in order to guarantee that the medicine is sold - if necessary -  in an appropriate packaging, which has to have a certain shape, a safety catch and/or any other safety precautions. This is indispensable, either in order to guarantee that the customer can measure out the medicine correctly or to prevent abuse of the medical product by children.

 

The German Medicine Act, the conditions and a list of active substances in question can be downloaded here Download.