2009 amendment to the German Medicines Act

This federal law was promulgated by the Federal Law Gazette I No. 63/2009 on 15.07.2009 and thus enters into force on 16.07.2009. On the one hand, it serves to adapt national law to the provisions of European law and thus to fulfill the implementation obligations and possibilities. On the other hand, it serves to adapt existing provisions to the requirements of practice and to clarify them.

Central cornerstones:

• Adaptations in connection with the Regulations (EC) on advanced therapy medicinal products and on medicinal products for paediatric use;
• Adaptation of the definition of medicinal product specialties to the European specifications;
• Requirements for the implementation of a "compassionate use program";
• Term "observational study" replaced by "non-interventional study" (this includes evaluations from registries and "correlation studies");
• Withdrawal of consent to participate in a clinical trial to be distinguished from withdrawal of consent to use data under data protection law;
• Reblistering by pharmacies;
• Change in the inspection frequency from the previous three years to five years for establishments that do not manufacture or control pharmaceuticals.

Notice:

The consolidated version will not be available for several weeks.

Queries:

MMMag. Bernd Unterkofler

Divisional Counsel

E-mail: bernd.unterkofler@ages.at

Phone: +43 (0) 50 555-36650

Download:

Federal Law Gazette BGBl. I No. 63/2009

Further inquiry note

basg@basg.gv.at