Medicinal Products Act (AMG) adapted to EU Regulation 536/2014


The Amendment of the German Medicinal Products Act [Arzneimittelgesetz – AMG] enters into force
The Clinical Trials Regulation, Regulation EU No 536/2014 is expected to come into application in 2019. This regulation is intended to further harmonise the approval, conduct and monitoring of clinical trials in the EU, and to replace the current Clinical Trials Directive 2001/20/EC. Since an EU regulation (unlike an EU directive) is directly applicable law in all EU member states, the German Medicinal Products Act (AMG) had to have certain rules that do not comply with the new EU Regulation removed. In addition, national regulations had to be defined for those areas in which the EU Clinical Trials Regulation still leaves the Member States some room for manoeuvre.

With the Fourth Law Amending the German Medicinal Products Act (AMG) and other regulations vated 20 December 2016, the German Medicinal Products Act (AMG) has now been amended accordingly in a two-stage process.

Article 1 of this amending law came into force on 23 December 2016. It regulates the preparatory measures required for the application of the Clinical Trials Regulation, Regulation EU No 536/2014. Here are the main points::

  • Ethics committees wishing to participate in the review of clinical trial applications after Regulation EU No 536/2014 comes into application must register with the German Federal Institute for Drugs and Medical Devices (BfArM), and must meet minimum requirements with regard to their organisation and composition.
  • The German Federal Ministry of Health will issue rules of procedure for future cooperation between ethics committees and higher federal authorities.
  • The ethics committees registered by 30 September 2017 must then issue a case assignment plan, which is to be updated annually and published by BfArM. This plan is intended to regulate the allocation of applications for authorisation submitted to registered ethics committees via the EU portal that is due to be set up in the future.
  • The German Federal Ministry of Health is empowered to establish a Federal Ethics Committee at BfArM and the Paul Ehrlich Institute (PEI) if this is necessary to ensure the timely processing of the applications for approval. This is intended solely as an emergency solution in the event that the registered ethics committees are unable to satisfactorily perform this task.

Since these preparatory measures will take some time to implement, it was essential to make the relevant changes to the German Medicinal Products Act (AMG) now so that they can be fully implemented by 2019.
You can find the current version of the German Medicinal Products Act (AMG), along with the amendments that have now come into force here.

Article 2 of the amending law ensures that there will be no contradictions between the terminology and processes of the German Medicinal Products Act (AMG) and those of the Regulation EU No 536/2014 when they come into application. In addition, where there is still room for manoeuvre on the national level, the amending law makes use of this. To this end, the following adjustments have been made:

  • A new definition of the term “clinical study” has been introduced as an overarching term encompassing both clinical trials and non-interventional studies.
  • The previous definition of the investigator according to the German Medicinal Products Act (AMG) has been replaced by the new concept of the Principal Investigator and Investigator (which has however been used in the past). The “Leiter der Klinischen Prüfung (LKP)” [Coordinating Investigator for Germany in multicentre trials] role has been scrapped.
  • The new approval procedures and time limits defined in the EU Clinical Trials Regulation are reflected in the German Medicinal Products Act (AMG).
  • The obligation to notify the supervisory authorities about the conduct of clinical trials as it existed according to Section 67 (AMG) has been scrapped.
  • Research in adults who are incapable of giving consent for the benefit of the patient population is now allowed under certain conditions.
  • Some special rules that apply to Germany specifically, such as the requirement for research subjects to have the informed consent discussion with a physician, will remain in place.

These amendments are scheduled to come into effect six months after the European Commission issues notification that the EU portal described in Regulation EU No 536/2014 and the associated database are functioning. Given the current status, this will not happen before 2019. Therefore, the adjustments described in Article 2 of the amending law are not yet taken into account in the current version of the German Medicinal Products Act (AMG).

According to Article 13 of the amending law, the German GCP Ordinance (GCP-V) will cease to be in force as soon as Article 2 comes into effect. Article 2 of the amending law will incorporate those sections of the GCP-V that will still be relevant when Regulation EU No 536/2014 comes into application into the text of the German Medicinal Products Act (AMG).