Medicinal products; notification of a clinical trial

Anyone wishing to conduct clinical trials in accordance with §§ 40ff. German Medicines Act (AMG) must notify the government responsible for the notifying party (sponsor, CRO, laboratory, test facility).

Responsibilities

• Government of Upper Franconia: responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia
• Government of Upper Bavaria: responsible for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia

The requirements for the clinical trial are set out in Section 40 et seq. AMG.

Extract of general requirements
In addition to the requirements set out in Regulation (EU) No. 536/2014, a clinical trial may only be conducted as long as

1. there is a sponsor or a representative of the sponsor for purely national clinical trials and for clinical trials conducted nationally and in third countries who is based in a Member State of the European Union or in another state party to the Agreement on the European Economic Area,
2. the person on whom the clinical trial is to be conducted (person concerned) is not placed in an institution by court or official order,
3. in the event that a human being is killed or the body or health of a human being is injured during the conduct of the clinical trial, insurance exists which also provides benefits if no one else is liable for the damage, in accordance with the following conditions:
   (a) the insurance must be taken out for the benefit of the person concerned by the clinical trial with an insurer authorized to do business in a Member State of the European Union or in another State party to the Agreement on the European Economic Area,
   (b) the scope of the insurance must be proportionate to the risks associated with a clinical trial and must be determined on the basis of the risk assessment in such a way that at least EUR 500 000 is available for each case of death or continuing incapacity of a person concerned by the clinical trial,
4. according to the state of scientific knowledge, in relation to the purpose of the clinical trial of a medicinal product consisting of or containing a genetically modified organism or a combination of genetically modified organisms, unacceptable adverse effects are not to be expected on
   a) the health of third parties and
   b) the environment,
5. it takes place in an appropriate facility in accordance with Article 50 in conjunction with point 67 of Annex I to Regulation (EU) No 536/2014.

For clinical trials with medicinal products that fall within the scope of Regulation (EU) No. 536/2014, the notification must be made online (see "Online procedure").

The AMG does not set deadlines.

The notification can be confirmed once all the necessary documents have been submitted and any outstanding issues have been clarified.

Costs for the notification confirmation: €50 to €5,000 (according to the list of costs - tariff no. 7.IX.8 / tariff item 1.1.4.3)

They are to be borne by the advertiser.