CHAPTER VII

SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL

Annual reporting by the sponsor to the Agency
Article 43
1
Regarding investigational medicinal products other than placebo, the sponsor shall submit annually through the database referred to in Article 40(1) to the Agency a report on the safety of each investigational medicinal product used in a clinical trial for which it is the sponsor.
2
In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may, if provided for in the protocol, submit a single safety report on all investigational medicinal products used in that clinical trial.
3
The annual report referred to in paragraph 1 shall only contain aggregate and anonymised data.
4
The obligation referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product.