GMP and Quality of IMP
GMP and Quality Documentation
For investigational medicinal products, including placebos, used in clinical trials, there are requirements for GMP and quality documentation that must be included in the application dossier for the clinical trial. These requirements vary depending on whether the investigational medicinal product is approved or not. Refer to "Documentation for the Quality of Investigational Medicinal Products for Use in Clinical Trials with Medicinal Products" and "Documentation for GMP for Use in Clinical Trials with Medicinal Products" for further details regarding requirements for GMP and quality documentation for investigational medicinal products in clinical trials (only in Danish).
Also, refer to Chapter 3 in EudraLex Vol. 10 for guidelines on preparing the Investigational Medicinal Product Dossier (IMPD) for documenting the quality of the investigational medicinal product, where applicable.
Auxiliary Medicinal Products
Clinical trials may also involve Auxiliary Medicinal Products (AxMP), which are medicinal products used in a clinical trial but not used as investigational medicinal products. Generally, only non-marketed and modified marketed AxMP need to be registered in CTIS, along with submission of GMP and quality documentation for these. The same requirements for GMP and quality documentation as stated in the above guidelines apply to non-marketed or modified marketed AxMP.
Note that it is not a requirement for marketed unmodified AxMP to be registered in CTIS. However, they must be listed in the cover letter or protocol for the trial. For further information regarding AxMP, refer to "Auxiliary Medicinal Products in Clinical Trials" in EudraLex Vol. 10.
For additional guidance on quality aspects in clinical trials, please refer to Chapter 3 in EudraLex Vol. 10 on the EC's website.
Labeling
Labeling must comply with the requirements as described in Annex VI under the Regulation and Regulation No. 2022/2239 to Regulation No. 536/2014. The labeling must be in Danish, but for preparations administered exclusively by hospital personnel, English labeling may be accepted. However, Danish instructions for personnel must be available.