Labelling
Here you will find answers to frequently asked questions about labelling.
Does the labelling of the IMPs have to be in German language?
Yes, labelling in German language is necessary. This labelling must comply with the requirements of Section 5 of the GCP Ordinance.
Is it possible to use marketed (licensed) medicinal products in the usual market packaging and labelling as study medication without study-specific relabelling?
Yes, if this is in agreement with the study design.
Exception: If the channel of distribution (wholesale, pharmacy) is not maintained, an additional label bearing the information “for clinical trial use only” is required (Section 47 sub-section 1 number 2 letter g AMG).
Which kind of accompanying document can contain relevant labelling information omitted in the labelling?
An accompanying document can be a patient information leaflet or card which is handed out to the subject together with the investigational medicinal product.
The document must not be submitted to the Federal Institute for Drugs and Medical Devices (BfArM), it is sufficient to confirm that the accompanying document includes the relevant information.
Example: The sponsor’s telephone number and the EudraCT number are stated in the patient information leaflet (part of the cover letter).
Is the repackaging and relabelling of a licensed medicinal product a manufacturing step?
Yes, it is. The manufacturer who releases a modified drug product after such a manufacturing step has to be stated under D.8.2 in the application form.
Can statement of the expiry date in the labelling of investigational medicinal products (IMP) be omitted when using IVR/IWR systems (IVRS: Interactive Voice Response System, IWRS: Interactive Web Response System)?
Yes, but only in specific circumstances.
As a rule, this is only possible in case of clinical trials in which the IMPs are exclusively administered by the personnel at the investigator site and are not dispensed to the volunteers.
Furthermore, the Qualified Person [QP] responsible for the IMP release must confirm that the IVRS/IWRS is in line with basic GCP and GMP requirements.
Immediately prior to administration of the IMPs their expiry date must be checked and documented by way of the IVRS/IWRS at the investigator site.
The authorities' expectations with regard to IVRS/IWRS and processes at sponsor and investigator sites are presented in detail in the "Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (EMA/INS/GCP/600788/2011)".
This document also includes a form with which the QP can declare GCP / GMP conformity of the IVRS/IWRS.
In the case of clinical trials where the expiry date is omitted, this declaration is to be included in the application documentation. Furthermore, it is to be confirmed that the IMPs concerned are not dispensed to the volunteers.
These documents are to be filed under the information on labelling of the IMP in the submitted documentation or are to be saved to the directory "09 Labelling" if submitting electronically.