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Information on the use of medicinal products containing thalidomide, lenalidomide or pomalidomide, in clinical trials

Date 2014.07.29

Section 3a of the Ordinance on the Prescription of Medicinal Products ("Arzneimittelverschrei­bungsverordnung", AMVV) of 21 December 2005 (BGBl. I p. 3632) as last amended by Article 1 of the Ordinance of 19 February 2013 (BGBl. I p. 312) applies to the use of medicinal products containing thalidomide, lenalidomide or pomalidomide, in clinical trials.

The following provisions apply for clinical trials where the concept of the trial does not allow prescription by way of T-forms:

1.       The sponsor is responsible for providing thalidomide, lenalidomide or pomalidomide for use in clinical trials if these are administered as investigational medicinal products (cf. Section 4 sub-section 24 AMG and Section 3 sub-section 3 GCP-V). The trial medication is dispensed to the patients by the investigator. The sponsors of ongoing clinical trials with investigational medicinal products containing thalidomide are supposed to present a list of all suspected cases of serious adverse reactions that occurred during the clinical trial at quarterly intervals. They are also requested to submit a report on the safety of the patients in accordance with Section 13 sub-section 6 GCP-V which shows how many patients were treated for how long during the reporting period and at which dosages of the investigational medicinal products containing thalidomide.

2.       The protocol is to specify that dispensing of investigational medicinal products that also include thalidomide, lenalidomide or pomalidomide in clinical trials to patients of childbearing potential by the investigator must not exceed the supply necessary for 4 weeks (in all other cases 12 weeks).

3.       The protocol should also reflect the conditions and requirements of the pregnancy prevention programme as well as the measures during and after the treatment with investigational medicinal products which also include thalidomide, lenalidomide or pomalidomide in accordance with Section 3a AMVV.

4.       Prior to treatment, all persons concerned must have been given the information material (informed consent sheets/checklists], treatment record booklet as well as a description of the pregnancy prevention programme). The information material is made available by the respective Marketing Authorisation Holder; in the case of thalidomide, the information material can also be downloaded from http://www.bfarm.de/DE/Bundesopiumstelle/T-Rezept/checklisten/_node.html. The statements made in the information brochure must also be part of the patient information.

5.       The principal investigator of a trial site who conducts clinical trials which include administration of thalidomide, lenalidomide or pomalidomide has to be registered in the T-register beforehand.

T-prescriptions should always be used in clinical trials where the concept of the trial allows prescription of investigational medicinal products that contain thalidomide, lenalidomide or pomalidomide. The stipulations of Section 3a of the Ordinance on the Prescription of Medicinal Products must be adhered to strictly.

The outer appearance of the T-prescription described there has been altered in accordance with the announcement of 17 June 2011.

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