Scenesse seems to be now formally released in Germany according to this google translate of a letter to the German EPP association.
* 1Bundesinstitut for drugs
BfArM, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn
EPP e.V.
Elke Hauke
Email: elkehaukeeyahoo.de Cc: vorstandeep p -deutschland.de
Episode request SCENESSE, Afamelanotide
Your character and message from: 25/04/2016
Dear Mrs. Hauke,
and Medical Devices
We refer to your inquiry of April 25, 2016 and e-mails to various persons in the BfArM of 21 March 2016 and the questions expressed are the start of treatment in Germany or to the outstanding steps. For this purpose we can len notification feature
According to additional requirement for the safe and effective use of SCENESSE® the MAH / Pharmaceutical entrepreneur pursuant to Annex IID of the product information bulletin the following additional risk minimization measures to fulfill (Clinuvel):
Before the introduction of SCENESSE in all Member States the holder of the marketing authorization with the competent national authority has to speak the content and format of the infor- mation package, including communications media, delivery modalities and other aspects, off. The holder of the marketing authorization shall also adopt agreements regarding the details of the program for controlled access, to ensure that SCENESSE is only issued to centers where doctors have received the information and have been trained appropriately.
The holder of the marketing authorization ensures that in all Member States, in the SCENESSE comes on the market, all healthcare professionals who are expected to apply the product, obtain the following information pack and be trained:
• Summary of Product Characteristics
• Material for Classroom
• Register information sheet.
The tuned according to admission requirements with the BfArM training materials for doctors of treatment centers as well as the details of the controlled distribution system were the BfArM mostly first filed in February 2016 and have been tested here then as soon as possible. It has been shown that for. T. extensive revisions were necessary, the BfArM has done with concrete information and formulating proposals, considerable assistance for the marketing authorization holder. This has the BfArM - different than usual - fulfilling the admission requirements with own personnel resources supported strongly un-. The latest materials, including some of the material for classroom training, were approved the necessary changes to the 04/20/2016. These changes, the company Clinuvel approved on 22.04.2016 and 04.25.2016, so that now all of the materials in connection with the training package for doctors or medical professionals in the treatment centers as well as in connection with the controlled distribution system from the final BfArM are approved. A corresponding notice to Clinuvel took place on 25.04.2016.
There are thus no longer open to aspects that require te before a marketing SCENESSE in Germany or in front of the required training of doctors and medical skilled specialists in the treatment centers of coordination with the BfArM.
We assume that those placed in your letter expressed concerns have been taken into account in appropriate manner with this date. Precisely because of the special situation of patients whose has always proactively taken the initiative to allow a speedy market access BfArM. If you want to visit us despite Now that the clearance with a delegation of your association, we are sure happy avail- able.
AI
