The table below lists tissue preparations which have a valid "authorisation for tissue preparations" pursuant to Section 21a, subsection 1 or 9 AMG or a valid marketing authorisation pursuant to Section 25, subsection 1 AMG.
An authorisation for tissue preparations according to section 21a, subsection 1 (Genehmigung) begins with the characters: PEI.G.xxxxx.xx.x.
An authorisation for tissue preparations according to section 21a, subsection 9 (Bescheinigung) begins with the characters: PEI.B.xxxxx.xx.x.
Tissue preparations that have been granted a marketing authorisation can be recognised by their marketing authorisation number which begins with the characters: PEI.H.xxxxx.xx.x.
Tissue preparations which have the marketing authorisation number 300xxxx.xx.x have been authorized by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Federal Institute for Drugs and Medical Devices) until September 2005 (14th amendment of the AMG, German Medicinal Products Act).
The list does not provide information as to whether the products are also available on the market. The information provided here is supplied without liability for errors or omissions. For information which is legally binding, please refer to the relevant marketing authorisation certificate. Official publications of the Paul-Ehrlich-Institut appear in the Bundesanzeiger (Federal Gazette).
If SPCs, package leaflets or public assessment reports are available in PharmNet, the gateway for information on medicinal products of the Federal Republic of Germany and the Länder (German Federal states), these are linked with the term PharmNet.
The most recent publication included in the section "Medicinal Products" is Federal Gazette publication No 435 (BAnz AT 12.07.2017 B10).
|Name||Marketing Authorisation Holder||License Number||License Date||Further Information|
Human-Knorpelgewebe, gefriergetrocknet, CHB
|Charité – Universitätsmedizin Berlin||PEI.H.03361.01.1||27.12.2005|
Human-Knorpelgewebe, gefrierkonserviert, CHB
|Charité – Universitätsmedizin Berlin||PEI.H.03364.01.1||27.12.2005|
Human-Knorpelgewebe, gefrierkonserviert, DIZG
|DIZG – Deutsches Institut für Zell- und Gewebeersatz gGmbH||PEI.H.03360.01.1||23.12.2005|