CHMP opinions on consultation procedures
Human
Regulatory and procedural guidance
Research and development
The European Medicines Agency (EMA) publishes a consultation procedure public assessment report (CPAR) on the opinions prepared by its Committee for Medicinal Products for Human Use (CHMP) following a consultation procedure with EMA on the quality, safety, benefits and risks of ancillary substances incorporated in a medical device.
EMA publishes the CPAR after the notified body confirms the granting of a Conformité Européenne (CE) mark for the device.
The Agency also publishes information on procedural steps taken after a consultation procedure.
For more information on the consultation procedure, see Ancillary medicinal substances in medical devices.
Human albumin
Cooper Surgical Inc
BSI Group The Netherlands B.V.
19/02/2011
210
Human albumin solution
Catalent Indiana LLC
DNV GL Nemko Presafe AS
16/02/2012
180
Human albumin solution
FertiPro N.V.
BSI Group The Netherlands B.V.
19/01/2012
210
Human thrombin
Baxter AG
TÜV SÜD Product Service GmbH
19/01/2012
204
Human serum albumin
Genea Biomedx PTY Limited
BSI Group The Netherlands B.V.
23/04/2015
210
Human thrombin
Biom'Up France SAS
BSI Group The Netherlands B.V.
25/09/2014
210
Human albumin
Irvine Scientific
National Standards Authority of Ireland (NSAI)
21/02/2008
176
Human albumin
Vitrolife Sweden AB
Det Norske Veritas Certification AS
28/06/2006
174
Human albumin solution / gentamicin sulfate
Kitazato Corporation
BSI Group
22/06/2023
210
Human serum albumin
Life Global Group LLC
BSI Group The Netherlands B.V.
26/01/2017
210
Human albumin
Origio a/s
Presafe Denmark A/S
14/12/2007
195
Gentamicin sulfate / sargramostim (GM-CSF) / heparin sodium / insulin human
Cooper Surgical, Inc.
BSI Group, The Netherlands
20/07/2023
210
Human albumin solution
NidaCon International AB
Det Norske Veritas Certification AS
21/02/2013
210
Human thrombin
Ferrosan A/S
Dnv Gl AS
19/05/2011
210
Human albumin
XVIVO Perfusion AB
Det Norske Veritas Certification AS
13/10/2005
180
human albumin solution
Shenzhen Vitavitro Biotech Co. Ltd.
BSI Group, The Netherlands B.V.
14/11/2024
203
Recombinant human albumin solution
Albumedix Ltd
DNV Product Assurance AS
25/01/2018
210