Validity of the Active Substance Manufacturer and Finished Drug Product Manufacturer
The Austrian Federal Office for Safety in Health Care (BASG)/Austrian Medicines and Medical Devices Agency points out that marketing authorisation holders are obliged to ensure that the quality of their medicinal products is in accordance with Article 4 of the Austrian Medicines Act (Arzneimittelgesetz, AMG).
In cases where the quality of an active substance is documented by an EDQM certificate (CEP, COS), the continuous validity of the certificate has to be ensured. Certificates transiently suspended or declared invalid as a result of negative GMP inspections are listed on the EDQM website www.edqm.eu/en/CEP-suspensions-withdrawals-restorations-1536.html or can be queried from the ‘Certification’ database (https://extranet.edqm.eu/publications/recherches_CEP.shtml).
Analogously, the quality of an active substance referring to an Active Substance Master File (ASMF) cannot be ensured after GMP inspections with negative outcome. Corresponding Non-Compliance Reports (NCRs) are published under http://eudragmdp.ema.europa.eu/.
In both cases, the quality of the active substances concerned can, from the view point of BASG/AGES, no longer be ensured and, as a result, fails to meet the requirements of the Austrian Medicines Act.
If necessary a different/new active substance manufacturer including respective documentation has to be approved via variation procedure.
Finished Drug Product
If a GMP-inspection of a finished drug product manufacturer has a negative outcome, a corresponding Non-Compliance Report (NCR) will be published under http://eudragmdp.ema.europa.eu/. The quality of medicinal product(s) concerned can, from the view point of BASG/AGES, no longer be ensured and, as a result, fails to meet the requirements of the Austrian Medicines Act.
If necessary a different/new finished drug product manufacturer including respective documentation has to be approved via variation procedure.
Created: 21.03.2009 | Page last modified: 21.01.2016