Share
News about supervision and inspection
-
24 September 2012
Important notice to marketing authorisation holders/representatives of medicines containing cephalosporins
Four Chinese companies have been found to have used waste gutter oil in the manufacturing of 7-aminocephalosporanic acid (7-ACA).
-
21 August 2012
Tests of glycerol used in magistral formulations and marketed medicinal products
Supplementing the enhanced control of active substances (the API project), the Danish Health and Medicines Authority has recently put increased focus on further testing of excipients. The Danish Health and Medicines Authority's laboratory has analysed the excipients glycerol and glycerol 85%. Samples of the excipient have been submitted by pharmacies that perform magistral formulations and by companies with marketed medicinal products. Analyses have been performed on glycerol batches from seven pharmacies and five companies.
-
05 July 2012
Suspension of Certificate of Suitability for the active substance Leflunomide
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP 2009-035/Leflunomide.
-
05 July 2012
Withdrawal of Certificates of Suitability for the active substances Chlorhexidine digluconate solution and Calcium dobesilate monohydrate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): CEP 2005-076-Rev 01/Chlorhexidine digluconate solution and CEP 2010-209-Rev 00/Calcium dobesilate monohydrate.
-
22 June 2012
Suspension of Certificates of Suitability for several active substances from the manufacturer Amoli Organics PVT Ltd
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended a number of Certificates of Suitability (CEP):
-
22 June 2012
Suspension of Certificate of Suitability for the active substance Povidone iodicated
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2009-166 / Povidone iodicated ...
-
08 June 2012 | Updated 13 June 2012
Certificates of Suitability for the active substances Oxytetracycline dihydrate and Oxytetracycline hydrochloride have been withdrawn
Updated: The following Certificates of Suitability (CEPs) have been withdrawn at the request of the manufacturer. CEP 2004-177-Rev 00/ Oxytetracycline dihydrate CEP 2008-165-Rev 00/ Oxytetracycline hydrochloride
-
17 April 2012 | Updated 12 June 2012
-
24 April 2012
The EDQM has withdrawn the Certificate of Suitability for the active substance Acetylsalicylic acid
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2006-195-Rev 00 / Acetylsalicylic acid.
-
24 April 2012
The EDQM has suspended the Certificate of Suitability for the active substance Stanozolol Micronised
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): R1-CEP 2002-222-Rev 01 / Stanozolol Micronised.
-
24 April 2012
The EDQM has withdrawn the Certificate of Suitability for the active substance Oxaliplatin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2005-158-Rev 00 / Oxaliplatin.
-
18 April 2012
The EDQM has withdrawn Certificates of Suitability for the active substance Diclofenac Sodium
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): R0-CEP 2006-304-Rev 00 Diclofenac Sodium and R1-CEP 2000-133-Rev 02 Diclofenac Sodium.
-
17 April 2012
The EDQM has withdrawn Certificates of Suitability from CSPC Innovation Pharmaceutical Co., Ltd.
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn a number of Certificates of Suitability (CEP) from CSPC Innovation Pharmaceutical Co., Ltd.
-
11 April 2012
The EDQM has suspended the Certificate of Suitability for the active substance Trimetazidine dihydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride.
-
28 March 2012
The EDQM has suspended the Certificates of Suitability for the active substances Pilocarpine nitrate and Pilocarpine hydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEPs): CEP 1997-034-Rev 02 / Pilocarpine hydrochloride and CEP 2002-202-Rev 00 / Pilocarpine nitrate.
-
22 March 2012
Danish package leaflet database checked for statutory uploads
Companies that sell medicines on the Danish market are obliged to make the newest package leaflet available at the Danish package leaflet website indlaegsseddel.dk. To ensure compliance with the rules, the former Danish Medicines Agency (now the Danish National Board of Health) has checked if all medicines sold in Denmark have a corresponding package leaflet on the website indlaegsseddel.dk. There are about 5,300 different medicines on the Danish market, and all of them have been checked. About 8 % had deficiencies in relation to the statutory requirements.
-
29 February 2012
Compliance check of package leaflets and product labelling (winter 2012)
Companies marketing medicines in Denmark are responsible for ensuring that their package leaflets and labelling comply with the Danish executive order on labelling. The Danish Medicines Agency regularly carries out random compliance checks of package leaflets and product labelling.
-
23 February 2012
The EDQM has suspended the Certificates of Suitability for the active substances theophylline, theophylline-ethylenediamine anhydrous and caffeine
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificates of Suitability (CEP) for a number of active substances.
-
07 February 2012
The EDQM has suspended the Certificate of Suitability for the active substance trimetazidine dihydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP R0-2007-254-Rev01 trimetazidine dihydrochloride.
-
07 February 2012
The EDQM has suspended the Certificate of Suitability for the active substance erythromycin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for the active substance erythromycin.
