CEP Suspension: R0-CEP 2013-274-Rev 00/Aceclofenac, R0-CEP 2013-135-Rev 00/Telmisartan – Jiangxi Synergy Pharmaceutical Co. LTD (China) (10/02/2016)
Notice to Pharmaceutical Companies – 02/10/2016
Following the inspection conducted by the German inspectorate, at the Chinese site in question, it was found to be "not in compliance" with the GMP [ed: Good manufacturing practices].
Therefore, the EDQM [ed European Directorate for the Quality of Medicines & Healthcare] has taken the decision to suspend the following certificates: CEP – R0-CEP 2013-274-Rev 00/ACECLOFENAC, R0-CEP 2013-135-Rev 00/TELMISARTAN.
Companies are asked to urgently verify whether, for medicines containing the following active substances and/or production intermediates: ACECLOFENAC, TELMISARTAN, authorized for the Italian market and/or products for export, it is present as an authorized supplier, the Pharmaceutical Workshop: JIANGXI SYNERGY PHARMACEUTICAL CO. LTD – JIANGXI FENGXIN INDUSTRIAL PARK, FENGXIN 330700 JIANGXI PROVINCE, PR CHINA.
Alone in the event of a positive response, the Company must immediately notify it, indicate any 
presence of an alternative production site to the one in question and proceed with the presentation of a declaration relating to the non-use of the pharmacologically active raw material and/or production intermediate produced in the aforementioned site until it is re-inspected with the issue of an updated GMP certificate or indicate the absence of an alternative production site and proceed with the variation request for the addition of a new production site and with the submission of a declaration relating to the non-use of the pharmacologically active raw material and/or production intermediate produced in the above-mentioned site until re-inspection of the same with issue of an updated GMP certificate.
Lastly, it is required for medicines authorized with mutual recognition procedure, to specify the European procedure code.
The notification must be received within the day February 17, 2016, to the following mailbox:
- infocepgmp@aifa.gov.it
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