Following an inspection by the Portuguese Agency, the pharmaceutical manufacturing site Symed Labs Limited, Telangana, India resulted as not in compliance with the GMP. Therefore, all its supplies have been stopped. The Italian Medicine Agency has asked all companies to check whether this site is included in the registration dossier of medicinal products authorized for the Italian and European market, or intended for exports. The inclusion of the site in the dossier must be immediately communicated to the Agency only by companies for which the site is authorized in the dossier, indicating an alternative site and submitting a variation application for its deletion/replacement. For medicinal products authorized through RMS or DCP, also the procedure code should be reported. The communication is to be sent within March 8th 2015.
Non compliance for an Indian manufacturing site
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