The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a revision of its GMP “Orange Guide” in January that incorporates the changes made to EU’s GMP Guide in the wake of the Falsified Medicines Directive (FMD). Included are new chapters regarding brokers of finished medicines and active substance manufacturers, distributors and brokers, along with a new appendix of names and addresses of other EU medicines regulators. [See IPQ July 29, 2013 for more on the impact of the FMD on the MHRA/EU GMPs.]
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