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EU extends GMP, GDP certificates through 2022 as pandemic effects linger

European regulators announced that good manufacturing practice (GMP) and good distribution practice (GDP) certificates, as well as other time-limited authorizations, will be extended through 2022.

GMP and GDP certificates, and other time-limited authorizations, should generally be automatically extended through the end of 2022. For sites located in the European Economic Area (EEA), the extensions should occur without any action on the part of the certificate holder, unless there are restrictions on the validity period stated in the clarifying remarks of the certificate.

GMP certificates for manufacturing sites of active substances and finished ingredients should be automatically extended through 2022 without the need for any action from the certificate holder. Exceptions to the automatic extension apply in situations where the issuing/supervisory authority takes action that affects the validity of the certificate and for certificates with restrictions on the validity period noted in the clarifying remarks. As with sites located in the EEA, the automatic extension does not apply to changes in the scope of the certificate.

All obligations for GMP and GDP still apply to certificate holders and manufacturers, distributors and wholesalers must continue to comply with applicable requirements.....




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Il rinnovato obbiettivo dell’accordo prevede il consolidamento delle attività di produzione...



ICH recaps progress made over past year, charts new topics

The International Council for Harmonisation (ICH) announced that “significant milestones”...



UE: Parlamento, proposte per farmaci più accessibili e convenienti

I deputati europei hanno avanzato proposte per rendere i farmaci più accessibili e convenienti,...