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

Regulatory NewsRegulatory News | 30 September 2021 |  By 

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

In April 2020, in light of new safety measures and travel restrictions imposed at the outset of the pandemic, the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission issued a notice extending GMP and GDP certificates, as well as time-limited manufacturing, import and wholesale authorizations, through the end of 2021 to ensure the availability of medicines for the region.

Now, a year and a half later, the agencies are once again extending the validity of those certificates as the pandemic shows little signs of abating as the more infectious Delta variant runs its course and travel restrictions are still present in many regions.

As such, the agencies have updated their notice to specify that 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.

Similarly, the updated notice says that 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.

The agencies further explain that a distant assessment by an EEA supervisory authority may be required for new sites in third countries when there is no applicable mutual recognition agreement (MRA) with local regulators. "In such cases, it should be indicated that the certificate has been granted on the basis of a distant assessment. Moreover, an on-site inspection should be conducted when circumstances permit," the notice states.

The notice also stresses that all obligations for GMP and GDP still apply to certificate holders and that manufacturers, distributors and wholesalers must continue to comply with applicable requirements.
"Supervisory authorities will remain vigilant to ensure the quality of medicines that are made available to patients in the EEA," the notice states.



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