GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022

Recommendation

14/15 December 2021

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In 2020 the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. A revision published in April 2020 stated that "the validity of GDP certificates should be extended until the end of 2021 without the need for further action from the holder of the certificate."

The guidance was updated again on 30 September 2021 to reflect the extended validity of GDP certificates.

The answer to question 2.4 now says:

"In light of difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, the validity of GDP certificates should be extended until the end of 2022 without the need for further action from the holder of the certificate.
The validity of time-limited wholesale authorisations should also be extended until the end of 2022 without the need for further action from the holder of the authorisation. This automatic extension does not apply where restrictions on the validity period are stated in the clarifying remarks on the GDP certificate and also does not cover changes in the scope of the authorisation (e.g. type of medicinal products or authorised operations).
On-site inspections will be conducted according to risk-based inspection planning, taking into account any restriction due to COVID-19."

The European Medicines Agency points out that this does not waive distributors' and wholesalers' obligations to comply with GDP standards."It is incumbent upon distributors and wholesalers to continue complying with GDP."

The extension also applies to GMP certificates.

For further information, please see the complete Q&A document Notice to stakeholders: questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.