COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations

Recommendation

Thursday, 1 October 2020 14.00 - 15.30 h

Webinar GDP for APIs

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.

Now the first revision of the document was published on 17 April 2020. Four new questions and answers (2.2, 2.3, 2.4 and 4.1) have been added in the update. Question 2.3 deals with GDP certificates and wholesale authorisations.

The answer 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 2021 without the need for further action from the holder of the certificate."  The same should apply for the validity of time-limited wholesale authorisations.

Routine on-site inspections will resume as soon as COVID-19 restrictions are lifted. Of course, it is upon distributors and wholesalers to continue complying with GDP. If necessary inspections - distant assessments or on site - may be launched at any time.

Please also see the complete Q&A document entitled QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC.