Update GMP and GDP Certificates, Anyone who has recently reviewed the Medicines and Healthcare products Regulatory Agency (MHRA) CMS may have noticed the notification at the bottom of the search page regarding GMP and GDP Certificates, stating the following:
“Due to the restrictions caused by COVID-19, the period of validity of GMP and GDP certificates is automatically extended until the end of 2023. On-site inspections will resume as soon as travel restrictions permit. The clarifying remark section of individual GMP and GDP certificates will indicate any exceptions. MHRA reserves the right to inspect a manufacturing or wholesaling site should the need arise.”
The further extension of certificates may allow manufacturers and wholesalers to continue their activities, within the scope of their licence(s), however the MHRA will continue to endeavour to perform re-inspections in advance of the validity date of the GMP and/or GDP certificate(s) to ensure continuity of the documentation. However due to the risk-based prioritisation of resources this has not always been possible, and the MHRA have advised that they are aware that some GMP/ GDP certificates have now passed their validity date.
It is important that wholesalers and manufacturers continue to perform the checks required to ensure an appropriate authorisation is held and that wholesalers maintain compliance with the Roles and Guidance for Pharmaceutical Distributors 2022 “The MHRA Green Guide” and that manufacturers maintain compliance with the Rules and Guidance for Pharmaceutical Manufacturers and Distributors “The MHRA Orange Guide” issued by the MHRA to account for the updates in guidance.
It is also essential that all wholesale dealers in Great Britain with a licenced site that has been named on the licence prior to the 1st of January 2021 and have been importing from Europe prior to 1st of January 2021 that intend to import Qualified Person certified medicines from the European Economic Area have submitted a variation to the add their named Responsible Person for import (RPi) by the 1st of January 2023.
For more information on MHRA CSM and to check GMP/ GDP certificates please follow the links below:
https://cms.mhra.gov.uk/mhra/gdp
https://cms.mhra.gov.uk/mhra/gmp
For more information on MHRA inspectorate please follow the links below:
https://mhrainspectorate.blog.gov.uk/
https://mhrainspectorate.blog.gov.uk/category/good-distribution-practice/
https://mhrainspectorate.blog.gov.uk/category/good-manufacturing-practice/
For more information on RPi please follow the links below:
https://pclportal.mhra.gov.uk/guidance/rpi-guidance/ https://www.gov.uk/guidance/acting-as-a-responsible-person-import