The continued availability of medicines is one of the most important priorities for EU authorities during the COVID-19 pandemic. As such the The European Medicines Agency has provided guidance on Addressing Supply Chain Shortages Due to the COVID-19 Pandemic. Following a virtual meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, a Q&A document was produced to provide guidance on the flexibility of regulatory requirements pertaining to medicines during the pandemic.
Marketing Authorisation Holders (MAHs) will be able to use manufacturing sites or sites responsible for quality control that are not specifically mentioned in the marketing authorisation in cases where the use of an alternative site is necessary to prevent/mitigate shortages of supplies in the EU.
If you are currently experiencing delays in Quality Control testing, Tepnel Pharma Services, is one of the largest independent pharmaceutical based FDA and MHRA inspected contract research organisations, offering Chemistry and Microbiology services to support Pharmaceutical Research and Development from preclinical enabling stability and formulation selection through to batch release testing for the market place.
We are here to support you during these challenging times. For further details and to discuss your requirements please contact:
Stewart Neithercut, Business Development Manager
Mobile : +44 (0) 7785 438 308
Office : +44 (0) 1506 424 270
Alternatively, please complete the contact form here.