Master Alliance Provisions Guide (MAPGuide)

UK Secretary of State – AstraZeneca, COVID-19 Vaccine Supply Agreement

  • Other | Regulatory strategy

4. Manufacturing Facilities and Materials
[…]
4.5 AstraZeneca shall use either the MHRA [Medicines and Healthcare products Regulatory Agency] procedure or the EMA [European Medicines Agency] centralised procedure or both in order to obtain the Marketing Authorisation in the Territory at the earliest possible date. If AstraZeneca uses only the EMA centralised procedure and if the Marketing Authorisation is not granted before 1 January 2021 and the EMA centralised procedure ceases to be a recognised procedure for granting a Marketing Authorisation under English law, then AstraZeneca shall follow the advice of the MHRA and take steps to secure a Marketing Authorisation as quickly as possible for the Territory based on that advice which may include pursuing a separate application for a Marketing Authorisation  with the MHRA in parallel with the EMA centralised procedure. AstraZeneca shall ensure that the Marketing Authorisation granted for the Territory will include the UK Supply Chain and the other Manufacturing facilities in Europe as Facilities qualified and validated for Manufacture of the Product to be supplied to Purchaser under this Supply Agreement. [“UK Supply Chain” refers to the Drug Substance Manufacturers and Drug Product Manufacturers listed on a redacted schedule to the agreement].