As countries in the European Union (EU) take baby steps towards reopening businesses and ramp up COVID-19 vaccination, the pandemic and the complexity of the human coronavirus continues to dictate updates to existing rules and procedures.
In an effort to expedite the vaccination roll-out whilst ensuring compliance with existing rules, the European Commission (EC) adopted legislation on the exceptional and temporary acceptance of variations to the terms of marketing authorisations.
Commission Delegated Regulation (EU) 2021/756 of 24 March 2021, published on 10 May 2021, replaces article 21 of Regulation (EC) 1234/2008, now specifically addressing the pandemic situation with respect to human influenza and human coronavirus.
Key points are:
- A duly recognised pandemic situation with respect to human coronavirus allows the exceptional and temporary acceptance of a variation to the terms of a marketing authorisation for a human coronavirus vaccine;
- Variations are possible where pharmaceutical, non-clinical or clinical data is missing;
- Variations are admissible only if the benefit-risk balance of the medicinal product is favourable; and
- Acceptance of a variation to the terms of a marketing authorisation does not release its holder from submitting the missing pharmaceutical, non-clinical and clinical data within a time limit set by the relevant authority.