Europe – Euro Regulatory Roundup

The United Kingdom has introduced legislation on the temporary authorization of unlicensed drugs and vaccines to support the rollout of COVID-19 products. Through the legislation, the UK is seeking to clarify the power to impose conditions on temporary authorizations and extend partial immunity from civil liability to pharmaceutical companies that outsource manufacturing.

Until the end of 2020, the European Medicines Agency (EMA) will handle the licensing of COVID-19 vaccines for use in the UK. However, the UK, like the remaining 27 member states, can temporarily authorize an unlicensed vaccine for domestic use pending the grant of an EMA license.

The government wants to make two changes to the temporary authorization rules. Firstly, the government wants to clarify the power of the licensing authority to impose conditions in relation to temporary authorizations.

“This will provide certainty for both the licensing authority and those in the supply chain about the nature of the licensing authority’s power in this area. Imposing conditions is central to having an effective system of regulatory control, and that is in the interests of everyone in the supply change,” officials wrote in a memo to explain the legislation…