#50751 Re: Novi korona virus - velika opasnost ili ne ? POGLEDATI PRVI POST!
Posted: 17/09/2021 14:12
What is an Emergency Use Approval?
Regulation 174 of the Human Medicine Regulations 2012 enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic. This regulation is an EU provision introduced in national law that allows for the authorisation of a medicine in response to a public health need. Instead of going through the centralised licensing route of the EMA (which is the normal route until the end of the Brexit transition period), the MHRA authorised the supply of the vaccine based on public health need, provided the batches of vaccine meet specific standards.
Regulation 174 of the Human Medicine Regulations 2012 enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic. This regulation is an EU provision introduced in national law that allows for the authorisation of a medicine in response to a public health need. Instead of going through the centralised licensing route of the EMA (which is the normal route until the end of the Brexit transition period), the MHRA authorised the supply of the vaccine based on public health need, provided the batches of vaccine meet specific standards.