As I said back in October, delivering a successful Covid-19 vaccine quickly was a huge challenge, but the diversity of the UK’s vaccine portfolio and the amendments made to the Human.
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As I said back in October, delivering a successful Covid-19 vaccine quickly was a huge challenge, but the diversity of the UK’s vaccine portfolio and the amendments made to the Human Medicines Regulations 2012 (
HMRs) meant that the UK was in a strong position to carry out a successful mass vaccination programme as soon as a vaccine could demonstrate its safety, quality and efficacy. Six months later, two vaccines have been widely administered in the UK (AstraZeneca/Oxford and Pfizer/BioNTech) – as of 3 April 2021, 31,523,010 first doses and 5,381,745 second doses have been administered. A third vaccine is also now available (Moderna).
MAJOR MARKET COMPARISON OF KEY COVID-19 LEGISLATION
As pharmaceutical companies worldwide race to supply vaccines
and therapeutics to fight the spread of COVID-19, understanding the
laws and regulations that could impact parties involved in the
COVID-19 pandemic supply chain is increasingly important. This
article provides an overview and comparison of legislation relevant
to manufacturers, suppliers, distributors, and health professionals
involved in the response to the COVID-19 pandemic in each of the
United States ( US ), European Union ( EU ),
United Kingdom ( UK ), and People s Republic of China
( PRC ), including measures to ensure (1) immunity from
COVID-19 countermeasure liability; (2) government ability to direct
(or redirect) resources; (3) emergency use authorizations; (4)
Orphan registered medicinal products
From:
Documents
The Orphan Register comprises:
EU marketing authorisations converted into Great Britain marketing authorisations in accordance with paragraph 6(7) of Schedule 33A the Human Medicines Regulations 2012 (as amended) where there is an existing European Union (EU) orphan designation, and the Great Britain marketing authorisation continues in effect with the remaining period of orphan market exclusivity.
Medicinal products that have received a marketing authorisation with orphan status on or after 1 January 2021 from the UK Licensing Authority, the MHRA. Under regulation 58D of the Human Medicines Regulations 2012 (as amended), a period of 10 years orphan market exclusivity is awarded from the date of marketing authorisation by the MHRA. An additional two years of exclusivity may be added where paediatric data requirements have been met.
Why the EU’s vaccine disaster doesn’t prove Brexit was right The UK’s vaccine success does not compensate for its catastrophic handling of the pandemic or the cost of leaving the EU.
Boris Johnson in Downing Street after signing the EU-UK trade deal on 30 December 2020 The Brexiteers are crowing. They say the success of the UK’s Covid-19 vaccination programme proves we were right to leave the European Union. Freed from Brussels’s suffocating embrace, we were able to procure, approve and rapidly distribute hundreds of millions of doses of Covid-19 vaccine while the EU’s bumbling bureaucrats were still getting out of bed.