Distributing vaccines and treatments for COVID-19 and flu

Posted on 13th September, 2020

 

UPDATE 06JAN21: UK Government create extended roles in its COVID19 Vaccine Team - "You do not need to be a current NHS healthcare professional, as full training will be provided"

UPDATE 18DEC20: The Human Medicines Regulations Dec 2020 - Read the Explantory Note on pages 6&7 - "...without precipitating the need for a manufacturer’s licence or marketing authorisation ... used for vaccination or immunisation against coronavirus or influenza ... advertising of medicinal products" 

UPDATE 16OCT20: The Human Medicines Regulations Oct 2020

UPDATE 16OCT 20: Consultation outcome 

__________ 

 

The Government is asking for your response to its consultation on Distributing vaccines and treatments for COVID-19 and flu that ends Friday 18 September 2020.

 

"The UK government, with the Minister of Health in Northern Ireland, is seeking views on proposed changes to the Human Medicine Regulations 2012. The consultation covers:

Documents to review:

The government is "working towards short timelines, but if you miss the date and still want to make comments, contact [them] at covidvaccineconsultation@dhsc.gov.uk and [they] will try to accommodate your comment before any changes are made."

------

See also: 

___________

 

UPDATES

 

UPDATE 06JAN21: UK Government create extended roles in its COVID19 Vaccine Team (PDF) with 3-6 month tenures:

"You do not need to be a current NHS healthcare professional, as full training will be provided. Please note, you will need healthcare experience for the Healthcare Professional and Clinical Supervisor roles – only vaccine specific training is provided."

 

 

UPDATE 18DEC20: The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (PDF)

Read the Explantory Note on pages 6&7 - "... all professionally justified acts of preparation and assembly of a coronavirus vaccine may be undertaken by or under the supervision of a doctor, nurse or pharmacist, at any location, without precipitating the need for a manufacturer’s licence or marketing authorisation ... to set aside these restrictions if the PGD is for a medicinal product used for vaccination or immunisation against coronavirus or influenza ... the licencing authority under the 2012 Regulations may temporarily authorise the sale or supply of medicinal products without marketing authorisations. The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 made wide ranging provision in relation to such temporary authorisations, including adapting the provisions of the 2012 Regulations relating to PGDs and the advertising of medicinal products to accommodate them."

 

UPDATE 16OCT20: The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (PDF)

 

UPDATE 16OCT 20Consultation outcome Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines (PDF Overview)

Make A Comment

Characters left: 2000

Comments (0)