Treialu tabledi gwrthfeirysol COVID

18 February 2022

Dear 

ATISN 16097 - Covid Anti-Viral Pills Trial - Wales  

Thank you for your request to the Welsh Government for information under the Freedom of Information Act (2000) received on 13 January 2022 relating to the covid anti-viral pills trial - Wales. Please accept our apologies for the delay in responding.  You requested the following: 

You referred to the  GOV.WALES website in which reference is made to the medication having been approved by the "Medicines and Healthcare Products Regulation Agency" [MHRA] for use in Wales.  

You wish for clarification on whether the medication has been approved by MHRA or authorised for emergency use in Wales under R.174 Human Medicines Regulations 2012.
 
Response

Ronapreve (casirivimab/imdevimab), Xevudy (sotrovimab), Lagevrio (molnupiravir), and Paxlovid (nirmatrelvir/ritonavir) were granted Conditional Marketing Authorisations (CMAs) by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Wales on 19 August, 2 December, 4 November, and 31 December 2021 respectively.

Next Steps

The request you sent me contains personal information about you - for example, your name and address. The Welsh Government will be the data processor for this information and, in accordance with the General Data Protection Regulation, it will be processed in order to fulfil our public task and meet our legal obligations under the Act to provide you with a response.

We will only use this personal information to deal with your request and any matters which arise as a result of it. We will keep your personal information and all other information relating to your request for three years from the date on which your request is finally closed.  Your personal information will then be disposed of securely.

Under data protection legislation, you have the right:    

• to be informed of the personal data we hold about you and to access it
• to require us to rectify inaccuracies in that data
• to (in certain circumstances) object to or restrict processing
• for (in certain circumstances) your data to be ‘erased’
• to (in certain circumstances) data portability
• to lodge a complaint with the Information Commissioner’s Office (ICO) who is our independent regulator for data protection

For further information about the information which the Welsh Government holds and its use, or if you wish to exercise your rights under the GDPR, please see contact details below:

Data Protection Officer
Welsh Government
Cathays Park    
CARDIFF
CF10 3NQ
Email: DataProtectionOfficer@gov.wales

If you are dissatisfied with the Welsh Government’s handling of your request, you can ask for an internal review within 40 working days of the date of this response. Requests for an internal review should be addressed to the Welsh Government’s Freedom of Information Officer at: 

Information Rights Unit, 
Welsh Government, 
Cathays Park, 
Cardiff, 
CF10 3NQ 

or Email: Freedom.ofinformation@gov.wales   

Please remember to quote the ATISN reference number above. 

You also have the right to complain to the Information Commissioner. The Information Commissioner can be contacted at: 

Information Commissioner’s Office, 
Wycliffe House, 
Water Lane, 
Wilmslow, 
Cheshire, 
SK9 5AF. 

However, please note that the Commissioner will not normally investigate a complaint until it has been through our own internal review process 

Yours sincerely