Subject: FOI request and open letter to MHRA—please share far and wide...
...not something to be taken lightly!
Just sent this to MHRA
I’ve just sent a FOI request and open letter to MHRA, see below:
Subject: FOI Request—substantial change in 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors: PART IV “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products (ATMPs)”
This is page 1:
I would like to request information relating to the Subject above, under the FOIA (Please refer to the Appendix for background and supporting information):
Is this change fully aligned with EUs REGULATION (EC) NO 1394/2007on ATMPs?
Since these new regulations, allowing thawing, manipulation of multi-dose products, etc, were only introduced thisyear,how was it possibleto approve frozen mRNA vaccines underThe Orange Guide2017edition?
Has a formal consultation involving UK organisations impacted by thechange been undertaken? (MHRA routinely holds consultations, for example “Consultation on how MHRA communicate with healthcare professionals to improve medicines…