UK regulatory documents
| HRA and REC approved document set | Documents (zip) |
| Initial MHRA application | Documents (zip) |
| Initial HRA, REC and MHRA approvals | Documents (zip) |
| Non-substantial amendment 1 | Documents (zip) |
| Addition of new site substantial amendment | |
| Substantial amendment 1 | |
| Substantial amendment 2 | |
| Substantial amendment 3 | |
| Substantial amendment 4 | |
| Substantial amendment 5 | |
| Substantial amendment 6 | |
| Substantial amendment 7 | |
| Substantial amendment 8 | |
| Substantial amendment 9 | |
| Substantial amendment 10 |
RECOVERY SA10 submitted to REC RECOVERY SA10 HRA categorisation letter |
| HRA letter | |
| Substantial amendment 11 |
RECOVERY SA11 submitted to REC RECOVERY SA11 HRA categorisation letter |
| Substantial amendment 12 |
RECOVERY SA12 submitted to REC RECOVERY SA12 categorisation letter |
| Substantial amendment 13 |
RECOVERY SA13 submitted to REC RECOVERY SA13 categorisation letter |
| Substantial amendment 14 | |
| Substantial amendment 15 |
SA15 was an REGN-COV2 IMPD update only |
| Substantial amendment 16 | |
| Non substantial amendment 3 | |
| Substantial amendment 17 | |
| Substantial amendment 18 | |
| Substantial amendment 19 | |
| Substantial amendment 20 | |
| Substantial amendment 21 |
RECOVERY SA21 submitted to REC RECOVERY SA21 amended documents
|
| Substantial amendment 22 | |
| Substantial amendment 23 | |
| Substantial amendment 24 | |
| Substantial amendment 25 | |
| Substantial amendment 26 | |
| Substantial amendment 27 | |
| Substantial amendment 28 | |
| Substantial amendment 29 | |
| Substantial amendment 30 | |
| Substantial amendment 31 | |
| Substantial amendment 32 |
SA32 does not apply to UK sites. |
| Substantial amendment 33 | |
| Substantial amendment 34 | |
| Substantial amendment 35 |
SA35 does not apply to UK sites |
| Substantial amendment 36 |
RECOVERY SA36 documents submitted to HRA |
| Substantial amendment 37 | |
| Non-substantial amendment 5 | |
| Non-substantial amendment 6 | |
| Non-substantial amendment 7 | |
| Modification of an Important Detail 1 |