Freedom of Information request (FOI 22/831)
Published 17 January 2024
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11th August 2022
FOI 22/831
Dear ,
Thank you for your email.
Please find below answers in table below;
| Company Authorisation Type | Total # of ‘Regulatory Flexibility’ Notifications received |
|---|---|
| Manufacturer (MIA) | 56 |
| Manufacturer (MIA/IMP) | 23 |
| Wholesaler | 85 |
In addition, can you please provide the breakdown of the number of requests of each type. For example;
| Description of Regulatory Flexibility Used | Total # of ‘Regulatory Flexibility’ Notifications received |
|---|---|
| Marketing authorisations | There are no notification requirement for the MA flexibilities. They are applied on a case by case basis and are not recorded in any searchable form. |
| Pharmacovigilance | 8 |
| Exceptional GMP flexibilities- Manufacture and importation | 123 |
| Exceptional GMP flexibilities- Pharmaceutical Quality System | 72 |
| Exceptional GDP flexibilities- Supply chain | 24 |
| Exceptional GDP flexibilities- Transportation | 27 |
| Exceptional GDP flexibilities- Facilities and equipment | 47 |
| Reduced re-testing of Imported products (3rd countries | 76 |
Any other summary or supporting information that may be available in relation to the above would also be gratefully received.
In response to the above, even though not requested, we have tallied up the total numbers received for each type of flex (GMP or GDP) and number of organisations that submitted each flex type
| Flexibility type | Total # of ‘Regulatory Flexibility’ Notifications received | Total # of Organisations submitting Flexibility |
|---|---|---|
| GMP | 260 | 79 |
| GDP | 66 | 56 |
Finally, please provide details of the number of reports received from QPs related to Annex 16 not providing enough flexibility to deal with the current logistical challenges quickly.
| Total # of reports received from QPs related to insufficient flexibility under Annex 16 |
|---|
| NIL* |
*There does not appear to be any complaints/reports received (from a GMDP perspective) regarding insufficient flexibility under Annex 16 as this would have prompted a re-visit of the published guidance and where required updates will have been made.
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Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency