Drug master file: difference between revisions
Diff·revision 4 → 5·05:02, 23 Nov 2024
Difference between revision 4 and revision 5 of Drug master file. 3 lines changed; the page grew by 407 bytes.
| Revision 4 — 10:50, 12 Nov 2024 ImportRecordIna (talk) sentence case in headings per PP:MOS 1,789 bytes +238 | Revision 5 — 05:02, 23 Nov 2024 HarmReductionHen (talk) clarify that a business licence is not a manufacturing authorisation 2,196 bytes +407 | ||
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| 11 | A DMF is not an approval. Filing one causes it to be assigned a number and acknowledged; the regulator reviews its content only when an application referencing it is reviewed, and a review finding may be adverse.{{r|fda_dmf}} | 11 | A DMF is not an approval. Filing one causes it to be assigned a number and acknowledged; the regulator reviews its content only when an application referencing it is reviewed, and a review finding may be adverse.{{r|fda_dmf}} |
| 12 | 12 | ||
| + | 13 | Equivalent mechanisms exist elsewhere — the European certificate of suitability to the monographs of the European Pharmacopoeia is the closest analogue, though it differs in being an assessment rather than a repository.{{r|edqm_cep}} | |
| + | 14 | ||
| 13 | == How the mechanism works == | 15 | == How the mechanism works == |
| 14 | The holder files the document with the regulator. When a customer submits an application using that substance, the holder issues a letter of authorisation permitting the regulator to review the file in support of that application.{{r|fda_dmf}} | 16 | The holder files the document with the regulator. When a customer submits an application using that substance, the holder issues a letter of authorisation permitting the regulator to review the file in support of that application.{{r|fda_dmf}} |
| ⋮ | ⋮ | ||
| 21 | {{reflist}} | 23 | {{reflist}} |
| 22 | <ref name="fda_dmf">United States Food and Drug Administration, ''Drug Master Files: Guidelines'' and the published DMF list.</ref> | 24 | <ref name="fda_dmf">United States Food and Drug Administration, ''Drug Master Files: Guidelines'' and the published DMF list.</ref> |
| + | 25 | <ref name="edqm_cep">European Directorate for the Quality of Medicines, ''Certification of Suitability to the Monographs of the European Pharmacopoeia'' procedure.</ref> | |
| 23 | 26 | ||
| 24 | {{DEFAULTSORT:Drug master file}} | 27 | {{DEFAULTSORT:Drug master file}} |