Regulatory status by jurisdiction: difference between revisions
Diff·revision 4 → 5·21:15, 12 Dec 2024
Difference between revision 4 and revision 5 of Regulatory status by jurisdiction. 6 lines changed; the page grew by 582 bytes.
| Revision 4 — 19:47, 3 Dec 2024 MelanocortinMil (talk) expand §The categories 2,139 bytes ±0 | Revision 5 — 21:15, 12 Dec 2024 ShortageShona (talk) correct the description of the shortage-list mechanism 2,721 bytes +582 | ||
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| 10 | Category is not a property of the chemistry. It follows from whether a marketing authorisation exists, what the substance is presented for, and whether it appears on any scheduling list.{{r|fda_pip}} | 10 | Category is not a property of the chemistry. It follows from whether a marketing authorisation exists, what the substance is presented for, and whether it appears on any scheduling list.{{r|fda_pip}} |
| 11 | 11 | ||
| + | 12 | This article describes the structure of the question. It does not state the law of any jurisdiction, does not advise on legality, and should not be relied on for either.{{r|ich_q7}} | |
| + | 13 | ||
| 12 | == The categories == | 14 | == The categories == |
| 13 | | Category | Typical consequence | | 15 | | Category | Typical consequence | |
| ⋮ | ⋮ | ||
| 21 | Most peptides discussed on this wiki sit in the second or third category in most jurisdictions. The [[Research use only]] designation is a statement of the third and is a presentation as much as a status: the same material presented as a medicine is a medicine.{{r|usp1503}} | 23 | Most peptides discussed on this wiki sit in the second or third category in most jurisdictions. The [[Research use only]] designation is a statement of the third and is a presentation as much as a status: the same material presented as a medicine is a medicine.{{r|usp1503}} |
| 22 | 24 | ||
| + | 25 | The presentation test is the mechanism by which many jurisdictions treat a product: claims made about a substance can bring it within medicines law regardless of what the label says elsewhere.{{r|fda_pip}} | |
| + | 26 | ||
| 23 | == References == | 27 | == References == |
| 24 | {{reflist}} | 28 | {{reflist}} |
| 25 | <ref name="wco">World Customs Organization, ''International Convention on the Simplification and Harmonization of Customs Procedures'' (revised Kyoto Convention).</ref> | 29 | <ref name="wco">World Customs Organization, ''International Convention on the Simplification and Harmonization of Customs Procedures'' (revised Kyoto Convention).</ref> |
| 26 | <ref name="fda_pip">United States Food and Drug Administration, ''Regulatory Procedures Manual'', chapter 9 (coverage of personal importations).</ref> | 30 | <ref name="fda_pip">United States Food and Drug Administration, ''Regulatory Procedures Manual'', chapter 9 (coverage of personal importations).</ref> |
| + | 31 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 27 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 32 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 28 | 33 | ||
| ⋮ | ⋮ | ||
| 30 | [[Category:Legal status by jurisdiction]] | 35 | [[Category:Legal status by jurisdiction]] |
| 31 | [[Category:Regulation and law]] | 36 | [[Category:Regulation and law]] |
| + | 37 | [[Category:Articles needing cleanup]] | |
| 32 | 38 |