PeptidePedia The community reference

Regulatory status by jurisdiction: difference between revisions

Diff·revision 9 → 10·15:25, 27 Feb 2025

Difference between revision 9 and revision 10 of Regulatory status by jurisdiction. 6 lines changed; the page grew by 556 bytes.

Revision 9 — 02:54, 13 Feb 2025
Areapercent_Ayo (talk)
split overlong sentence
2,721 bytes ±0
Revision 10 — 15:25, 27 Feb 2025
DMF_Dermot (talk)
add the note that this wiki does not give legal advice
3,277 bytes +556
1{{Infobox concept1{{Infobox concept
2| name = Regulatory status by jurisdiction2| name = Regulatory status by jurisdiction
+3| subtitle = Regulation and law
3| Determined by = Regulatory category, not chemical identity4| Determined by = Regulatory category, not chemical identity
4| Categories = Medicine, research reagent, controlled substance, unregulated5| Categories = Medicine, research reagent, controlled substance, unregulated
2425
25The 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}}26The 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}}
+27
+28== Why status differs ==
+29Marketing authorisations are granted jurisdiction by jurisdiction, so a molecule approved in one country is unapproved in another until an application succeeds there. Approval timing therefore produces genuine differences in status for identical material.{{r|fda_pip}}
+30
+31Scheduling decisions are made nationally and reflect local policy. Substances prohibited in sport under anti-doping rules are subject to a separate regime again, which is contractual rather than legal in most cases.{{r|wco}}
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27== References ==33== References ==