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HomeGlossaryUK Primary Authority scheme (supplement firms)
Compliance

UK Primary Authority scheme (supplement firms)

In short

The Primary Authority scheme under the Regulatory Enforcement and Sanctions Act 2008 lets a UK supplement business enter a formal partnership with one local Trading Standards or Environmental Health authority (the Primary Authority) and receive 'assured advice' that binds ever...

The Primary Authority scheme under the Regulatory Enforcement and Sanctions Act 2008 lets a UK supplement business enter a formal partnership with one local Trading Standards or Environmental Health authority (the Primary Authority) and receive 'assured advice' that binds every other local authority across England, Wales, Scotland and NI. For a supplement brand selling nationally it is the single most cost-effective protection against inconsistent local enforcement — and is becoming the de facto standard for serious UK supplement firms.

Regulatory anchors
  • Regulatory Enforcement and Sanctions Act 2008
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Score your compliance gap — then download the validation pack.
A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
Related terms
UK Trading Standards (supplement enforcement)UK Food Supplements (England) Regulations 2003
Software that covers UK Primary Authority scheme (supplement firms)
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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