This policy is fully drafted and structured, ready to brand and complete for your service. It covers:
1. Purpose
2. Scope
3. The two regimes
4. The test that actually applies
5. Where each of our services sits
6. Keeping the two arms distinguishable
7. Introducing or changing a service
8. Common misunderstandings
9. If we discover we are operating outside our registration
10. Roles and responsibilities
11. Monitoring and audit
12. Related documents
13. Review
CQC fundamental standard
Regulation 12 (Safe care and treatment)
This document is written to evidence that standard. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
Legislation & standards it maps to
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - in particular Regulation 12 (Safe care and treatment), Regulation 17 (Good governance) and Regulation 20 (Duty of candour)
Health and Social Care Act 2008 - sections 10 and 11 (requirement to register), Schedule 1 (regulated activities) and Schedule 2 (exceptions and exemptions), including the exception for primary pharmacy services
Care Quality Commission (Registration) Regulations 2009 - in particular Regulation 12 (Statement of purpose), Regulation 15 (Notice of changes) and Regulation 20 (Notifications)
Pharmacy Order 2010 and the General Pharmaceutical Council standards for registered pharmacies and for pharmacy professionals
Human Medicines Regulations 2012 (as amended)
Medicines Act 1968
Who it applies to
All pharmacists, pharmacist independent prescribers, pharmacy technicians, dispensers, clinical and administrative staff, directors and contractors of [Organisation Name]
How it works
Buy securely with Stripe - instant, no VAT, no account needed.
Download your editable Word file from the link we email you straight away.
Complete the placeholders for your service, then have it approved before use.
Add the optional updates subscription and we keep it current as guidance changes.