This policy is fully drafted and structured, ready to brand and complete for your service. It covers:
1. Purpose
2. Scope
3. Policy statement and principles
4. Definitions
5. Sources of safety information
6. Receiving, triaging and recording alerts
7. Alert classification and response timescales
8. Acting on medicine recalls
9. Acting on medical device alerts and recalls
10. Reporting through the Yellow Card scheme
11. Record keeping and information governance
12. Roles and responsibilities
13. Training
14. Monitoring, audit and review
15. Related documents
16. Glossary
17. References
Legislation & standards it maps to
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Care Quality Commission (Registration) Regulations 2009
Human Medicines Regulations 2012
Medicines and Medical Devices Act 2021
Medical Devices Regulations 2002 (SI 2002/618)
The Misuse of Drugs Regulations 2001
Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR)
Health and Safety at Work etc. Act 1974
Who it applies to
All directors, registered managers, prescribers, clinical staff, dispensing and stock-holding staff, and administrative staff (whether employed, bank, locum, agency or contracted) of [Organisation Name]
How it works
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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.