Protocol for Selling Non‑Prescription (OTC) Medicines Online

1. Purpose

To ensure the safe, legal, and ethical sale of non‑prescription (over‑the‑counter, OTC) medicines via online platforms, protecting patient safety and ensuring regulatory compliance.

2. Scope

This protocol applies to all staff and systems involved in the advertising, sale, supply, dispatch, and follow‑up of non‑prescription medicines sold online by the service.

It applies to:

• Website and e‑commerce platforms

• Remote consultations or questionnaires

• Order processing and fulfilment

• Customer support and aftercare

3. Regulatory and Legal Framework

• Human Medicines Regulations 2012

• MHRA guidance on distance selling of medicines

• Consumer Protection Regulations

• Advertising Standards Authority (ASA) guidance

• General Data Protection Regulation (GDPR)

4. Definitions

• Non‑Prescription / OTC Medicines: Medicines that can be sold without a prescription but may still require professional oversight.

• Distance Selling: Sale of medicines without face‑to‑face contact, including online platforms.

5. Governance and Accountability

• A Responsible Pharmacist / Clinical Lead must oversee online medicine sales

• Clear lines of accountability must be documented

• Systems must be auditable and inspection‑ready

6. Approved Medicines List

• Only medicines legally classified as non‑prescription may be sold

• Medicines must be sourced from licensed and approved suppliers

• A current approved product list must be maintained and reviewed regularly

7. Online Information and Advertising

The website must clearly display:

• Medicine name and active ingredients

• Intended use and limitations

• Clear dosing instructions

• Warnings, contraindications, and side effects

• Advice on when not to use and when to seek medical advice

• Statement that medicines may not be suitable for everyone

Advertising must:

• Be factual, balanced, and not misleading

• Avoid exaggerating benefits or minimising risks

• Comply with ASA and MHRA advertising guidance

8. Customer Assessment and Safeguards

Before supply:

• Customers must complete an online questionnaire where appropriate

• Screening must include age, pregnancy/breastfeeding status, allergies, and relevant medical conditions

• High‑risk responses must trigger escalation to a healthcare professional

Medicines must not be supplied if:

• There is uncertainty about safety or suitability

• The customer provides incomplete or concerning information

9. Age Verification

• Robust age‑verification measures must be in place

• Medicines must not be supplied to individuals below the legal age where restrictions apply

10. Professional Oversight

• A healthcare professional must be available for advice and escalation

• Clear contact details must be provided to customers

• Decisions to refuse supply must be documented

11. Ordering, Packing, and Dispatch

• Orders must be checked for accuracy before dispatch

• Medicines must be packaged securely and discreetly

• Temperature‑sensitive medicines must follow cold‑chain requirements (if applicable)

• Dispatch records must be maintained

12. Information Supplied with Medicines

Each order must include:

• Patient information leaflet (PIL)

• Clear usage instructions

• Safety warnings and advice

• Contact details for queries or concerns

13. Refusal, Cancellation, and Returns

• The service reserves the right to refuse supply on clinical or safety grounds

• Reasons for refusal must be documented

• Medicines returned must not be re‑sold

• Refunds must follow consumer law and internal policy

14. Incident Reporting and Complaints

• Adverse reactions, errors, or near misses must be reported

• Incidents must be investigated and learning shared

• A clear complaints process must be available to customers

15. Data Protection and Confidentiality

• Customer data must be handled in accordance with GDPR

• Secure systems must be used for storage and transmission of data

• Confidentiality must be maintained at all times

16. Training and Competency

• Staff involved in online medicine sales must be trained and competent

• Training must include OTC medicines, safeguarding, and escalation procedures

• Training records must be maintained

17. Audit and Review

• Regular audits of online sales, refusals, and incidents

• This protocol must be reviewed annually or following regulatory change

Document Control

Approved by: Caroline Balazs
Role: Advanced Practitioner Clinical Lead
Date: 01/01/2026
Review Date: 01/01/2027
Version: 1.0