Effective Date: 2025/05/09
Version: 1.0
Applies to: All services provided by NewGen Pharmacy Ltd via www.newgenpharmacy.co.uk

1. Purpose

This policy explains the specific legal exemptions that NewGen Pharmacy Ltd uses when we sell, supply, or administer medicines.
By setting this out clearly, we:

• Show how we comply with the Human Medicines Regulations 2012, and

• Provide clear information to patients and other healthcare professionals about how these exemptions work in practice.

2. Regulatory Framework

NewGen Pharmacy Ltd operates within a defined legal and professional framework.
We follow:

2.1 Key Legislation

• Human Medicines Regulations 2012, including Schedules 17 and 19

2.2 Supporting Guidance

• MHRA guidance on the sale, supply, and administration of medicines

• Specialist Pharmacy Service (SPS) resources on legal mechanisms for medicine administration

Together, these documents guide how we deliver safe and lawful pharmacy services.

3. Exemptions Overview

The law allows several specific exemptions. These exemptions enable certain medicines to be supplied or administered without a traditional prescription in defined circumstances.

3.1 Patient Group Directions (PGDs)

Patient Group Directions (PGDs) allow specified registered healthcare professionals to supply and/or administer named medicines to groups of patients without individual prescriptions.

NewGen Pharmacy Ltd may use PGDs, for example for vaccination services, and we always do so in line with:

• Current legislation, and

• Any relevant professional guidance.

3.2 Schedule 17 Exemptions

Under Schedule 17 of the Human Medicines Regulations 2012, the law allows specific healthcare professionals to sell, supply, or administer certain prescription-only medicines (POMs) without a prescription, as long as they stay within their professional scope of practice.

These professionals include:

• Midwives

• Chiropodists / Podiatrists

• Optometrists

• Orthoptists

• Paramedics

Each professional group has its own defined list of medicines covered by these exemptions. For detailed lists and conditions, please refer to the relevant MHRA guidance on the rules for the sale, supply, and administration of medicines for specific healthcare professionals.

3.3 Schedule 19 Exemptions

Schedule 19 permits any person to administer certain parenteral medicines in an emergency. Typical examples include:

• Adrenaline

• Glucagon

• Naloxone

These exemptions apply only in genuine emergency situations and must follow the conditions set out in the regulations.

3.4 Section 10 Exemption

Under Section 10 of the Medicines Act 1968, pharmacists may prepare and supply unlicensed medicines (often called “specials”) for an individual patient in response to a prescription. In this situation, a marketing authorisation is not required, but all other legal and professional standards still apply.

4. Professional Responsibilities

Healthcare professionals who work under these exemptions must:

• First, make sure they have appropriate training and are competent for the activity.

• Next, practise strictly within the boundaries of their professional role and registration.

• Finally, follow all relevant guidelines, local protocols, and legal requirements at all times.

These responsibilities help ensure that patients receive safe, effective, and lawful care.

5. Patient Information

Patients who receive services under any of these exemptions will be informed as appropriate. We aim to explain:

• Which exemption applies, and

• How it affects the way your medicine is supplied or administered.

If you have questions about how these exemptions relate to your treatment, please contact our pharmacy team. We will be happy to provide further clarification.

6. Review and Updates

We review this policy at least once a year. In addition, we update it sooner if:

• There are changes to relevant legislation, or

• New professional or regulatory guidance becomes available.

By doing this, we ensure that our practice remains fully aligned with current legal and regulatory requirements.