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 delineates the specific legal exemptions under which NewGen Pharmacy Ltd operates concerning the sale, supply, and administration of medicines. It ensures compliance with the Human Medicines Regulations 2012 and provides clarity to patients and healthcare professionals regarding these exemptions.

2. Regulatory Framework
NewGen Pharmacy Ltd adheres to the following regulatory frameworks and guidance:

Human Medicines Regulations 2012, including Schedules 17 and 19.

MHRA Guidance on the sale, supply, and administration of medicines.

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

3. Exemptions Overview
3.1 Patient Group Directions (PGDs)
PGDs allow certain registered healthcare professionals to supply and/or administer specified medicines to groups of patients without individual prescriptions. NewGen Pharmacy Ltd may operate under PGDs for services such as vaccinations, in accordance with legal requirements.

3.2 Schedule 17 Exemptions
Under Schedule 17 of the Human Medicines Regulations 2012, specific healthcare professionals are permitted to sell, supply, or administer certain prescription-only medicines (POMs) without a prescription, within the scope of their professional practice. These professionals include:

• Midwives
• Chiropodists/Podiatrists
• Optometrists
• Orthoptists
• Paramedics

Each professional group has specific medicines they are authorized to handle under these exemptions. For detailed information, refer to the MHRA guidance on 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 emergency situations, such as:

• Adrenaline
• Glucagon
• Naloxone

These exemptions are strictly for emergencies and must comply with the conditions outlined in the regulations.

3.4 Section 10 Exemption
Under Section 10 of the Medicines Act 1968, pharmacists are allowed to prepare and supply unlicensed medicines (commonly known as “specials”) in response to a prescription for an individual patient, without the need for a marketing authorization.

4. Professional Responsibilities
Healthcare professionals operating under these exemptions must:

Ensure they are adequately trained and competent.

Operate strictly within the scope of their professional practice.

Adhere to all relevant guidelines and legal requirements.

5. Patient Information
Patients receiving services under these exemptions will be informed accordingly. If you have questions about how these exemptions apply to your treatment, please contact our pharmacy team for clarification.

6. Review and Updates
This policy will be reviewed annually or as required to ensure ongoing compliance with legal and regulatory changes.