Specials are unlicensed medicines manufactured or sourced to meet specific clinical needs.
NHS Circular PCA(P)(2015)17 requires community pharmacy contractors to seek Health Board authorisation before ordering or dispensing specials and imported unlicensed medicines. This applies when the products are not listed in Part 7S/7U of the Drug Tariff or are unavailable from an NHS manufacturing unit in Scotland, England, or Wales. Both the pharmacist and the prescriber carry increased legal responsibility when supplying unlicensed medicines.
Before Ordering a Special
- Confirm clinical need: Discuss with the prescriber that an unlicensed medicine has been prescribed. Consider licensed or “off-label” alternatives (e.g. opening capsules, dispersing tablets in water etc.).
- Inform the patient: Ensure the patient is aware the product is unlicensed.
How to Request Authorisation
- Complete the NHS Lothian Specials Authorisation Form
- Email to: loth.specials@nhs.scot
(Must be sent from an NHS email for secure patient data handling) - Processing times: Monday–Friday (excluding public holidays), 10am–4pm. Requests are processed the same working day.
Forms & Resources
- Special Authorisation Request Form
- PCA(P)(2015)17 Part A (Generic Framework for Specials Authorisation Process)
- PCA(P)(2015)17 Part B (FAQs)
- MHRA Guidance Note 14
- RPS Prescribing Specials Guidance
- NHS Lothian Procedure for the Use of Unlicensed Medicines
- BAD Preferred Specials List
Important Notes
- Authorisation is valid for up to 12 months only.
- If the item price varies by more than 20% within the 12 month period, reauthorisation is required.
- An authorisation is required for every patient
- Do not send certificates of analysis (COA), conformity (COC), or invoices.
- This process applies only to unlicensed medicines – not ACBS products, foodstuffs, stoma items, or high-cost licensed drugs.
For queries, contact: loth.specials@nhs.scot
.
Last updated 19/05/25 EBR