Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Orphan designation

United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs

Orphan or rare disease designationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

£124,194

2025 to 2027 fee schedule

What is the Orphan designation in United Kingdom?

Orphan status for medicines for rare, life-threatening or chronically debilitating conditions. The MHRA decides it when it grants the marketing authorisation. It brings ten years of market exclusivity, which can be twelve years with paediatric rewards. Conditions affecting not more than 5 in 10,000 people in the UK, or medicines unlikely to recover their investment.

How much does the Orphan designation cost?

The orphan major application, full fee is £124,194 for 2025 to 2027 fee schedule.

What are the steps of the Orphan designation?

1. Orphan request with the application; 2. Assessment with the application; 3. Orphan status at grant.

Outcome: An orphan marketing authorisation with market exclusivity and fee refunds.

Legal basis: Human Medicines Regulations 2012, regulations 50G and 58D

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Orphan request with the applicationThe applicant states the orphan request in the marketing authorisation application cover letter.
2. Assessment with the applicationThe orphan criteria are assessed during the marketing authorisation assessment.
3. Orphan status at grantOrphan designation is decided at the time the marketing authorisation is granted.

Requirements

What the applicant must provide or meet

Eligibility

Life-threatening or chronically debilitating conditionThe medicine diagnoses, prevents or treats a life-threatening or chronically debilitating condition.
Rare in the UK or not profitableThe condition affects not more than 5 in 10,000 people in the UK, or the medicine is unlikely to earn enough to justify the investment.
No satisfactory method, or significant benefitNo satisfactory authorised method exists in the UK, or the medicine offers significant benefit.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
Orphan major application, full feeApplication · 2025 to 2027 fee schedule · If orphan status is granted, part of the fee is refunded or waived: 100% for small and medium companies, 50% in some exceptional cases, 10% otherwise.	£124,194

Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, Generic medicine application, Biosimilar application, Well-established use application, Reclassification to pharmacy or general sale, International Recognition Procedure, Recognition A, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP). See all routes on the or explore them in the .

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.