§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇩🇰Denmark	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	DKMA	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	Yes	Yes
Reliance pathway	Available	Available
Reference agencies	EMA (Centralised Procedure — directly valid), EU/EEA Member States (DCP / MRP), EU CMDh	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — EU Centralised Procedure · International Recognition Procedure (IRP)
Pathway name	EU Centralised Procedure	International Recognition Procedure (IRP)
Approval timeline	210–300 days	60–110 days
Application fee	EUR 350,000	GBP 35,305
Annual renewal	EUR 130,000	GBP 0
Local representative	Not required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	No	Yes
Local responsible person	Yes	Yes
RP role	QPPV established in the EEA (any EEA member) per EU GVP Module I; QPPV is the contact for DKMA pharmacovigilance. Danish-language pharmacovigilance literature monitoring required for products marketed in Denmark. A Pharmacovigilance System Master File (PSMF) location must be declared.	Qualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	4 designations	4 designations
Examples	Accelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	EU variations framework (Commission Regulation 1234/2008 as amended) — Type IA / IAIN (do-and-tell), Type IB (tell-wait-do), Type II (prior approval), Extensions and Article 61(3) notifications. DKMA processes variations for nationally / DCP / MRP authorised products; EMA processes variations for centrally-authorised products.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.
Renewal cycle	Standard renewal at 5 years post first authorisation; subsequent unlimited validity unless DKMA / EMA decides on safety grounds to require further renewal. CMAs renewed annually until conversion to full MA.	Initial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
Pharmacovigilance	EU pharmacovigilance framework (Directive 2010/84/EU and Regulation 1235/2010) implemented via Danish Medicines Act and DKMA executive orders. EudraVigilance reporting mandatory; PSURs per EURD list submitted to EMA PSUSA. Danish ADR reports collected by DKMA via the national e-reporting portal (for healthcare professionals and consumers, plus the Meldknappen quick-reporting button). DKMA holds a PRAC seat. Strong epidemiological surveillance via Danish national health registers (Civil Registration System CPR-linked; Danish National Patient Register; Danish National Prescription Registry).	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–106 days	30–60 days
GCP standard	ICH E6(R3) GCP; EU Clinical Trials Regulation 536/2014 (EU CTR); Danish Medicines Act and Committee Act on Health Research Ethics (Komitéloven)	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	Yes	No
HTA required	Yes	Yes
HTA body	Medicinrådet (the Danish Medicines Council) for hospital medicines and treatment guidelines; the Reimbursement Committee (Medicintilskudsnævnet), which advises DKMA, for outpatient general reimbursement decisions.	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

DenmarkDKMA
United KingdomMHRA

English submissions

DenmarkYes
United KingdomYes

CTD accepted

DenmarkYes
United KingdomYes

eCTD accepted

DenmarkYes
United KingdomYes

Reliance pathway

DenmarkAvailable
United KingdomAvailable

Reference agencies

DenmarkEMA (Centralised Procedure — directly valid), EU/EEA Member States (DCP / MRP), EU CMDh
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — EU Centralised Procedure · International Recognition Procedure (IRP)

Pathway name

DenmarkEU Centralised Procedure
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Denmark210–300 days
United Kingdom60–110 days

Application fee

DenmarkEUR 350,000
United KingdomGBP 35,305

Annual renewal

DenmarkEUR 130,000
United KingdomGBP 0

Local representative

DenmarkNot required
United KingdomNot required

Local manufacturing

DenmarkNot required
United KingdomNot required

GMP inspection

DenmarkRequired
United KingdomNot required

MAH & local presence

Local entity required

DenmarkNo
United KingdomYes

Local responsible person

DenmarkYes
United KingdomYes

RP role

DenmarkQPPV established in the EEA (any EEA member) per EU GVP Module I; QPPV is the contact for DKMA pharmacovigilance. Danish-language pharmacovigilance literature monitoring required for products marketed in Denmark. A Pharmacovigilance System Master File (PSMF) location must be declared.
United KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Denmark4 designations
United Kingdom4 designations

Examples

DenmarkAccelerated Assessment (EMA CP), Conditional Marketing Authorisation (CMA), PRIME (Priority Medicines) +1
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

DenmarkEU variations framework (Commission Regulation 1234/2008 as amended) — Type IA / IAIN (do-and-tell), Type IB (tell-wait-do), Type II (prior approval), Extensions and Article 61(3) notifications. DKMA processes variations for nationally / DCP / MRP authorised products; EMA processes variations for centrally-authorised products.
United KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.

Renewal cycle

DenmarkStandard renewal at 5 years post first authorisation; subsequent unlimited validity unless DKMA / EMA decides on safety grounds to require further renewal. CMAs renewed annually until conversion to full MA.
United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

Pharmacovigilance

DenmarkEU pharmacovigilance framework (Directive 2010/84/EU and Regulation 1235/2010) implemented via Danish Medicines Act and DKMA executive orders. EudraVigilance reporting mandatory; PSURs per EURD list submitted to EMA PSUSA. Danish ADR reports collected by DKMA via the national e-reporting portal (for healthcare professionals and consumers, plus the Meldknappen quick-reporting button). DKMA holds a PRAC seat. Strong epidemiological surveillance via Danish national health registers (Civil Registration System CPR-linked; Danish National Patient Register; Danish National Prescription Registry).
United KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

DenmarkAvailable
United KingdomAvailable

Compassionate Use

DenmarkAvailable
United KingdomAvailable

Emergency Import

DenmarkAvailable
United KingdomAvailable

Parallel Import

DenmarkPermitted
United KingdomPermitted

Clinical trials

CTA approval

DenmarkRequired
United KingdomRequired

Ethics approval

DenmarkYes
United KingdomYes

CTA timeline

Denmark60–106 days
United Kingdom30–60 days

GCP standard

DenmarkICH E6(R3) GCP; EU Clinical Trials Regulation 536/2014 (EU CTR); Danish Medicines Act and Committee Act on Health Research Ethics (Komitéloven)
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

DenmarkRegulated
United KingdomRegulated

Reference pricing

DenmarkYes
United KingdomNo

HTA required

DenmarkYes
United KingdomYes

HTA body

DenmarkMedicinrådet (the Danish Medicines Council) for hospital medicines and treatment guidelines; the Reimbursement Committee (Medicintilskudsnævnet), which advises DKMA, for outpatient general reimbursement decisions.
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)