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The UK Market Entry Programme
Six workstreams. One accountable UK partner.
For an overseas company, filing in the UK means setting up a local entity, arranging access to licensed capability, meeting MHRA dossier requirements and running quality and safety systems, all at once. Our programme brings these together and runs them from the UK.
What's included
The workstreams.
Each workstream has a named owner, defined deliverables and a fixed set-up scope. Recurring oversight starts once each system is in place.
UK company & governance
We form and administer the UK entity that will hold your licence.
- Company formation and registered office
- Business bank account opening
- Legal formalities and statutory set-up
- Programme management across all workstreams
Licensed capability
We secure the licensed capability your filing depends on.
- Identifying suitable third-party WDA(H) holders
- Access to MIA batch-release capability with a Qualified Person
- Arrangement agreements between your entity and the licence holders
- Technical and quality agreements
Marketing authorisation
We take your product from dossier to submission and support it through assessment.
- Dossier gap analysis against UK requirements
- Choice of route: national or International Recognition
- Module 1 and UK product information, labelling and leaflet
- Submission, validation and MHRA correspondence as your contact
Responsible Person
We set up the RP function and keep it running.
- Appointment of an eligible, named Responsible Person
- GDP oversight of suppliers, customers and records
- Recall, complaint and returns procedures
- Continuing retained oversight
Quality management
We build a quality system the MHRA expects to see.
- Quality manual and GDP standard operating procedures
- Supplier and customer qualification
- Change control, deviations and CAPA
- Self-inspection and continuing QMS maintenance
Pharmacovigilance
We put your UK safety obligations in place before they apply.
- Pharmacovigilance system and master file (PSMF)
- Qualified Person for Pharmacovigilance (QPPV) on retainer
- Adverse reaction reporting to the MHRA
- Literature monitoring, signal and periodic report planning
Phases
How the programme unfolds.
Timings are typical for a generic product on the national route. A route through International Recognition can shorten the assessment phase considerably.
Month 0–1
Establish
Set-up fee agreed and paid. UK company and bank account formed. RP and quality system started.
Months 1–6
Access & file
Licence-holder agreements in place. Dossier completed and submitted. PV system and QPPV live.
To grant, ~18 months
Assess
MHRA questions answered, with RP, QA and QPPV retainers continuing month by month.
Ahead of launch
Launch readiness
Your own licences, warehouse and batch-release arrangements for commercial supply.
Scope
What the programme covers, and what it doesn't.
We set clear boundaries from the start, so you can budget accurately and there are no surprises with the regulator.
Included
- UK company formation, banking and legal formalities
- Arranging access to third-party WDA(H) and MIA batch-release licences for filing
- Marketing authorisation submission support and MHRA correspondence
- Responsible Person set-up and retained oversight
- Quality management system set-up and maintenance
- Pharmacovigilance system set-up and QPPV retainer
Separate or later
- MHRA statutory fees, which are payable to the MHRA
- VAT
- Per-batch release fees, once batch release begins after grant
- Your own wholesale and manufacturing licences and warehouse for commercial launch
- Commercial distribution of the product
- Dossier generation from scratch, such as new bioequivalence studies
Engagement model
Transparent, milestone-based fees.
Every programme is quoted in pounds sterling, against a written scope.
- Fixed set-up costs, quoted per workstream and paid against agreed milestones.
- Recurring oversight (Responsible Person, QA/QMS and QPPV), charged monthly and paid quarterly in advance.
- Funds held in your entity. After formation, programme funds are paid into your UK company's own bank account.
- Co-investment may be available for the right long-term partnership.
- Confidentiality as standard. Every engagement starts with a mutual NDA and a conflict check. Our conflicts policy.
What we'll need from you: your product list, the current dossier (CTD Modules 1–5) or a dossier source, GMP certificates and site master files for manufacturing sites, active substance information, and details of any existing approvals.
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