Introduction
Whether you’re approaching end of Phase III and preparing a submission, expanding an asset geographically, or registering a newly acquired asset, the path to EU & UK market access demands a carefully orchestrated regulatory strategy.
At Integral Pharma Solutions, we specialise in helping clients navigate the full lifecycle – from asset acquisition or development to Marketing Authorisation (MA) and ongoing compliance as a Marketing Authorisation Holder (MAH).
This guide breaks down the five essential phases you need to master – regardless of whether you’re a first-time filer or reactivating a dormant asset.
Stage 1: Strategic Asset Assessment
Before pursuing a Marketing Authorisation, assess whether your asset is regulator-ready.
We help clients evaluate:
- Regional strategy selection: UK national, MRP/DCP, or CP
- Legal Basis selection, including reference products
- Clinical and non-clinical data sufficiency
- IP and exclusivity considerations
Bonus: For acquired or in-licensed products, we help validate transferability and readiness for EU/UK registration.
Stage 2: Dossier Preparation & Submission Planning
Whether creating a new dossier or adapting an existing one:
- Module 1 Development, including:
- Creation of required regulatory statements and documents such as Risk Management Plans (RMPs), Environmental Risk Assessments (ERAs), and administrative forms.
- Preparation of local product information (SmPC, PIL, labels) and artwork in line with EU/UK format and language requirements.
- Ensure compliance with eCTD requirements (Modules 2–5)
- Compilation, validation, and electronic (eCTD) publishing
Tip: Don’t assume a non-EU dossier will transfer directly – Module 1 differences and regional expectations matter.
Stage 3: Regulatory Procedure Execution
Your asset’s success depends on choosing the right procedure:
- UK national – required for UK-only access
- MRP/DCP – for simultaneous EU markets
- Centralised Procedure (CP) – for orphan drugs, biologics, and pan-EU coverage
We provide hands-on support in:
- Authority interactions (MHRA, EMA, RMS/CMSs)
- Clock-stop responses and timelines
- Submission strategy refinement based on asset maturity and region
Stage 4: MAH Set-Up and Regulatory Infrastructure
Securing Marketing Authorisation brings immediate responsibilities – but some must be prepared in advance of submission.
At the time of application you need:
- A valid MAH legal entity in the region of submission
- A Qualified Person for Pharmacovigilance (QPPV) and fully developed Pharmacovigilance System Master File (PSMF)
- A Qualified Person (QP) with details of manufacturing sites, batch release, and local contact points
What must be ready by approval:
- Finalised local SmPC, PIL, and artwork in compliance with language and packaging rules, ready for launch.
- Operational pharmacovigilance infrastructure, including signal detection and adverse event reporting mechanisms.
- Compliance with serialization and Falsified Medicines Directive (FMD) requirements.
Integral Pharma Solutions can act as your MAH, provide QPPV services, and oversee all pre- and post-authorisation regulatory operations.
Stage 5: Post-Marketing Support & Lifecycle Management
Success doesn’t end with approval – it evolves with compliance.
We manage:
- PV systems and safety reporting
- Renewals, variations, and line extensions
- Authority correspondence and audit preparation
- Oversight of your manufacturers and suppliers
Case in point: We recently helped a client re-launch a dormant authorisation in the UK with full compliance within 60 days.
Conclusion: Plan Beyond the Application
Bringing an asset to market is more than submitting a dossier – it’s about establishing the operational, legal, and regulatory infrastructure that supports the product long-term.
At Integral Pharma Solutions, we support your journey every step of the way – from asset strategy through authorisation and beyond.
📩 Ready to optimise your market entry?
Contact us today to discuss your asset and objectives.
Your MAH Partner in Europe and UK 
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