European Marketing Authorization Holder (MAH)

Your Trusted MAH Partner in Europe

A Marketing Authorization Holder (MAH) is the legal entity responsible for obtaining and maintaining the authorization to market a medicinal product across Europe. The MAH ensures compliance with EU/UK regulations, including Good Manufacturing Practices (GMP), pharmacovigilance obligations, supply chain oversight, and quality control. The responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH. For pharmaceutical companies without an EU or UK presence, securing an experienced MAH partner is critical to regulatory success.

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ProPharma's Comprehensive MAH Services

Navigating both the specific country and centralized European regulations and requirements to supply medicinal products to the European markets can be a complex challenge.

With decades of experience, our experts provide a full spectrum of MAH services to support pharmaceutical companies in successfully navigating the regulatory requirements across Europe. Our tailored solutions ensure compliance, streamline market entry, and maintain product integrity.

Regulatory & Compliance Support

Guidance on selecting the optimal regulatory pathway
Full gap analysis, MAA readiness assessment and pre-submission activity support
End-to-end regulatory submissions for marketing authorization applications (Centralized, Decentralized, Mutual Recognition, and National Procedures)
Maintenance of marketing authorizations, including variations and renewals
Dossier preparation and procedural management
Lifecycle management

Pharmacovigilance & Safety Management

PV gap analysis to ensure inspection readiness
Full pharmacovigilance system implementation, including QPPV services
Development and maintenance of the Pharmacovigilance System Master File (PSMF)
Signal detection, case processing and submission, literature search, and risk management planning
Compliance with Good Pharmacovigilance Practices (GVP) requirements
Provision of Local responsible Person for Pharmacovigilance (LPPV), as applicable

Quality & Manufacturing Oversight

EEA/UK GMP compliance support, including Qualified Person (QP) and Responsible Person (RP) services
Batch release and supply chain oversight for seamless product distribution
Manufacturing license (MIA) support and QP declarations
Labelling, packaging, and serialization compliance with EEA/UK standards

Market Access & Commercialization

Strategic support for pricing and reimbursement
Joint Clinical Assessment (JCA) dossier preparation and submission
National Health Technology Assessment (HTA) dossier preparations and submissions
Guidance on selecting the optimal market entry
Competitive landscape analysis and product positioning
Price and reimbursement maintenance, including renewals

Tailored Solutions for Specific Challenges

Pharmaceutical companies—whether generic or biosimilar manufacturers, orphan drug or ATMP (cell and gene) manufacturers, non-EU companies or innovative drug developers—face unique challenges in obtaining EU marketing authorization. We offer specialized solutions to address these hurdles.

Challenges Faced by Non-European Companies & ProPharma Solutions

ProPharma offers comprehensive support by guiding companies through regulatory pathways, conducting gap analyses, facilitating regulatory meetings, ensuring quality compliance, and providing QPPV services. With expertise in pricing strategies and logistics, ProPharma streamlines the EU market entry process for US companies, ensuring regulatory success and commercial viability.

Challenge: Understanding EMA requirements vs. FDA and/or other regional regulations.

Solution: ProPharma provides expert guidance on EEA/UK regulatory frameworks.

Challenge: Adapting US-based clinical data to meet EEA/UK standards.

Solution: ProPharma conducts gap analyses and supports data generation.

Challenge: Engaging effectively with EMA and national authorities.

Solution: ProPharma facilitates pre-submission meetings and regulatory discussions.

Challenge: Aligning with EEA/UK GMP, GDP, and GVP requirements.

Solution: ProPharma assists in quality system implementation and compliance.

Challenge: Setting up a compliant EEA/UK pharmacovigilance system in more than 30 countries.

Solution: ProPharma offers full pharmacovigilance services, including QPPV and LPPV appointment tailored to our clients needs.

Challenge: Navigating European JCA requirements and complex country-specific HTA and reimbursement processes.

Solution: ProPharma prepares JCA dossier for submission on a European level and develops country-specific pricing and reimbursement dossiers for submission.

Challenge: Establishing an efficient and compliant supply chain.

Solution: ProPharma provides MIA and QP declaration support.

Challenges Faced by Generic or Biosimilar Development Companies & ProPharma Solutions

ProPharma provides tailored solutions by offering expert guidance on bioequivalence studies, dossier compliance, and regulatory submissions, as well as comprehensive support for GMP implementation, QPPV services, and pricing strategies. By streamlining the authorization process, ProPharma enables generic and biosimilar development companies to efficiently enter and succeed in the European market.

Challenge: Proving bioequivalence to the Reference Medicinal Product (RMP) requires well-designed studies and robust data analysis.

Solution: ProPharma advises on study design, conducts rigorous data analysis, and ensures EMA compliance for successful bioequivalence demonstration.

Challenge: Selecting the optimal approval pathway can be complex.

Solution: ProPharma provides strategic guidance and application management centralized and across multiple EU member states.

Challenge: Adapting existing data to meet EU regulatory standards.

Solution: ProPharma ensures dossier compliance, including API characterization and stability studies.

Challenge: Variations or withdrawals of the RMP affecting generic approvals.

Solution: ProPharma actively monitors RMP changes and advises on regulatory updates.

Challenge: Ensuring compliance with EEA/UK GMP standards.

Solution: ProPharma supports GMP implementation and quality assurance.

Challenge: Maintaining a compliant pharmacovigilance system.

Solution: ProPharma offers full pharmacovigilance support, including QPPV services and risk management.

Challenge: Navigating country-specific aggressive generic drug price controls and pricing regulations.

Solution: ProPharma provides full competitive pricing analysis followed by reimbursement preparation and submission with price maintenance support.

Why Choose ProPharma?

With over 20 years of experience in regulatory affairs, ProPharma has successfully supported pharmaceutical companies worldwide in achieving marketing authorization, achieving reimbursement, and maintaining compliance. We provide:

A trusted partner for all MAH responsibilities

Expert guidance tailored to your specific regulatory and market access needs

Comprehensive support from regulatory submissions to post-market compliance

Proven success in navigating EEA/UK regulatory and country-specific pricing and reimbursement challenges

Partner with ProPharma to simplify your market entry across Europe and ensure long-term compliance. Contact us today to learn more about how we can support your marketing authorization needs.

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