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.
Why Choose ProPharma?
With over 20 years of experience in commercializing medicinal products, 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, including acting as your MAH
- Expert guidance tailored to your specific regulatory and market access needs
- Comprehensive support from regulatory submissions to post-market compliance
- Proven success in navigating country-specific pricing and reimbursement challenges
- EU and UK MIA licenses and WDA support
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.
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.
News & Insights
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
July 24, 2025
FDA Publishes over 200 Complete Response Letters (CRLs)
FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.
July 24, 2025
Navigating EMA and Global Regulations for Medical Information Services
ProPharma guides clients through global medical information regulatory landscapes, ensuring compliance and excellence across markets with tailored solutions, AI integration, and continuous training.
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
July 8, 2025
From Drafts to First Patient in Record Time
Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...
.png?width=320&height=185&name=Successful%20Pre-IND%20Meetings%20WP%20(1).png)
June 23, 2025
FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...
A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...
June 18, 2025
Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina
Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...
July 29, 2025
Avoiding Common Pitfalls During FDA Inspections
Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...
.png?width=320&height=185&name=labeling-webinar-thumbnail%20(1).png)
July 22, 2025
Inside FDA Review: Crafting a Quality ANDA Labeling Submission
Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...
July 10, 2025
MAH Essentials: Ensuring Compliance for European Market Entry
This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...
News & Insights
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
July 24, 2025
FDA Publishes over 200 Complete Response Letters (CRLs)
FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.
July 24, 2025
Navigating EMA and Global Regulations for Medical Information Services
ProPharma guides clients through global medical information regulatory landscapes, ensuring compliance and excellence across markets with tailored solutions, AI integration, and continuous training.
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
July 8, 2025
From Drafts to First Patient in Record Time
Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...
June 23, 2025
FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...
A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...
June 18, 2025
Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina
Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...
July 29, 2025
Avoiding Common Pitfalls During FDA Inspections
Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...
July 22, 2025
Inside FDA Review: Crafting a Quality ANDA Labeling Submission
Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...
July 10, 2025
MAH Essentials: Ensuring Compliance for European Market Entry
This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...