As a Marketing Authorisation (MA) holder in the European Union (EU), a pharmaceutical company has a range of responsibilities. These responsibilities are aimed at ensuring the quality, safety, and efficacy of the authorized medicinal product throughout its lifecycle. Here are the key responsibilities of an MA holder in the EU:
- Product Quality and Compliance: The MA holder is responsible for ensuring that the authorized medicinal product is manufactured, packaged, and labelled in compliance with Good Manufacturing Practice (GMP) regulations. They must maintain a comprehensive quality management system and oversee the product’s quality control throughout its supply chain. The GMP responsibilities of the MAH based on EMA reflection paper are the following:
- Outsourcing and Technical Agreements
- Audits and Qualification Activities
- Communications with manufacturing sites
- Defects, complaints and recalls
- Ensuring continuity of supply
- Continual improvements activities
- Falsified medicines
- Pharmacovigilance: The MA holder has a crucial role in pharmacovigilance, which involves monitoring and assessing the safety profile of the medicinal product. They must establish and maintain a robust pharmacovigilance system to collect, evaluate, and report adverse events and other safety information to the regulatory authorities.
- Product Information and Labeling: The MA holder is responsible for the accuracy, completeness, and up-to-date information provided in the product’s Summary of Product Characteristics (SmPC), package leaflet, and labeling. They must ensure that the information reflects the latest scientific knowledge and is consistent with regulatory requirements.
- Compliance with Regulatory Requirements: The MA holder must comply with all applicable EU regulations and guidelines, including the provisions of the Marketing Authorization, GMP, Good Distribution Practice (GDP), and any specific requirements related to the product category (e.g., biologics, generics).
- Post-Authorization Obligations: The MA holder is responsible for fulfilling post-authorization obligations specified by the regulatory authorities. This includes submitting annual safety update reports (PSURs), variation applications for changes in the product or its labeling, and ensuring compliance with any post-authorization commitments or obligations.
- Inspections and Audits: The MA holder should be prepared for inspections and audits by regulatory authorities to assess compliance with regulatory requirements. They must provide necessary documentation, cooperate with inspectors, and address any identified deficiencies or non-compliance.
- Batch Release and Supply Chain Oversight: The MA holder is responsible for releasing each batch of the medicinal product for the EU market. They must ensure that the product is released only if it meets the required quality, safety, and efficacy criteria. The MA holder should also oversee the supply chain to ensure proper storage, transportation, and handling of the product.
- Record Keeping and Document Management: The MA holder must maintain comprehensive and accurate records related to the authorized medicinal product. This includes records of manufacturing, quality control, pharmacovigilance, and other relevant documentation. Proper document management systems should be in place to ensure accessibility and traceability of records.
- Communication with Regulatory Authorities: The MA holder is responsible for maintaining effective communication with the regulatory authorities. This includes timely reporting of any changes, safety issues, or non-compliance events related to the product, as well as responding to inquiries or requests from regulatory authorities.
It’s important for the MA holder to stay updated with evolving regulatory requirements, guidelines, and best practices to fulfill their responsibilities effectively. Regular interaction with regulatory experts, participation in industry forums, and staying informed about changes in regulations will help ensure compliance and the continued availability of the authorized medicinal product in the EU market.
MIAS holds an MIA granted from the Irish regulatory authority (HPRA), for companies looking to maintain a minimal operational presence in Europe we support companies by taking on the responsibility of EU QP release and RP services.
For more information on how we can help please contact us.