EU Regulatory Affairs
Explore all topics, guides, and frameworks related to EU Regulatory Affairs.
Articles in this section
31- How National Marketing Authorisation Procedures Work in the EU How national marketing authorisations fit within the EU medicines regulatory system, including the role of national competent authorities and the relationship between national, mutual recognition and decentralised procedures. Read Article →
- How EU Marketing Authorisation Decisions Are Implemented and Maintained After Approval Explains how an EU marketing authorisation becomes operational after approval and how its authorised terms, regulatory status, product information and post-authorisation changes are maintained throughout the lifecycle. Read Article →
- CHMP Scientific Opinions and European Commission Marketing Authorisation Decisions Explains how the CHMP scientific opinion differs from the European Commission marketing authorisation decision and why the distinction matters for EU regulatory status, traceability and pharmacovigilance. Read Article →
- Potential Serious Risk to Public Health: How It Is Assessed A practical explanation of the potential serious risk to public health threshold, its legal context, the Commission guidance, and the distinction between a qualifying Article 29 concern and an ordinary scientific disagreement. Read Article →
- What Happens When Member States Disagree During an MRP or DCP? Explains how a CMS objection develops into a formal disagreement, the role of the coordination group, the applicant's involvement and the transition to an EU-level procedure when agreement cannot be reached. Read Article →
- How RMS and CMS Roles Work Together in MRP and DCP Explains the division of assessment, review, coordination, communication and decision-making responsibilities between the RMS and CMSs without duplicating dedicated RMS and CMS articles. Read Article →
- Mutual Recognition Procedure (MRP): How It Works How the Mutual Recognition Procedure works in practice, including the existing national authorisation, Reference Member State, Concerned Member States, assessment report, recognition and resolution of concerns. Read Article →
- Decentralised Procedure (DCP): How It Works How the Decentralised Procedure allows an applicant to seek national marketing authorisations in several Member States through a coordinated assessment led by a Reference Member State. Read Article →
- How the EU Centralised Marketing Authorisation Procedure Works How a medicinal product moves through the EU centralised marketing authorisation procedure, including eligibility, pre-submission activities, validation and the start of scientific assessment. Read Article →
- Article 20 Pharmacovigilance Procedures for Centrally Authorised Medicines A textbook explanation of the Article 20 pharmacovigilance procedure for centrally authorised medicines, including its legal trigger, initiation by the European Commission, PRAC and CHMP roles, MAH participation and implementation of the regulatory outcome. Read Article →
- Article 107i Urgent Union Procedures: How Urgent Safety Action Works How urgent Union pharmacovigilance procedures are initiated, assessed by PRAC and carried through CHMP or CMDh, including the distinction between urgent safety action and ordinary referral procedures. Read Article →
- How an EMA Referral Changes the SmPC, Package Leaflet and Risk Management Plan A practical explanation of how an EMA referral can change the SmPC, Package Leaflet, labelling and Risk Management Plan, and how the MAH implements and governs those changes. Read Article →
- What Does the Marketing Authorisation Holder Do During an EMA Referral? How an MAH organises, responds to and implements an EMA referral, including the interaction between regulatory affairs, pharmacovigilance, medical, quality and other functions. Read Article →
- What Happens After a PRAC Recommendation? CHMP, CMDh and the European Commission How a PRAC recommendation moves through the EU regulatory system, including the roles of CHMP, CMDh and the European Commission and the distinction between scientific recommendations, opinions, positions and legally binding decisions. Read Article →
- How PRAC Assesses a Safety Issue During an EMA Referral How the Pharmacovigilance Risk Assessment Committee evaluates a referred safety issue, including the assessment framework, rapporteur and co-rapporteur roles, evidence sources, benefit-risk reasoning and development of the PRAC recommendation. Read Article →
- How an EMA Safety Referral Starts: From Safety Concern to Formal EU Procedure A textbook explanation of how a safety concern moves from routine pharmacovigilance and regulatory assessment into a formal EU referral, and how the legal basis, urgency, product scope and initiating authority determine the procedure. Read Article →
- EMA Referral Types Explained: Article 20, Article 31, Article 107i and Article 30 A textbook guide to distinguishing Article 20, Article 31, Article 107i and Article 30 referrals in EU medicines regulation, with particular attention to pharmacovigilance, Union interest, urgency, harmonisation and the roles of PRAC, CHMP and CMDh. Read Article →
- How to Read and Cite EU Pharmaceutical Legislation: Regulations, Directives, Decisions and Guidance How to identify the legal instrument behind an EU medicines requirement, establish its legal effect, read amendments and consolidated texts, and build a defensible regulatory citation. Read Article →
- EMA, European Commission, National Competent Authorities, CHMP, PRAC and CMDh: Who Does What? How EMA, the European Commission, national competent authorities, CHMP, PRAC and CMDh interact, what each body is responsible for, and why their roles should not be conflated. Read Article →
- How EU Pharmaceutical Legislation Is Structured How to navigate the layers of EU medicines legislation, distinguish legally binding instruments from guidance, and determine which source should govern a regulatory question. Read Article →
- What Is a Marketing Authorisation in the EU? An in-depth guide to the EU marketing authorisation as the legal framework governing the placing of a medicinal product on the market, from the evidence base and benefit-risk assessment through authorised conditions of use and continuing obligations. Read Article →
- How the EU Medicines Regulatory System Works A structured foundation for understanding how EU medicines regulation works, from Union legislation and marketing authorisation through scientific assessment, national implementation and post-authorisation oversight. Read Article →
- Centralised, National, Mutual Recognition and Decentralised Procedures Explained How centralised, national, mutual recognition and decentralised procedures work, why the routes differ and how regulatory professionals should determine which procedure applies. Read Article →
- Article 30 Referral in EU Medicines Regulation: Divergent National Decisions and Harmonisation A structured explanation of Article 30 referrals, the Union mechanism used to resolve qualifying divergent national decisions concerning the same medicinal product and establish a harmonised regulatory position. Read Article →
- Article 31 Non-Pharmacovigilance Referral in EU Medicines Regulation: Quality, Efficacy and Union-Level Regulatory Assessment A detailed guide to the Article 31 non-pharmacovigilance referral pathway, with emphasis on quality and efficacy concerns, CHMP assessment, authorisation scope and the transition from scientific opinion to regulatory implementation. Read Article →
- Article 31 Pharmacovigilance Referral: Legal Basis, Procedure and Regulatory Consequences in the EU A textbook-quality guide to Article 31 pharmacovigilance referrals, explaining why the procedure is initiated, how the Union-level assessment operates, how PRAC, CMDh and CHMP interact, and how the final regulatory outcome is implemented and incorporated into pharmacovigilance systems. Read Article →
- Article 29(4) Referral in EU Medicines Regulation: Legal Basis, Procedure and Regulatory Decision-Making A comprehensive guide to Article 29(4) referrals under Directive 2001/83/EC, explaining how an unresolved disagreement in a mutual recognition or decentralised procedure becomes a Union-level CHMP assessment and, ultimately, a European Commission decision. Read Article →
- What Is CMDh? Role, Functions and Regulatory Significance in the EU Medicines System A textbook-quality explanation of CMDh, the EU coordination group responsible for questions concerning nationally authorised human medicines under the mutual recognition and decentralised procedures. Read Article →
- What Is a Concerned Member State (CMS) in EU Regulatory Affairs? A detailed guide to the Concerned Member State (CMS), explaining its legal and scientific role in MRP and DCP, relationship with the RMS, participation in regulatory decisions, and significance for pharmacovigilance and regulatory affairs. Read Article →
- What Is the Reference Member State (RMS) in EU Regulatory Affairs? A textbook-quality guide to the Reference Member State (RMS), explaining its legal role, responsibilities, relationship with CMSs and CMDh, and practical significance for regulatory affairs and pharmacovigilance. Read Article →
- Centralised, National, Mutual Recognition and Decentralised Procedures Explained A practical and regulatory comparison of centralised, national, mutual-recognition and decentralised marketing-authorisation procedures in the European Union. Read Article →