The Decentralised Procedure (DCP)

Launching a medicine in 27 European countries at once is a race against a 210-day clock. One failed validation or one unresolved objection from a Concerned Member State can cost you a year. The Decentralised Procedure (DCP), set out in Directive 2001/83/EC, is the route to a marketing authorisation across the EEA for a medicine never authorised in Europe before: one Reference Member State assesses, every Concerned Member State approves. This two-hour online training turns the procedure into one clear method, from choosing your Reference Member State to the variations that follow approval.

Across ten lessons, this certified course covers every stage of the DCP with real regulatory cases, from legal basis and eligibility to generics, lifecycle maintenance and the DCP versus the MRP. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply the Decentralised Procedure in practice.

Why teams choose this course

• Built with European regulatory affairs experts, with what reviewers look for in every lesson
• Every rule lands on a real incident, from the thalidomide withdrawal to the data integrity enforcement of the 2010s, so it sticks
• Covers the full lifecycle, not just Day 0 to Day 210: national phase, variations, renewals and repeat-use
• Two focused hours, self-paced, with a narrated video, interactive blocks and a knowledge check in every lesson
• One-year self-paced access per learner, with a CPD/CEU certificate your QA can verify online

What you’ll learn

• Place the DCP among the four routes to a European marketing authorisation and choose it over the MRP when it fits
• Map the roles of the applicant, the Reference Member State, the Concerned Member States and the CMDh
• Select the right Reference Member State and prepare, submit and validate a compliant dossier through CESP
• Run the Day 0 to Day 210 timeline and manage the clock stop and your responses
• Resolve disagreement through CMDh referral and Article 29(4) arbitration without losing the procedure
• Apply the generic and hybrid rules, including bioequivalence and data exclusivity, inside a DCP
• Build a dossier and procedure file that stands up to national competent authority review and inspection

Who should enroll

• Regulatory affairs officers and submission teams planning a European launch
• CMC, clinical and pharmacovigilance specialists contributing to a DCP dossier
• Project managers and regulatory strategists choosing between European routes
• Quality and compliance teams maintaining authorisations after approval

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum

Lesson: A Brief History of European Medicines Authorisation

Lesson 1: The European Marketing Authorisation Landscape

Lesson 2: Legal Basis, Scope and Eligibility

Lesson 3: The Key Players and Choosing Your Reference Member State

Lesson 4: Preparing and Submitting the Application

Lesson 5: Step 1, the Assessment Phase from Day 0 to Day 120

Lesson 6: Step 2, Reaching Agreement from Day 120 to Day 210

Lesson 7: When Consensus Fails, Referral and Arbitration

Lesson 8: The National Phase and Granting the Authorisation

Lesson 9: Generics and the Decentralised Procedure

Lesson 10: Lifecycle, Harmonisation and the DCP versus the MRP

Conclusion

Glossary

Final Assessment