Pharmaceutical Product Registration in European Union

The European Union (EU) is a strategically important market for pharmaceutical organisations aiming for a strong commercial presence across 27 member states. Drug Product Registration in the European Union requires a clear understanding of the regulatory framework under the European Medicines Agency (EMA) and national competent authorities.

At DDReg, we support global sponsors, pharmaceutical manufacturers, and marketing authorisation holders with Pharmaceutical Product Registration in the European Union, covering end-to-end regulatory planning, dossier development, submission management, and post-approval lifecycle support.

A medicinal product cannot be marketed in the EU without a valid Marketing Authorisation (MA). The registration pathway depends on product classification, intended use, target indication, and eligibility criteria.

• New Chemical Entity (NCE)
• Biosimilar
• Generic Medicinal Product
• Advanced Therapy Medicinal Product (ATMP)
• Orphan Drug
• Herbal Medicinal Product
• OTC and Rx Drugs

Correct classification aligns the submission process with EMA and national requirements and helps sponsors determine the correct authorization route.

• + Centralised Procedure
  • Single submission to EMA.
  • One Marketing Authorisation valid across all EU/EEA states.
  • Mandatory for biologics, oncology drugs, ATMPs, orphan drugs, and emerging therapies.
• + Decentralised Procedure (DCP)
  • Suitable when no prior national approval exists.
  • One Reference Member State evaluates the dossier, and other Concerned Member States participate in the assessment.
• + Mutual Recognition Procedure (MRP)
  • Used after initial national approval.
  • Additional member states recognise an existing authorisation.
• + National Procedure
  • Applicable for single-state market entry or early engagement in a specific country.
• + Documentation Requirements for EU Drug Registration

  Applicants must submit an electronic Common Technical Document (eCTD) including:

  • Module 1: EU-specific administrative information
  • Module 2: Quality overall summaries
  • Module 3: CMC details
  • Module 4: Non-clinical studies
  • Module 5: Clinical trial documentation and safety data

  Compliance with GMP, GDP, labelling, EU legal requirements, and pharmacovigilance systems is mandatory.

• + Lifecycle Management After Marketing Authorisation

  After approval, companies must maintain compliance through:

  • Renewals (initial renewal at 5 years)
  • Variations (Type IA, IB, II)
  • PSUR submissions
  • Pharmacovigilance oversight via a qualified EU QPPV
  • Safety signal management
  • Labelling and SmPC updates

  Lifecycle maintenance ensures continued access and regulatory alignment across the EU.

DDReg offers specialised EU Drug Registration Services including:

• Product classification and eligibility assessment
• Regulatory strategy for EU submission
• EMA scientific advice support
• eCTD dossier preparation, review and publishing
• GMP & compliance readiness
• End-to-end submission coordination for Centralised, DCP, MRP or National Routes
• Post-approval regulatory maintenance
• Pharmacovigilance, PSUR submissions, and QPPV support
• MA transfer and lifecycle activities

• Proven expertise in EMA and EU regulatory pathways
• Strong command of dossier planning, technical documentation, and risk-based regulatory execution
• Experience supporting innovator products, biosimilars, OTC, and lifecycle submissions
• Global-to-local execution model helping accelerate EU market readiness