Post-Authorisation Follow-Up Procedures for Medicinal Products at BfArM

Overview of Post-Authorisation Obligations

After a medicinal product receives marketing authorisation, BfArM oversees ongoing compliance and lifecycle management to ensure continued quality, safety, and efficacy. These follow-up procedures are governed by EU regulations (Regulation (EC) No 726/2004, Directive 2001/83/EC) and national law, applying to nationally authorised, decentralised, mutual recognition, and centralised products where BfArM acts as competent authority. Follow-up procedures - BfArM

Variations to the Marketing Authorisation

• Changes to the authorised product (e.g., manufacturing process, indications, posology, SmPC updates) require a variation application.
• Classified as Type IA (minor), Type IB (moderate), or Type II (major) per EU guidelines.
• Applications submitted via BfArM (national/DCP/MRP) or EMA (CP).
• Timelines vary: immediate notification for some Type IA, up to 30–90 days for others; Type II may take 60–210 days.
• Worksharing possible for multiple procedures affecting the same product.

Renewal of Marketing Authorisation

• Authorisations are renewed every 5 years (initially); subsequent renewals may be indefinite.
• Renewal application submitted 9 months before expiry.
• Focus on up-to-date benefit-risk evaluation, including PSUR data, new safety information, and post-authorisation commitments.
• BfArM assesses renewal for national/DCP/MRP products.

Periodic Safety Update Reports (PSURs)

• PSURs submitted at defined intervals (e.g., every 6 months initially, then annually or longer).
• Provide cumulative safety data, new risk-benefit analysis, and proposed actions.
• Single assessment procedure (EU single assessment) for harmonised substances.
• BfArM reviews national-specific aspects and contributes to EU procedures.

Risk Management Plans (RMPs) and Pharmacovigilance

• RMPs required for new active substances, biosimilars, and certain high-risk products.
• Updated throughout the lifecycle when new risks emerge or significant changes occur.
• Pharmacovigilance obligations include adverse reaction reporting, signal detection, and additional monitoring if needed.

Additional Follow-Up Measures

• Post-authorisation safety studies (PASS) or efficacy studies (PAES) may be imposed as conditions.
• Annual re-assessment for certain products with conditional or exceptional authorisation.
• BfArM provides guidance on submission formats (eCTD), fees, timelines, and procedural questions.

These follow-up procedures ensure that authorised medicinal products in Germany remain safe and effective over time, with proactive management of emerging data and risks in coordination with EU partners. Follow-up procedures - BfArM