Module232025

07/05/2025

Article 34

Post-authorisation requirements

• Article 34 sets out arrangements for risk management and pharmacovigilance

• Requires submission of annual reports on progress vs the PIP for authorised drugs with PIP deferrals • Competent authorities to be informed in case of non-compliance

The Organisation for Professionals in Regulatory Affairs

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Article 35

Post-authorisation requirements

• Applies where a drug is authorised for a paediatric indication, has collected the associated incentives and these have expired • MAH must: • Transfer MA to another MAH who will continue to market OR • Make the data available to another MAH so they can obtain an MA under Article 10(c) of Directive 2001/83/EC (informed consent) AND • Notify EMA of any intention to discontinue marketing ≥6 months in advance

Understandable efforts to ensure continuity of availability of authorised paediatric medicines

The Organisation for Professionals in Regulatory Affairs

34