Module232025

07/05/2025

Article 22

Modification of a PIP

• Very important legal provision

• Allows the applicant to request changes to the PIP

• Requests for modification can be submitted at any time

• There is no limit on the number of modification requests that can be made

The Organisation for Professionals in Regulatory Affairs

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Article 23

Compliance with the PIP

• Competent authority receiving an MAA must confirm PIP compliance • PDCO can be requested to confirm compliance by: • The applicant (prior to MAA submission) • EMA or national competent authority (during MAA validation) • CHMP or national competent authority (during MAA review)

• PDCO has 60 days to give an opinion on PIP compliance

The Organisation for Professionals in Regulatory Affairs

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