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Regulatory compliance with medicines

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WQ.201/2025

WRITTEN QUESTION TO THE MINISTER FOR HEALTH AND SOCIAL SERVICES BY DEPUTY H.L. JEUNE OF ST. JOHN, ST. LAWRENCE AND TRINITY

QUESTION SUBMITTED ON TUESDAY 6th MAY 2025

ANSWER TO BE TABLED ON WEDNESDAY 14th MAY 2025

Question

"Further to the response to Written Question 151/2025, in which the Minister explained the need for rigorous regulatory compliance with medicines legislation and strict adherence to Good Manufacturing Practice (GMP) standards and multiple licensing requirements, will he advise –

  1. whether the standards and licence requirements include the need for an independent regulatory authority or whether, in his assessment, Jersey's current process is sufficient to adhere to all requirements;
  2. what processes and framework are in place to ensure GMP compliance;
  3. how he intends to assure GMP compliance across the entire lifecycle of any medicinal products manufactured or handled in the Island;
  4. what current staff expertise there is within Government to ensure GMP compliance, including –
  1. whether there is any programme of continual training to ensure high standards of expertise; and
  2. to what standards staff are trained; and
  1. what budget, if any, is allocated specifically for compliance within this area?"

Answer

Additional time is required to provide a comprehensive response to this request due to the nature of the questions posed and the complexity of the policy issues/regulatory matters concerned.

A complete response will be submitted by the next deadline for written question responses.