What does it take for Medsafe to pull a medicine off the shelves?

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Medsafe says the normal criteria it uses to decide if a medication should be withdrawn from use are set out in the Medicines Act 1981 (section 35). They are:

  • if the medicine can no longer be regarded as a medicine that can be administered or used safely for the purposes indicated in the application for consent; or
  • the specifications and standards with respect to the manufacture of the medicine that were included in the terms of a consent can no longer be regarded as satisfactory; or
  • the efficacy of the medicine can no longer be regarded as satisfactory

In addition, section 36 of the Medicines Act provides a statutory mechanism by which the Medsafe can raise questions with the relevant company about the safety and efficacy of the medicine.

A spokesperson for Medsafe says: “Unless there is evidence that the Pfizer vaccine is no longer safe or satisfactory for use in terms of the criteria set out above, Medsafe would not be in the position to take any regulatory action.

“Medsafe has no current concerns about the vaccine that would trigger this process. 

“Medsafe continues to monitor suspected adverse reactions reported following vaccination. These reports are assessed by experienced medical assessors.

“Medsafe also obtains expert advice on adverse reactions reported and trends in reporting. Medsafe is not planning regulatory action at this time in relation to the Pfizer vaccine.”

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