Regulatory in brief | Norway, US, New Zealand

Regulatory in brief | Norway, US, New Zealand

29 March 2021 - Deborah Wilkes

The Norwegian Medicines Agency (NoMA) is postponing some non-prescription medicines work due to the COVID-19 pandemic, the US has a new secretary of the Department of Health & Human Services (HHS), and New Zealand’s Medsafe has announced changes affecting medicines containing paracetamol.

NoMA postpones work

The Norwegian Medicines Agency (NoMA) is postponing its annual review of the list of non-prescription medicines that can be sold in general-sale retail outlets.

NoMA said the COVID-19 pandemic had led to a significant increase in its workload during 2021 and the review of the list had been downgraded.

Applications for changes to the list would not be considered before 2022, said NoMA, adding that no changes to the list would be made in 2021.

US confirms new health secretary

The US Senate has confirmed Xavier Becerra as secretary of the Department of Health & Human Services (HHS) under President Joe Biden.

Becerra was attorney general of California from 2017-2021 and served 12 terms in Congress as a member of the US House of Representatives.

Commenting on his appointment, the US Consumer Healthcare Products Association (CHPA) said Becerra had “decades of experience working on important healthcare policy issues, both federally and in the state of California, and is taking the helm at an unprecedented time for healthcare in this country”.

New Zealand makes paracetamol changes

New Zealand’s Medsafe is changing the warning and advisory statements for non-prescription medicines containing paracetamol.

The change follows a consultation that ended on 31 January 2020. The consultation was a response to a recommendation of the Medicines Adverse Reactions Committee to improve the safety of paracetamol use in New Zealand after a report of acute liver failure in a young child.

Implementation dates for the changes are 1 October 2022 for solid oral dose forms and suppositories, and 1 April 2023 for liquid dose forms.

Medsafe said medicines released for supply in New Zealand after these dates must have updated package labels, and all new medicine applications should comply with the requirements.

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