Published: 26 March 2020

Medicines

COVID-19 Alert Level 4 - Manufacturers and suppliers of medicines as essential services

Medicines are essential services
Risk management for medicine producers and suppliers
Medsafe actions and guidance

Medicines are essential services

At 11.59 pm on 25 March 2020 New Zealand moved to COVID-19 Alert Level 4. This alert level requires all businesses to close except for essential services.

The Government has published an Essential Services list (PDF 137 KB, 4 pages). This list includes "Any entity producing health sector equipment, medicines, and PPE".

It's important to understand this list has been published by the New Zealand Government, not by Medsafe. Medsafe agrees that production and supply chain of medicines (as defined under the Medicines Act 1981) is essential. However, it is the responsibility of businesses to determine which functions of their operations are essential and which functions should temporarily cease.

This advice does not cover manufacturers of 'natural health products' or 'complementary health care products' (including 'listed medicines' for the Australian market). Manufacturers and distributors of these products should contact the Ministry of Business, Innovation and Employment (MBIE) for advice on whether they are considered essential, or whether they are non-essential products whose manufacture and distribution should temporarily cease. See below for contact details.

Wholesalers should determine which of their products (if any) are essential, and which are non-essential products whose supply can be temporarily ceased and make appropriate staffing arrangements.

If you are unsure if your products are an essential service, contact MBIE:

Risk management for medicine producers and suppliers

While operating during this time, we understand that businesses involved in producing medicines (ie, manufacturers and those involved in the supply chain) may be operating with limited on-site staffing to reduce the risk of COVID-19 transmission. Medsafe's expectation is that businesses use appropriate risk assessment to determine which operations and tasks are essential at this time. Businesses that operate under Good Manufacturing Practice (GMP) should use their quality system to justify and document any departures from standard operating procedures and manage the associated risk. If you have questions relating to GMP you can contact us at: GMP@health.govt.nz.

It's important that medicines continue to be manufactured to high standards of quality and that control of the supply chain is maintained.

MBIE has published guidance on their website that businesses should follow, relating to staff safety and minimising the risk of COVID-19 transmission in the workplace.

Medsafe actions and guidance

We have published information regarding Medsafe's working arrangements during COVID-19 Alert Level 4.

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