Import of Apotex products under close monitoring

This is an update to our release on Monday 14 September.

The Ministry of Health’s drug regulatory arm Medsafe has negotiated an agreement with pharmaceutical manufacturer Apotex to temporarily restrict importation of medicines produced by Apotex at its two manufacturing sites in Toronto, Canada.

This follows a similar move in the United States last week, where further imports of Apotex medicines manufactured from these two sites has ceased. Apotex has also voluntarily recalled 40 medicines from the US market and three from the Canadian market. No batches of the medicines recalled in the US and Canada are available in New Zealand.

The agreement to temporarily restrict imports in New Zealand is effective today. It has come about after concerns were identified by the US Food and Drug Administration (FDA) when they found deviations from accepted manufacturing processes at two Apotex manufacturing plants in Toronto, Canada.

Medsafe Group Manager Dr Stewart Jessamine says the temporary restriction on imports is a precautionary measure which will remain in place until Medsafe is satisfied that Apotex had improved its manufacturing practices. "At this point, there is no reason for people to be concerned about taking any medicines manufactured by Apotex. There is no suggestion that people have been put at risk by taking any medicines made at any Apotex plants," Dr Jessamine said. “The issue that has been identified relates to the assurance of quality manufacture at the Canadian plants.”

Apotex makes and markets a wide range of medicines which are supplied to 115 countries worldwide. Medsafe has been working closely with PHARMAC, New Zealand's pharmaceutical funding and purchasing agency, to identify which Apotex medicines are available in New Zealand. PHARMAC funds 30 medicines supplied by Apotex, of which 20 are made at the two sites.

PHARMAC medical director, Peter Moodie, said Apotex products are widely used in New Zealand as they are in many countries and PHARMAC was keen to ensure continued supply of high quality medicines for New Zealanders.

“As a precaution, PHARMAC has begun discussions with other companies to ensure that future supply requirements can be met in the event that the import restriction is required for longer than expected.

“Our first priority is to ensure New Zealanders can have ongoing access to their medicines,” Dr Moodie said

Since the cessation of imports to the US last week, Medsafe has been in discussions with the FDA, Health Canada, PHARMAC and Apotex to obtain up to date, accurate information about the international situation. Health Canada is currently auditing the two affected Apotex sites in Etobicoke and Weston. Due to the size and scale of Apotex's operations in Toronto, the site visits alone will take at least a month. The audit is being carefully followed by medicine regulatory authorities around the world.

"We will continue to actively monitor this situation and will inform healthcare professionals and consumers if the situation changes significantly", he said.

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