Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Note: This consent is given subject to the following conditions:

• Provisional consent is to be granted for 12 months to address an urgent stock shortage in the market.
• The medicine may only be marketed or distributed when no other periciazine immediate release oral dose forms with consent to distribute under section 20 of the Medicines Act 1981 are available on the New Zealand market.
• Provisional consent may only be renewed following a risk assessment of the current periciazine supply situation in New Zealand. Should the applicant intent to market the product beyond expiry of the provisional approval for commercial reasons, a new medicine application should be submitted to Medsafe accompanied by a full data set in compliance with New Zealand’s medicines regulatory requirements.
• The sponsor should provide regular updates to Medsafe on the usage of this medicine and notify Medsafe immediately of any reports indicating an adverse reaction or quality issue associated with the medicine.

Note: This consent is valid for 12 months from the date of publication of this notice.

Note: This consent is given subject to the following conditions:

• Provisional consent is to be granted for 12 months to address an urgent stock shortage in the market.
• The medicine may only be marketed or distributed when no other periciazine immediate release oral dose forms with consent to distribute under section 20 of the Medicines Act 1981 are available on the New Zealand market.
• Provisional consent may only be renewed following a risk assessment of the current periciazine supply situation in New Zealand. Should the applicant intent to market the product beyond expiry of the provisional approval for commercial reasons, a new medicine application should be submitted to Medsafe accompanied by a full data set in compliance with New Zealand’s medicines regulatory requirements.
• The sponsor should provide regular updates to Medsafe on the usage of this medicine and notify Medsafe immediately of any reports indicating an adverse reaction or quality issue associated with the medicine.

Note: This consent is valid for 12 months from the date of publication of this notice.

Dated this 26th day of June 2018.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).