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~ HEALTH MANATU llAUORA

Ref: H201900475

Dear -

Response to your request for official information

133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000

I refer to your request of 12 February 2019 under the Official Information Act 1982 (the Act) for:

" .. . Can I please have a count of how many unregistered medicine notifications the MOH has received for CBD products since the beginning of 201 7, and if possible a breakdown of what products these notifications were for?

Can I also have a count of how many active MOH approvals there are for the following categories of products, Pharmaceutical grade medicinal cannabis products that do not have consent for distribution in New Zealand, and

Non-pharmaceutical grade medicinal cannabis products."

The information relating to this request is itemised below.

Can I please have a count of how many unregistered medicine notifications the· MOH has received for CBD products since the beginning of 2017, and if possible a breakdown of what products these notifications were for?

The exemption provisions in section 29 of the Medicines Act 1981 al low supply of an unapproved medicine authorised by a medical practitioner, provided certain specified information is provided to the Director-General of Health ( delegated to Medsafe ). This information is to be supplied as soon as practicable after the end of every month in which the product was supplied.

I have interpreted your request for unregistered medicine notifications to refer to the monthly notifications relating to supply under these provisions and received by Medsafe.

The first notification of supply was for the month of July 2017. Monthly notifications have been suppl ied from September 2017, up to and including January 2019.

The products that have been supplied include:

• Tilray THC10:CBD10 1 0mg/ml Oral Drops • Tilray CBD25 25mg/ml Oral Drops • Ti I ray CBD100 100mg/ml Oral Drops

• Thoughtcloud 750mg Oral Drops • Endoca Hemp Oil CBD3% Oral Drops • The Good Earth CBD Oil 25mg/ml Oral Drops.

Please note that not every product has been supplied every month.

Can I also have a count of how many active MOH approvals there are for the following categories of products, Pharmaceutical grade medicinal cannabis products that do not have consent for distribution in New Zealand, and

Non-pharmaceutical grade medicinal cannabis products.

Category of product Count

Pharmaceutical grade medicinal cannabis products that do not have consent for 0 distribution in New Zealand

Non-pharmaceutical grade medicinal 46

cannabis products

Please note that the majority of these approvals (44) are for Tilray products, and the Ministry of Health is aware that some of these are now considered to be pharmaceutical grade products.

I trust this information fulfils your request. You have the right, under section 28 of the Act, to ask the Ombudsman to review any decisions made under this request.

Please note this response (with your personal details removed) may be published on the Ministry of Health website.

Yours sincerely

K ~l;\ enana roo 1ng Deputy Director-General Health System Improvement and Innovation