Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 3 · Supply of Therapeutic Products
16. Records of supply of prescribed therapeutic products
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A supplier must, in respect of the supply by retail sale of any therapeutic product prescribed by a qualified practitioner or collaborative prescribing practitioner, keep at the premises where or from which the therapeutic product is supplied a record, complying with paragraphs (2) and (3), of every such supply.
The record required under paragraph (1) must contain all of the following particulars:
the date of supply;
the name, identity card or other identification document number, and contact details, of the person to whom the therapeutic product is supplied;
the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name, and the total amount supplied;
if the therapeutic product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner or collaborative prescribing practitioner who signed the prescription.
The record in paragraph (1) must be made on the day on which the therapeutic product is supplied or, if that is not reasonably practicable, within 24 hours after that day, and must be kept for a period of at least 2 years after the date of the supply.
A supplier must make available for inspection by the Authority at all reasonable times any record made under paragraph (1).
This regulation does not apply to the supply of any therapeutic product by wholesale.
Subregulation 1
A supplier must, in respect of the supply by retail sale of any therapeutic product prescribed by a qualified practitioner or collaborative prescribing practitioner, keep at the premises where or from which the therapeutic product is supplied a record, complying with paragraphs (2) and (3), of every such supply.
Subregulation 2
The record required under paragraph (1) must contain all of the following particulars:
the date of supply;
the name, identity card or other identification document number, and contact details, of the person to whom the therapeutic product is supplied;
the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name, and the total amount supplied;
if the therapeutic product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner or collaborative prescribing practitioner who signed the prescription.
Subregulation 3
The record in paragraph (1) must be made on the day on which the therapeutic product is supplied or, if that is not reasonably practicable, within 24 hours after that day, and must be kept for a period of at least 2 years after the date of the supply.
Subregulation 4
A supplier must make available for inspection by the Authority at all reasonable times any record made under paragraph (1).
Subregulation 5
This regulation does not apply to the supply of any therapeutic product by wholesale.