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Queensland Health Application for exemption of medicine labelling –

S2, S3, S4, S8 drugs and poisonsSection 132(n) Health Act 1937

Section 11 Health (Drugs and Poisons) Regulation 1996

Privacy statement - please read carefully The personal information and documents collected for the purpose of this application will be securely stored, and only accessible and used by authorised persons for purposes in accordance with the Health Act 1937 and Health (Drugs and Poisons) Regulation 1996. Queensland Health may be required to make enquiries of, and exchange personal information with, other State, Territory or Commonwealth entities regarding any matters relevant to this application. The department will not disclose any personal information provided with this application and supporting documents to any other third parties without your consent unless required or authorised by law. The Information Privacy Act 2009 (Qld) sets out the obligations for the collection and handling of personal information by Queensland Health. For information about how Queensland Health protects your personal information, or to learn about your right to access your own personal information, please see our website at www.health.qld.gov.au.

When is this form to be used? Section 11 of the Health (Drugs and Poisons) Regulation 1996 (HDPR), requires that a package containing a controlled drug (S8), a restricted drug (S4) or a poison (S3 and S2) must bear a label that complies with the current Poisons Standard, part 2. Section 11 also describes circumstances when a package may be labelled in an alternative way (an exemption) to the Poisons Standard, part 2, and in such circumstances this alternative way must be certified by the Chief Executive (or delegate) of Queensland Health. This form is to be used by an entity seeking such certified alternative way. The Chief Executive can only certify an alternative way of labelling a package containing a controlled drug, a restricted drug, or an S3 or S2 poison under one of the following circumstances— (i) an appropriate authority1 has authorised (whether by approval, exemption or some other way) the package to be

labelled in the alternative way. In these circumstances, an entity MUST also obtain certification that the labellingexemption applies in Queensland; or

(ii) the Chief Executive is satisfied the alternative way is unlikely to adversely affect public safety, having regard to thenature of the drug or poison and the purpose for which it is to be used.

Section 1 – Applicant details Provide details of the entity seeking certification of the alternative way

Entity legal name: ACN

Entity trading name (if relevant): ABN

Contact person: Position in entity:

Email: Phone:

Address: Town/suburb: P/C

Are you, the applicant, the TGA sponsor of the medicines proposed to be packaged in an alternative way?

Yes No, please describe the relationship with the sponsor:

Section 2 – Type of application (please choose one of the below only)

An appropriate authority has authorised (whether by approval, exemption or some other way) the package to be labelled in the alternative way Please attach copy of the exemption provided by the appropriate authority

An exemption is being sought in Queensland f irst i.e. no other appropriate authority has authorised (whether by approval, exemption or some other way) the package to be labelled in the alternative way Please provide the reasons the labelling exemption is being sought noting the Chief Executive must be satisfied the alternative way is unlikely to adversely affect public safety, having regard to the nature of the drug or poison and the purpose for which it is to be used (and attach relevant information)

Rescheduling Importation due to medicines shortage

Other:

1 The current Poisons Standard, section 1.5 sets out other ways for labelling exemptions and Part 1 provides the definition of ‘appropriate authority’

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Queensland Health Application for exemption of medicine labelling –

S2, S3, S4, S8 drugs and poisonsSection 132(n) Health Act 1937

Section 11 Health (Drugs and Poisons) Regulation 1996

Section 3 – Medicine/s proposed to be labelled in an alternative way

Please complete below or alternately attach with relevant information

ARTG ID Schedule Descriptor Form Strength Pack size/use

Section 4 – Proposed term of exemption and additional information

Please nominate the period of time for which the certif ication is sought Months

Please specify the proposed end date for the exemption Date

Please provide your justif ication for the length of term and any additional information to support your application:

Section 5 – Declaration

I certify that I have authority to make this application on behalf of the applicant.

I declare that, to the best of my knowledge, all information provided in and with this application form is true and correct in every detail.

I understand that if anything has been stated in this application form, or in an attachment provided with this application, that is false or misleading, any certif ication may be cancelled or amended.

I consent to Queensland Health making enquiries of , and the exchange of information with, the authorities of any Australian state or territory or of the Commonwealth, regarding any matters relevant to this application.

Full name of authorised representative Signature of authorised representative Date

Position in entity

Submitting this application Please submit completed forms via email to Healthcare Approvals and Regulation Unit (HARU)

Email: HARU@health.qld.gov.au

Web: www.health.qld.gov.au/clinical-practice/guidelines-procedures/medicines/labelling-

exemptionsApplication for exemption of medicine labelling – S2, S3, S4, S8 drugs and poisons