application for an approval to use scheduled medicines … · web viewthis form is to be used to...

Information for applicants This form is to be used to apply for or amend a Section 18(1) Approval, under the

Health (Drugs and Poisons) Regulation 1996, to use scheduled medicines (including Schedule 2 and 3 poisons, restricted drugs and controlled drugs) for therapeutic purposes.

Please complete electronically or print clearly, date and sign. Answer all questions in full

An Approval is generally granted to an individual, but in certain circumstances consideration may be given to grant an approval to a business entity.

Entity applicants must nominate a responsible person for supervising the use of the approved scheduled medicines.

If there are more than two directors or more than one partner applying for the Approval, attach an additional page with the relevant information as listed in section 1.

If an Approval granted to an individual specifies the name of the employer, then the Approval is only valid while the individual is employed by that employer.

Please attach additional pages with the required information, indicating clearly which section of the form it applies to.

Applications must be scanned and emailed to [email protected] and original documents retained by the applicant to be produced on request.

Documents requiredApplications for an Approval (or amendment of an approval) must include the following documents

Individuals

Certified evidence of identity such as drivers licence, passport or Adult Proof of Age Card

Certified copy of qualifications and/or training Evidence of hospital credentialing Details of any matters disclosed in section 6

Partnerships Applicants involved in partnerships must provide proof of partnership documentation in addition to information required by individuals

Entities Current Company Extract issued by the Australian Securities and Investments

Commission (ASIC) Details of any matters disclosed in section 6

Application for an approval to use scheduled medicines and/or poisons for therapeutic purposes - How to apply

Application for an approval to use scheduled medicines

mailto:[email protected]

Queensland HealthApplication for approval to use scheduled

medicines/poisons for therapeutic purposesPrivacy statement - please read carefullyThe 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.

Section 1 - Applicant – include full name, as it appears on identification

A. Individual applicants

Surname Given name/s

Residential address

Phone number

Place of birth

Email Date of birth

Employer name and address

Postal address as per residential address, or;

Current/previous approval number (if applicable)

B. Corporate applicants – incorporated entities only

Company name ACN

Registered address Postal address as per registered address, or;

Current/previous approval number (if applicable)

Director 1 – include full names as they appear on formal identification (e.g. driver licence)


Date of birth Place of birth

Residential address

Phone number

Email

Director 2 – include full names as they appear on formal identification (e.g. driver licence)


Date of birth Place of birth

Residential address

Phone number

Email

Nominated person responsible for supervising the use of scheduled substances.

Name

Position


Section 2 - Employer endorsement – individual applicants only

This section should be completed by the applicant’s supervisor or employer. For applicants employed by the Hospitals and Health Services (HHS), this section must be signed by the Chief Executive of the HHS

Name of applicant Employer

Endorser details

Full name Position

Email Phone number

By signing this document, I confirm that the details provided by the applicant are true and correct, and that the applicant is required to possess and use the scheduled medicines listed on this form as part of their employment. I support this application.

Signature Date

Section 3 - Purpose of application

Please explain the reasons for requiring an Approval. **

** Attach any other relevant information in support of the application (may include certified copies of evidence of relevant qualifications, credentialing from the Hospital, relevant training including anaphylaxis training ,quality use of medicine training, project grant and/or proposal, ethics committee approval, prescribing trials approval etc).

Term of Approval - For how many months do you require an Approval? (maximum 24 months)

Section 4 - Scheduled substances requested

List the scheduled substances that you are requesting as per the Standard for Uniform Scheduling of Medicines and Poisons (The Poisons Standard – Therapeutic Goods Act 1989)

Schedule number/type of scheduled substance (schedule 2, 3, 4, or 8)

SUSMP descriptor Form, e.g. Amps, solution, vials, powder, etc.

Strength (e.g. mg/mL) Max quantity held at any one time (mLs, grams, vials, etc.)


Section 5 - Storage & Security

Controlled medicines (S8) must be stored in a manner that complies with Appendix 6 of the Health (Drugs and Poisons) Regulation 1996. Restricted medicines (S4) must be held at all times in secure, locked storage.

Building name Physical address

as per above organisation address, or;

Phone number

Name of contact at storage location

What is the nature of the storage? (Provide details of room, receptacle, vehicle, etc.)

Who will have access to stored scheduled substances and how will access be restricted to Approval holders only? (Provide details of safe, storeroom, key holders, etc.)

Please refer to the relevant sections of the Health (Drugs and Poisons) Regulation 1996 about storage of different scheduled substances.

Section 6 - Disclosure

Have you/has the applicant:

Been convicted of an indictable offence? (drink driving and minor traffic offences are not indictable)

Yes No

Been convicted of an offence against the Health Act 1937, or the Health (Drugs and poisons) Regulation 1996, or equivalent legislation in another Australian jurisdiction?

Yes No

Held an Approval and/or an Endorsement granted under the Health (Drugs and Poisons) Regulation 1996, or under equivalent legislation in other states or territories, that was suspended or cancelled?

Yes No

Been refused an Approval under the Health (Drugs and Poisons) Regulation 1996 or a repealed provision, or a corresponding law (including in other states or territories)?

Yes No

If any questions are answered ‘YES’, attach documentation providing details of the offence, the nature of the offence and the circumstances of its commission and include a criminal history record (Australia-wide) if indictable offences are declared.

Section 7 - Declaration

I/we 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/we understand that if anything has been stated in this application form or an attachment provided with this application, that is false or misleading, the Approval granted may be cancelled or suspended.

I/we consent to Queensland Health the making of enquiries of, and the exchange of information with the authorities of any Australian State, Territory, Commonwealth or the applicant’s employer regarding any matters relevant to this application.

I/we have read, understand and agree to comply with the relevant provisions of the Health (Drugs and Poisons) Regulation 1996 (www.legislation.qld.gov.au): to this application.


http://www.legislation.qld.gov.au/

Section 7 – Declaration continued

Individual applicant or Signatory 1

SignaturePosition

Date

Full Name (printed)

Signatory 2 (if applicable)

SignaturePosition

Date

Full Name (printed)

More informationSubmit signed and completed application forms to:Chief Executive, Queensland HealthC/o Healthcare Approvals and Regulation [email protected]

If you require any further information about this application, please contactHealthcare Approvals and Regulation Unit (HARU)[email protected]: 07 3708 5264


