Guide to completing this application
1.	This application form is to be used to apply for a licence to manufacture poisons under the Medicines and Poisons Act 2019 (MPA) and the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 (Poisons Regulation). Information on poison manufacturing licences is available at the Department of Health’s website.
2.	Please print clearly and answer all questions in full. Your nominated Queensland contact will be notified if information is incomplete or additional information is required. This may delay the application process. 
3.	The correct descriptor and schedule of the poison must be indicated in section 4, otherwise the application will be refused. This must be consistent with the description under the Poison Standard.
4.	For explanation of poison terms in this application, please see the Department of Health’s website.
5.	Manufacturers with multiple manufacturing sites may be able to apply for a single licence covering all of the sites. 
6.	A holder of a manufacturing licence will be required to have a Substance Management Plan (SMP) prior to commencing regulated activities [Chapter 4, Part 2 of the MPA]. For more information on SMPs, please the Department of Health’s website. 
7.	Each manufacturing site must have a manufacturing supervisor [section 18 of the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 (Poisons Regulation). Where there is more than one manufacturing supervisor for a site, their roles must be clearly specified, e.g. the list of poisons that they supervise the manufacturing of. Supervisors must possess appropriate qualifications (refer to the Departmental Standard ‘Competency requirements for authority holders dealing with poisons – version 1’. 
8.	The documents listed below are required to be submitted with this application form. To avoid unnecessary delays, ensure you provide all the required documents:
a.	A current company extract from the Australian Securities and Investments Commission (ASIC);
b.	Verified copies of proof of identity documents for each director/chairperson/partner.
c.	Verified copies of the supervisor’s qualifications
9.	Photocopied documents including evidence of identity must bear the signature, name and occupation of an authorised identifier (verified copy) i.e. signed by health or legal professionals, Public Health Unit officers, government representatives, public servants, bank officers.
10.	The person signing on behalf of an entity must be an Executive Officer or a person authorised to sign on behalf of the entity. 
11.	If the space provided in any section is insufficient, please attach additional documents with the required information, indicating clearly which section of the form it applies to. 
12.	For information on fees, please see the Poisons Licence Fee Schedule. 
13.	The Department may carry out inquiries in relation to your application as considered necessary.
14.	Timeframes for processing of applications may take up to 90 days. 
How to submit this application
This application must be submitted by post, if you require assistance in relation to completing your application form, contact the Public Health Licensing Unit at Licensing@health.qld.gov.au. 
To submit your application, send the attached application form, accompanied by all supporting documents (verified where required) and the applicable fee, to:
The Chief Executive, 
Queensland Health
Public Health Licensing Unit
PO Box 2368
FORTITUDE VALLEY   QLD   4006
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 Medicines and Poisons Act 2019 and Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021. 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 – Type of application	
	New – Complete whole application (section 75 of the MPA) (if your licence has expired, you need to apply for a new licence)	
	Amendment to an existing licence – Licence Number:       (section 78 of the MPA)
Complete section 2 and all sections that require amending	
	Replacement of lost/destroyed licence – Licence Number:       (section 83 of the Poisons Regulation)
Complete section 2 and sections 8 – 11	
SECTION 2 – Applicant details	
Provide details of the legal entity seeking the licence 	
 Company	 Sole Trader	 Partnership	 Other      	
Legal name of legal entity or individual:      	
Trading name:      	ACN (if applicable):      	
Phone:      	Email:      	
Postal address:      	Town/Suburb:      	P/C:      	
For individuals, provide your personal details; for other entities, provide the personal details of all directors/chairpersons or partners. Attach further information if required	
Executive Officer or other person authorised to sign on behalf of the entity (e.g) Director/Chairperson/Partner 1	
Title:      	Surname:      	Given name/s:      	
Previous names (including maiden name):      	
Phone:      	Email:      	
Executive Officer or other person authorised to sign on behalf of the entity Director/Chairperson/Partner 2	
Title:      	Surname:      	Given name/s:      	
Previous names (including maiden name):      	
Phone:      	Email:      	
If there are additional Executive Officers/Directors/Chairpersons/Partners/other persons to be listed, please complete and attach to this application, the form ‘Additional Executive Officers/ Directors/Chairpersons/Partners/other persons attachment’. 	
Nominated Queensland contact	
Name:       	Phone:       	Email:       	

SECTION 3 – Sites where regulated activities are to occur	
Manufacturing site 1 of ____ name of location      	
Site address:      	Town/Suburb:      	P/C:      	
Storage arrangements	
Address where the poisons will be stored:      	
Describe onsite location where poisons will be stored:      	
Describe measures to ensure the poison are stored securely:       	
Manufacturing Supervisor information (section 18 of the Poisons Regulation) 	
Title:      	Surname:      	Given name/s:      	
Highest relevant qualification:      	Institution:      	Year of completion:      	
*If there are additional manufacture sites to be listed, please complete and attach to this application, the form ‘Additional manufacture sites’ attachment. 	
Person nominated to supervise the destruction of high-risk poisons (S8, S9 and S10) 
(s.35 of the Poisons Regulation)	
Title:      	Surname:      	Given name/s:      	Position:      	
Phone:      	Email:      	
SECTION 4 – Regulated poison/s to be purchased for manufacturing poisons at site 1 of ____ name of location      	
Provide details of the regulated poisons to be used to manufacture the final products, with reference to the schedule and descriptor (name) used in the Poisons Standard. Note Schedule 5 and 6 substances are not regulated poisons.	
Poisons Standard Descriptor	Schedule	Form, e.g. Amps, solution, etc.	Concentration	
     	     	     	     	
     	     	     	     	
     	     	     	     	
     	     	     	     	
     	     	     	     	
     	     	     	     	
SECTION 5 – Regulated poison/s in the final manufactured product at site 1 of ____ name of location      	
Provide details of the regulated poisons in the final manufactured products, with reference to the schedule and descriptor (name) used in the Poisons Standard.	
Poisons Standard Descriptor	Schedule	Form, e.g. Amps, solution, etc.	Concentration	
     	     	     	     	
     	     	     	     	
     	     	     	     	
     	     	     	     	
     	     	     	     	
SECTION 6 – Substance Management Plan (SMP)	
Have you prepared a SMP in accordance with section 93 of the MPA?	 Yes    No	
SECTION 7 – Duration of the licence	
Please specify the term of licence sought:	
  1 year	  2 years	  3 years	  4 years	  5 years	
SECTION 8 – Requesting a replacement licence	
  I declare that my existing manufacturing licence has been lost, stolen or damaged.	
SECTION 9 – Disclosure (relates to individual applicants or where this disclosure is relevant to the named entity itself – not the Executive Officer or other person authorised to sign on behalf of the entity)	
Have you, the applicant:		
a)	Been convicted of an indictable offence (drink driving and minor traffic offences are not indictable offences)?	 Yes    No	
b)	Been convicted of an offence against the Medicines and Poisons Act 2019, Health Act 1937 (including the Health (Drugs and Poisons) Regulation 1996) (repealed) or equivalent legislation in another Australian jurisdiction?	 Yes    No	
c)	Held a licence, approval and/or an endorsement under the Medicines and Poisons Act 2019, Health Act 1937 (including the Health (Drugs and Poisons) Regulation 1996) (repealed) or equivalent legislation in another Australian jurisdiction, that was suspended or cancelled?	 Yes    No	
d)	Been refused a licence, approval and/or an endorsement under the Medicines and Poisons Act 2019, Health Act 1937 (including the Health (Drugs and Poisons) Regulation 1996) (repealed) or equivalent legislation in another Australian jurisdiction?	 Yes    No	
Provide further details to questions answered 'yes' as an attachment to your application	

SECTION 10 – Consent and declaration	
	I consent to the chief executive, Queensland Health (or delegate) making enquiries of, and exchanging information with other Queensland authorities, any Australian state or territory, or of the Commonwealth, regarding any matters relevant to this application. If relevant information cannot be obtained from other entities, the chief executive (or delegate) will determine the application on the information available.	
	I declare that, to the best of my knowledge, all information provided in this application form, or in an attachment provided, is true and correct.	
	I understand that if anything has been stated in this application form, or in an attachment provided, that is false or misleading, any substance authority granted may be suspended or cancelled.	
Full name of applicant or authorised person:
     

Position      	Signature of applicant or authorised person (where applicant is an entity) – sign or insert an image of your signature: 
	Date (DD/MM/YYYY):      	

SECTION 11 – Payment of fees	
Has an application fee been paid for a Queensland Medicines Manufacturing/Wholesale Licence	 Yes		 No      
(if yes, state date of application or licence number _______________ )	
Fee payable (Please refer to the schedule of fees)	$     	
 Tick 1 box only	 Cheque or Money Order enclosed (payable to Queensland Health)
 Payment by Credit Card (complete payments details in section 15)	
Note: this is a GST free item. Department of Health ABN 66 329 169 412	
Credit card payments – do not overwrite any digits	
•	This page should only be completed if payment is being made by Mastercard or Visa.
Note: American Express is NOT available
•	If an error is made, cross through the digit using a single line and write the correct digit above and initial the change.
•	If emailing application, do not include credit card details with this form. Call to pay over the phone or print this page and send via post.	
Name of Applicant:	     	
Prescribed fee:	$     	 Tick 1 box only	 Mastercard	 Visa	
Name on card (print)	     	
Expire date:	___ / ___	
Signature of cardholder		

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Card number: