Nominating a Responsible Person

Nominating a Responsible Person

The holder of (or an applicant for) a licence or permit must nominate one (or more) Responsible Persons to be named on the licence or permit document to be responsible for the following tasks:

Ensure that the licence/permit holdercomplies with the conditions of the licence/permit, and
Notify the Department of Health Drugs and Poisons Regulationof any amendments which may be required to the licence/permit or the conditions on the licence/permit (e.g. change of company or trading name, change of address, change of Responsible Person), and
Maintain the Poisons Control Plan, and
Ensure that there is a periodic review (at least annually) of the Poisons Control Plan, to ensure that the licence/permit holder continues to comply with relevant legislation and required standardsand to retain a documentary record of the review process, and
Provide periodic confirmation (at least annually) that the licence/permit holder is operating in a manner consistent with the Poisons Control Plan, and

Forward to the Department of Health Drugs and Poisons Regulation any proposed amendments to the Poisons Control Plan for assessment.

Note: The holder of a licence or permit must immediatelynotify the Department of Health Drugs and Poisons Regulation if the named Responsible Person ceases to be responsible for this role and must immediatelyapply to the Department of Health Drugs and Poisons Regulation to nominate another person.

Minimum requirements that apply to a nominated Responsible Person

For Schedule 4 and/orSchedule 8 and/or Schedule 9 poisons: an appropriate qualification* OR an appropriate health-related qualification** OR at least 5 years of recent experience and proven training in the handling and recording of poisons and controlled substances.
For Schedule 2 and/or Schedule 3 and/or Schedule 7 poisons: at least 5 years of recent experience and proven training in the handling and recording of similar poisons and controlled substances.
For the provision of health services: an appropriate health-related qualification**
For licences relating to the supply of drugs of dependence***, a National Police Record Check is to be carried out in relation to the nominated Responsible Person and to any other person who is to have unsupervised access to those drugs. Such a National Police Record Check must be made available for inspection by the Department of Health Drugs and Poisons Regulation if requested.

*Note:’an appropriate qualification’ would be one that includes significant studies in Chemistry

**Note: ‘an appropriate health-related qualification’would be one that includes studies relating to human or animal health(e.g. medical practitioner, dentist, pharmacist, nurse, ambulance officer, veterinary practitioner)

***Note:The term‘drugs of dependence’relatesto those poisons or controlled substances that are listed in Schedule 11 of the Drugs, Poisons and Controlled Substances Act 1981 (the Act), which may be viewed via a link from the Department of Health Drugs and Poisons Regulation website at

How to Complete an Application– Part 1 –by the person nominating the ResponsiblePerson

Note: A separate application form is required for each person to be nominated

Enter the full corporate and/or business/trading names of the holder of (or applicant for) a licence or permit that is applying to nominate a Responsible Person. Note: This is NOT usually the name of the person who is being nominated.
Enter the licence/permit address.
Enter the licence or permit number(s)(if this nomination relates to an existing licence or permit).
Enter the full name of the person being nominated (with a clear identification of the surname).
Describe the position that the nominated person holds (or is to hold) in the organisation and/or the duties or role of that position relevant to the poisons or controlled substances involved (e.g. Operations Manager, Warehouse Supervisor, Director of Nursing, CEO, Regulatory Affairs Officer).
Select if this nomination is an initial nomination (in the case of a newlicence/permit application) OR is a replacement forone (or more) existing named Responsible Person(s) OR isin addition to the existing namedResponsible Person (or persons)(in the case of an existing licence/permit).
The declaration must be completed and signed by a person who is authorized by the licence/permit holder (or applicant) to sign documents on its behalf, and the signature witnessed by an adult witness, (i.e. 18 years or older). This declaration is NOT by the nominated person unless the person nominating is also the person being nominated.

How to Complete an Application – Part 2 – by the person nominated to be Responsible Person

Enter the relevant details and complete the consent and declaration, namely:

Full name (with a clear identification of the surname),and
Date of birth, and
Full details of relevant qualification(s)and/or accreditation(s), where required(see Page 1 for minimum requirements), and
Full details of relevant employment history and/orrelevant training, where required(see Page 1 for minimum requirements) and
Signature for consent of and declaration by the nominated person and witnessing of that signature by an adult witness (i.e. 18 years or older).

How to Submit the Completed Nomination Application

Note: The application cannot be processed unless:

All details are completed, and
All supporting documentation has been provided, including photocopies of relevant qualifications and/or accreditation (where required) and/or relevant employment history and/or training (where required) (e.g. professional registration, practicing certificates, accreditation for handling dangerous goods), and

The appropriate fee has been paid- see theDepartment of Health Drugs and Poisons Regulation website at

The completed ORIGINALnomination form,supporting documentationand fee payment should be forwarded to:

THE CHIEF OFFICER

DRUGS AND POISONS REGULATION

DEPARTMENT OF HEALTH

GPO BOX 4541

MELBOURNEVIC 3001

For any further information - Phone: 1300 364 545 or Email:

Department of Health

Name of organisation (of existing or proposed licence/permit(s)):

Address (of existing or proposed licence/permit(s)):

IF this application relates to EXISTING licence(s) or permit(s), then

A. Complete the licence or permit number(s):
B. Mark ONE of the following to indicate if the applicant:
is in addition to the current responsible person(s), OR
is to replace ALL current responsible persons, OR
is to replace ONLY the following current responsible person(s): (List those to be replaced):
Details of the person being nominated as a responsible person:

Full name:(▪ As shown on a form of identification, such as a driver’s licence; ▪ Identify the surname by underlining it)

Position or role in the organisation:

Date of birth (Example of format: 01 / JAN / 1965) :

Declaration by the person completing the application to nominatea Responsible Person:

I,
(provide full name)
of:
(provide full address)
hereby declare that:
(a) I am duly authorised to complete and sign this application on behalf of the licence/permit holder (or applicant), and
(b) The nominated person has been made aware of the provisions of the Drugs, Poisons and Controlled Substances Act 1981 and the Regulations made there under, relevant to the poisons and controlled substances to which this licence/permit relates, and
(c) The nominated person has been made aware of the contents of the Poisons Control Plan and has been made aware of his/herresponsibility to ensure compliance by the licence/permit holder (or applicant) with the Poisons Control Plan, and
(d) The information that I have supplied in this application is true and correct in every particular and that this declaration is made in the knowledge that a person making a false declaration is liable to prosecution under Section 49 of the Drugs, Poisons and Controlled Substances Act 1981.
Signed:
(signature)
at:
(address where declaration signed)
on the: day of:
and witnessed in the presence of:
(print full name of adult witness)
(signature of adultwitness)

Relevant Websites:

Drugs and Poisons Regulation:

Drugs, Poisons and Controlled Substances Act 1981 and Drugs, Poisons and Controlled Substances Regulations 2006:

(To be completed by the Responsible Person applicant.)

As the responsible person applicant, I declare to be eligible to be nominated because:
With this application, I have included evidence of an appropriate qualification (one that included significant studies in chemistry and/or human or animal health).
Evidence may include a copy of the original qualification certificate OR a printed copy of:
▪ A current Australian Health Practitioner Regulation Agency registration record, available from the following webpage:
(This would be necessary for responsible person applicants of health service permits).
▪ Or a university record, if it is available from therelevant university’s website. Web-pages from some universities that have allowed their graduates to view their records online have included:
-DeakinUniversity:
-MonashUniversity:
-SwinburneUniversity of Technology:
-The University of Melbourne:
The above web-page addresses were current as at May 2014.
OR:
In the space below, I have provided details of my recent employment history which I declare has included at least five years experience and proven training in the handling and recording of scheduled substances, similar to those on the (proposed or existing) licence or permit [including employer(s), period(s) of employment, and role(s) which related to the handling and recording of the scheduled substances]:
(Note: For a health service permit, this declaration alone would not be sufficient, so a qualification (from the section further above on this page) would be necessary for a health service permit).
9. Consent and Declaration by the Nominated Person:
I,
(provide full name)
of:
(provide full address)
hereby declare that:
(a)I consent to this application for my nomination as Responsible Person, and
(b)I have not been found guilty of any indictable offence in the past ten years, save and except for those offences declared below.
Note: An indictable offence is an offence deemed to be an indictable offence under section 2B of the Crimes Act 1958 (Vic.)
The details of any guilty finding(s) are as follows:
Date: / / Offence:
Court: Penalty:
and,
(c)I have familiarised myself with the provisions of the Drugs, Poisons and Controlled Substances Act 1981 and the Regulations made there under, relevant to the poisons or controlled substances to which this licence/permit relates, and
(d)I have familiarised myself with the Poisons Control Plan and I understand that my responsibility is to ensure and oversee compliance by the licence/permit holder (or applicant) with the Poisons Control Plan, and
(e)I undertake that any proposed changes to the Poisons Control Plan will be forwarded to the Department of Health Drugs and Poisons Regulation for assessment, and I understand that any changes to the Poisons Control Plan that are accepted by the Department of Health Drugs and Poisons Regulation are to be implemented forthwith, and
(f)The information I have supplied in this application is true and correct in every particular and that this declaration is made in the knowledge that a person making a false declaration is liable to prosecution under Section 49 of the Drugs, Poisons and Controlled Substances Act 1981.
Signed:
(signature)
at:
(address where declaration signed)
on the: day of:
and witnessed in the presence of:
(print full name of adult witness)
(signature of adultwitness)

Department of Health