Licences

1. What is this guideline about?

1. This guideline is made pursuant to section 6A of the Agvet Code.
2. The purpose of this guideline is to set out our principles and processes in relation to performing our functions and exercising our powers relating to issuing licences under Part 8 of the Agvet Code.
3. It covers exemptions from licensing, the process of applying for and determining applications for licences, the particulars and conditions of licences, and suspensions and cancellations of licences.
4. The provisions of the Agvet Code and the Agvet Code Regulations covered by this guideline are outlined in the annexure to this guideline. 
5. This guideline commences on 1 July 2014.

2. What are ‘exempt products’ and ‘exempt persons’?

1. Under section 121(4) of the Agvet Code, a person must not carry out a step in the manufacture of chemical products at premises unless:
   1. under the Agvet Code Regulations, the products are ‘exempt products’ or the person is an ‘exempt person’ in relation to the manufacture of the products
   2. the person is a holder of a licence that is in force that authorises the carrying out of that step in relation to the products at those premises, or
   3. the person holds a permit that authorises the carrying out of that step in relation to the product at those premises (see Section 6A guideline – permits).
2. Exempt products are specified in regulation 59 of the Agvet Code Regulations. Examples of exempt products include:
   1. an agricultural chemical product
   2. any skin cleanser or shampoo
   3. any equine hoof protectant.
3. Exempt persons are specified in regulations 59A, 59B, 59C and 59D of the Agvet Code Regulations. These exemptions cover persons such as:
   1. the transferee of a business that holds an Australian Pesticides and Veterinary Medicines Authority (APVMA) licence, provided the conditions specified in the regulation are met, including the person complies with the terms of the licence as if they were the holder (regulation 59D)
   2. the legal representative of a licence holder who has died or the trustee in bankruptcy of a licence holder, provided the conditions in the regulation are met (regulation 59C)
   3. a person performing a single step of manufacture that involves only either packaging and/or labelling, or analysing or testing of the chemical product, and the person is authorised by way of inclusion on another person’s APVMA licence (regulation 59A).  In these cases, the single-step manufacturer (sub-contractor) must only perform the step for the holder on whose licence they are included, and can only be included on one APVMA licence
   4. a person performing a single step of manufacture that consists only of applying a label that contains only a name and address and/or the registration number of the chemical product to a package or packages of the product (regulation 59A).

3. Applying for a licence – what do we require?

1. An application for a licence must comply with the requirements of section 122(1) of the Agvet Code. The applicant must also comply with any notice we issue under section 122(2) of the Agvet Code.
2. We may issue a notice under section 122(2) of the Agvet Code requiring an applicant to provide further information or to allow an inspection, where we think the information sought or the inspection is necessary for us to determine the application.
3. For example, we may issue a notice under section 122(2) to obtain:
   1. more information in relation to the chemical product proposed to be manufactured (such as product type), the steps or other circumstances of manufacture, or the persons who will be responsible for production and quality
   2. further clarification of information already given to us as part of or in relation to the application.
4. The notice will state a ‘reasonable time’ within which the applicant must give us the specified information for the purposes of section 122(2)(a) of the Agvet Code. In determining what constitutes a ‘reasonable time’, we will take into account the requirements of the proposed notice, such as the kind of information required to be provided, whether the information is readily available, and the steps the recipient would need to take to provide the information. We will also take into account the needs of the applicant, including the urgency with which they would like us to determine the application.
5. The notice will state a ‘reasonable time’ at which an inspector, or another person authorised by us in writing, may conduct the inspection for the purposes of section 122(2)(b) of the Agvet Code. In determining what constitutes a ‘reasonable time’, we will take into account the nature and circumstances of the inspection and the availability of the inspector or other authorised person to conduct the inspection. We will also take into account the needs of the applicant, including the urgency with which they would like us to determine the application.

4. How do we determine an application for a licence?

1. We must issue a licence to the applicant unless we are satisfied of one or more of the matters in section 123 of the Agvet Code, in which case we must refuse the application. We set out some of these requirements below. 

4.1. When will we require you to undergo an audit?

1. One of the requirements for the issue of a licence is that, if directed by the APVMA CEO, the applicant:
   1. undergoes an audit by one of our inspectors, or another person we authorise, of the facilities, equipment, systems, processes, procedures and personnel to be used in the manufacture of the chemical products, and
   2. demonstrates to our satisfaction that they will comply with the conditions to be imposed on the licence if the licence is issued (section 123(1)(b) and regulation 59E). 
2. Ordinarily, the APVMA CEO will make such a direction unless:
   1. the licence has been applied for as a result of a transfer of business, the new licence would largely cover the same chemical products and manufacturing steps, premises, personnel and processes, and the previous licence holder was recently audited, or
   2. the applicant is applying for a licence in respect of a facility licensed by the Therapeutic Goods Administration (TGA) or accredited by the National Association of Testing Authorities (NATA), Australia, that the applicant has requested we consider and that we have assessed as covering the scope of the proposed APVMA licence. 

4.2. What are ‘special circumstances’ and which manufacturing principles are irrelevant?

1. We must refuse an application for a licence if we are satisfied of any of the matters set out in sections 123(1)(e) or 123(1)(f) of the Agvet Code, unless:
   1. in our opinion, ‘special circumstances’ make it appropriate to issue the licence (section 123(2), or 
   2. in the case of a failure to comply with a manufacturing principle in connection with the manufacture of chemical products, we think that the failure is not relevant (section 123(1C)).
2. We may regard the following as ‘special circumstances’:
   1. Where a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, was convicted of an offence referred to in sections 123(1)(e)(iv) to 123(1)(e)(vi)
   2. Where a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, was ordered to pay a pecuniary penalty referred to in sections 123(1)(e)(vii) to 123(1)(e)(ix)
   3. Where a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, contravened a condition of a manufacturing licence referred to in section 123(1)(e)(x) and where the applicant has put in place sufficient controls to ensure that the relevant contravention will not occur again
   4. Where a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, held a manufacturing licence or permit that was cancelled under the provisions referred to in section 123(1)(e)(xi), and where the applicant has put in place sufficient controls to ensure that the relevant contravention will not occur again
   5. Where a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, failed to comply with a manufacturing principle in connection with the manufacture of chemical products (section 123(1)(f), and where the applicant has put in place sufficient controls to ensure that the relevant contravention will not occur again
   6. Where there is no other manufacturer capable of manufacturing a particular chemical product and the product needs to be manufactured to deal with an emergency, or where its manufacture is in the national interest (for example, a novel product aimed at combatting a high-risk disease or pest), and there is no suitable alternative product available
3. We may regard the failure to comply with a manufacturing principle in connection with the manufacture of chemical products as not relevant where the failure was due to an oversight and was subsequently rectified in a timely fashion. For example, if inadvertent non-compliance is identified in an audit and is then rectified within the period specified in the audit report or, if a period is not specified, as soon as practicable, we may regard it as not relevant.

5. What are the particulars of a licence?

1. Under section 123(4) of the Agvet Code, a licence must state the person to whom it is issued, the products to which it relates, and the conditions to which it is subject other than those referred to in section 126(4) (see below).
2. A licence also contains other particulars, including the:
   1. premises to which it relates
   2. category of licence (as defined in regulation 3 of the Agvet Code Regulations)
   3. steps of manufacture
   4. date of issue.
3. Generally, if a licence holder wishes to change the particulars of a licence, the holder would need to submit a new application for a licence.
4. However, we may consider varying the following particulars of a licence:
   1. The category of licence, but only if the chemical products covered could be described as products to which the existing licence relates and the change is not to a higher risk category of licence
   2. The steps of manufacture
   3. The name of the licence holder, but only where the legal identity of the licence holder has not changed (for example, where the licence holder changes its business name)
   4. Minor changes to the address of the same premises as the result of changes by local council (e.g. street or lot numbers or postcode), or the addition of adjacent unit/s in the same industrial complex or similar
5. In deciding whether to vary a particular of a licence, we will take into account the matters set out in sections 122 and 123 of the Agvet Code, to the extent that they are relevant.

6. What are the conditions of a licence?

1. A licence is subject to the conditions mentioned in section 126 of the Agvet Code (section 123(3)).

6.1. Mandatory conditions

1. Under section 126(4) of the Agvet Code, each licence is, except as otherwise stated in the licence, subject to the conditions that the holder of the licence will:
   1. ensure that the chemical products conform to any standard that applies to them
   2. allow an inspector to enter premises at which the chemical products are manufactured and to exercise the monitoring powers under section 131A of the Agvet Code in relation to premises, and
   3. comply with the conditions prescribed in regulations 60, 61 and 62 of the Agvet Code Regulations.
2. It is a condition of each licence that the holder of the licence give to us on or before each anniversary of the day on which the licence comes into force certain information including, if we request, the details of chemical products manufactured by or on behalf of the holder of the licence during the previous 12 months (regulation 60). We will usually request these details:
   1. prior to a GMP audit being conducted (that is, it usually forms part of the pre-audit information we seek from the holder)
   2. following or as part of a recall of products manufactured under the licence
   3. after receiving an adverse experience report in relation to products manufactured under the licence
   4. as part of performing our compliance functions under the Agvet Code and the Agvet Code Regulations, or
   5. at any other time considered necessary by the APVMA. 
3. It is a condition of each licence that the holder of the licence keep at the premises to which the licence relates, for a specified period, certain records and, if it is not unreasonable in the circumstances, a sample from each batch of the finished products (regulation 61(5)). It may be unreasonable for the licence holder to keep such samples in the following circumstances:
   1. the size of the packaging makes storage impractical, and the chemical product or active constituent is low risk
   2. removal of a sample for storage is too costly or otherwise impractical, and the chemical product or active constituent is low risk.
4. It is a condition of each licence that the holder of the licence if directed by our CEO, undergo a GMP audit and demonstrate to our satisfaction compliance with specified conditions (regulation 61(8)). Our CEO is likely to direct that a licence holder undergo an audit in the following circumstances:
   1. Consistent with any recommendations or other information contained in a previous audit (including a previous GMP audit of the licence holder, any relevant audit performed prior to the issue of the licence, or any relevant audit conducted by the TGA or NATA)
   2. Where we obtain information that suggests that, since any previous audit relied on (including a previous GMP audit of the licence holder, any relevant audit performed prior to the issue of the licence, or any relevant audit conducted by the TGA or NATA), information we have obtained indicates that relevant circumstances or risks have changed (for example, as a result of a recall process, receiving an adverse experience report, or the performance of our compliance functions)
   3. Where a variation to the licence is being sought and the capability of the manufacturer for the new activity has not been already confirmed by audit
5. It is a condition of each licence that, if the audit identifies a non-conformance by the holder of the licence that, in the auditor’s opinion, is a ‘critical non-conformance’, the holder must notify us of the critical non-conformance within 3 working days of being told of it by the auditor (regulation 61(8B)). We regard:
   1. a ‘critical non-conformance’ as a ‘major non-conformance’ that poses a risk to treated animals or users and must be corrected immediately
   2. a ‘major non-conformance’ as a failure to satisfy a key requirement, or a failure that may pose a risk to product quality 
   3. a ‘minor non-conformance’ as a minor or less serious non-conformance that is unlikely to pose a risk to product quality.
6. It is a condition of each licence that, following a GMP audit of the holder of a licence, the holder must give us specified information within a period we determine (regulation 61(8C)(a)). This period is usually 25 working days from the completion date of the audit.

6.2. Discretionary conditions

1. Under section 126(1) of the Agvet Code, a licence may be subject to:
   1. the conditions that we impose for the purpose of ensuring that the holder of the licence manufactures the chemical products in accordance with the manufacturing principles and any standards that apply to the products, and
   2. any other conditions relating to the manufacture of the products that we think appropriate to impose.
2. We will, for the purposes of section 126(1) of the Agvet Code, impose conditions on a licence so that, in deciding to issue the licence, we can be satisfied that all applicable statutory requirements are met.
3. We will impose conditions on licences for the purposes of section 126(1) that are:
   1. consistent with the Agvet Code and the Agvet Code Regulations, and otherwise lawful
   2. consistent with our regulatory approach as set out in the guidelines 
   3. capable of being monitored and measured.
4. The following are examples of conditions that we may impose on a licence under section 126(1) of the Agvet Code:
   1. For a facility licensed by the TGA and recognised by the APVMA for the purposes of licensing:
      1. the licence holder must perform all aspects of veterinary chemical manufacture, including analysis and testing using the same:
         1. premises
         2. plant and equipment
         3. processes and procedures
         4. documentation, and 
         5. personnel (including those persons responsible for production and quality)
         that are used in the manufacture of human therapeutics, as inspected and licensed by the TGA
      2. prior to each TGA audit, the licence holder must arrange for the TGA auditor to verify during the audit that all aspects of veterinary chemical manufacture are carried out within the scope of that TGA licence
      3. the licence holder must maintain their TGA licence and advise us in writing within 10 working days of any changes in the scope of that licence
      4. the licence holder must provide us with copies of all TGA audit reports and correspondence related to the conduct and closure of such audits, within 10 working days of receipt of those reports or correspondence.
   2. For a NATA accredited laboratory whose accreditation is recognised by the APVMA for the purposes of licensing:
      1. the licence holder must perform all aspects of laboratory analysis or testing or both of veterinary chemical products using the same:
         1. premises
         2. plant and equipment
         3. laboratory procedures
         4. documentation, and 
         5. personnel (including those persons responsible for production and quality)
         that are inspected by and covered under the NATA accreditation.
      2. the licence holder must maintain their NATA accreditation and advise us in writing within 10 working days of any changes in the scope of that accreditation that are likely to impact on the analysis or testing or both of veterinary chemical products
      3. the licence holder must also provide us with copies of all NATA assessment reports and correspondence related to the conduct and closure of such assessments, within 10 working days of receipt of those reports or correspondence.
   3. If additional premises (either secondary or tertiary premises used by the licence holder, or premises used by sub-contractors to perform steps of manufacture of the kind specified in regulation 59A of the Agvet Code Regulations), conditions authorising the steps of manufacture that can be performed by the licence holder and sub-contractors of the licence holder at each premises.

6.3. New conditions or changing existing conditions 

1. We may, by written notice given to the holder of a licence, impose new conditions on a licence or vary or remove existing conditions (section 126(2) of the Agvet Code).
2. We may decide to impose new conditions on a licence, or vary or remove existing conditions, in the following circumstances:
   1. To prevent imminent risk of unintended harm to animals, plants, or things, or to the environment
   2. To prevent imminent risk to persons of death, serious injury or serious illness
   3. To prevent imminent risk of impact on trade or commerce between Australia and places outside Australia
   4. Where a GMP audit of the licence holder identifies a condition that should be imposed on the licence
   5. Where the licence holder requests that a new condition be added or that an existing condition be varied or removed, and we agree to the request
   6. Where the condition is determined by the APVMA as being no longer relevant or necessary (in the case of removal)
3. If the notice states that the action is necessary to prevent imminent risk of the kind set out in section 126(3)(a), the imposition of the new condition or the variation of an existing condition takes effect on the day we give the notice to the holder. In all other cases, it takes effect on the day stated in the notice. The day stated in the notice will ordinarily be 28 days after we give the notice to the holder. However, we may agree an earlier day with the holder (section 126(3)(b)).

7. Suspension or cancellation of a licence – when and why?

1. Section 127 of the Agvet Code sets out, among other things, the grounds on which we may suspend or cancel a licence.
2. We will usually cancel rather than suspend a licence in the following circumstances:
   1. Where the cancellation has been requested by the holder in accordance with section 127(1)(d)
   2. Where there are grounds to suspend or cancel the licence and we are unable to contact the licence holder or the licence holder has failed to respond to us
   3. Where there are grounds to suspend or cancel the licence and the licence holder is not operating at the premises to which the licence relates
   4. Where the holder ceases to carry on the business of manufacturing the chemical products to which the licence relates, in accordance with section 127(1)(e)
3. We will nearly always suspend or cancel a licence when the holder has asked in writing that the licence be suspended or cancelled (see section 127(1)(d)).
4. If we take steps to suspend a licence, the length of the suspension will be informed by the period nominated by the holder if the suspension was requested or, in other circumstances, our assessment of the time required for the holder to address the ground that led to the suspension. The suspension period will usually be no longer than 2 years. Often, an initial period of suspension of 12 months will be imposed.  
5. If we propose to suspend or cancel a licence, except when asked to do so by the holder, we must, subject to specified exceptions (section 127(2a)), give the holder written notice of the proposed action, including reasons for the proposed action, and, except if the proposed action is to be taken because of a failure to pay a prescribed fee, give the holder an opportunity to make, within a ‘reasonable time’ stated in the notice, written submissions to us in relation to the proposed action (section 127(2)). In determining what constitutes a ‘reasonable time’, we will take into account the reasons for the proposed suspension or cancellation, and what, if any, action we consider could be taken to address the grounds leading to the proposed suspension or cancellation.
6. If a licence is suspended or cancelled, we may, by written notice to the holder, revoke the suspension or cancellation (section 127(7)). We may revoke a suspension or cancellation in the following circumstances:
   1. Where the suspension or cancellation was requested and the licence holder has reversed their request within 3 months of the date of effect of the suspension or cancellation
   2. Where we are satisfied that the defects that led to the suspension or cancellation have been rectified

8. Annexure – relevant legal provisions

1. Part 8 of the Agvet Code regulates the manufacture of chemical products. It makes it an offence to carry out a step in the manufacture of certain chemical products without a permit or a licence (subject to certain exemptions). 
2. Part 8 deals with, among other things, the issuing of licences to take steps in the manufacture of chemical products at particular premises. Part 7 deals with the issuing of permits. We have issued a separate guideline in relation to permits (see Section 6A guideline – permits). 

   Note: Section 121 of the Agvet Code provides for offences relating to manufacture and licences (see also regulations 59, 59A, 59B, 59C and 59D of the Agvet Code Regulations). Section 122 deals with the application for a licence. Section 123 deals with the issue of a licence (see also regulation 59E of the Agvet Code Regulations). Section 124 deals with the period of a licence. Section 126 deals with the conditions of licences (see also regulations 60, 61, 61A and 62 of the Agvet Code Regulations). Section 127 deals with suspension and cancellation of licences. Section 128 deals with publication of a list of manufacturers and other things.