Therapeutic Goods (Guidelines for Multi-Site Licences) Instrument 2020

The instrument rests on a small number of tightly defined concepts that determine eligibility for a multi‑site licence and shape compliance obligations.

Multi‑site licence: The instrument does not define the word "licence" itself but uses the term as defined in subsection 3(1) of the Act (s 4 note). The instrument specifies the factual and organisational circumstances in which a single licence may cover two or more manufacturing sites (ss 5-6). The criteria are cumulative; all listed paragraphs must apply for the licence to lawfully cover multiple sites (s 5(2), s 6(2)).

Fixed site and mobile (non‑fixed) site: The instrument distinguishes a fixed manufacturing site (the place at which the manufacturing steps are principally carried out) from additional sites which may be fixed or, in the case of blood products, mobile (s 5(2)(a); s 6(2)(a)(ii)). For blood and blood components, mobile sites are permitted for collection only (s 6(2)(a)(ii)).

Permitted steps at additional sites: For therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue, allowed activities at the additional site(s) are limited to: storage of primary packaging materials, starting materials, in‑process materials or finished product; secondary packaging of finished product; or release for supply of packaging materials, starting materials, in‑process materials, or finished product (s 5(2)(a)(i)-(iii)). For blood and related products, additional sites may involve storage (for fixed additional sites) or collection (for mobile additional sites) (s 6(2)(a)(i)-(ii)).

Single quality system: A pivotal organisational requirement is that "all steps in the manufacture of the therapeutic goods are to be covered by a single quality system" (s 5(2)(b), s 6(2)(b)). The instrument defines "quality system" as the organisational structure, responsibilities, procedures, instructions, processes and resources for implementing quality management (s 4). This concept centralises responsibility for quality across multiple sites.

Inspectability and inspection proximity: Each additional site must be "capable of being inspected within the relevant period" (s 5(2)(c), s 6(2)(c)). The instrument also imposes a geographic/proximity constraint, requiring that "the total travel time between the sites under inspection does not exceed 60 minutes" (s 5(2)(d), s 6(2)(d)). The phrase "relevant period" is used but not defined in the instrument; its meaning will be informed by the Act and the regulator's inspection planning.

Definitions shaping scope: Several definitions narrow or expand what counts as starting material and packaging material depending on whether the therapeutic goods are blood products or otherwise (s 4). For non‑blood goods, "starting material" excludes packaging material (s 4). For blood and related products, "starting material" covers any material that may contact or be included as an ingredient or component in the therapeutic goods (s 4). The instrument also defines in‑process material, secondary‑packaging and plasma (s 4), tying the scope of permitted activities at additional sites to specific points along the manufacturing and handling continuum.

Repeal of prior guidelines: The instrument explicitly repeals the Therapeutic Goods (Multi‑Site Manufacturing Licences) Guidelines of 2010 (s 7; Schedule 1). That means the 2010 instrument is removed from the regulatory instruments specified in Schedule 1 as of this instrument’s commencement.

Authority and commencement: The instrument is made under s 38A of the Act (s 3) and commenced the day after registration, recorded as 1 April 2020 (s 2). The text includes an explicit note that several terms are already defined in subsection 3(1) of the Act (s 4 note), signalling that this instrument functions as a set of administrative criteria within the broader statutory scheme.

Together these concepts frame a multi‑site licence approach that centralises quality oversight, restricts additional sites to limited activities, requires inspectability and imposes a 60‑minute travel time constraint. The instrument’s structure is prescriptive and procedural rather than declaratory of licensing outcomes; it sets eligibility conditions rather than describing licensing procedures or penalty regimes.

The instrument affects several identifiable groups by altering the criteria under which one licence may cover multiple manufacturing locations.

Manufacturers and prospective licence holders: Entities that manufacture therapeutic goods,whether medicines, medical devices (as encompassed by the Act’s definitions), or blood and blood‑related products,are directly affected. The instrument determines when a single licence can lawfully encompass more than one site. Where a manufacturer seeks a multi‑site licence, it must structure operations to satisfy the cumulative conditions in s 5(2) or s 6(2) depending on the product type. This shapes decisions about where to locate primary manufacturing steps, where to store materials, where to conduct secondary‑packaging and where to release products for supply (s 5(2)(a); s 6(2)(a)).

Quality and compliance staff: The requirement that "all steps in the manufacture of the therapeutic goods are to be covered by a single quality system" (s 5(2)(b), s 6(2)(b)) places responsibilities on quality assurance, quality control and compliance teams. Those teams must design and maintain an integrated organisational structure, procedures and resources that apply across multiple sites (s 4 definition of "quality system"). Internal control systems, documentation, training and management chain arrangements will need to reflect the single quality system requirement.

Site operators and managers: Managers of additional sites that perform permitted steps (storage, secondary‑packaging, release for supply, or collection in the case of blood products) must ensure their operations integrate with the single quality system and remain capable of inspection (s 5(2)(a); s 6(2)(a)). Mobile collection sites for blood and blood components are specifically contemplated (s 6(2)(a)(ii)), which affects mobile collection operators, blood services and health providers who use non‑fixed collection points.

Regulators and inspectors: The instrument conditions multi‑site licensing on the capacity for inspection within "the relevant period" and on a travel‑time limit of 60 minutes for sites under inspection (s 5(2)(c)-(d), s 6(2)(c)-(d)). This affects the operational planning of the regulator (the Department of Health / regulator acting under the Act), as it determines which multi‑site arrangements are acceptable based on inspectability and geography. Inspectors will rely on these criteria when determining whether a licensee’s multi‑site arrangement complies with licence conditions.

Supply chain partners and contractors: Organisations that provide storage, packaging, or transport services for therapeutic goods may be affected because the instrument permits additional sites to be used for storage and secondary‑packaging (s 5(2)(a)). Contractors that host storage or secondary‑packaging operations must be integrated into the licensee’s single quality system where those activities fall within the multi‑site licence.

Legal and compliance advisers: Lawyers, compliance officers and auditors advising manufacturers will need to structure compliance opinions, contractual arrangements and audit scopes to reflect the limited activities permitted at additional sites, the single quality system requirement and the inspectability and proximity constraints (s 5(2), s 6(2)).

Patients and downstream purchasers: Indirectly affected, because the instrument shapes where certain handling steps may occur and how quality oversight is organised. The instrument distinguishes blood‑related products from other therapeutic goods and imposes different allowances for mobile collection (s 6), which can influence access models for blood collection services.

Those not affected in the same way: Entities that do not hold manufacturing licences or do not engage in permitted additional‑site activities are not directly regulated by these particular guidelines. The instrument does not change licensing requirements themselves, fee structures, or the definition of licence offences; it focuses on when a licence may lawfully cover multiple sites under the Act (s 3).

Overall, the instrument reallocates organisational responsibility to the licence holder (single quality system) while constraining geographic dispersion (60‑minute total travel time) and limiting permissible activities at additional sites. That changes the compliance perimeter for a wide set of operational and legal actors associated with therapeutic goods manufacture.

The instrument imposes a set of obligations (expressed as necessary conditions) on applicants or holders of a multi‑site licence and clarifies the narrow circumstances in which a licence may cover multiple sites. It does not itself enumerate rights such as appeal rights or fee entitlements; those remain governed by the Act.

Cumulative eligibility conditions: The central duty for a licence holder or applicant is to ensure that all the conditions in the applicable section apply. For therapeutic goods other than blood and related products, s 5(2) states that all of the listed paragraphs must apply for the licence to cover multiple manufacturing sites. For blood, blood components, haematopoietic progenitor cells or human tissue, s 6(2) requires all listed paragraphs to apply. Because the conditions are cumulative, failing any one removes eligibility for a multi‑site licence under these guidelines.

Site‑activity restrictions: A licence holder must confine additional site activities to the permitted steps. For non‑blood goods, additional sites may only be used for (i) storage of primary packaging materials, starting materials, in‑process materials or finished product; (ii) secondary‑packaging of finished product; or (iii) release for supply of packaging materials, starting materials, in‑process materials, or finished product (s 5(2)(a)(i)-(iii)). For blood products, additional fixed sites may be used for storage and mobile sites for collection (s 6(2)(a)(i)-(ii)). The instrument thus limits the rights of a licence holder to distribute manufacturing steps across sites.

Single quality system duty: The licence holder must ensure "all steps in the manufacture of the therapeutic goods are to be covered by a single quality system" (s 5(2)(b), s 6(2)(b)). The instrument defines quality system to include organisational structure, responsibilities, procedures, instructions, processes and resources for implementing quality management (s 4). Practically, this allocates to the licence holder the duty to design, maintain and enforce a cross‑site quality system.

Inspectability duty: All sites covered by the licence must be "capable of being inspected within the relevant period" (s 5(2)(c), s 6(2)(c)). The instrument does not set what the "relevant period" is, but it imposes a compliance duty to ensure that inspection access and readiness are in place for whatever the regulator’s relevant period is determined to be under the Act or operational practice.

Proximity constraint: The licence holder must ensure that "the total travel time between the sites under inspection does not exceed 60 minutes" (s 5(2)(d), s 6(2)(d)). This is a quantifiable constraint on how geographically dispersed the sites may be for multi‑site licensing.

Duty to locate principal manufacturing steps at one fixed site: A licence holder must ensure that "steps in the manufacture of the therapeutic goods are to be carried out at one fixed site" and that additional sites only perform permitted functions (s 5(2)(a), s 6(2)(a)). This allocates the duty to concentrate principal manufacturing activity.

Implied duties arising from definitions: The definitions in s 4 impose additional practical duties. For example, where starting material is defined differently for blood products, licence holders must treat contact materials and ingredient components for blood products as starting material (s 4). The definition of in‑process material as partly processed starting material that must undergo further manufacturing before final dosage form (s 4) requires licensees to track and manage such materials in compliance with the single quality system.

Rights (implicit): The instrument grants, implicitly, the right to hold a single licence that covers multiple sites where all conditions are satisfied. It also clarifies permitted operational arrangements,such as allowing mobile sites for blood collection (s 6(2)(a)(ii)),which can be interpreted as an operational right to use such sites within a licensed framework.

No statutory penalties in instrument: The instrument itself does not create offences or set administrative penalties; it operates as a guideline for licensing under the Act. Therefore, enforcement actions and rights to administrative review or appeal will be those provided in the Act and other instruments (s 3). The instrument’s criteria will be applied by the regulator in exercising licensing powers under the Act.

Recordkeeping and integration duties (practical implication): While the instrument does not prescribe specific recordkeeping requirements, the single quality system definition implies duties to document procedures, responsibilities and resources across sites (s 4, s 5(2)(b), s 6(2)(b)). Licence holders must structure their compliance activities accordingly to demonstrate conformity with the multi‑site criteria.

Overall, the instrument transforms licensing eligibility into a set of organisational and geographic duties on licence holders and applicants, while providing them the practical right to have multiple sites covered by a single licence where those duties are met.

The instrument itself does not set out penalties, offence provisions, or detailed enforcement mechanisms. Its legal effect is to provide guideline criteria for when a licence may cover multiple manufacturing sites, made under the authority of section 38A of the Therapeutic Goods Act 1989 (s 3). Enforcement, inspection powers, sanctions, and offences are matters addressed by the Act and other regulatory instruments; the instrument references those authorities but does not restate them.

Inspection capability as a licensing condition: The instrument conditions multi‑site licensing on the sites being "capable of being inspected within the relevant period" (s 5(2)(c), s 6(2)(c)). That creates an operational precondition for licensing and for continuing to have sites covered by a licence. If a site cannot be inspected within the relevant period, it would not meet the instrument’s criteria, and therefore it would fall outside what the instrument permits to be covered by a single licence. Any consequences for non‑compliance with licensing conditions,such as variation, suspension or cancellation,are matters for the regulator under the Act and are not specified in this instrument.

Geographic constraint and inspection logistics: The 60‑minute total travel time constraint (s 5(2)(d), s 6(2)(d)) serves as an objective threshold that the regulator can apply when assessing proposals for multi‑site licences. Failure to meet this criterion would mean the arrangement does not meet the guideline and may affect licensing decisions. The instrument does not describe remedial processes, but the immediate enforcement implication is that the regulator may decline to cover multiple sites under the one licence if the criterion is not satisfied.

Delegated instrument status: The instrument was made by a delegate of the Secretary of the Department of Health (Tracey Duffy) on 31 March 2020 (instrument header and s 3), and it functions as an administrative guideline under the Act. Enforcement therefore takes place within the regulator’s statutory powers rather than through penalties articulated in this instrument.

Absence of monetary penalties or clause‑specific sanctions: Because the instrument contains no penalty clauses, there are no instrument‑specific fines or offences to be enforced. Any enforcement action would be taken under the Act’s general licensing, compliance and enforcement framework. Practitioners should therefore look to the Act for the precise mechanisms, powers to inspect, and available sanctions.

Practical enforcement levers: In practice, the regulator can enforce compliance with the instrument’s criteria by refusing to grant a multi‑site licence, by refusing to include certain sites on a licence, or by taking action under the Act where a licensee’s operations do not conform with licence conditions. The instrument provides objective criteria (permitted activities, single quality system, inspectability, 60‑minute travel time) that the regulator can use to justify licensing decisions or regulatory action under the Act, but the instrument itself stops short of specifying enforcement procedures.

In short, the instrument defines conditions that the regulator will apply when deciding whether a licence may cover multiple sites, but all enforcement, sanctioning and detailed inspection powers remain contained in the Act; the instrument does not replicate or expand those powers.

The instrument operates as a subordinate instrument under the Therapeutic Goods Act 1989 and expressly relies on definitions and statutory authority contained in that Act. It does not itself amend the Act or create standalone statutory offences. The interactions with other law are therefore primarily internal to the regulatory architecture created by the Act.

Made under authority of the Act: The instrument was made under s 38A of the Therapeutic Goods Act 1989 (s 3). It therefore functions within the statutory framework set up by the Act, providing guidelines as to when a single licence may encompass multiple manufacturing sites. The instrument notes that a number of expressions it uses,licence, manufacture, medicine, supply, therapeutic goods,are defined in subsection 3(1) of the Act (s 4 note). That anchoring means the instrument’s terms must be read in light of those statutory definitions.

Cross‑references inside the instrument: The definition of plasma in s 4 refers explicitly to manufacturing required to be licensed under Part 3‑3 of the Act. That reference links the instrument to specific parts of the Act that govern particular manufacturing activities. The instrument therefore presupposes the existence of other licensing requirements and regulatory obligations in the Act (s 4).

Regulatory regime and inspection: The instrument requires that all sites be "capable of being inspected within the relevant period" (s 5(2)(c), s 6(2)(c)). The "relevant period" is not defined in the instrument; it is a term that must be understood in the context of the Act and the regulator’s inspection policies or regulations. Thus, the instrument interacts with the Act’s inspection and compliance schedule provisions and with any subsidiary instruments or administrative policies that set inspection frequency.

Repeal of prior instrument: The instrument expressly repeals the Therapeutic Goods (Multi‑Site Manufacturing Licences) Guidelines of 2010 (s 7; Schedule 1). That repeal replaces the earlier guideline instrument with the current one; any interactions, transitional arrangements or references to the 2010 guidelines in other instruments may be affected by that repeal. The instrument itself does not include transitional provisions beyond the repeal item.

No express interaction with other Acts in the text: The instrument contains no express references to other Commonwealth laws, state or territory statutes, or administrative instruments beyond the Act and Part 3‑3. Any obligations arising under other laws (for example, workplace health and safety, environmental, transport or state blood services regulation) are not mentioned in this instrument and remain separate legal obligations for licensees and site operators.

Interpretation and operation dependent on Act: Because the instrument relies on the Act for key definitions and for legal authority, interpretation and operational effect will depend on how the Act and its subsidiary instruments allocate licensing powers, define inspection periods, set compliance powers and prescribe remedies. The instrument should therefore be read as a targeted guideline that modifies the shape of multi‑site licensing within the broader statutory framework, rather than as a stand‑alone regulatory regime.

Practitioners must therefore consider the instrument alongside the Act, relevant regulations, and any other instruments or policy documents that address inspection frequency, licence application processes and enforcement powers to understand the full legal position.

This instrument contains a concise recorded history contained within its own provisions; there is no separate amendment schedule within the text. The instrument was made and dated 31 March 2020 by Tracey Duffy (First Assistant Secretary, Medical Devices and Product Quality Division, Health Products Regulation Group, Department of Health) and commenced on 1 April 2020, being the day after registration, as set out in the commencement table (s 2 and instrument header).

Commencement detail: Section 2 contains a commencement table stating that "The whole of this instrument" commenced "The day after this instrument is registered" with the commencement date shown as 1 April 2020. The instrument includes a note that the table relates only to the provisions as originally made and that it will not be amended in the instrument text to reflect later amendments (s 2).

Authority and making: Section 3 records that the instrument is made under s 38A of the Therapeutic Goods Act 1989. The instrument header and preamble name the delegate (Tracey Duffy) and give the date of making as 31 March 2020.

Repeal of prior instrument: Section 7 together with Schedule 1 records that the Therapeutic Goods (Multi‑Site Manufacturing Licences) Guidelines of 2010 are repealed in full (s 7; Schedule 1 item 1). The Schedule item states "The whole of the instrument. Repeal the instrument." That is the only express repeal or amendment action recorded in the instrument.

No subsequent amendments recorded in the text: The instrument as provided contains no further amendment entries, no transitional provisions, and no savings clauses. There is no additional schedule listing subsequent amendments or revocations. If the instrument is amended after its original making, those amendments are not recorded in the instrument text supplied here; s 2 contains an explicit note that the commencement table relates only to the instrument "as originally made."

Implication for legal research and citation: Practitioners relying on the instrument should note that the instrument replaced the 2010 guidelines on its commencement date. Any references or compliance approaches based on the 2010 instrument should be reviewed in light of the 2020 instrument. For a complete legislative history beyond the contents of this instrument, reference to the legislative instrument registry or the Federal Register of Legislation is necessary; the instrument itself does not provide a running amendment history beyond its making, commencement and the repeal of the 2010 guidelines.

In sum, the instrument’s amendment history within the provided text is limited to its making (31 March 2020), commencement (1 April 2020), and repeal of the 2010 guidelines (s 7; Schedule 1). No further amendments or historical entries are recorded in the supplied instrument.

The instrument as supplied contains no references to litigation, judicial interpretation, or case law. It does not list any court challenges, tribunal decisions, or administrative appeals that interpret or apply its provisions. The instrument is a statutory guideline instrument made under s 38A of the Therapeutic Goods Act 1989 and, within the text provided, neither asserts nor summarises any litigation history.

Implications for practice: Because the instrument contains no recorded litigation history, practitioners seeking authoritative interpretation of ambiguous terms in the instrument,such as "the relevant period" for inspections, how to calculate "total travel time between the sites under inspection" or the detailed scope of "single quality system" across multiple jurisdictions,will need to rely on administrative guidance from the Department of Health, regulatory practice, or subsequent case law and tribunal decisions as they arise. None of those materials are contained within the instrument text supplied.

No transitional or savings provisions referring to existing litigation: The instrument repeals the 2010 guidelines (s 7; Schedule 1) but does not include transitional or savings provisions that speak to ongoing enforcement actions, existing appeals, or pending litigation commenced under the repealed instrument. The absence of such provisions in this text means practitioners should consult the regulator or the instrument registry for any administrative notes or transitional arrangements that the Department may have issued at the time of commencement.

Recommendation for counsel and compliance officers: Given the lack of litigation history embedded in the instrument, advisers should plan on interpreting and applying the instrument’s criteria in light of the Act, any accompanying regulator guidance or policy documents, and administrative practice. If disputes arise over licence coverage for multiple sites, the parties will likely have to litigate or seek administrative review under the Act’s mechanisms; the instrument does not itself describe those dispute resolution pathways.

In short, there is no litigation history recorded in the instrument; any legal contestation of the instrument’s meaning or application must be sourced from external case law or administrative decisions occurring after its commencement, which are not contained in the text provided.

The instrument is short but contains several technical features and drafting choices that create practical pitfalls and compliance risks. The following items identify precise points of potential confusion or unintended operational constraints, grounded in the instrument text.

Cumulative conditions mean a single failure defeats multi‑site coverage: Both ss 5(2) and 6(2) state that a licence may cover two or more sites "where all of the following paragraphs apply." The use of cumulative language means that failing to satisfy any single paragraph removes entitlement to multi‑site coverage. In practice this requires licence applicants to design operations to meet every criterion simultaneously,site activities, single quality system, inspectability, and the 60‑minute travel time limit.

"One fixed site" requirement restricts distributed manufacture: The instrument requires that "steps in the manufacture of the therapeutic goods are to be carried out at one fixed site" with additional sites limited to certain activities (s 5(2)(a), s 6(2)(a)). This restricts the licence holder’s ability to split principal manufacturing steps across multiple fixed sites. A manufacturer that de‑centralises primary manufacturing processes across facilities risks falling outside the instrument’s permitted multi‑site licensing model.

Scope of permitted activities is narrow and product‑specific: For non‑blood goods, additional sites are limited to storage, secondary‑packaging, or release for supply (s 5(2)(a)). For blood products, mobile sites can only undertake collection while fixed additional sites may conduct storage (s 6(2)(a)). Any activity beyond those listed,such as primary processing, critical in‑process production steps, final sterile filling, or formulation,appears excluded from permitted additional‑site activities. Organisations that contemplate using contract manufacturers or satellite processing facilities must check whether those activities fall within the listed permitted steps.

Different definitions of starting material can change scope: The instrument defines "starting material" differently for blood products and for other therapeutic goods (s 4). For non‑blood goods, starting material "excludes packaging material" whereas for blood and related products it includes any material that may contact or be included in the product. This alters what counts as a permitted storage item at an additional site and could cause compliance misclassification if not carefully applied.

"Capable of being inspected within the relevant period" is ambiguous: The instrument conditions multi‑site licensing on being capable of inspection "within the relevant period" (s 5(2)(c), s 6(2)(c)), but it does not define that period. This ambiguity shifts operational risk to licensees who must ensure readiness for unknown inspection timing or seek regulator clarification. It also places weight on the regulator’s interpretation of "relevant period" derived from the Act or inspection policies.

60‑minute total travel time is a hard threshold: The instrument requires that "the total travel time between the sites under inspection does not exceed 60 minutes" (s 5(2)(d), s 6(2)(d)). This is an objective constraint but will raise practical questions: How is travel time calculated (door‑to‑door, average traffic conditions, by private vehicle or public transport)? Does it apply to the sum of travel times when an inspector must visit multiple sites in a single inspection run? The instrument does not specify these details, so logistical interpretations may vary and should be clarified with the regulator.

Single quality system centralisation may create contractual complexity: The requirement that "all steps ... are to be covered by a single quality system" (s 5(2)(b), s 6(2)(b)) can be difficult to operationalise when additional site operations are outsourced to third‑party contractors. Licence holders must ensure contractual obligations and practical control allow the single quality system to be applied across sites, which may require changes to supply agreements, audit rights, and document control mechanisms.

Repeal of 2010 guidelines without transitional text: The instrument repeals the 2010 guidelines in full (s 7; Schedule 1) but does not include transitional provisions. Entities that structured multi‑site arrangements under the 2010 guidelines must check whether their existing licences were updated or whether regulator practice provides transitional relief. The absence of transitional text in the instrument creates a potential compliance gap unless the regulator has otherwise addressed it administratively.

No penalty clauses means enforcement pathways are indirect: Because the instrument itself contains no offences or penalties, non‑compliance will be addressed under the Act. Practitioners must therefore align the instrument’s criteria with the Act’s licensing conditions and enforcement tools; failing to do so risks enforcement actions under the Act without a specific instrument clause to guide remedial steps.

Mobile collection limits for blood: Section 6(2)(a)(ii) permits mobile non‑fixed sites only for the collection of blood or blood components. Use of mobile sites for other activities related to blood products,such as on‑site processing or storage,would fall outside the instrument’s permitted activities and therefore outside the scope of multi‑site licensing under this guideline.

In sum, the precision of the instrument’s language and the cumulative nature of the conditions create several operational "gotchas" related to decentralised manufacturing, outsourced contractors, ambiguous inspection timing and travel time calculation, and differences in definitional scope for blood versus non‑blood products. Practitioners should verify interpretations with the regulator and align contractual and operational arrangements to the instrument’s precise requirements (ss 4-6).

The instrument sets out objective criteria; compliance requires translating those criteria into organisational arrangements, documentation and operational practices. The following steps are grounded in the instrument text and indicate how a licence applicant or holder should proceed to ensure multi‑site coverage is consistent with ss 5(2) and 6(2).

1. Determine which section applies to your product line: Identify whether the manufactured therapeutic goods are blood, blood components, plasma, haematopoietic progenitor cells or human tissue (s 4 definitions). If they are any of those, ss 6 applies; otherwise, ss 5 applies. The definitions in s 4 materially affect what counts as starting material and which additional site activities are permitted.

2. Concentrate principal manufacturing at one fixed site: Ensure that the principal manufacturing steps are performed at one fixed site, and plan to use additional sites only for the narrow permitted activities in the applicable section (s 5(2)(a) for non‑blood goods; s 6(2)(a) for blood goods). For non‑blood goods permitted activities include storage, secondary‑packaging and release for supply (s 5(2)(a)(i)-(iii)). For blood products, fixed additional sites may be used for storage and mobile sites for collection (s 6(2)(a)(i)-(ii)).

3. Establish and document a single quality system: Implement an integrated quality system that covers all manufacturing steps across the fixed and additional sites (s 5(2)(b), s 6(2)(b)). The quality system should define organisational structure, responsibilities, procedures, instructions, processes and resources as those terms are set out in the instrument’s definition of "quality system" (s 4). Ensure cross‑site document control, unified quality policies, training programmes and audit schedules are in place and documented.

4. Ensure all sites are inspectable within the regulator’s "relevant period": Make provisions for inspection readiness at all sites. Although the instrument does not define "relevant period" (s 5(2)(c), s 6(2)(c)), practical steps include maintaining up‑to‑date records, ensuring physical access for inspectors, and aligning site opening hours and security arrangements to facilitate inspection on short notice. Request clarification from the regulator on the relevant inspection period to avoid uncertainty.

5. Observe the 60‑minute travel‑time rule: Plan the geographic grouping of sites such that the total travel time between sites under inspection does not exceed 60 minutes (s 5(2)(d), s 6(2)(d)). Calculate realistic travel times using conservative assumptions (peak traffic, door‑to‑door estimates) and document the methodology used to justify the chosen site configuration. If a site is near the threshold, obtain written confirmation from the regulator or consider co‑locating functions.

6. Contractual integration where third parties are involved: If storage, secondary‑packaging or collection is outsourced, ensure contracts grant the licence holder sufficient control to apply the single quality system across the third‑party site, including audit rights, corrective action obligations, access for inspectors and responsibilities for recordkeeping. The instrument requires the single quality system to cover all steps (s 5(2)(b), s 6(2)(b)); contractual arrangements must reflect that requirement.

7. Map and classify materials carefully: Use the instrument’s definitions when classifying materials. For non‑blood products, packaging material is excluded from "starting material" (s 4), which affects whether storage of certain items at additional sites qualifies under s 5(2)(a)(i). For blood and related products, "starting material" includes materials that may contact or be included in the product (s 4). Document material flows and ensure in‑process materials are tracked under the quality system (s 4 definition of "in‑process material").

8. Update licence applications and notifications: When applying for or varying a licence to cover multiple sites, explicitly address how each cumulative condition is satisfied: site roles, evidence of the single quality system, inspectability commitments, and travel time calculations. Because the instrument operates as a guideline for multi‑site licensing under the Act (s 3), application packages should tie each factual matter to the corresponding instrument paragraph.

9. Seek regulator clarification where ambiguous: For ambiguous terms,such as "the relevant period" or the method for calculating travel time,seek written guidance from the regulator to reduce enforcement risk. The instrument leaves these points undefined (ss 5-6), so proactive clarification can prevent divergent interpretations.

10. Review existing licences after repeal of 2010 guidelines: If operations were structured under the 2010 guidelines, review whether current licence coverage aligns with the 2020 instrument (s 7; Schedule 1). Because the 2010 instrument is repealed, ensure that old practices that relied on the repealed text have been aligned to the new criteria.

11. Maintain cross‑site documentation and audit evidence: Prepare evidence demonstrating that all steps are governed by the single quality system, that sites are inspection‑ready, and that permitted site activities are limited to those specified in the applicable section. Keep records of quality audits, training, corrective actions and communications with the regulator.

12. Plan operational contingency: Because multi‑site coverage depends on meeting all cumulative criteria, plan contingencies such as fall‑back to single‑site licensing or consolidation of functions if any condition becomes untenable (for example, if an inspection finds a site non‑compliant or if travel time constraints change due to relocation).

Following these steps will align a multi‑site arrangement with the instrument’s criteria: one fixed manufacturing site for principal steps, permitted additional‑site activities, a single cross‑site quality system, inspectability within the relevant period, and total travel time between inspected sites not exceeding 60 minutes (ss 4-6). Where uncertainties remain, obtain regulatory clarification and document the rationale for operational choices.