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Section 19A: Guidance for industry

Supplying substitute medicines when registered medicines are unavailable or in short supply

4 January 2018

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Making an application

The Section 19A application form sets out the information needed to obtain approval, including:

  • details of the medicine to which the application applies
  • details of the medicine(s) included in the ARTG for which there is a supply issue (if applicable), including details of an actual shortage and the relevant Medicine Shortages Information identification number
  • justification that the approval is in the interests of public health
  • evidence that any likely conditions of approval will be met, including details of:
    • proposed packaging and labelling of the medicine
    • information to be provided to health professionals and consumers
    • manufacture of the medicine.

All documentation provided with the application must be in English or else accompanied by a English translation. We will accept translations provided the applicant is prepared to make a declaration that it is a true translation from an accredited translator. It does not need to be certified unless the applicant feels that this is necessary. If one of the languages in a bilingual document is English, a translation is not required.

The TGA provides a template to assist you with your preparation of a Dear Healthcare Professional Letter.

Section 1 - Details of applicant

Provide details of the person (company) applying to import or supply the medicine in Australia, including contact details of the individual responsible for preparing the application under section 19A.

Note: The company in whose name the approval is sought, email address and phone number may be identified in the Section 19A approvals database on the TGA website if approval is granted.

Section 2 - Application type

Identify whether the application is for the approval of a specified medicine, on the basis that:

  • all substitute medicines included in the ARTG are unavailable or in short supply and: OR
  • there is no substitute medicine included in the ARTG but an application for inclusion in the ARTG (registration) has been made in relation to the specified medicine – subsection 19A(2).

Duration of approval

Propose the duration of approval (this should not normally exceed 12 months).

For unavailability or short supply, the proposed duration should not exceed the expected duration of the unavailability or shortage.

Provide justification for the duration requested, considering the following:

  • expected duration of the medicine shortage (if applicable), including:
    • whether the issue leading to short supply has been identified and whether appropriate steps are being taken to rectify the problem
  • expected approval date for the section 23 application (if applicable)
  • period of Good Manufacturing Practice (GMP) evidence.

Note: Section 19A approvals may lapse before the period of approval has expired – go to Lapsing of approvals.

For unavailability or short supply: Applicants will need to provide the reason why a medicine included in the ARTG will remain unavailable if the total duration of the medicine shortage has exceeded, or is expected to exceed, 12 months.

Determining amount to import

Approval under section 19A only allows for the import and supply of the medicine and does not permit you to export the medicine. Therefore, only import the amount of medicine that you need to supply.

When determining the volume of stock you import under section 19A, consider that:

  • an approval under section 19A can lapse before the end of the nominated period - for example, in the situation where a medicine shortage ends earlier than expected (for more information and examples, go to Lapsing of approvals)

    AND

  • excess stock cannot be supplied after lapsing or expiry of the approval.

Repeat applications

Provide information on any previous section 19A approvals granted to you in relation to the medicine. Include details of:

  • the reason for proposing repeat approval under section 19A
  • the date on which each of the previous section 19A approvals will expire, or has expired or lapsed
  • supply of the medicine under previous section 19A approvals.

Section 3 - Availability of ARTG registered goods

This section applies if the application relates to the unavailability or short supply of medicines included in the ARTG.

If there is no medicine included in the ARTG that could act as a substitute for the medicine for which section 19A approval is being sought, proceed to Medicine intended to be imported or supplied.

Provide details of:

Potential substitutes included in the ARTG

Provide details of any medicines included in the ARTG that could act as a substitute for the medicine for which section 19A approval is being sought, including those for which you are not the sponsor[2]. For guidance, go to Suitable substitutes. Note the following definitions for terms used in the application form:

  • quantity and container type: quantity per pack – e.g. number of tablets per bottle or blister pack; vials per pack; or if supplied as a kit, a description of the contents – and the type of container used for the medicine
  • availability: an estimate of how much stock is currently available at the sponsor, distributor, hospital and retail levels (if known)
  • reason for short supply: an explanation of the reason for the unavailability or shortage (if known), for example:
    • increased demand
    • manufacturing delays
    • cessation of supply
    • recall of stock
    • lack of raw material
    • delay in supply
    • other reasons – provide details.

Confirm availability

If you are not the sponsor of one or more of the relevant medicines included in the ARTG, we recommend that you seek information from the sponsors on the availability of their medicines. We understand that obtaining information on availability is dependent on the cooperation of the sponsors of medicines that are in short supply or unavailable.

We use this information to assess how the unavailability or short supply has been determined, and how restoration of supply will be managed. Provision of this information in your application may enable TGA to reduce the time for processing the application.

We may also contact the sponsors of the medicines that are in short supply or unavailable – go to Processing your application.

Potential substitutes that are unsuitable

Provide details of any potential substitute medicines you identified (go to Suitable substitutes) that you assessed as unsuitable. Note the following definitions for terms used in the application form:

  • Quantity and container type of the unsuitable substitute: quantity per pack – e.g. number of tablets per bottle/blister pack or vials per pack; or if supplied as a kit, a description of the contents – and the type of container used for the medicine
  • Reason why the apparent substitute is unsuitable: provide a brief justification as to why you consider that the apparent substitute is unsuitable – for guidance go to Suitable substitutes.

Section 4 - Medicine intended to be imported or supplied

Kind of goods (medicine)

Provide details of the kind of goods (medicine) included in Schedule 10 to the Therapeutic Goods Regulations 1990.

Details of the medicine

Provide details of the medicine for which section 19A approval is being sought, noting the following definitions for terms used in the application form:

  • Quantity and container type of the medicine: quantity per pack – e.g. number of tablets per bottle/blister pack or vials per pack; or if supplied as a kit, a description of the contents – and the type of container used for the medicine
  • Indication(s) approved in the foreign country of origin: provide the indication(s) for which the medicine is registered or approved for general marketing in the foreign country specified in Approval status of the medicine (if applicable)
  • Proposed indication(s):

    Where there is a section 23 application under evaluation by the TGA:

    • the proposed indication(s) should be the indication(s) sought for inclusion in the ARTG.

    Where the medicine is being sourced from a foreign country, the proposed indication(s) depend on the nature of the substitution to the medicine included in the ARTG that is in unavailable or in short supply:

    • exact substitute[3]: use the Australian indication(s), unless there is a clinical reason to restrict the indication(s)
    • not an exact substitute: generally, only the indication(s) common to both medicines will be approved for use under section 19A.

If applicable, provide a brief description of any clinically important differences between the medicine for which section 19A approval is being sought and the medicine included in the ARTG that could act as a substitute.

Approval status of the medicine

Specify whether the medicine is:

  • the subject of a current application for inclusion in the ARTG (under section 23 of the Therapeutic Goods Act).

    OR, if the medicine included in the ARTG is unavailable or in short supply:

  • approved for general marketing in at least one of the foreign countries specified by the Secretary.
    • Note: The medicine that is the subject of the application must be same goods that are registered or approved for general marketing in the foreign country specified by the secretary under section 19A(3) of the Therapeutic Goods Act.
    OR
  • Not available in any of the specified foreign countries, but meets the criteria at When the country is not specified.

When the country of registration or approval is not a specified foreign country, provide the following information regarding the substitute medicine and the country where it is registered or approved for general marketing. This is a guide only; we may consider other matters and request additional information if necessary.

Details of the regulatory system of the country of approval
  • Name of the country where approval for general marketing has been granted.
  • Name of the authority that regulates medicine in the foreign country.
  • Approval reference or number issued by the regulatory authority.
  • Details of the country's collaborative arrangements that may provide greater confidence in their regulatory system, for example:
    • Pharmaceutical Inspection Cooperation Scheme (PIC/S)
    • the European Union or the European Free Trade Association (EFT) and the European Economic Area
    • International Medical Crisis Response Alliance (IMCRA) member
    • International Generic Drug Regulators Programme (IGDRP) member
    • membership of any other collaborative arrangement related to medicines put in place with TGA.
  • Other information about the regulatory authority that you consider important to support your application, for example:
    • established Good Manufacturing Practice and Good Clinical Practice inspection program
    • established pre- and post-marketing responsibilities and capabilities, including a pharmacovigilance system that is capable of detecting safety signals
    • adopted international guidelines for quality, safety and efficacy (for example, International Conference on Harmonisation guidelines)
    • capacity of the regulatory framework and its history in regulating medicines to a high standard
    • track record of approving safe and effective medicines.
Details of the regulation of the medicine in the foreign country
  • How long has the product been registered or approved and marketed in the country of approval?
  • Specify the type of assessment for registration or approval. For example whether the approval was based on:
    • full evaluation of the dossier by the regulatory agency in that country
    • approval by a regulator in another country
  • Has the same medicine been assessed by any other regulatory authorities?
  • Is the same medicine also registered or approved for general marketing in other countries?
  • Is the medicine WHO prequalified?
  • Have any international pharmacopeia been applied to the medicine (for example, the European Pharmacopeia, British Pharmacopeia and United States Pharmacopeia for medicines)?
  • Have any safety or other issues been identified with the medicine?

Section 5 - Justification that supply is in the interests of public health

Provide the following information to demonstrate that the supply of the medicine is in the interests of public health:

  • information relating to the patient population that uses the medicine, including details such as the size of the population and the particulars of use - for example, whether there is widespread use, intermittent widespread use, or emergency use
  • information relating to whether the health of the population that uses the medicine would be particularly disadvantaged if the medicine was not available, including the specific characteristics and/or disadvantages for any subgroup
  • information identifying any potential substitutes for that medicine included in the ARTG and information relating to whether those substitutes are available for that population (or subgroup), including details of their actual availability (as specified under Section 3)
  • information as to whether there are any specific clinical considerations in relation to using potential substitutes that could result in health issues for that population (or subgroup), including details of those considerations and potential health issues. If specific characteristics of the patient population (e.g. allergy related matters) are a factor, this can be included
  • contraindications relating to the medicine(s) that are different to the medicine that is unavailable or in short supply
    • include all contraindications if there is no medicine that is unavailable or in short supply
  • any other factors that could influence or have an impact on public health.

Section 6 - Packaging and labelling

All medicines supplied under section 19A are required to carry the approval holder's name and address. The label should allow health professionals and consumers to easily identify the active ingredient(s), strength and dosage form.

For medicines sourced from a foreign country, supply the medicine in the packaging from that country, with supplementary labelling applied as appropriate.

To supply medicines under section 19A:

  • label the package with your company's name and address
  • ensure the package text is in English, or apply a supplementary label with an English translation of the active ingredient(s), strength and dosage form

    AND

  • ensure the active ingredient(s), strength and dosage form are visible on the package.

Any label applied over the approved packaging from the country of origin is supplementary labelling. If the supplementary label contains details other than the approval holder's name and address, the manufacturer responsible for labelling must have evidence of GMP.

Provide images of the packaging and labels as supporting documents. One or more of the images you provide may be published on the TGA website. These images may vary depending on the type and approval status of medicine and may include (but not limited to) one or more of the following examples:

  • an image of the packaging approved in the country of origin
  • an illustration of the placement of supplementary labels
  • an illustration of the package design.

Medicine information package insert

Provide details of the type and source of the information insert to be included in the packaging for the substitute medicine with an indication of the date of last review by the national authority. For example:

  • Product Information (PI)
  • Consumer Medicines Information (CMI)
  • Patient Information Leaflet (PIL)
  • an equivalent information document from another country
  • supplementary information for users.

For unavailability or short supply, indicate the source of the proposed information insert to be included with the substitute medicine. This is usually the insert supplied with either:

  • the medicine included in the ARTG that is unavailable or in short supply
  • the section 23 application for inclusion in the ARTG
  • the medicine registered or approved for general marketing in the foreign country.

Provide evidence of GMP in section 8 for any medicine information package inserts that are not covered in the foreign registration or approval for general marketing.

Section 7 - Distribution of medicine information

When you supply a medicine under section 19A, you need to provide information as appropriate to:

  • relevant health professionals
  • suppliers
  • consumers.

Dear Healthcare Professional Letter

Supply a draft Dear Healthcare Professional Letter to ensure safe use of the medicine with the application.

All letters should:

  • advise that the medicine has not been approved for general marketing by the TGA and is being supplied under a section 19A approval
  • outline any contraindications
  • describe any potential safety risks
  • advise recipients to report adverse events to you or to the TGA
  • provide your contact details.

Where the approval is associated with the unavailability or short supply of a medicine included in the ARTG, the letter should also:

  • identify the medicines that are unavailable or in short supply that the section 19A approved medicine is intended to replace
  • provide the reason the medicines are unavailable or in short supply
  • clearly outline the differences between the medicines that are unavailable or in short supply and the medicine approved under section 19A
  • identify the changes to practice that healthcare professionals may need to make, or changes consumers may need to make, compared with the medicines that are unavailable or in short supply.

An example Dear Healthcare Professional Letter is provided. This example relates to an application to supply a substitute medicine due to shortage of a medicine included in the ARTG.

The letter is also available as a template.

Distribution of the letter

You will need to provide the Dear Healthcare Professional Letter to the health professionals you supply with the medicine.

  • Where there is no substitute medicine included in the ARTG

    The Dear Healthcare Professional Letter may only be provided to medical practitioners at their request or with supply of the medicine approved under section 19A. Mass distribution of a Dear Healthcare Professional Letter is not permitted because this may be considered as advertising a therapeutic good not included in the ARTG (section 42DL(1g) of the Therapeutic Goods Act).

  • Where the medicine is being supplied to cover the unavailability or short supply of medicines included in the ARTG

    We will consider a request from you to distribute the Dear Healthcare Professional Letter to inform relevant health professionals who have not been supplied with the medicine of the availability of a substitute medicine to address the unavailability or shortage of a registered medicine. However, if you have applied to the TGA for inclusion of the substitute medicine in the ARTG, please ensure that the letter cannot be regarded as advertising.

Provide a list of the recipients or groups of recipients to whom each of the letters are to be distributed.

The distribution of the Dear Healthcare Professional Letter for repeat section 19A approvals should be similar to the original approval. Consider whether any additional recipients would be appropriate.

Other letters

Sometimes you need to provide information about the medicine supplied under section 19A to other suppliers and users. Consider whether the following letters are appropriate:

  • Dear Wholesaler Letter, when you need to provide information to wholesalers. For example:
    • information relating to the medicine shortage
    • other supply information.
  • Dear Patient or Customer Letter, when you need to provide information to the patient or customer. For example:
    • confirmation as to whether the medicine information package insert will be provided separately to the medicine
    • information relating to the appearance or use of the medicine, particularly information that is different from the patient's current treatment
    • any other specific information relevant to the patient or customer.

The other letters usually contain information similar to the Dear Healthcare Professional Letter, but with appropriate language for the recipient.

Section 8 - Details of manufacturer(s)

Provide the details for all manufacturers associated with the substitute medicine, including the final product manufacturer and the manufacturer responsible for release for supply.

Evidence of Good Manufacturing Practice

Provide details of the evidence of GMP as supporting documents for all manufacturers involved in the steps of manufacture, including (but not limited to):

  • finished product manufacturer
  • quality control testing (if different from the finished product manufacturer)
  • supplementary labelling:
    • only provide details of the manufacturer responsible for labelling if the supplementary label includes details other than the approval holder's name and address, as manufacturing certification is required
    • you do not need to provide the details of the manufacturer if the step in manufacturing consists of adding the approval holder's name and address only, as it is exempt from the requirement of GMP under item 5 of Schedule 8 to the Therapeutic Goods Regulations 1990
  • medicine information package inserts not covered by foreign country registration or approval for general marketing.

Acceptable sources of GMP evidence may be obtained from:

We will consider other sources of GMP evidence on a case-by-case basis, including (but not limited to):

  • Medsafe – when the manufacturer is located in New Zealand.
  • FDA – when the manufacturer is located in USA:
    • a copy of the GMP certificate is not required for FDA certifications – compliance will be checked in the FACTS database.
  • Health Canada – when the manufacturer is located in Canada.
  • Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) – when the manufacturer is located in the country where certification has been granted.

Clearly state the expiry period for all GMP evidence. Section 19A approval is not given for a period exceeding the date of expiration of any GMP compliance for relevant manufacturers.

Australian manufacturing steps

Provide details of any manufacturing steps that will occur in Australia following importation, including evidence of GMP. For example:

  • secondary packaging
  • supplementary labelling
  • medicine information package inserts.

If the supplementary label only includes the sponsor's name and address, you do not need to provide details of the manufacturer responsible for supplementary labelling.

Section 9 - Supporting documentation

Provide supporting documentation in English. For more details, go to Making an application.

  • Evidence of registration or general marketing approval in the relevant foreign country:

    If applicable, provide documented evidence that the medicine has been registered or approved for general marketing by the national authority in the relevant foreign country.

  • Medicine information package insert or Patient Information Leaflet:

    Provide a copy of:

    • the medicine information package insert or PIL that will be provided with the medicine

      AND

    • if different from above, the medicine information package insert or PIL approved in the foreign country where the medicine is registered or approved for general marketing. (if applicable).
  • Product Information or equivalent

    If applicable, provide the Product Information or equivalent that is approved in the foreign country where the medicine is registered or approved for general marketing.

  • Product images

    Provide true size, colour images of the packaging and labels for the container, primary packaging and intermediate packaging to be placed on the section 19A medicine. Show the placement of supplementary labels.

    Please provide images that have sufficient resolution to ensure that all text is legible, as we may publish one or more images on the TGA website.

  • Evidence of GMP

    Provide evidence of GMP for relevant manufacturing site(s).

  • Draft Dear Healthcare Professional Letter and other letters

    Provide drafts of the proposed Dear Healthcare Professional Letter and any other letters to be supplied with the goods to ensure safe use of the product.


Footnotes

  1. Sponsor: The person in relation to whom the goods are included in the ARTG.
  2. Exact substitute means same active ingredient, strength, route of administration and dosage form.

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