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ARGOM Appendix 3: Guidelines on presentation aspects of OTC applications

Version 1.0

12 October 2012

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4. Product Information (PI)

Product information (PI) is a term used to describe the technical information approved by the TGA and intended for distribution to health professionals. It may be distributed via publications such as Medical Information Management System (MIMS).

The PI presents a scientific, objective account of the medicine's usefulness and limitations for the benefit of health professionals recommending or prescribing the product. The PI must be consistent with the data supporting the application. It does not include promotional material (refer to the ASMI's Code of Practice for further information regarding promotional material).

Paragraph 23(2)(ba) of the Act requires an application for the registration of a 'restricted medicine' to include product information for that medicine, otherwise it would be considered "not effective".

Restricted medicines are defined in the Restricted Medicine Specification 2011 and include:

  • prescription medicines in Schedules 4 and 8 of the current Poisons Standard, and
  • medicines in Schedule 3 of the current Poisons Standard and which are only available from a pharmacist.

The secretary may also require applications in relation to other medicines not in Schedule 3, 4 or 8 of the current Poisons Standard to have approved product information. Examples where this may occur include:

  • Products with active ingredients that are new chemical entities (NCEs) that at the time of the application have not been scheduled
  • Products with new indications and/or new directions for use that have been approved on the basis of clinical data
  • Products where a PI has been required by the TGA delegate following recommendation by the Advisory Committee on Non-prescription Medicines (ACNM) [previously Medicines Evaluation Committee (MEC)](e.g. all nicotine replacement products, some 'new' combinations of active ingredients)
  • Products that are not scheduled but by reason of circumstances under which it is used such as in hospital setting or require medical supervision i.e. in medical and/or dental procedures. Examples include sucralfate and topical anaesthetics for use in medical procedures.

4.1 Form

As a part of an application to register a 'restricted medicine', a draft product information document must be lodged in a form approved by the secretary under section 7D of the Therapeutic Goods Act 1989 (the Act). This is the Form for providing product information for a restricted medicine or other medicine in relation to which the Secretary requires product information to be provided (the Form). The form must also be used if the Secretary has given the applicant notice as referred to in subparagraph 25(1)(da)(ii) requiring the application to give the Secretary a product information.

The Form requires that the draft PI provided in relation to the medicine must be set out under the specified heading in the specified order.

Additional notes for OTC medicines are provided below in Section 4.1.1.

4.1.1 Additional notes

In the situation where there is no product information available in relation to a particular heading in the form (e.g. clinical trial data) for OTC medicines, the section need not be completed and words to the effect of "This information is not available" should be included under the heading.

In addition, for the following headings in the Form, further clarification and explanations are provided:

(i) Name of the medicine

The CAS Registry number should be provided for each therapeutically active ingredient.

(ii) Description

This section should also include

  • A list of the active ingredients (using AANs) expressed quantitatively
  • A list of the excipients (using AANs) expressed qualitatively

(iv) Clinical trials

For OTC products which are not registered on the basis of clinical trial data, this heading need not be completed. However, this information is required if a new indication, direction of use, new patient population are approved on the basis of clinical trial data.

(v) Indications

The therapeutic application means the approved use of the medicine and the PI 'Indications' must be consistent with the indications to be included in the ARTG.

(vi) Contraindications

This section should also include:

  • Hypersensitivity to the active ingredient(s), to any active ingredients of the same or similar pharmacological/ chemical class (where relevant), and to the excipients.

(vii) Precautions

This section should also include:

  • Examples of the circumstances where caution and dosage adjustment is required including "Use in renal impairment" and "Use in hepatic impairment" (to be included where applicable).

(ix) Adverse effects

This section should include warnings of possible adverse effects (adverse reactions) that may occur under normal circumstances of use, or in particular circumstances such as use in patients with renal, hepatic or cardiac failure, the elderly or children. These effects should be quantified (giving frequency in terms of severity and clinical importance) where known.

The PI should include information on adverse events observed in post-marketing data, where this information is available.

Information on adverse effects observed in clinical trials should be included in the PIs of products that were approved on the basis of data that included clinical trials, and in the PIs of products where new indications and/or directions for use were approved on the basis of clinical trial data. In these cases, the PI could include information on adverse events observed in the clinical trials for both active and placebo (or comparative treatment) groups and set out as required in the approved form.

Where terms in the approved form such as 'rare', 'uncommon' (etc.) are used, the meaning should be consistent with the Council for International Organizations of Medical Sciences (CIOMS) definitions:

  • very common ≥ 10%
  • common ≥ 1% and < 10%
  • uncommon ≥ 0.1% and < 1%
  • rare ≥ 0.01% and < 0.1%
  • very rare < 0.01%

(x) Dosage and administration

Dosage information should be consistent with the dosage instructions on the labels. The directions for use of products intended for symptomatic relief should include a qualifier such as 'as required' or 'when necessary'.

Where relevant, the following information should also be included:

  • doses for different age groups
  • maximum daily doses (for each age group, where appropriate)
  • maximum recommended duration of use

For OTC medicines, some of the subheadings included in this section in the approved form need not be completed if these details have not been approved by the TGA or did not constitute part of the data evaluated by the TGA.

(xi) Overdosage

For OTC medicines, a statement advising contacting the Poisons Information Centre for advice would be required, and where possible, the symptoms, signs and recommended treatment of overdosage or accidental poisoning.

4.1.2 Core PI documents

The TGA and the Australian Self Medication Industry (ASMI) have developed core PI documents based on information in standard reference texts and previously evaluated and approved PIs for a number of OTC ingredients, and these may also be used as a reference.

4.2 Requirements for the PI following changes to scheduling classification

4.2.1 Schedule 3 Pharmacist only medicines

All applications to register 'Pharmacist Only Medicine' (Schedule 3) products must be accompanied by a draft PI document, in the approved form, which will be evaluated as part of the application. References should be provided for all technical information, for example, doses, contraindications, precautions, and adverse effects.

Submission of a draft PI will also be required with variation applications arising when a product is rescheduled to 'Pharmacist Only Medicine' (Schedule 3) (e.g. down-scheduling from 'Prescription Only Medicine' (Schedule 4) or up-scheduling from 'Pharmacy Medicine' (Schedule 2) or unscheduled).

4.2.2 Down-scheduling from Schedule 4 Prescription only medicines to Schedule 3 Pharmacist only medicines

For those products that have been down-scheduled from 'Prescription Only Medicine' (Schedule 4) status, where no changes have been made to the TGA-approved PI (other than a change to the poisons schedule section of the PI), a copy of the PI should be included in the application, together with an assurance that no changes (other than a change to the poisons schedule) have been made. Changes to the PI will be needed if only some of the prescription indications are approved for the OTC product (e.g. cases where the acceptable OTC indications are restricted on the basis of an SUSMP schedule entry), and to ensure that the directions for use are consistent with those on the proposed OTC product labelling. Other aspects of the PI may also need to be updated in accordance with the approved form.

4.2.3 Down-scheduling from Schedule 3 Pharmacist only medicines

Where products are down-scheduled to 'Pharmacy Medicine' (Schedule 2) or unscheduled status, sponsors are encouraged to retain the existing PI, and maintain its currency. Sponsors should consider quality use of medicine (QUM) principles if the deletion of a PI is proposed. In any case, deletion of a current PI will require approval by the TGA – such a change will not be approved for products for which the Secretary has specifically required a PI, unless adequately justified by the sponsor.

4.4 Changes to the PI

Where changes are made to the PI, a variation application should be submitted to the TGA requesting approval of the amended PI. Relevant changes to PI should be highlighted (e.g. through the provision of 'track changes' labels or a table detailing all the proposed changes).

For applications to vary an entry on the ARTG or change the conditions to which the inclusion of the medicine is subject, and require a change to the existing product information, must include a draft product information document in the application.

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