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Section 19A: Guidance for industry
Supplying substitute medicines when registered medicines are unavailable or in short supply
Example Dear Healthcare Professional Letter
[Section 19A applicant company letterhead]
Dear Healthcare Professional
Shortage of [registered medicine] Aust R [XXX] and alternative supply arrangement under Section 19A of the Therapeutic Goods Act 1989
The Australian registered medicine, [registered medicine AUST R XXXXX], sponsored by [Australian sponsor], is [unavailable/in short supply] due to [reason for short supply/unavailability]. Supply of [registered medicine] is expected to resume [date, if known].
[Applicant company] has been able to arrange supply of an alternative product [section 19A approved medicine] on a temporary basis. This product is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until [expiry date of the notice of approval] for the following indication(s):
- [Indication(s) specified in the notice of approval]
[Section 19A approved medicine] is registered and marketed in [one of the specified countries].
Please note the following information regarding differences between [section 19A approved medicine] and [registered medicine AUST R XXXXX]. [Provide information on the Quantity and container type, strength, dosage form, indication(s), formulations, description, scheduling, labelling and other relevant comparisons/differences between the products. Include any contraindications and potential safety risks].
Please refer to the Australian Product Information [prescribing information] for [recommended dosing, adverse reaction profile].
[For CMI/Patient leaflet in a foreign language] Patients should be advised to disregard the CMI/patient leaflet for [section 19A approved medicine] contained within the pack and refer to the Australian Consumer Medicines Information available from [pharmacist, website, pack].
[Provide information on PBS reimbursement if applicable.]
Adverse Event Reporting
Reporting any suspected adverse event is important for the continued monitoring of the safety of all medicines. Any adverse events which are experienced with [section 19A approved medicine] should be reported by healthcare professionals and patients to the [applicant company] on [phone number] or by email [email address]. Alternatively, this information can be reported to the TGA.
Please forward this information to relevant staff members in your organisation.
For further information, please contact [applicant company name] on [phone number] or email [email address].