26 July 2017

Introduction

This guideline is designed to assist you in completing the Notification of antibiotic imports return. Antibiotic substances are controlled under Regulation 5A of the Customs (Prohibited Imports) Regulations 1956. The Notification of antibiotic imports must be completed for each antibiotic permit issued.

Completing the form

The table below will assist you in identifying the required information for completing the permit application form.

Part of application form Explanation of required information
1. Importer information

Importer's name

State your full name.

Postal address

Provide the address where you would like future permits to be posted. Permits will be sent by standard mail unless an express post envelope accompanies the application.

Company name

Provide the full business name of the company or organisation of the importer.

Company address

Provide the address of the company or organisation of the importer if different to postal address

2. Declaration and Consent

Make sure you have read and understand the declaration and have signed the consent. Complete the contact details of the importer signing the form.

Schedule 1: Details of Antibiotics IMPORTED

Permit Number

If the antibiotic permit that you reporting on has more substances on it than the Schedule 1 allows for, indicate the number of pages of Schedules you have used.

Antibiotic name

Provide the common name of the antibiotic (e.g. penicillin)

Trade name

Provide the trade name of the antibiotic product to be imported (e.g. Pentax)

Manufacturer

Provide the name of the antibiotic manufacturer

Country of origin

Indicate the country where the antibiotic was manufactured

End use

Specify the purpose for which the antibiotic is to be used e.g. human, veterinary.

Form

Indicate the form of the finished goods, for example tablets, capsules, vials, ampoules etc.

Quantity

Specify the total number of packs that make up the proposed shipment. For example 25 packs of 24 tablets; 100 bottles of 100 mL; 1000 boxes of 100 tablets, 250 boxes of ampoules.

Pack size

Provide details on the pack type for example; 24 tablet blister pack; box of 6 x 2mL ampoules.

Unit size

Specify the unit size, e.g. 50mL vial, 25mg tablet etc

Strength

Specify the strength (concentration) of the antibiotic in metric weight units e.g. 2mg/ml. If the concentration of the antibiotic is in IU or similar, you must convert to standard weights and volumes (mg, ml, etc.)

4. Declaration and Consent

Submitting a Form F - Antibiotic Return

You can submit your Form F - Antibiotic Return in the following ways:

Mail Drug Control Section
Office of Drug Control
(MDP 95) GPO Box 9848
Canberra ACT 2601
Fax 02 6203 1740
Email dcs@health.gov.au

It is the responsibility of the importer to ensure that Notification of antibiotic imports is returned before 31 July following the expiry of a permit to the Drug Control Section. Failure to comply with this condition may result in cancellation of current import permits.


Version history
Date Version Amendments Approved by
8 December 2016 1.0 Original publication ODC
26 July 2017 1.1 Updated contact information ODC