Individual, multi- and variable dose forms

Related veterinary medicinal products that have different dosage masses or different concentrations must be registered as separate products. This is because they have different pharmaceutical properties, which may result in different stability, different efficacy and safety profiles. Different label instructions may be needed to ensure safe and effective use. The packs containing those doses should be easily recognised and differentiated, so that inadvertent overdosing or underdosing may be avoided.

Individual-dose forms

Individual-dose forms include tablets, caplets, capsules, implants, sachets, syringes and pipettes packaged and presented for use as a discrete dose for an individual animal. Where there is more than one dosage mass (for example, tablet size) of an individual dose form the distinguishing product name as approved by the APVMA should include numbers and/or words to indicate the different dosage mass. Each dosage mass will require a separate registration.

This requirement applies even if the different dosage masses are made from the same bulk formulation. For example, if a company formulates a bulk mix containing 1 gram per kilogram (g/kg) of active ingredient, then makes it into three different tablet sizes—for example, 10 milligram per tablet (mg/tab), 20 mg/tab or 50 mg/tab—each of the three tablet sizes will require separate registration.

Each of these separate products may have several pack sizes. The pack size should indicate the number of doses in each pack, rather than the dosage mass—for example, 10, 50 or 100 tablets. Provided they have identical label instructions, the different pack sizes will not require different product names, and may be registered as a single product.

Multi- and variable-dose forms

Multi- and variable-dose forms include powders, pastes and liquids packaged and presented for use as a bulk pack where discrete doses need to be measured out before administration or application to an individual animal. Where there is more than one concentration of a multi- or variable-dose form, the distinguishing product name as approved by the APVMA should incorporate numbers and/or words to indicate the different concentration. Each concentration will require a separate registration.

This requirement applies even if the different concentrations are made from the same bulk formulation. For example, if a company formulates a bulk mix containing 1 gram per litre (g/L) of active ingredient, then makes it into three different concentrations by adding or instructing the addition of diluent—for example, 10 milligram per millilitre (mg/mL), 20 mg/mL or 50 mg/mL—each of the three concentrations will require separate registration.

Each of these separate products may have several pack sizes. The pack size should indicate the weight or volume in each pack, rather than the concentration—for example, 1 L, 5 L or 10 L packs. Provided they have identical label instructions, the different pack sizes will not require different product names, and may be registered as a single product.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.