New policies

REGISTRATION OF MULTIPLE FORMULATIONS

On the basis of their risk, an alternative formulation for a trade name product can be registered when the proposed changes do not alter the following properties of the registered trade name product:

• concentration(s) of the active ingredient(s);
• trade name of the product;
• toxic substances scheduling of the product;
• formulation type;
• physical and chemical char-acteristics of the formulated product to the extent that the efficacy, safety and/or residue profile changes, requiring reassessment.

In order to register multiple formulations under one licence/ registration, each proposed formulation must be assessed as a ‘Change in formulation’ (C1) and, therefore, the appropriate data must be sent in with the application to facilitate this assessment.

The registration of alternative formulations of anti-fouling paints and desensitising agents does not proceed in the manner described. Please contact the ACVM Group if you have queries regarding these applications.

WHEN CHANGES TO A REGISTERED/LICENSED PRODUCT PROMPT A NEW REGISTRATION

Any one of the following changes to a trade name product and its formulation will prompt a new registration:

• addition, substitution or deletion of an active ingredient;
• change in formulation type;
• change in trade name;
• an application for multiple formulations that have a different toxic substances scheduling than the registered formulation.

Other factors may require a new registration, but these will be assessed on a case by case basis.