Questions and Answers - Registering a Pest Control Product under the Protection of Proprietary Interests Policy

List of Products for which the Exclusive Use Period has Elapsed

Why is the Pest Management Regulatory Agency (PMRA) providing this information?

The data supporting the registration of a new active ingredient typically has an 'exclusive use' period of 10 years after the date of its first registration. Currently, the PMRA will accept an application to register generic products based on a registered product's data in the final 18 months of this exclusive period.  The provided list identifies active ingredients for which the exclusive use period may have already elapsed or may be set to elapse within the next 18 months.

Does the PMRA intend on updating this list?

The PMRA intends to update this list on a quarterly basis.

Does the exclusive use period for a new active ingredient elapse 10 years after the date of first registration?

The regulations provide a minimum of 10 years of exclusive protection for the data supporting the registration of a new active ingredient.  However, by adding minor uses of significance, the registrant of that active ingredient can extend the exclusive use period by up to five years.

If the exclusive period is extended by the addition of minor uses, will this extension be reflected in the provided list?

If the exclusive use period is extended by the addition of minor uses, that extension will not be reflected in the provided list. The list will simply include the active ingredients whose normal exclusive period of 10 years may have elapsed or may elapse within the next 18 months. To officially determine if the exclusive period of a product has, or will, elapse, an application will need to be made to the PMRA as detailed in DIR2010-04.

List of Compensable Data

Why is the PMRA providing this information?

Until an on-line database is developed, the PMRA will provide a listing of the data compensation lists generated to date.

What is the procedure for obtaining a copy of the previously determined compensable data list for a specific product?

To obtain an electronic copy of a specific data compensation list, please contact our publications office and provide the PMRA Number for the list.

Does the PMRA intend on updating this list?

The PMRA intends to update this list on a quarterly basis.

Do the lists reflect the data that is compensable on the date they are requested?

No. The lists reflect the data that were compensable on the date that they were finalized by the PMRA. The assessment date is provided for each data compensation list.  There will be situations where the compensable period has elapsed for some of that data.  Additionally, there will be other situations where compensable data needs to be added to the list.  Examples of the latter case include when new data was provided for a re-evaluation or a product amendment was approved by the PMRA since the list was produced.

Upon receipt of a data list can I enter directly into negotiations as prescribed under the regulations with the data owner?

To enter into negotiations as prescribed under the regulations, an application must be submitted to the PMRA as detailed in DIR2010-04.  The PMRA will establish whether the applicant's product and the cited precedent are equivalent and determine the current data compensable list.

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