Memorandum to Registrants, Applicants and Agents - Reinforcement of Directive 2006-05 - Requirements for Submitting Data Index

16 August 2010

As per Regulatory Directive DIR2006-05, Requirements for Submitting Data Index, Documents and Forms, Health Canada's Pest Management Regulatory Agency (PMRA) requires an e-Index in XML format for all applications and documents sent to the PMRA. The reason for this requirement is three-fold:

• More efficient and streamlined processing of documents submitted to the PMRA;
• Allows Applicants/Registrants to accurately identify/describe the documents they are submitting to the PMRA;
• Allows Applicants/Registrants to identify whether their documents contain Confidential Business Information, thus helping ensure that such information is not publicly released by the PMRA.

Since the introduction of this Directive, the PMRA has allowed a gradual implementation of the requirement for an e-Index, and has permitted certain documents and application types to be sent without an e-Index. However, the PMRA will now be reinforcing the requirement for an e-Index for all applications and documents sent to the PMRA. There are five exceptions, though we highly encourage an e-Index in these cases, as well.

• Emergency registrations
• Pre-submissions
• Grower Requested Own Use Submissions
• Discontinuations
• Sales Reports

Applications and documents received by the PMRA after October 15, 2010 without an e-Index will cause the application process to be placed "on-hold" as well as cause other potential delays until a properly formatted e-Index is received.

For information on compiling an e-Index and submitting to the PMRA, please visit PMRA's e-Index Builder.

If you have any questions, please contact PMRA's Pest Management Information Service.