Health Canada Natural and Non-prescription Health Products Directorate (NNHPD) has updated its guidance regarding how applications for natural health products (NHPs) (new, or amendments and notifications for existing products) are processed, assessed and issued a regulatory decision. These updates are intended to achieve better outcomes for the health and safety of Canadians by ensuring that authorized NHPs meet regulatory requirements and align with the policy of current practices, tools and systems.
One of the recently updated areas is Information Request Notices (IRNs) issued by Health Canada.
The Directorate aims to issue only one comprehensive IRN that includes all deficiencies identified with the application; the IRN will have a specified response time between 2 to 15 calendar days depending on the complexity of the information requested.
The response to NNHPD must address each of the items listed in the comprehensive IRN and the Directorate acknowledges that it is the responsibility of applicants to be available (or have a designated party available) to respond to IRNs in a timely manner. NNHPD will not send IRNs for issues identified in a previous IRN that are not adequately addressed nor will NNHPD request information a second time if the applicant has submitted an incomplete or deficient response. Instead the Product Licence Application (PLA) will be rejected.
Another important revision of the guidance document represents the addition of a list of PLA submissions refusal criteria to help applicants improve their documents processes. Administrative errors and lack of information update are high on the refusal list along with inconsistency and incomplete information.
Contact our experienced team here at SNI for any IRN help you need. After all, we are experts in NHP regulatory matters, and we will help you draft complete responses and in a timely manner!