Natural Health Products Directorate proposes changes to the site licensing model, GMP standards and product licence applications
The Natural Health Products Directorate (NHPD) is seeking input regarding proposed changes to the Natural Health Product Regulations, the current site licensing model, the Good Manufacturing Practices (GMP) standards, and the information required for a natural health product (NHP) licence application.
NHPD is proposing to move away from the existing self-assessment licensing model to one that includes an on-site verification of compliance with the standards of GMP prior to a site licence being issued or renewed. If the proposal goes forward, a report or certificate issued following an on-site audit will be required as proof of compliance. For non-sterile products, the audit may be conducted by a third-party auditing body recognized by Health Canada. For sterile products, the audit must be conducted by a Health Canada inspector or another recognized competent authority. The same level of GMP compliance will be required from domestic and foreign manufacturers, packagers and labellers. While importers will still be required to provide a Quality Assurance Report, an additional program imposing random post-licence on-site GMP compliance verification is being proposed to confirm the information supplied by importers, who are not currently subject to on-site inspections.
The NHPD is also proposing changes to renewal time frames for site licences. For manufacturers, packagers and labellers of sterile products, site licences will be valid for two years. For manufacturers, packagers and labellers of non‐sterile products, site licences will be valid for three years. Site licences for importers of NHPs would be valid for three years.
Changes to GMP standards are also being considered to clarify who is responsible for GMP compliance. Greater responsibility will be placed on product licence holders for activities they contract to independent manufacturers, packagers and labellers. Product licence holders will also be responsible for ensuring that information is available to support the expiry date on an NHP.
The proposed changes to the GMP standards will also require manufacturers, packagers and labellers to have greater control over raw materials, to maintain control over operations in accordance with the Master Production Document and to implement predetermined sampling procedures that obtain representative samples of the batches of the material they are taken from. Other changes will clarify what records must be retained and where they should be housed. Finally, the NHPD is proposing to set minimum requirements for testing facilities.
The NHPD has proposed that product licence applications must contain importer (if applicable), manufacturer, packager and labeller information before a product licence will be issued. If such information is not provided, a conditional licence may be issued; however, permission to sell a product would be granted only after the required information was provided and a full product licence issued.
Consultation on these proposed changed is open for commentary until October 28, 2011. More information can be found online at http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/rbasl_afrdle_concept-eng.php.
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