Post-Market (Adverse Reaction Reporting, License Amendments/Renewals)
License Amendments and Renewals
As products and facilities change and evolve, so should their registrations, which must be updated to reflect changes instated after licensing or notification. Product changes may include brand name revisions, addition or deletion of ingredients, and revisions to marketing claims, among many others. Manufacturing facilities might change their processes, equipment, staff, or suppliers. Some of these changes trigger the need for new notifications (as is the case when a medicinal ingredient is added to a cosmetic, changing its classification to a therapeutic product). Others require updating of the existing license/notification (as is the case with brand name or distributor changes).
Our team of regulatory experts can identify when and how a product license or notification needs to be renewed or updated. We can help guide you through this process to ensure your business is always in compliance with the regulations set for its category.
Adverse Reaction Reporting
Cosmetovigilance is post-marketing surveillance that monitors the undesirable effects (defined as an adverse reaction for human health) attributed to the use of cosmetic products. The regulatory requirements for reporting adverse reactions to the governing body differs from market to market.
Although adverse reaction reporting is not yet mandatory for cosmetics in Canada, brand owners are encouraged to take this voluntary step as a part of their cosmetovigilance. NHP Consulting can assist companies to distinguish between the necessary details required for reporting when completing the Consumer Product Incident Form, which is submitted in confidence online to Health Canada.
Adverse reaction reporting for cosmetics is also voluntary in the United States: The Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse events involving CFSAN-regulated products, which include dietary supplements, cosmetics, foods, and other products. CAERS receives reports through MedWatch, emails, telephone calls, faxes, letters, and electronic transfers from the Office of Regulatory Affairs (ORA) District Offices’ Field Accomplishments and Compliance Tracking System (FACTS). NHP Consulting can assist consumers, health professionals, and manufacturers in making voluntary reports of adverse events associated with cosmetic products to CAERS.
In the EU, serious undesirable effects (SUEs), defined as “undesirable effects which result in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death,” must be reported to authorities within a specific timeframe (20 days). Before the notification of the SUE, Responsible Persons, Distributors and Competent Authorities must conduct a causality assessment to ensure that the undesirable effect meets seriousness criteria and is attributable to the use of the cosmetic product. After notification of the SUE, corrective actions may be recommended by the authorities to mitigate the frequency and nature of the SUE. NHP Consulting can help companies determine the required details to support the causality assessment before notification is handed over to the Responsible Person or Distributor as well as assist in complying with the recommended corrective actions.