3/20/2024 0 Comments Prescription liquid laxativeWhere no Schedule B monograph exists for the dosage form, specifications should be similar to those of a comparable compendial dosage form. It is also noted that all products are subject to Part C, Division 2 of the Food and Drug Regulations.Īll ingredient (medicinal and non-medicinal) and finished product specifications must meet or exceed the standards described in the publications referred to in Schedule B to the Food and Drugs Act, or equivalent standards. Products must comply with the requirements in the Food and Drugs Act and associated Regulations. Both regulators will continue to explore if there may be additional opportunities for future OTC monograph initiatives. This initiative is one step in the ongoing collaboration between Health Canada and the TGA to work toward greater regulatory convergence and harmonization where feasible. The proposed Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard describes the requirements necessary to receive marketing authorization for oral antitussive non-prescription products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults to relieve dry cough due to cold. The proposed Non-prescription Oral Stool Softener Laxatives Labelling Standard describes the requirements necessary to receive marketing authorization for non-prescription oral stool softener laxative products containing docusate sodium or docusate calcium as a single ingredient for use in adults and children 6 years of age and older for use as a stool softening laxative to relieve occasional constipation. Two labelling standards have been developed ( Non-prescription Oral Adult Antitussive Cough and Cold and Non-prescription Oral Stool Softener Laxatives) because they meet the goals of aligning the ongoing work of both regulators and reducing unnecessary differences. Health Canada and the Australian Therapeutic Goods Administration (TGA) continue to work under the Regulatory Cooperation Initiative (RCI) project to explore various ways of work sharing between the two regulatory agencies. Our file number: 15-103676-125 Regulatory Cooperation Initiative (RCI) Over-the-Counter (OTC) Products Proposed Draft Monographs for Comment
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |