The Bureau of Policy, Science and International Programs in the Pharmaceutical Drugs Directorate released a consultation on Guidance on Co-Packed Drug Products on Mars 18th.
Cosmetics Alliance will be working with your Product Compliance and Market Access Committee to offer any feedback the Committee deems important for inclusion.
The goal of the consultation is to explain the current regulatory requirements for co-packaged drug products and their components and to clarify:
- when a drug information number (DIN) must be assigned before it can be marketed in Canada
- the requirements for authorizing, packaging, labelling, importing and distributing a product
- the submission requirements for post-market changes and other authorizations that may be required
The objective of the consultation is to help ensure that certain products are regulated in a way that:
is practical
- aligns with industry realities
- addresses consumer and public health needs
