Cosmetics Alliance identified inaccuracies in DEL Bulletin No.136 that do not align with the requirements outlined in the Regulations. We brought these concerns to the attention of the Regulatory, Operations and Enforcement Branch (ROEB).
We have since been advised that all public postings of this incorrect DEL Bulletin No.136 have been removed. An amended version will be shared with stakeholders through an DEL Bulletin email, which will address and correct the noted inaccuracies.
Only drugs found on List A of the NHPR or List D of the FDR are permitted to be distributed as samples. These samples are NPDs or NHPs and they may be distributed in the following ways:
- directly to adult consumers (those 18 years of age or older)
- to a practitioner or pharmacist, for further distribution to their patients, in accordance with their scope of practice
Distribution of these samples may be done by an individual or representative of an organization.
Criteria for drugs distributed as samples:
- meet all criteria and qualifiers on List A (NHPR) or List D (FDR)
- adhere to the parameters set out in their market authorization
The inconsistencies we found are summarized as follows:
- There is no requirement for drugs distributed as samples to be “manufactured” (i.e. fabricated, packaged, labelled) in recognized countries per the other list in the F&DR.
- Samples may also be distributed directly to adult consumers (those 18 years of age or older) not only to a practitioner or pharmacist, for further distribution to their patients, in accordance with their scope of practice.
