3 replies to this topic

[CNicHRZ]

We import a variety of Natural Health Products into Canada and have a license from the NNHPD to do so. 

However recently a supplier of ours is having packaging shortages and is unable to secure packaging with a NPN number, so they've asked us if we can take the product without this. They have another label format for the product which excludes the NPN and any associated health claims. However, the ingredients/formula remains the same and will still contain medicinal ingredients. 

My question is- is this allowed? The guidance from the NNHPD is rather vague, but my gut feeling is telling me no, as the product still contains the medicinal ingredients which may be considered misleading. 

If anyone has any advice of experience in this, I'd greatly appreciate the help! Thanks in advance. 

[Scampi]

No and No--the regulation is actually crystal clear---under 2.1 below they've used the word MUST that means it MUST have the NPN on the exterior display panel

 

You may be able to apply to affix a tamper evident label including the NPN but you must be given written permission before you move any of that product

 

https://www.canada.c...lling.html#a2.1

 

2.1 Information required on the principal display panel of the inner and outer labels

You must include the following information on the principal display panel of both the inner and outer labels, if there is an outer label, as outlined in section 93 of the Regulations. If there is only one label, you must put the information on the principal display panel of that label. See section 4.0 (Flexibilities) for more information on other formatting options if the package cannot fit a label with all the required information.

• Brand name
  This is the name used to distinguish or identify the product. You must only use one brand name per product per paragraph 5 (e) of the Regulations, as set out in your product’s terms of market authorization. Note: you may not use a brand name that implies a recommended use that is different than what appears in the approved terms of market authorization for that product. Failing to do so could be considered a violation of section 9 of the Food and Drugs Act.
• Product number
  You will get a product number from Health Canada after Health Canada issues your product’s terms of market authorization. It must be clearly identified on the label by the prefix NPN, or the prefix DIN-HM. Your product number should be displayed horizontally on the label.

[CNicHRZ]

 

No and No--the regulation is actually crystal clear---under 2.1 below they've used the word MUST that means it MUST have the NPN on the exterior display panel

 

You may be able to apply to affix a tamper evident label including the NPN but you must be given written permission before you move any of that product

 

https://www.canada.c...lling.html#a2.1

 

2.1 Information required on the principal display panel of the inner and outer labels

You must include the following information on the principal display panel of both the inner and outer labels, if there is an outer label, as outlined in section 93 of the Regulations. If there is only one label, you must put the information on the principal display panel of that label. See section 4.0 (Flexibilities) for more information on other formatting options if the package cannot fit a label with all the required information.

• Brand name
  This is the name used to distinguish or identify the product. You must only use one brand name per product per paragraph 5 (e) of the Regulations, as set out in your product’s terms of market authorization. Note: you may not use a brand name that implies a recommended use that is different than what appears in the approved terms of market authorization for that product. Failing to do so could be considered a violation of section 9 of the Food and Drugs Act.
• Product number
  You will get a product number from Health Canada after Health Canada issues your product’s terms of market authorization. It must be clearly identified on the label by the prefix NPN, or the prefix DIN-HM. Your product number should be displayed horizontally on the label.

 

 

Thanks for the reply. However how does work regarding the removal of an NPN? If the supplier wished for the item to no longer have this, would removing the claims be enough for to satisfy the labelling requirements? Or are they also required to reformulate the ingredients and treat it as a separate product? Thanks! 

[Scampi]

The latter, you would have to reapply with the different formulation as the existing one would still be non compliant as they have that product listed as containing that ingredient