3 replies to this topic

[nehank]

Hello all, 

 

I am working for a dietary supplement company in US and want to understand what all 3rd party audits are acceptable by Health Canada. 

 

I know NSF and SGS are acceptable. Not sure what others qualify.

 

Appreciate everyone's help. 

 

Thanks,

[olenazh]

I haven't found any specific requirements of Health Canada to auditing organizations. If you don't have any requirements from your customers (e.g. Costco has its own list of recognized auditing/certifying bodies) - then it's up to you who you turn to for 3rd party audit as long as the company has proper credentials.

[Brothbro]

I am unsure on acceptability from Health Canada, but our facility goes through Eurofins for a DS 3rd party audit. I would say they're a good company to work with and offer rather competitive pricing.

[Scampi]

If you mean for an International Trade Certificate--no I could not find a list of acceptable companies

https://www.canada.c...rtificates.html

 

How Does a Third-Party Become an Issuer of ITCs?

Criteria for Self-Attestation

Disclaimer: Health Canada will not be responsible for complaints resolution

1. Policies, procedures and standards: The 3rd party should possess and make publicly available in both official languages, the policies, procedures and standards it uses to ensure that the ITCs are readily available to industry.
2. Expertise: The 3rd party should possess the knowledge, skills and competencies required to successfully:
   1. issue the certificates - this includes:
      1. the review of product and site licensing status of NHPs available on Health Canada's website;
      2. monitoring of changes in the licensing status of products and sites; and
      3. determining an acceptable period of validity of the ITC for foreign regulatory bodies.
   2. have the capacity to issue ITCs in both English and French;
   3. have performance evaluation measures to ensure timely issuance of the ITCs;
   4. review, evaluate and adjudicate complaints regarding the ITCs; and
   5. have ITCs notarized by a Notary Public or a Commissioner of Oaths.
3. Corporate Relations: The 3rd party should possess mechanisms to ensure timely communication with applicants when required.
4. Conflict of Interest: The 3rd party should not have any conflict of interest. The 3rd party should not be a party regulated by Health Canada under the Natural Health Products Regulations (e.g., a manufacturer). Industry associations, composed of regulated parties, who act as 3rd party issuers should ensure no one member has issuing authority.