Site License

NHP SITE LICENSING… Time is running out!

2005 was the deadline for compliance with the Site Licensing requirements. Midway through the licensing process, many suppliers were caught off guard with the initial flurry of refused shipments at the border, due to lack of a valid Site Licenses. This caused havoc in the NHP industry. Many companies had to wait in queue for their Site Licenses to be issued in order to have their inventory released by customs.

Faced with an overwhelming number of backlog of product license applications, Natural Health Products Directorate (NHPD) finally agreed to push the deadlines forward a year thus easing the pressure on industry to comply with imminent deadlines.

MCS Gold Seal of Approval for NHP Site Licensing Agreements!

The NHP regulations separate the GMP activities into four main categories that require a Site License:

  • Manufacturing
  • Packaging
  • Labeling
  • Importing

Select MCS Associates Inc.
as your Regulatory Affairs Consultant for “HEALTH CANADA”.

Contact us
about any CANADIAN Regulatory issues facing your company

It is very common in the NHP industry for a product owner to outsource site licensable activities to a vendor. This outsourcing has created situations where the line of responsibilities between product owners, manufacturers, packagers, labelers and importers can become blurred.

MCS helps product license holders to avoid situations where they have taken on some of the responsibilities of the manufacturer, packager, labeler or importer without a proper Site License.

Some GMP responsibilities have been ignored due to oversight assuming that the other party was carrying out this regulated activity. MCS ensures against this possibility for your company.

The NHP Industry is in transition and GMP compliance is emerging as an important concept for both domestic sites and their foreign site suppliers.

MCS Associates helps Importers conform to NHPD regulations. The importer must complete due diligence and ensure that their foreign suppliers are GMP compliant. The foreign audit must be conducted by a person who meets NHPD requirements for a third party auditor

Our MCS audit team consists of trained lead auditors and internal auditors who have experience in conducting third party audits internationally as well as in Canada.

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MCS Provides

Assistance for Manufacturers, Importers, and Distributors requiring a Site License

Submissions such as:
  • Standard Operating Procedures (SOP)
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Training
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