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REGULATORY
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NHP Compliance’s regulatory services are extensive and you can rest assured that
confidentiality is paramount to what we do.
We can help you:
- Perform product evaluations to determine your product's appropriate category
(drug, NHP, dietary supplements, cosmetic, medical devices, consumer products, etc.)
- Determine submission requirements (confirming type of product licence
application [PLA] required)
- Prepare and submit:
- Site licence applications (SLAs) and associated documents for Canadian,
U.S., and foreign manufacturing facilities, including QA reports
- PLAs and associated documents:
- Non-traditional
- Compendial
- Transitional (i.e., drug to NHP)
- Amendments and notifications
- International Trade Certificate applications
- Address NHP Directorate (NHPD) queries, such as:
- Information Request Notifications
- Processing Deficiency Notifications
- Provide expertise in the NHP regulatory field
- Respond to any queries related to NHPs, whether the questions come from a
client or the NHPD
- Transition drug product DINs to Natural Product Numbers (NPNs), where
applicable
- Act as your qualified Quality Assurance Personnel (QAP)
Our Good Manufacturing Practices (GMP) associates are uniquely qualified to
consult on NHPs; we have been assisting clients with the transition from DIN to NPN
since the inception of the NHPD and before initial guidances were drafted.
For a comprehensive summary of the NHP GMP regulations, SLAs, PLAs, labelling
and packaging requirements, and specific requirements for clinical trial products,
read our QuickNote™ titled, Natural Health Products Regulations. The FAQ section in this document provides a full list of links to NHP
resource documents.
As per the NHP GMPs:
- You need an NPN for natural health products in Canada. There are separate GMPs for drug products and natural health products.
- Domestic fabricators/manufacturers, packagers/labellers, and importers must
have a site licence. Sites with a site licence must comply with the NHP GMPs.
- Importers must also appoint a Quality Assurance (QA) person in Canada to
disposition product and to ensure compliance.
We can take you through the entire process, from the initial site application
through setup of your quality system to release of your finished marketed
product. NHP Compliance can help you establish or re-organize your Quality
Control system for NHPs to meet NHPD requirements. See QAP Services for more
information.
Did you know?
NHP Compliance has advised and consulted on NHPs for many
companies. We are familiar with the nuances of these new regulations, and
continue to stay up-to-date with changes as they evolve. Contact us now»
FAQs
- If I have a warehouse that stores NHPs, do I need a site licence?
Yes. The manufacturer or importer where goods are stored needs to ensure that
they practice GMP.
- If I am a manufacturer of NHPs in the U.S., what do I need to do to market
my product in Canada?
You will need a product licence and a Canadian importer with a site licence.
Each manufacturing, packaging, and labelling site requires a QAR or equivalent. See our flowchart, Importing a Natural Health Product or Drug into Canada for more information.
- For the first five years, what is the frequency of renewing a site licence?
Annually for the first three years and again on the fifth year.
- What is a Compendial Application?
A product licence application that meets all the monograph requirements in
NHPD’s Compendium of Monographs for that product.
- How do I support the shelf life of my product at launch?
Stability data from accelerated studies, real time studies or from similar
product formulations may be used.
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