NHPD Stage 2: The Product Licensing System
By
December 31, 2009, NHPs that currently have a product license as a Drug
Identification Number (DIN) will have transferred to have a Natural Product
Number (NPN) or a Homeopathic Number (DIN-HM).
This
transition period allows six years for NHPs with
a valid DIN to obtain a product license under the Regulations.
·
Natural Product Number (NPN): is an eight (8)
digit numerical code following the acronym NPN assigned to each NHP approved to
be marketed under the NHP Regulations.
·
Homeopathic Medicine Number (DIN-HM): is an
eight (8) digit numerical code following the acronym DIN-HM assigned to each
homeopathic medicine approved to be marketed under the NHP Regulations.
Note:
Health
Canada intends to complete compliance activities with respect to all currently
noncompliant products as of January 1, 2008.
In other words, all NHPs presently
on the market but which do not have a DIN, NPN or DIN-HM,
must be registered by this date.
As of this date there will be no NHPs on the market that have not been
the subject of a product licence application
This
means that all currently non-compliant NHPs will be subject to appropriate
compliance and enforcement actions, as determined by the NHPD and the Health
Products and Food Branch Inspectorate (HPFBI).
Compliance
and enforcement activities exercised by Health Canada will be prioritized on a
risk mitigation basis and be conducted according to risk based product
categories.
NHPs
identified as posing an unacceptable risk to the health of Canadians will be
removed from sale. Any required
enforcement actions will be carried out by the HPFBI.
The nature of the compliance actions will be in accordance with the
HPFBI’s Compliance and Enforcement Policy (POL-0001).
An NPN and/or
the DIN-HM number is issued once a product is authorized for sale in Canada by
the NHPD. The NHPD has a standard of
evidence framework that indicates the type of information necessary to support
an application for a NHP license.
