Herbal medicinal products in the European Union - AESGP

i) How does your country regulate intermediate products of herbal origin that
are intended for further processing by an authorised manufacturer or for the
preparation of a magisterial or an officinal formula?
See answer to point IX.1.3 b) below.
j) How does your country assess the safety and efficacy of plants which are not
native to North America or Europe and have not been subjected to extensive or
accessible scientific research (e.g. some of the Chinese or South American herbs)?
Traditional herbal references must be submitted that support the indication/therapeutic use,
part of the plant used, dosage for the part of the plant used, the dosage form and the daily and
single dose. Illogical combinations of herbs (e.g., combinations that contain one ingredient
used as a diuretic and a second ingredient used as a laxative) would be questionable.
k) How many herbal medicinal products are authorised in your country? What
are the major ingredients and indications?
The Therapeutic Products Programme (TPP) has been issued Drug Identification Numbers
for numerous herbal products for several years. The products are for OTC self-medicating,
self-limiting conditions.
IX.1.3 Application of Good Manufacturing Practices to herbal medicinal
products
a) Does your country apply Good Manufacturing Practices requirements to
herbal medicinal products?
Herbal products making no therapeutic claims are classified as foods and are therefore
subject to voluntary food guidelines for good manufacturing practices. Herbal products
making therapeutic claims are considered as drugs and are subject to the same good
manufacturing practices as other drug products. For the latter, the requirements are
prescribed by Division 2, Part C of the Regulations to the Food and Drugs Act. Supplementary
Guidelines for the Manufacture of Herbal Medicinal Products [CAN 7], based on W H O
guidelines, have also been developed which provide further guidance appropriate for these
products.
b ) How does your country’s control of the starting (raw) material of herbal
medicinal products compare with the standards of the European Pharmacopoeia?
The regulation of herbal medicinal products as drug products is in its infancy in Canada
and regulations are still being developed for these products. Currently, there is only
certification by the manufacturer that the raw materials have been tested and meet the
appropriate GMP standards. Drug manufacturers must ensure that raw materials meet
appropriate standards. GMP standards for Active Pharmaceutical Ingredients, based on
international standards, are under consideration but may require regulatory changes.
c ) Are GMP inspections carried out in your country and in third countries that
are exporting herbal medicinal products or raw material to Canada?
GMP inspections can be carried out in third countries but this is not a common practice.
Foreign sites must demonstrate GMP compliance. The importer is required to demonstrate
that the site meets GMP standards equivalent to Canada’s. This can be demonstrated by
corporate audits or inspections conducted by the foreign regulatory authority.
Although manufacturers of natural health products are currently exempt from establishment
licences, they are required to have a GMP inspection prior to obtaining a Drug Identification
Number.
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