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Regulation of Homeopathic Medicines in Canada
The CHPA has enjoyed a long and productive working relationship with Health Canada's Therapeutic Products Directorate (TPD) and Natural Health Products Directorate (NHPD). The association meets with TPD and NHPD at least twice a year to address issues of common concern and in 2002 and 2003 has been represented in an industry advisory body to NHPD in the development and implementation of the new Natural Health Product Regulations. This cooperation has been key for the development of a Canadian regulatory framework that is appropriate for homeopathic medicines. The major components of the regulatory framework are described below.
Cost Recovery
In August 2000, TPD and CHPA reached an agreement on a modified fee structure for registration of homeopathic products that takes into consideration the fact that manufacturers and distributors of homeopathic medicines hold a great number of DIN´s with low sales volumes for each. This cost recovery model has encouraged the availability of recognised homeopathic medicines to Canadian consumers at reasonable costs.
Group DIN Submissions (April 1996 - February 1998)
CHPA and TPD jointly managed an initiative known as the Homeopathic Compliance Project Group. This cooperative initiative streamlined the product license application and review process, permitting over 4000 Drug Identification Numbers to be granted to approximately 40 companies in compliance with Health Canada's drug licensing requirements for homeopathic medicines.
GJMP Guidelines (October 1996)
CHPA assisted Health Canada in the development and implementation of the Labelling Standard - Homeopathic Preparations (issued in 1995, revised May 1997).
Labelling Standard - Homeopathic Preparations (May 1997)
CHPA assisted Health Canada in the development and implementation of the Labelling Standard - Homeopathic Preparations (issued in 1995, revised May 1997).
Recognition of Major Pharmacopeias
CHPA spearheaded industry efforts to have Health Canada recognize three pharmacopoeias in the evaluation of product license submissions and indications for use. These are:
* Homeopathic Pharmacopoeia of the United States (HPUS) (United States)
* Homöopathisches Arzneibuch (HAB) (Germany)
* Pharmacopée Française (PhF) (France)
Indications for Use of Homeopathic Medicines
At CHPA's encouragement, Health Canada agreed to allow indications for use for multi?ingredient homeopathic medicines. (Indications for Use - Multi-Ingredient Low Dilution Homeopathic Preparations, issued March 1997, revised September 1998).
Interim DIN Enforcement Directive (first issued January 1998)
This directive identified a number of sub-categories of natural health products and homeopathic medicines as products subject to special compliance and enforcement measures, allowing the products to be imported into Canada and sold without a DIN pending completion of the Natural Health Product Regulations.
Although the position held by CHPA is that homeopathic medicines are pharmaceutical products and should be regulated using the Drug Identification Number (DIN) product license of TPD, Health Canada has included homeopathic medicines within the definition of Natural Health Product, a new sub-category of drug products that will be regulated under the new Natural Health Product Regulations that are being phased in over a six year period beginning on January 1, 2004. Under these new regulations, homeopathic medicines will continue to be regulated as drug products. After January 1, 2009, all homeopathic medicines will be identified by a unique product license consisting of the letters DIN-HM plus an 8 digit number.
Product Availability Under the new NHP Regulations
The new Natural Health Product Regulations have been developed in consultation with CHPA and homeopathic practitioners with the important objective of making a greater number of homeopathic medicines available in Canada. Allowing Canadian access to products that are readily available in other countries such as the US and the EU. Several hundred products that could not previously be licensed will be eligible for product licensing, importation and distribution after January 1, 2004.
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