introduction to consumer health...
TRANSCRIPT
Introduction to
Consumer Health Products
No part of this publication may be reproduced without the written permission of CHP Canada.
© Consumer Health Products Canada
CHP Canada - December 2012
The Essentials of Consumer Health Products
MODULE 1
MODULE 1 INTRODUCTION TO CONSUMER HEALTH PRODUCTS
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Contents
I. Introduction ..................................................................................................................................... 3
II. Consumer Health Products Canada (CHP Canada).................................................................. 4
INTRODUCTION ...................................................................................................................................................................... 4
CHP CANADA’S HISTORY ........................................................................................................................................................ 4
CHP CANADA’S MISSION ........................................................................................................................................................ 5
CHP CANADA’S GOVERNANCE STRUCTURE ............................................................................................................................... 5
CHP CANADA WEBSITE .......................................................................................................................................................... 7
III. Regulators at Health Canada ................................................................................................ 8
HEALTH CANADA .................................................................................................................................................................... 8
HEALTH CANADA’S AGENCIES .................................................................................................................................................. 9
HEALTH PRODUCTS AND FOOD BRANCH OF HEALTH CANADA (HPFB) ........................................................................................ 9
HPFB: THERAPEUTIC PRODUCTS DIRECTORATE (TPD) ............................................................................................................ 10
HPFB: NATURAL HEALTH PRODUCTS DIRECTORATE (NHPD) ................................................................................................... 11
HPFB: OTHER DIRECTORATES AND OFFICES ........................................................................................................................... 12
HEALTHY ENVIRONMENTS AND CONSUMER SAFETY BRANCH (HECS) ........................................................................................ 13
GOVERNMENT ELECTRONIC DIRECTORY SERVICES (GEDS) ....................................................................................................... 13
IV. Legislative and Regulatory Framework for Consumer Health Products .................................. 14
LEGISLATIVE HISTORY ........................................................................................................................................................... 14
LEGISLATION DEFINED .......................................................................................................................................................... 14
SCHEDULES .......................................................................................................................................................................... 15
REGULATIONS ...................................................................................................................................................................... 15
REGULATORY PROCESS .......................................................................................................................................................... 16
POLICIES AND GUIDELINES..................................................................................................................................................... 16
VOLUNTARY STANDARDS ....................................................................................................................................................... 17
FOOD AND DRUGS ACT ......................................................................................................................................................... 17
FOOD AND DRUG REGULATIONS ............................................................................................................................................ 17
NATURAL HEALTH PRODUCTS REGULATIONS ........................................................................................................................... 18
FURTHER INFORMATION........................................................................................................................................................ 18
V. Glossary ......................................................................................................................................... 19
LIST OF ACRONYMS .............................................................................................................................................................. 20
CHP CONTACT ..................................................................................................................................................................... 20
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I. Introduction
Consumer health products have a wide range of purposes, from preventing or reducing the risk of disease, to the
treatment or symptomatic relief of injuries, chronic conditions and any number of everyday ailments. Vitamins,
headache remedies, allergy medications, toothpaste, herbal remedies, sunscreens, acne lotions and lip balms are some
examples of commonly used consumer health products. Consumer health products can be purchased without a
prescription. They are available at pharmacies, supermarkets and even some convenience stores.
All consumer health products that have been approved for sale in Canada by Health Canada have a product number on
their labels. The prefix of the number indicates whether the product has been approved according to the Food and Drug
Regulations or the Natural Health Products Regulations. For example, a product with the prefix “DIN” (Drug
Identification Number) has been approved according to the requirements of the Food and Drug Regulations, whereas a
product with the prefix “NPN” (Natural Product Number) or “DIN-HM” (Homeopathic Medicine Number) has been
approved according to the requirements of the Natural Health Products Regulations. A product with a prefix “EN”
(Exemption Number) is awaiting review as a natural health product by Health Canada according to the Natural Health
Products Unprocessed Product Licensed Regulations (NHP UPLAR), which are to be repealed in February 2013. NHP
Regulation will be covered in detail in Module 6.
In this Module, you will learn about:
the history, mission, governance structure and online presence of Consumer Health Products Canada, the
national association representing the consumer health products industry in Canada;
the federal bodies responsible for regulating the consumer health products industry in Canada, their roles,
how to contact them, and how to retrieve relevant information from them; and
the legislative and regulatory framework for consumer health products in Canada.
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II. Consumer Health Products Canada (CHP Canada)
INTRODUCTION
Consumer Health Products Canada (CHP Canada) is the national industry association representing manufacturers,
marketers and distributors of consumer health products, including over-the-counter medications and natural health
products. Association members are at the forefront of the industry, accounting for the greatest proportion of sales in
Canada’s $4.7 billion consumer health products market. CHP Canada has been the leading advocate for the consumer
health products industry for over a century. We are committed to working with our members, the broader healthcare
sector and governments to create more opportunities for people to manage their own health through the responsible
use of safe and effective consumer health products.
CHP CANADA’S HISTORY
The Association's original focus was on fair trade and pricing practices, but realizing that membership in the Association
could provide broader benefits for member companies, the Proprietary Association of Canada (PAC) was created as an
expansion of the PATA concept and was incorporated in 1936. It was at this time that the organization also became
more explicitly a manufacturer's association. By the 1960s, regulatory issues made up the core of PAC's programs.
1896 • Proprietary Articles Trade Association (PATA) was founded by a group of drug manufacturers, wholesalers and retailers.
1936 • PATA expands and the Proprietary Association of Canada was incorporated.
1960’s • The Association focused on regulatory issues, self-regulation, and self-care advocacy.
1987 • Name changed to Nonprescription Drug Manufacturers Association of Canada.
2009 • Name changed to Consumer Health Products Canada (CHP Canada).
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The Association played an increasingly important role in the self-regulation of the industry, working with the Advertising
Standards Council and other organizations on voluntary codes and guidelines. At this time, Canada established its
publicly funded universal healthcare system, and the Association’s task of advocating the positive role of self-care in the
system became increasingly important.
Over the years, Consumer Health Products Canada has maintained its place as the leading advocate for the consumer
health products industry in Canada. The Association continues its work today, collaborating with Health Canada in
legislative and regulatory renewal, informing members about emerging issues, and advocating the value of making self-
care one of the pillars of our healthcare system.
CHP CANADA’S MISSION
CHP Canada envisions a day when self-care is broadly recognized and supported as being an integral part of
Canadian healthcare.
The key to achieving this mission lies in building on the confidence and trust that Canadians have in consumer health
products and in the industry that produces them.
CHP CANADA’S GOVERNANCE STRUCTURE
CHP Canada is governed by a Board of Directors along with several other committees and task forces on which
members are invited and encouraged to participate.
CHP Canada’s mission is to advance Canadian self-care by building an environment
that improves opportunities for people to manage their own health
through the responsible use of safe and effective consumer health products.
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CHP Canada’s Governance Structure
CHP Canada's OTC (over-the-counter) Committee and NHP (natural health products) Committee provide insight into
issues of concern to the consumer health products industry as a whole.
The mandate of the OTC Committee is:
o to provide support for CHP Canada programs aiming to help establish a regulatory regime that
encourages market access for evidence-based consumer health products.
o to develop proactive interventions to encourage regulatory incentives, curtail possible regulatory
barriers to market access for innovative OTCs, and provide support for programs promoting self-care
and the responsible use of consumer health products.
o to focus on OTC pre-market licensing, Good Manufacturing Practices, the OTC switch environment,
scheduling, and issues that impact the advertising and labelling of OTCs.
The mandate of the NHP Committee is:
o to provide support for CHP programs aiming to help establish a regulatory regime that supports
innovation and a level playing field for evidence-based natural health products.
o to develop proactive interventions to encourage regulatory incentives and curtail possible regulatory
barriers to market access for innovative natural health products.
o to focus on issues relating to NHP site and product licensing, the NHP switch environment, and issues
that impact the advertising and labelling of NHPs.
CHP Canada’s task forces are formed on an as-needed basis to work on specific issues.
The work of the Association is guided by a strategic plan with annual operating plans that are available to CHP
Canada members on the Member’s area of the Association’s website.
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CHP CANADA WEBSITE
CHP Canada’s website is your source for information on the consumer health product industry and association
initiatives. Access valuable resources online and stay up to date on the issues impacting the industry.
CHP Canada’s website is integrated with social media and we encourage members to take part in discussions online -
everyone has a voice and CHP Canada is listening. Follow us on Twitter and like us on Facebook to stay up to date
on the latest research, regulatory action and media coverage affecting consumer health products. Join our exclusive
Members Only group on LinkedIn to discuss emerging trends.
Employees of CHP Canada member companies may have access to the Member’s Area of the website and can
register to receive our weekly Netfax publication. To apply for an access code, go to www.chpcanada.ca and click on
Member’s Area. Fill out the form, and your account will be activated within 24 hours.
CHP Canada’s website is constantly evolving - if there is something you would like to see on our site, please let us
know by sending an email to [email protected].
www.chpcanada.ca
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III. Regulators at Health Canada
HEALTH CANADA
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their
health (http://www.hc-sc.gc.ca/index-eng.php).
Health Canada’s Mission and Vision:
Health Canada is lead by the Minister of Health, who is an elected Member of Parliament. The Minister appoints the
Deputy Minister and the Associate Deputy Minister. Health Canada’s agencies report directly to the Minister while
branches report to the Associate Deputy Minister and the Deputy Minister.
Health Canada Organizational Chart
See the complete chart at: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/index-eng.php.
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health.
Health Canada is committed to improving the lives of all Canada’s people and to making
this country’s population among the healthiest in the world as measured by longevity,
lifestyle and effective use of the public health care system.
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HEALTH CANADA’S AGENCIES
The Public Health Agency (http://www.phac-aspc.gc.ca/index-eng.php) focuses on preventing chronic diseases, like
cancer and heart disease, preventing injuries and responds to public health emergencies and infectious disease
outbreaks.
The Patented Medicine Prices Review Board (http://www.pmprb-cepmb.gc.ca/english/home.asp?x=1) is a quasi-
judicial body that protects consumers and contributes to healthcare by ensuring that the manufacturers’ prices of
patented medicines are not excessive. Some consumer health products, if patented, could be subject to PMPRB
price control process on a complaints basis. Overall, consumer health products are exempt from PMPRB’s price
reporting requirements.
HEALTH PRODUCTS AND FOOD BRANCH OF HEALTH CANADA (HPFB)
The mandate of the Health Products and Food Branch (HPFB) of Health Canada is to manage the health-related
risks and benefits of health products and food through an integrated approach; this approach aims to:
o minimize health risk factors for Canadians by maximizing the safety provided by the regulatory system
for health products and food;
o promote conditions that enable Canadians to make informed decisions with regard to their health.
Further information on the HPFB can be accessed at: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-
dgpsa/index-eng.php.
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Health Products and Food Branch Organizational Chart
See the complete chart at: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/3kit-fiche/factsheet_fiches-
info_16-eng.php.
HPFB: THERAPEUTIC PRODUCTS DIRECTORATE (TPD)
The Therapeutic Products Directorate (TPD) is the federal authority that regulates human drugs, including over-
the-counter medications and medical devices.
Submissions for over-the-counter medications are administratively processed through TPD’s Submission Information
and Policy Division.
Guidance documents, policies and regulatory amendments impacting drugs are developed by TPD’s Bureau of
Policy, Science and International Programs (BPSIP).
Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a
product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations.
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TPD’s Bureau of Pharmaceutical Sciences reviews the chemistry and manufacturing information submitted as a part
of an over-the-counter medication submission review. Module 5 will cover the review process for over-the-counter
medications.
Information on what’s new for drugs and other health products can be accessed at: http://www.hc-sc.gc.ca/dhp-
mps/prodpharma/update-miseajour/index-eng.php.
Information on drug warnings, advisories and recalls can be accessed at the MedEffect Canada website:
http://www.hc-sc.gc.ca/dhp-mps/medeff/subscribe-abonnement/index-eng.php#subscribe.
HPFB: NATURAL HEALTH PRODUCTS DIRECTORATE (NHPD)
The Natural Health Products Directorate (NHPD) is the federal authority that regulates natural health products.
Industry’s points of contact with Health Canada about natural health product submissions are Submission
Coordinators within the Natural Health Product Directorate’s Bureau of Product Review and Assessment.
Guidance documents, policies, and regulatory amendments impacting natural health products are developed by
NHPD’s Bureau of Policy and Risk Management.
Answers to frequently asked questions from industry can be accessed at: http://www.hc-sc.gc.ca/dhp-
mps/prodnatur/faq/question_industry-industrie-eng.php.
NHPD’s electronic subscriber service (for BEEP messages) can be accessed at: http://www.hc-sc.gc.ca/dhp-
mps/prodnatur/activit/list/index-eng.php.
The regulation of over-the-counter medications are administered the Nonprescription Drug Evaluation Division
(NDED) within the Bureau of Product Review and Assessment. In the past, NDED was administered by the Bureau of
Gastroenterology, Infection and Viral Disease (BGIVD) of the Therapeutic Products Directorate.
Industry’s point of contact with Health Canada about submissions for over-the-counter medications are NDED’s
Regulatory Project Managers.
The role of the NHPD is to ensure that Canadians have ready access to natural health products
that are safe, effective and of high quality, while respecting freedom of choice
and philosophical and cultural diversity.
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HPFB: OTHER DIRECTORATES AND OFFICES
Marketed Health Products Directorate
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/index-eng.php
This Directorate works to ensure that HPFB programs take a consistent approach to post-approval safety
surveillance, assessment of signals and safety trends, and risk communications concerning all regulated,
marketed health products.
HPFB Inspectorate
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php
This Inspectorate is responsible for branch-wide compliance and enforcement activities, enabling a
consistency of approach across the spectrum of regulated products.
The Inspectorate’s core functions are compliance monitoring and compliance certification and investigation,
supported by establishment licensing of drugs and medical devices and laboratory analysis.
Office of Consumer and Public Involvement
http://www.hc-sc.gc.ca/ahc-asc/public-consult/index-eng.php
This Office provides information and opportunities for Canadians to become meaningfully involved in the
decision-making process of HPFB regarding priorities, policies and programs.
Policy, Planning and International Affairs Directorate
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/ppiad-dppai/index-eng.php
The mandate of this Directorate is to improve the ability and capacity of HPFB to implement regulatory
policy and develop consistent approaches to regulating risks.
This Directorate promotes HPFB’s interests internationally.
Biologics and Genetic Therapies Directorate
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/bgtd-dpbtg/index-eng.php
This Directorate regulates biological drugs (products derived from living sources) and radiopharmaceuticals
for human use.
Food Directorate
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/fd-da/index-eng.php
This Directorate is responsible for establishing policies, setting standards, and providing advice and
information on the safety and nutritional value of food.
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HEALTHY ENVIRONMENTS AND CONSUMER SAFETY BRANCH (HECS)
This Branch is responsible for regulating consumer products, cosmetics and workplace hazardous materials. They
also regulate tobacco and controlled substances, and provide drug analytical services.
Register for the Cosmetics Listserv at : http://www.hc-sc.gc.ca/cps-spc/person/cosmet/subscribe-
abonnement/index-eng.php.
For more information on HECS, cosmetic regulation and consumer product regulation:
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hecs-dgsesc/index-eng.php.
GOVERNMENT ELECTRONIC DIRECTORY SERVICES (GEDS)
The Government Electronic Directory Services (GEDS) website (http://sage-geds.tpsgc-pwgsc.gc.ca/) provides
contact information for federal public servants for all regions across Canada.
Contact information includes addresses, telephone numbers and email addresses, as well as the hierarchical position
of each contact.
Navigation tools allow the public to access contacts in all Directorates, Offices, Bureaus and Divisions.
Government Electronic Directory Service Webpage
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IV. Legislative and Regulatory Framework for Consumer Health Products
LEGISLATIVE HISTORY
The Government of Canada developed several legislative schemes in the 19th and 20th centuries to regulate the
production, manufacture, promotion, sale and distribution of food and health products.
This legislation aimed to protect the consumer against health hazards and fraud.
Food and drug regulation began in Canada as a result of an amendment to the Inland Revenue Act that was passed
in 1874, over concerns about the common practice of adulterating liquor with substances like salt, opium, hemp and
tobacco. Instead of prohibiting alcoholic beverages, the amendment prohibited the adulteration of food, drink and
drugs.
However, the amendment to the Inland Revenue Act was not deemed suitable for controlling against drug
adulteration because it did not define drugs and had no provisions for product freshness. Thus, the Adulteration Act
was passed in 1884 that defined food and drugs and the adulteration of each.
The Proprietary or Patent Medicine Act was passed in 1909 to protect the public against certain drugs from being
administered without medical supervision; it was the first legislation to register medicines.
The Opium and Narcotic Drug Act was passed in 1920 to impose strict control over such substances.
The Food and Drugs Act was passed in 1920 with regulations for licensing drugs. The legislation gave the Minister of
Health powers to cancel or suspend a license for violating the requirements set out in regulations. Substantive
amendments were made in 1934 and 1953 that formed the basis of the regulations in place today and required
manufactures to file submissions before marketing their drug.
LEGISLATION DEFINED
Legislation refers to laws, called Acts, which are enacted by Parliament, the legislative arm of government
(http://www.hc-sc.gc.ca/dhp-mps/legislation/index-eng.php).
Federal Acts express the policies of the Canadian Parliament.
Federal Acts create standards of general applicability with binding legal effect on all Canadians and are unlikely to
change in the medium term.
Federal Acts embody provisions that may substantially affect personal rights, describe fundamental requirements or
prohibitions, or establish a public body.
Did you know that the Food and Drugs Act dates back to 1920?
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Acts included are organized into sections, which contain the main provisions of the Acts.
SCHEDULES
A Schedule is often found at the end of an Act (or Regulation).
Schedules contain provisions of the Act, often of a more technical nature than those in the sections.
The Act should include authorities to amend the Schedule(s), such as the Governor-in-Council, so that the
Schedule(s) can be modified administratively, when necessary, without having to engage in the legislative process
through Parliament.
One important schedule to the Food and Drugs Act is Schedule F, which lists all the drugs that require a prescription
by a physician in Canada. Module 5 will cover in detail the process for switching a product from prescription status
to consumer health product status.
REGULATIONS
Regulations (or Rules) are documents of a legislative nature, subordinate to Acts of Parliament and produced where
Parliament delegates its law-making powers to other bodies (http://www.hc-sc.gc.ca/dhp-mps/legislation/index-
eng.php).
Regulations are made pursuant to statutory authority, as per the Statutory Instruments Act.
Regulations impose rules of conduct of general applicability, which are legally binding.
Regulations may include any rule, bylaw, order or proclamation of a legislative nature made pursuant to statutory
authority.
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REGULATORY PROCESS
Regulatory Process
* Represent public consultation process. RIAS = Regulatory Impact Analysis Statement
TB = Treasury Board
Further information on the Federal Guide to the Regulatory Development Process can be found at: http://www.tbs-
sct.gc.ca/ri-qr/documents/gfrpg-gperf/gfrpg-gperf01-eng.asp
POLICIES AND GUIDELINES
Health Canada Guidelines reflect departmental policy and express recommended standards that derive from
Legislation; they do not have the force of law or regulation (http://www.hc-sc.gc.ca/dhp-mps/legislation/index-
eng.php).
Policies and Guidelines are of general applicability for either internal or public purposes.
Policies and Guidelines may explain how various laws will be interpreted by the relevant agency.
Policies and Guidelines may outline general principles that will guide the relevant agency in its activities.
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Alternate approaches to the principles and practices described in Policies and Guidelines may be acceptable,
provided they are supported by adequate justification.
VOLUNTARY STANDARDS
Voluntary standards do not have the authority of law.
Voluntary standards are usually adopted by an organization, such as a trade or professional association or a
recognized standards development organization, in the self-interest of that group, and members can contract into
compliance with the standards.
If a member contracts into compliance with an organization’s voluntary standards, it is possible for the organization
to enforce those standards.
CHP Canada’s voluntary initiatives for marketing, advertising, and labelling can be found on CHP Canada’s website
under “ Industry in Action”:
http://www.chpcanada.ca/index.cfm?fuseaction=main.DspSubPage&PageID=82&SubPageID=2196&fkMainPage=0
FOOD AND DRUGS ACT
The Food and Drugs Act is an Act of Parliament addressing the manufacture, import, export, transportation across
provinces and sale of food, drugs, medical devices and cosmetics.
Section 9(1) of the Act prohibits misleading representation of these products.
Legislation governing food, drugs, cosmetics and therapeutic devices is found in Part I of the Food and Drugs Act.
Further information on the Food and Drugs Act can be accessed at: http://laws-lois.justice.gc.ca/eng/acts/F-27/.
FOOD AND DRUG REGULATIONS
The Food and Drug Regulations elaborate principles or rules designed to control or govern conduct with respect to
food, drugs, medical devices and cosmetics.
Part C of the Food and Drug Regulations deals with drugs and includes the following Divisions:
o Division 1 – General
o Division 1A – Establishment Licences
o Division 2 – Good Manufacturing Practices
The Food and Drugs Act aims to ensure that food, drugs, medical devices and cosmetics are safe, that
ingredients are disclosed, and that drugs are effective and not sold as food or cosmetics.
Policies and Guidelines allow for flexibility in approach.
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o Division 5 – Drugs for Clinical Trials Involving Human Subjects
o Division 8 – New Drugs (human and veterinary)
o Division 9 – Analgesics
Module 4 will cover the Food and Drug Regulations in details. Further information on the Food and Drug Regulations
can be accessed at: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/.
NATURAL HEALTH PRODUCTS REGULATIONS
All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which
came into force on January 1, 2004 and include the following Parts:
o Part 1 – Product Licences
o Part 2 – Site Licences
o Part 3 – Good Manufacturing Practices
o Part 4 – Clinical Trials Involving Human Subjects
o Part 5 – General (e.g., labelling and packaging)
o Part 6 – Amendments, Transitional Provisions and Coming into Force
Module 6 will cover natural health product regulations in detail. Further information on the Natural Health Products
Regulations can be accessed at: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php and at
http://gazette.gc.ca/archives/p2/2003/2003-06-18/html/sor-dors196-eng.html.
FURTHER INFORMATION
Further information on the legislative and regulatory framework for drug products can be accessed at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php.
Further information on the legislative and regulatory framework for natural health products can be accessed at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php.
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V. Glossary
LIST OF ACRONYMS
LIST OF ACRONYMS
Acronym Full Name Associations:
ASC CACDS CAPDM CAPRA CCTFA CGPA CHFA CHPA CPhA FCPC NAPRA Rx&D
Advertising Standards Canada Canadian Association of Chain Drug Stores Canadian Association for Pharmacy Distribution Management Canadian Association of Professional Regulatory Affairs Canadian Cosmetic, Toiletry and Fragrance Association Canadian Generic Pharmaceutical Association Canadian Health Food Association Consumer Healthcare Products Association (US) Canadian Pharmacists Association Food and Consumer Products of Canada National Association of Pharmacy Regulatory Authorities Canada’s Research-Based Pharmaceutical Companies
Health Canada:
ADM BGIVD DG EII HPFB HPFBI MHPD NDED NHPD/PAC TPD
Assistant Deputy Minister Bureau of Gastroenterology Infection and Viral Diseases Director General Environmental Impact Initiative Health Products and Food Branch Health Products and Food Branch Inspectorate Marketed Health Products Directorate Nonprescription Drug Evaluation Division Natural Health Products Directorate/Program Advisory Committee Therapeutic Products Directorate
General Terms:
ADR ANDS APA CDSA CEPA CRP / TRP CTA DIN DSL DTCA eIRN EL EAC F&DA
Adverse Drug Reaction Abbreviated New Drug Submission Advertising Preclearance Agency Controlled Drugs and Substances Act Canadian Environmental Protection Act Child Resistant Packaging / Tamper Resistant Packaging Clinical Trial Application Drug Identification Number Domestic Substances List Direct-to-Consumer Advertising Early Information Request Notice Establishment License Expert Advisory Committee Food and Drugs Act
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GERA GMP ICL IRN MAH NC NDS NHP NMI NOC NOD NON NPN OTC PLA PDN SANDS SAP SNDS TMA
Group on Electronic Regulatory Affairs Activities Good Manufacturing Practices In Commerce List Information Request Notice Market Authorization Holder Notifiable Changes New Drug Submission Natural Health Products Non-Medicinal Ingredients Notice of Compliance Notice of Deficiency Notice of Noncompliance Natural Product Number Over-the-Counter Product Licence Application Product Licence Application Deficiency Notice Supplemental Abbreviated New Drug Submission Scientific Advisory Panel Supplemental New Drug Submission Terms of Market Authorization
Other Groups:
FDA MHRA NDSAC PAAB PMPRB TGA WSMI
Food and Drug Administration Medicines and Healthcare Products Regulatory Agency (UK) National Drug Scheduling Advisory Committee Pharmaceutical Advertising Advisory Board Patented Medicine Prices Review Board Therapeutic Goods Administration (Australia) World Self-Medication Industry
CHP CANADA CONTACT
Questions? Contact the following CHP Canada staff member for more information:
Robert White - Director of Scientific and Regulatory Affairs
email: [email protected]
telephone: 613-723-0777, ext. 228
September 6, 2013