INTERNATIONAL

PHARMACEUTICALS &
CUSTOM REGULATIONS IN
CANADA
 INTRODUCTION
The pharmaceutical sector is
one of the most innovative
and profitable industries in
Canada
Canada’s generic drug
industry generates 40% of its
sales volume from exporting
made-in Canada
pharmaceuticals, primarily
to the United States
Canada has the 9th largest
pharmaceutical industry -
accounting 3% of the world
market by sales
Generic pharmaceutical
companies export more
than $1B annually from
Ontario
 Logistics is generally the detailed
organization and implementation of
a complex operation

LOGISTICS In a general business sense, logistics

is the management of the flow of
things between the point of origin
and the point of consumption in
order to meet requirements of
customers or corporations
 PHARMACEUTICAL LOGISTICS

Medical logistics is the logistics of pharmaceuticals, medical and surgical

supplies, medical devices and equipment, and other products needed to
support doctors, nurses, and other health and dental care providers

Because its final customers are responsible for the lives and health of their
patients, medical logistics is unique in that it seeks to optimize
effectiveness rather than efficiency
 PRINCIPLES OF PHARMACEUTICAL
LOGISTICS

Quality is essential -
Adherence to no local purchase
Do no harm recognized unless certified by
standards pharmaceutical
professional

Only medical Cold chain –

professionals can people and the Security
order supplies equipment
 GLENMARK

01 02 03
Pharmaceutical company Glenmark India has a Glenmark also hosts
headquartered total range of 300 additional 46 patented
in Mumbai, India that was products of which 22 brands exclusively for the
founded in 1977 by products are patented international market
Gracias Saldanha as products under the name including other generic
a generic drug and active of Glenmark. drug.
pharmaceutical
ingredient manufacturer
 GLENMARK OPERATES
India

Africa

Middle east

Russia

South America

Central and Eastern Europe

 Data assessment

Ordering and Procurement

SUPPLY CHAIN Transport

Storage

Distribution
 Logistics flow :
it is a strategic
management of
activities
involved in the
acquisition and
conversion of
material to
finished products
to the customer
https://www.youtube.com/watch?v=
E8RXGrRtqtQ
 SUPPLY CHAIN PROCEDURES
Done by medical people, logisticians and other technical people = multi-sectoral

Logistics looks into the local availability and quality of

• medical supplies
• transport lines
• storage options
• cold chain
• customs procedures
• distribution methods/modalities.

Medical organizations are quick in providing basic medical assistance in

emergencies – 48-72 hours
 ORDERING AND PROCUREMENT

Medical personnel in charge of ordering Logistics personnel to provide accurate figures on stock levels

Logistics triggers minimum level ordering

Logistics to ensure regular ordering, avoid emergency orders

Logistics to ensure correct labeling and terminology requested

Logistics personnel in charge of procurement Project , capital , international

Most drugs are ordered through big pharma for the quality control

Donations of drugs are not advised

Order tracking and tracing

 MINIMUM LABEL INFORMATION

Common
International Pharmaceutical Manufacturers
Lot (batch) number
Denomination (CID form and strength name
or generic name)

Quantities by Must be in local

Packing condition Expiry date
bottles languages (script)
 TRANSPORT TYPE

Air- for emergencies, expensive/fast

Sea – for large quantities, cheap/slow

Railroad – for large quantities, cheap/slow

Road – for normal operations,

optimal/medium to fast
 HUMIDITY

• Fungus and bacteria;

• Hastens chemical reactions;
• Tablets may soften up;

TEMPERATURE

• Vaccines & some other drugs require cold chain

(refrigerators, ice boxes)
STORAGE AND • Registry & control of temperatures (responsible person,
thermometers)
ENVIRONMENTAL • Loss of strength, degeneration into toxic product
FACTORS • Follow directions on label
• Avoid extreme temperatures
• Ambient temperature: 15-30oC
• Refrigeration temperature: 2-8oC
• Freezing temperature: 0 - 15oC

LIGHT

• Keep drugs out of direct sunlight

 HOW ARE DRUGS REVIEWED IN
CANADA?

Drugs are authorized for sale in Canada once

they have successfully gone through the drug
review process.

Throughout the process, the safety and

well-being of Canadians is the
paramount concern.
 WHAT IS THE HEALTH PRODUCTS
AND FOOD BRANCH?

Health Canada's HPFB is the national authority that These products include drugs,
regulates, evaluates and monitors the safety, efficacy, medical devices, disinfectants and
and quality of therapeutic and diagnostic products
available to Canadians sanitizers with disinfectant claims.
 WHAT IS THE INTENT OF A CLINICAL
TRIAL?

This provides a
The intent of a controlled
clinical trial is to environment where
research and the procedures for
gather information drug administration
on a drug's dose, and the evaluation
effectiveness and of the results are
safety in humans. closely monitored.
 DOES HPFB REVIEW CLINICAL
TRIALS?

Prior to the commencement of a clinical trial in Canada, HPFB

reviews the information submitted in the clinical trial application.

This application requests permission to distribute the drug to

responsible clinical investigators that are named in the
application.
 WHAT IS
DONE WITH If clinical trial studies prove that the drug has potential
therapeutic value that outweighs the risks associated
THESE with its use (e.g. adverse effects, toxicity), the sponsor
may choose to file a New Drug Submission with HPFB.
RESULTS?
 STEPS IN REVIEW PROCESS FOR A
DRUG
When a sponsor decides that it
This contains information and
would like to market a drug in
data about the drug's safety,
Canada, it files a "New Drug
effectiveness and quality.
Submission" with HPFB.
It includes the results of the
preclinical and clinical studies,
whether done in Canada or
elsewhere, details regarding the
production of the drug,
packaging and labelling details,
and information regarding
therapeutic claims and side
effects.

HPFB performs a thorough review

HPFB evaluates the safety,
of the submitted information,
efficacy and quality data to
sometimes using external
assess the potential benefits and
consultants and advisory
risks of the drug.
committees.
 STEPS IN REVIEW PROCESS FOR A
DRUG
HPFB reviews the information that the sponsor proposes to provide to health
care practitioners and consumers about the drug (e.g. the label, product
brochure).

If, at the completion of the review, the conclusion is that the benefits
outweigh the risks and that the risks can be mitigated, the drug is issued a
Notice of Compliance (NOC), as well as a Drug Identification Number (DIN)
which permits the sponsor to market the drug in Canada and indicates the
drug's official approval in Canada.

In addition, Health Canada laboratories may test certain biological

products before and after authorization to sell in Canada has been issued.
This is done through its Lot Release Process, in order to monitor safety,
efficacy and quality.
MONOGRAPHS USED FOR REVIEW
PROCESS
• A monograph is a scientific standard -
Information about an ingredient, product
or class of products:
• its properties
• acceptable use or purpose
• Dosage
• duration of use
• risk information
• The monograph represents Health
Canada's knowledge and experience
about what is necessary for the safe and
effective use of the ingredient, product,
or class of products
 • If an applicant wants to market a product that follows
a monograph exactly, the process to obtain approval
will be faster because Health Canada has already
pre-cleared the information.
MONOGRAPHS
USED FOR • The Natural and Non-prescription Health Products
REVIEW Directorate's (NNHPD) product licensing system allows
applicants to reference monographs for certain non-
PROCESS prescription drugs to support the safety and efficacy
of these products, allowing for an expedited review of
the License/DIN application.
 Once a drug is on the market, regulatory controls continue.

The distributor of the drug must report any new information

received concerning serious side effects including failure of
the drug to produce the desired effect.

MONITORING The distributor must also notify HPFB about any studies that
OF DRUG have provided new safety information and request approval
for any major changes to the manufacturing processes, dose

AFTER regime or recommended uses for the drug.

HPFB conducts market surveillance, monitors adverse reaction

APPROVAL reports, investigates complaints and problem reports, and
manages recalls, should the necessity arise.

In addition, HPFB licenses most drug production sites and

conducts regular inspections as a condition for licensing
 IMPORTING PHARMACEUTICALS

Import for commercial use – steps to

follow
Importing pharmaceuticals is • Obtain a site license – requires physical site in
extremely tightly regulated Canada where business or individual wish to
by Health Canada and manufacture, package, label and/or import
health products
strictly enforced by the
• Done to meet requirements of – safety,
Canadian Border Service sanitation, security measures
Agency (CBSA) • Every party involved should be licensed – from
airline carrying the pharmaceuticals to all
warehouses where products will be stored
 Natural Health Products Regulations sets
requirements, rights and responsibilities in
regard to site licensing.

The purpose is to –
• Ensure the Natural and Non-prescription Health Products
PURPOSE - Directorate (NNHPD) is aware of all the sites at which
businesses are manufacturing, packaging, labelling,
SITE LICENCE importing and storing Natural Health Products (NHPs) in
Canada
• To meet the regulatory requirements related to
manufacturing, packaging, labelling or importing these
natural health products for sale
• To require site licence holders to demonstrate that they
comply with the Good Manufacturing Practices (GMP)
 • Import for commercial use – steps to follow

• Obtain to Drug Identification Number (DIN) for new

pharmaceutical product by Health Canada
• Lengthy process – carrying out in-depth clinical
trials to ensure product is not harmful to humans

IMPORTING • Follow proper regulations about packaging and

PHARMACEUTICALS labeling as well
• Example – for shipping narcotics – require
specific forms for custom declaration
• Natural health products (NHPs) such as vitamins,
herbal remedies and homeopathic medicine –
treated same as the over-the-counter drugs and
require site license and Natural Product Number
(NPN) for importation
 • https://www.youtube.com/watch?v=FXP8rj7Mohk
• Transporting healthcare products needs the
establishment of complex logistical methods to
maintain a pharmaceutical shipment’s integrity.
CONCLUSION • It requires specific equipment, storage facilities,
harmonized handling procedures and, above all,
strong cooperation among the cold chain partners.
 Chetan Mehmi

THANK YOU Shivani Sharma

Jaspreet Kaur