LO 3: Functioning with legal and ethical framework

Introduction to legal bases of pharmacy practice

Definition of terms

Law
 Is the boy of principles that govern conduct and observance of which can be enforced
in courts.
 It demarcates what is permissible from what is not.
 It must be obeyed and followed by citizens and is subject to legal citizens sanctions or
consequences.
 Is developed in order to ensure that the relationship among persons conform to
certain standard
Pharmaceutical law/ Pharmaceutical Jurisprudence

What is pharmaceutical?
The definition of pharmaceutical depends on the scope of pharmaceutical law, if the law
covers so many items such as drug, cosmetics, medical supplies and sanitary items, it can
be defined as follow: Pharmaceutical shall mean drug, cosmotic, medical supplies, medical
instrument and sanitary item.
Drug is any substances or mixture of substances used in the diagnosis, prevention and
treatment of a disease affecting human and animal. This will include narcotic drugs &
psychotropic substances, pesticide, medicated animal feeding stuff, poisons, radio
pharmaceuticals, blood & blood products, vaccines.
Narcotic drug: is any drug product subject to control according to Narcotic drug control
convention of the United Nations ratified by the country
Psychotropic substance is any substance subject to control according to psychotropic
substance control convention of the united Nations ratified by the country.
Poison is a substance that may cause danger to human, animal, plant or environment when
taken in a small quantity.
Cosmetic is any preparation intended to be applied to human body for cleansing beautifying,
promoting attractiveness or altering the appearance without affecting the body’s structure or
function. Includes like
 Skin cream,
 lotions,
 perfumes,
 lipstick,
 Shampoos etc.
Medical supply is any article that may be used on the inner or outer part of the body for
diagnosis or treatment of disease in human or animal. This includes suturing materials,
 syringes,
 needles,
 bandages,
 guaze,
 cotton & other laboratory,
 surgery and dental instruments such as x-ray machine, ultrasound, microscope etc.
Substances and Items other than drug that may be covered in the law include:
 Food
 Cosmotics
 Poisons
 Medical device
 Chemicals
 Pesticides
 Insecticides
 Herbicides
 Toiletries
 Detergents

 Pharmaceutical laws/ Pharmaceutical jurisprudence

 is the “Science or philosophy of law governing pharmaceutical sector or services”

 is a rule of human conduct binding up on all persons engaged in practice of
Pharmacy.
 It is also restrictive like other laws.

 Pharmacy law gives certain rights for a Pharmacy personnel and it takes away
freedom.
 It says a Pharmacy personnel should:
 Possess certain training.
 Be registered and licensed to practice Pharmacy

The scope of pharmaceutical law

 The scope of law on pharmaceutical depends on the range of elements included in the
definition of pharmaceutical and accordingly the law can be divided into two on such
basis.
 Law dealing with drugs
  Law that covers other substances and items as well as drugs

The need for legislation on pharmaceuticals

The major reasons for legislation dealing with pharmaceuticals are:

1. To ensure proper implementation of pharmaceutical policy.

2. To determine the role of Pharmacy law executive agency, medical practitioners,
Pharmacy personnel, manufacturers, whole sellers, retail outlets, health institution and
customers in ensuring availability, quality assurance, proper storage, distribution and
use of pharmaceuticals.
3. To ensure that the final customers receive pharmaceuticals of proven quality, safety
and efficacy.
4. To ensure the implementation of the pharmaceutical sector as to the required
standard. i.e. pharmaceutical:
 Manufacturing
 Import
 Export
 Local procurement
 Storage
 Inventory control
 Whole distribution
 Use
 Prescribing
 Dispensing
 Patient use
 Control & administration
 Licensing
 Registration of professionals
 Marketing Authorization/Evaluation & Registration
 Inspection
 Clinical trials
 Post marketing surveillance
 Adverse drug reaction reporting
 quality defective drug reporting
 Efficacy related complaint reporting
 Promotion & advertisement
  Laboratory Analysis
 Provision & control of pharmaceutical information
 Control of controlled substances
 Narcotic drugs & psychotropic substances
 Poisons
 Radiopharmaceutical
5. To ensure fair trade in pharmaceutical sector
Directions: Answer all the questions listed below. Use the Answer sheet provided in the
next page:

Part I Write true if the statement is correct or writes false if the statement is incorrect
on the space provided.
1. Narcotic Drug means any drug subject to control according to Narcotic Drugs
Conventions of the United Nations ratified by Ethiopia.
2. Cosmetic is any preparation intended to be applied to human body for cleansing
beautifying,
Part II. Choose the best answer from the given alternatives and encircle your best answer.

3. Which one of the following substance is may cause damage to man, animal, plant
and environment when taken in small quantity.?
A. Food C. Drug
B. Poisons D. Cosmetic
4. The major reasons for legislation dealing with pharmaceuticals are?
A. To ensure proper implementation of pharmaceutical policy.
B. To determine the role of Pharmacy law executive agency and medical practitioners,
use of pharmaceuticals.
C. To ensure that the final customers receive pharmaceuticals of proven quality, safety
and efficacy.
D. All of the above.
2. National drug policy

 is a guide for action, containing the goals, set by the government for the pharmaceutical
center, set by the government for the pharmaceutical sector and the main strategies and
approaches for attaining them.
 It provides a frame work to coordinate activities of pharmaceutical sector participants the
public and private sectors, nongovernmental organization, donors and other interrelated
parties nation’s drug policy although similar in many ways to those of other countries,
may different objectives, strategies and approaches

What is a national drug policy?

 A political commitment to a goal and a guide for action.
 It expresses and prioritizes the medium- to long-term goals set by the government for
the pharmaceutical sector, and identifies the main strategies for attaining them.
 It provides a framework within which the activities of the pharmaceutical sector can be
coordinated.
 It covers both the public and the private sectors, and involves all the main actors in the
pharmaceutical field.
Why is a national drug policy needed?
 To present a formal record of values, aspirations, aims, decisions and medium- to
long-term government commitments;
 To define the national goals and objectives for the pharmaceutical sector, and set
priorities;
 To identify the strategies needed to meet those objectives, and identify the various
factors responsible for implementing the main components of the policy;
 To create a forum for national discussions on these issues.
Objectives of a National Drug policy
The general health related objectives

 To ensure:
 Access: equitable availability and affordability of essential drugs
 Quality: the quality, safety and efficacy of all medicines
 Rational use: the promotion of therapeutically sound and cost-effective use of drugs
by health professionals and consumers.
Other Goals of NDP
 Economic related goals
 To reduce foreign exchange for pharmaceutical import
 To provide jobs (dispensing, pre-packaging, production of pharmaceuticals)
 National development goal
 Develop national pharmaceutical production
 To take a stand on intellectual property rights
Drug policies differ by country due to difference in፡

1. The structure of health care system

2. The number of trained pharmacist and physicians
3. The capacity of the drug regulatory agency
4. Features of pharmaceutical distribution system and
5. The levels of funding for pharmaceuticals.

Example: Objectives of Ethiopian NDP

 To meet the country’s demand for essential drugs and to systematize its supply,
distribution and use.
 To create conducive situations to make the prices of drugs compatible with the
people’s purchasing power.
 To ensure the safety, efficacy and quality of drugs.
 To develop a domestic drug manufacturing capacity and gradual supply to the export
market
 To expand the training of manpower and drugs research and development.
 To devise ways and means for the utilization of traditional drugs in the regular health
services after ensuring their safety and efficacy.

Self-Check -2 Written Test

Directions: Answer all the questions listed below. Use the Answer sheet provided.:
Part I. chooses the best answer from the given alternatives and encircles your best answer.
1. Which of the following guide for action, containing the goals, set by the government
for the pharmaceutical center, set by the government for the pharmaceutical sector
and
the main strategies and approaches for attaining them?
A. National drug policy
B. Drug supply system
 C. National drug formality
D. CR
2. Drug policies differ by country due to difference in፡
A. The structure of health care system
B. The number of trained pharmacist and physicians
C. The capacity of the drug regulatory agency
D. Features of pharmaceutical distribution system and
Short Answer Questions
3. List out the Major components of a national drug policy
 4. Ethical issues in pharmacy practice areas

Introduction to legal basis of Pharmacy practice

Law

 is the boy of principles that govern conduct and observance of which can be enforced in courts.
 It demarkets what is permissible from what is not.
 It must be obeyed and followed by citizens and is subject to legal citizens sanctions or
consequences.
Pharmaceutical laws

Types of law

Law occurs in a variety of hierarchal forms.

1. Constitution -a broad statement of power of government and its branches.

 It is the highest form of law.
 All other forms of law must be consistent with this law.
 It determines the political, economical and socio-cultural rights and obligations of
government and citizens.
2. Treaty/Convention – agreement between nations or states of the same country or among
countries; e.g. Narcotic and Psychotropic substances control convention.
3. Statues – written laws passed by legislative body; e.g. parliament.
4. Regulations – administrative enactment of the executive branch of government that fulfills
statutory policy and procedure; e.g. Drug enforcement administration (DEA).
Legal System

 Legal system is process of making, enforcement and interpreting law

 It includes legislative, executive and judicial system.
Legislative system - is law making process.
 Who should make a law? E.g. in Ethiopia HPR
 What should a law include?
  The content depends on political, economic and socio-cultural development as well as
international situation.
N.B. There is no one law that can serve every country or there is no one internationally
accepted law. However, the laws of different countries share so many principles in common.
Executive system
 is an authorized governmental boy responsible to administer and enforce a law.
 In Ethiopia – FHACA is responsible to administer and enforce drug administration and
control proclamation No. 176/1999.
 In USA, DEA - to administer and enforce the controlled substance act.
Executive body may also authorized to do
a. Legislative action
 Authorized to issue regulation principle draft law.
b. Judicial action
 Interpret law; e.g. suspending and revoking license, revoke professional registration
certificate.
Judicial system
Judicial process includes

 Interpreting a law
 Holding trail
 Receiving of evidence or testimony
 Taking measures accordingly
 Appeal

The need for legislation on pharmaceutical

Pharmaceutical law – is a rule of human conduct binding up on all persons engaged in practice of
Pharmacy. It is also restrictive like other laws.

Pharmacy law gives certain rights for a Pharmacy personnel and it takes away freedom. It says a
Pharmacy personnel should:

 Possess certain training.

 Be registered and licensed to practice Pharmacy.
The scope of pharmaceutical law
The scope of law on pharmaceutical depends on the range of elements included in the definition of
pharmaceutical and accordingly the law can be divided into two on such basis.

1. Law dealing with drugs

2. Law that covers other substances and items as well as drugs
The major reasons for legislation dealing with pharmaceuticals are:

 To ensure proper implementation of pharmaceutical policy.

 To determine the role of Pharmacy law executive agency, medical practitioners, Pharmacy
personnel, manufacturers, whole salers, retail outlets, health institution and customers in
ensuring availability, quality assurance, proper storage, distribution and use of
pharmaceuticals.
 To ensure that the final customers receive pharmaceuticals of proven quality, safety and
efficacy.
 To ensure the implementation of the pharmaceutical sector as to the required standard.
 To ensure fair trade in pharmaceutical sector.

Strategies for the assuring drug quality, safety and efficacy

A. Professional registration
 No Pharmacist or other Pharmacy personnel are legally allowed to practice the profession
Pharmacy unless or otherwise he/she is registered.
 Professionals should be registered in order to ensure their competence.
 Pharmacists and other Pharmacy personnel registration can be issued by:
- Drug regulatory authority
- Board of Pharmacy
- Professional association
- Ministry of Health
N.B. The law should clearly indicate should do the professional registration.
Requirements to be registered
 Education
 Age usually not less than 21 years
 Good moral characters
 Non-drug addict
 Non – alcohol addict
 Free from violation of laws governing the sector
  Experiences and training
 As part of training
 After graduation – apprentices
 Health conditions
 Free from mental illness, physical condition
 Citizenship
 Examination
 Theoretical
 Practical
 Registration fee
 Validity period of the registration /re-registration: It ranges from 5-10 years.
.
Suspension and revocation of the registration:

 Revocation of registration is not a punishment rather it is protection of the public

Conditions for revocation

 If registration is obtained by fraud

 If the professional is unfit, b/c of
 Drug addiction
 Intoxication liquor
 Mental illness
 Physical conditions
 Violations of laws governing sector
 Violation of controlled substances law
 Less common ground for revocation
 International adulteration of drugs
 Aiding of an unregistered person to practice pharmacy
 Unprofessional conduct
 False advertisement
 Negligence
 The law should indicate who should suspend & revoke registration
 Ministry of health
 Board of pharmacy
  Professional association
 Drug regulatory association

B. Evaluation and registration of pharmaceutical

placing of pharmaceutical product on a market of a country requires a marketing authorization,
which is also called” Licensing” or “registration” or “evaluation & registration” from concerned
pharmacy law executive Agency. The procedure includes an assessment of both
pharmaceutical product & manufacturing procedures and facilities.

In comprehensive evaluation and registration system data on

 Pharmaceutical
 Pharmacological
 Toxicological
 Therapeutic
 Clinical investing actions
 Pre-clinical investigations (for new drugs) are analyzed. If pharmaceutical product is
registered “certificate of registration” is issued by the executive agency.
Re-registration of pharmaceutical product

 Registration certificate of pharmaceutical is valid for a limited period. It has to be renewed

every certain year. The validity period of certificate of registration varies from three to five
years.

Re-registration of pharmaceutical is necessary in order to accommodate the change in quality, .

C. Licensing of premises
 No one is allowed to establish Pharmacy establishments/practice without getting license
/authorization to do so from legally authorized bodies after assuring the fulfillment of
requirements.
 Types of Pharmacy establishments
- Manufacturer of pharmaceuticals
- Importer of pharmaceuticals
- exporter of pharmaceuticals
 Pharmaceutical retail outlets
 Pharmacy
 Drug shop
  Rural drug vender
 Pharmaceutical quality control lab.
 Pharmaceutical promotion offices

The need of license is,

1. to insure the quality, safety, efficacy as well as proper management and utilization of
pharmaceuticals.
2. to ensure the fulfillment of requirements or standards i.e. personnel, premises, equipment,
facilities, standard operation procedures (SOP), etc…
Issuance of license is by:
- Board of Pharmacy
- Drug Regulatory Authority
- MOH
 License has to be renewed at certain intervals. In most countries (including Ethiopia) license
is renewed at the binging of every physical year.

D. Inspection
 Pharmacy law exclusive agency is legally authorized to undertake pharmaceuticals inspection
in Pharmacy establishments in order to ascertain to whether there has been a contravention on
law act.
 The agency should assign persons with adequate knowledge and experience of the selected
and policy laws, regulations and directives as inspectors.
 The rights and obligations of inspectors have to be clearly indicated in the law.
 Inspectors are empowered to:
 enter any premises.
 enter any ship, air craft, and vehicle.
 take sample of any medicinal product sold/supplied
 take copies of any entry
 seize and detain any substance or article or document which they have reasonable cause to
believe
Types of inspection

1. Pre-licensing inspection – It is the type of an inspection undertaken in order to ensure the

fulfillments of requirements by Pharmacy establishment before a license is issued.
2. Post- licensing inspection - It is the type of an inspection undertaken on licensed Pharmacy
establishments in order to ascertain whether there has been a contravention of the law.
Two types of post-licensing inspection

a) Emergency inspection
b) Regular inspection

E. import of pharmaceuticals
 Import of pharmaceuticals must be legally controlled in order to ensure that the imported
pharmaceuticals are
 of proven quality, safety, and efficacy.
 on the basis of the country’s need.
Requirements to import pharmaceuticals
1. License/authorization to import pharmaceuticals
No one is allowed to import drugs, medical supplies and other pharmaceuticals unless otherwise
licensee/authorized by regulatory authority to do so.
Exemption from license
Drugs
 for personal use
 for research
 for laboratory testing
 From donation in emergency and compelling conditions.
License to import pharmaceuticals is issued by drug regulatory authority after assuring the
fulfillment of requirements shown below
a. Personnel
b. Premises – for receiving, storing, dispatching and doing administrative works.
c. Equipments and facilities – for receiving, storing, inventory control
d. Standard operation procedures (OSP) – to be followed when ordering, port clearance,
inventory control, distributing compliant collection and analysis, product recall, etc…
2. Market authorization of pharmaceuticals
Obtaining license to import pharmaceuticals especially drugs and medical supplies is not sufficient,
obtaining market authorization for each product from regulatory authority is legally needed in most
countries.
Obligations of importer of Pharmaceuticals
 Not import and distribute pharmaceuticals which are adulterated, counterfeited and
substandard.
 Not use the premises for purpose other than specified in the license.
 Not make change of address or modify premises.
1. Distribute pharmaceuticals only to those licensed or authorized institutions and in accordance
with their level.
2. Keep and provide information’s as may be requested by
F. Control of Pharmaceutical outlets
 No person is allowed to run drug retail outlet without getting/licensed from pharmaceutical
regulatory authority.

Self-Check -3 Written Test

Directions: Answer all the questions listed below. Use the Answer sheet provided in the next
page:
Multiple choose
1. All of the following is required for professional registration, except.
A. Education
B. Age usually not less than 21 years
C. drug addict
D. Experiences and training
2. License may be issued by:
A. Board of pharmacy
B. Drug regulatory authority
C. Ministry of health
 D. All of the above
3. Which of the following type of licensing isorder to ensure the fulfillment of requirements by
pharmacy establishment before a license is issued?
A. Pre-licensing
B. Post-licensing

Short answer
4. What is rationality of Inspection of pharmaceutical
1. Laws Governing the Practice of Pharmacy

Food, Drugs and Cosmetics Act

Food, Medicine and Health Care Administration and Control Proclamation (Proclamation
No. 661/2009)

This Proclamation may be cited as the “Food, Medicine and Health Care Administration and
Control Proclamation No. 661/2009”.

In this Proclamation
”food” means any raw, semi-processed or processed substance for commercial purpose or to be
served for the public in any way intended for human consumption that includes water and other
drinks, chewing gum, supplementary food and any substance which has been used in the
manufacture, preparation or treatment of food, but does not include tobacco and substances used
only as medicines

Food safety and quality administration and control

Registration and License

1. Any food may not be manufactured, imported, exported, stored, distributed, transported or
made available for sale or use to the public without permit of the appropriate organ.

2. Any food production institution shall not change the type and production process of the food
without obtaining a permit from. And having it registered with, the executive organ.

Food Safety and Quality Control

1. No food or its raw material, additive or packaging material shall be put into use unless it
complies with the international and national safety and quality standards.

2. Any food shall be preserved in accordance with the standards set or adopted by the
appropriate organ.

3. Any person may not operate a laboratory established for food quality control unless it is
receives certificate of competence from the executive organ.

4. Any person may not operate a food catering service without obtaining a certificate of
competence from the appropriate organ.

5. A certificate of competence issued in accordance with sub-article (4) of this Article shall be
renewed every year.

6. It is prohibited for any institution that engages in food production, processing, storing,
distribution and transportation to hire an employee having contact with the product and who is
infected with communicable disease.

Food Import and Export

1. Any imported food shall be accompanied by a certificate of quality and safety authenticated by
the concerned government organ of the exporting country.

2. The executive organ may issue safety certificate for export food that needs the same.

Food Irradiation

Radiation treatment of food shall be carried out upon ascertaining by the executive organ that it is
designed to meet the requirements of safety and good hygienic practice of food processing.

Narcotic Drugs and Psychotropic Substances Act

Narcotic Drug means any drug subject to control according to Narcotic Drugs Conventions of
the United Nations ratified by Ethiopia. This shall also include a drug that is categorized as
narcotic drug by the Authority;

Psychotropic Substance means any substance subject to control according to psychotropic

Substances Convention of the United Nations ratified by Ethiopia. This shall also include a
substance that is categorized as psychotropic substance by the authority;

Narcotic Drugs and Psychotropic Substances

Special License Requisite

A special license issued by the Authority shall be required to import, export, manufacture or
distribute narcotic drugs.

A special license to import, export, manufacture, possess or store narcotic drugs psychotropic
substances shall be issued only to persons having drug trade license shall be issued only to
persons having drug trade license organizations

Import and Export

1. Any person having a permanent special license to import or export narcotic drugs or
psychotropic substances. shall apply for a special import or export permit for each
consignment; such special permit shall be valid only for ninety (90) days.

2. No person shall import or export narcotic drugs or psychotropic substances through post office
or by ship.
3. No person shall import or export narcotic drugs or psychotropic substances packing them with
other drugs or articles.

4. Any person who imports or exports narcotic drugs or psychotropic substances shall comply
with packaging guidelines issued by the Authority(Federal Negarit Gazeta - No. 60 29 th June,
1999- Page 1113)

Prescriptions

1. Only a medical practitioner who is registered and have a special license shall prescribe narcotic
drugs.
2. Psychotropic substances shall be prescribed by a licensed and registered medical practitioner.
3. No medical practitioner shall prescribe narcotic drugs and psychotropic substances for himself.
4. Narcotic drugs and psychotropic substances shall only be prescribed on a special prescription
paper.
5. The management of and standard that any prescription for narcotic drugs or psychotropic
substances shall fulfill would be set forth in the regulation to be issued pursuant to this
Proclamation
Storage

 Narcotic drugs and psychotropic substances and invoices, registers, and prescriptions shall
be stored in a lockable metal cupboard or in a special room the key of which shall at all
times remain in the hands of the authorized professional.

Disposal

 Any person shall keep damaged, expired, or seized narcotic drugs or psychotropic
substances in a separate place and shall dispose them in accordance with the directive to
be issued by the Authority pursuant to this Proclamation
Cessation of Business

 Any person who is licensed pursuant to this Proclamation and who ceases to operate his
business shall deal with the stocks of narcotic drugs, psychotropic substances, invoices,
other documents, and prescriptions related to same as directed by the Authority

Recording and Reporting

  Any person who is licensed pursuant to this Proclamation shall keep records and send
reports about narcotic drugs or psychotropic substances in accordance with a directive that
shall be issued by the Authority

Drug Abuse Prevention; Poisons Act

 “Poisons” means a substance that may cause damage to man, animal, plant and
environment when taken in small quantity. A poison by its action on tissue organ of the body
can impair function or destroy life.
 Is a law governing poisons in order to ensure their proper handling transportation storage
and use as well as proper record keeping and reporting
o The lists of poisons are usually divided into two parts:
Poisons in part I
 These poisons can be sold only by authorized seller of poisons i.e. from retail pharmacies
or whole sale by or under the supervision of a pharmacist
Poisons in part II
 These poisons can be sold from retail pharmacy or whole sale and other shop keeper who
are listed or authorized by local regulatory authorities

5.5.3. Tort Law

 Tort is a Latin word meaning twisted and refers to conduct that is wrong of twisted
 Most of the torts of pharmacists are
 Act of Negligence
 Violation of law as negligence
 Liability for Negligence

5.5.4. Commercial Law

Self-Check -5 Written Test

Directions: Answer all the questions listed below. Use the Answer sheet provided.
Part I:-Choose the best answer from the given alternatives and encircle your best answer
1. Which one of the following substances is may cause damage to man, animal, plant and environment
when taken in small quantity.
A.
B. Food
C. Poisons
D. Drug
E. Cosmetic
2. Most of the torts of pharmacists are

A. Act of Negligence
B. Violation of law as negligence
C. Liability for Negligence
D. All of the following

3. Which one of the following drug retail out-let run by a regiDrug store
A. Drug shop
B. Community pharmacy
C. Drug vendor
D. Community pharmacist.
Part II:-Instruction Give short answer for the following questions(out of 3%)
4. List out the Prohibited activities by pharmacist/druggist(2pts)
A. _______________________________
B. _______________________________
C. _______________________________
D. _______________________________
5. Write Type of inspection(1pts)
A. _______________________________
B. _______________________________
 6. Laws, regulations and directives pertaining to pharmaceutical

services in Ethiopia

Product registration

 Placing of pharmaceuticals on a market of a country requires a market authorization

which is also called “licensing” or “registration” or “evaluation and registration” from
concerned Pharmacy law executive agency.
 Pharmaceutical evaluation and registration is a process of evaluation the quality, safety
and efficacy of pharmaceutical before and after it is marketed or made available for use.
 The procedure includes an assessment of both pharmaceutical product and of
manufacturing procedures and facilities.
 In comprehensive evaluation and registration system, data on pharmaceutical,
pharmacological, toxicological, therapeutics, clinical and preclinical investigations (for
new drugs) are analyzed.
 The scope and stringency of pharmaceutical evaluation and registration vary from country
to country and also from product to product.
Registration of Pharmaceuticals
 Registration of certificate of pharmaceutical is valid for limited period.
 It has to be renewed every certain year.
  The validity period of certificate of registration varies from three years to five years.
 Re-registration of pharmaceutical is necessary in order to accommodate the change
in quality, safety, efficacy, strength, pack size that might happen in between.

Pharmaceutical marketing and promotion

 It is expressly forbidden for a member of the pharmaceutical profession to use his/her

professional status to promote or endorse or in any other manner support publicly any
product or medicinal or otherwise.
 Members of the pharmaceutical profession must not participate in promotional
methods that encourage patients and society to equate medicines with ordinary items
of commerce
Promotion:
Shall refer to all informational and persuasive activities by manufactures and
distributors the effect of which is to induce the prescription.

The information provided shall be:

 Accurate, fair and good taste and in such a way to conform not only to legal requirement
but also to ethical standards.
 Based on up- to- date evaluation of all the available scientific evidence
 Sufficient to the therapeutic -usefulness of the preparation
 Sample of informational and promotional must be submitted to the authority for approval
prior to any promotional activity.
 Information for advantages of pharmaceutical preparation should be with its
disadvantages
 Exagerated claims must not be made and superlative must not be used
 No commercially interested party, and no person should issue an advertisement without
the consent of pharmacy law executive agency.
 Self-Check -6 Written Test

Directions: Answer all the questions listed below. Use the Answer sheet provided :
Instruction: Choose the best answer from the given alternatives and encircle your best
answer.
1. Re-registration of pharmaceutical is necessary in order to accommodate the change
in________
A. Quality
B. Safety
C. Efficacy
D. Strength
E. All of the above
.Short Answer Questions
2. What is Product registration and Registration of Pharmaceutical

Reference
1. DiMatteo, M.R. (1994). Enhancing patient adherence to medical recommendations.
2. National CRC Manual June 2017 ethiopia
3. Dispensing of Pharmaceuticals-III | ORHB december 2017
4. Beth A. Lown, Julie Rosen and John Marttila. An Agenda For Improving
Compassionate Care: A Survey Shows About Half Of Patients Say Such Care Is
Missing. Health Affairs 30, no.9 (2011):1772-1778.
5. FDRE, Regulation No ,299/2013, Food, Medicine and Health Care Administration and
Control, Council of Ministers Regulation
6. J Med Ethics-2003-Macklin-275-80.pdf
7. J Med Ethics-2008-Molewijk-120-4.pdf
8. Harry Chambers, Harry E. Chambers Effective Communication Skills for Scientific and
Technical Professionals 2000
9. EMA, Code of Ethics for Doctors practicing in Ethiopia, 2009

10. Royal Pharmaceutical Society of Great Britain, Code of Ethics for Pharmacists and
Pharmacy Technicians, Aug, 2007