PHA 3204:Pharmacy

laws and regulations

Diploma in Pharmacy
By: Dr Mangeni Moses H. PharmD, MPS,
PGDME
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 Basic Definitions:
Law:
➢System of rules that govern a particular
country or community and may be enforced
by the imposition of penalties.
3.Regulation:
➢ A rule or order issued by a government
agency and often having the force of law.

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Act:
➢ A bill which has passed through the various
legislative steps required and has become law.
Bye-law:
➢ A law that is made by a local authority and that
applies only to that area.
Rights:
➢ Are legal, social, or ethical principles of freedom or
entitlement
➢ Power, privilege, demand, or claim possessed by a
particular person by virtue of law
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Ethics:
➢Are morals that guide people about what is
good or bad.

➢These are moral values and principles that

govern a person’s behavior in society.

Ordinance:
An executive decision of a government which
has not been subjected to a legislative
assembly.
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Torts:
➢The body of law which allows an injured
person to obtain compensation from the
person who caused the injury.

Felony:
➢A serious crime punishable by a term of
imprisonment of not less than one year or
death penalty.

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 TYPES OF LAWS
1. Criminal Law:
➢ Laws designed to protect the society as a whole from
wrongful actions.
2. Constitutional Law:
➢ The fundamental rules that determine how those who
govern are selected, the procedures by which they
operate, and the limits to their powers.
3. Civil Law:
➢ Law that helps solve problems which occur between
individuals or groups.
4. Statutory Law: Law written by the parliament or
congress
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5.Common Law:(Judge declared Law)
➢ It’s a body of unwritten laws based on legal
precedents established by the courts
6. Administrative Law:
➢ refers to regulations from government agencies.
7. Customary law:
➢ A law consisting of customs that are accepted as legal
requirements or obligatory rules of conduct.
8. Labour law
9. Martial / military law

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 Sources of Law
 The legal system of Uganda is based on law derived
from different sources. These sources include;
➢ Legislation
➢ Delegated Legislation ( statutory laws, Bye-
laws)
➢ Judicial precedents
➢ English Common Law
➢ Customs
➢ African customary law
➢ Ecclesiastical Law or Religion
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 Purposes/functions/relevance of laws
➢Maintains order in society
➢Source of penalties to law breakers
➢Settles conflicts and disputes
➢Promotes the welfare of people in the society
➢Protects the rights of citizens
➢Delivers justice in the community
➢Provide equality

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 Similarities of law & Ethics
➢ They are both an instrument of order in the society
➢ Both are concerned with preventing immoral and
unlawful acts in society
➢ Are both aimed at creating and having a better
society
➢ Both regulate the conduct & behaviour of individuals
in the society
➢ Both create guiding principles for professional groups
such as lawyers, pharmacist, doctors.
➢ Both work in hand to establish moral boundary for all
people in the society
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 Differences of Law VS Ethics

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 Differences of Law VS Ethics

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 Roles of Ethics to pharmacy professionals
 Eases decision making by the professionals
 Also help to assure clients that services offered
by a profession are of quality
 Help to determine the expected level of
performance
 Help to protect the practice of professionals
 Also help to maintain the integrity of a
profession
 Also regulates the behavior of members of a
profession
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Code of ethics / Conduct

➢The Code: is the Society’s core guidance on

the conduct, practice and professional
performance expected of an individual.

➢Code of ethics (ethical code): is a set of

principles and rules designed to promote
ethical conduct on the individual or
organizational level.

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Code of Ethics/conduct for pharmacy
professionals:
1.should be concerned with the welfare of the
patient and the general public.
2. should apply professional competences to
enhance the health of the community and
society
3. should uphold the trust and rights of his/her
patients.
4. should at all times uphold reasonably
accepted standards of behavior.

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 Code of Ethics/conduct for
pharmacy professionals:
5. should maintain a level of competence sufficient
to provide his/her professional services effectively
and efficiently

6. should collaborate with members of other health

professionals to ensure the provision of best
possible quality of health care.

7. should be aware and comply with the

requirements of this code and all relevant
legislations.
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 Key Concepts and Principles of Medical
Ethics/ Ethical Principles
The 4 main principles of Medical Ethics
1. Autonomy
2. Beneficence
3. Non-Maleficence
4. Justice

Others are concepts or Core behavioral norms

1. Confidentiality
2. Privacy
3. Consent
4. Veracity
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5. Fidelity
 1. AUTONOMY

➢ The right of an individual to make decision about

their own life and body without coercion by others.

 For example; an informed, competent adult patient

can refuse or accept treatments, drugs, and surgeries
according to their wishes.

In the principle of autonomy is implied the concept of

a) Consent and b) Confidentiality
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 a) Consent
Consent is a person’s agreement to
receive a professional service or
treatment appropriate for them and
will be based on both their
preferences and values and the
information with which they have
been provided.

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 Valid consent
The consent you obtain must be valid. For consent to
be valid the person must be:
1) Capable of making that particular decision.
2) Acting voluntarily, that is, they must not be
under pressure from anyone to make a
particular decision.
3) Provided with sufficient information to enable
them to make the decision.
4) Capable of using and weighing up the
information provided during the decision-
making process.
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 2. Beneficence
➢Beneficence means doing or promoting
good as well as preventing, removing
and avoiding evil or harm.

E.g. providing information about

emergency first aid to reduce the risks of
HIV infection or accident.

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 3. Non maleficence
➢Non-maleficence refers to non-infliction of
harm to others or doing no harm to a
patient
✓It guards against avoidable harm to subjects.

E.g. Use of sterile needles, Avoiding to give a

patient drugs that they are allergic to

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 4. Justice / Equity
➢It means that everyone is entitled to the
same treatment or treating individuals
fairly.
▪ It encompasses the appropriate distribution of
limited resources; without discrimination, etc

▪ E.g.: You should not discriminate on the basis

of age, sex, religion, color, race, tribe, social
standing, financial situation, profession,…
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5. Veracity
▪ Veracity is the principle of truth telling,
Honesty and accuracy and it is grounded
in respect for persons and the concept of
autonomy.

6. Fidelity/ loyalty
▪ Do as you say you will do PLUS respect
confidentiality

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 Ethical Misconduct/ Professional
Misconduct
1. Over charging on products
2. Disclosure of patient’s information
3. Inappropriate behaviour e.g. drunkenness/
drug abuse.
4. Having a romantic relationship with patients
5. Asking for incentives from patients and
promoters
6. Giving wrong information to patients
7. Disrespecting co-workers
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 Laws and regulations that govern
pharmacy practice in Uganda are;
➢Pharmacy and drugs Act 1970

➢National drug policy and authority Act

1993
➢Allied health professionals Act 1996

➢National medical stores Act 2001

➢Narcotics and Psychotropics Act 2015

➢Penal code Act section 212 on abortion

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Bodies responsible for the control
and regulation of pharmacy
practice and pharmaceutical
services include:
➢National drug authority
➢Pharmaceutical society of Uganda
➢National medical stores
➢Allied health professionals council.
➢Pharmacy board- PDA & AHP Act

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Roles of pharmacy laws and regulations
➢ They establish permitted and prohibited conduct for
pharmacy professionals and pharmaceutical outlets.
➢ Set the criteria that a pharmaceutical outlet must
satisfy to be licensed by a country .
➢ They set the criteria that pharmacy professionals must
meet to be registered/licensed .
➢ They establish the pharmacy professionals’
responsibilities for operating a pharmaceutical outlet &
offering pharmaceutical services.
➢ They establish the requirements for information that
must be on the prescription label, such as the name
and quantity of the prescribed
➢ They also Provide for discipline and penalties for
violations
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Roles of Dispensers in health care .
 Processing of prescriptions
 Monitoring of drug utilization in health
centers
 Making extemporaneous prescriptions
and small scale drug manufacture.
 Providing drug information to other
healthcare professionals.
 Participate in Primary Health Care
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activities
 Roles of Dispensers in health care
 Carrying out health promotion.
 Procure and receive drugs in the
health centers.
 Sale and market drugs
 Ensuring quality assurance of drugs.
 Training of other health care
workers.
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 Process of registration of a Dispenser

➢Successful completion of the course of

Diploma in Pharmacy from an Allied
Health training institution.
➢The applicant then fills up the prescribed
application form issued by the AHPC.
➢After filling the form, one proceeds to pay
the prescribed fee.

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 Process of registration a Dispenser
➢Then submit the filled forms a long with the
following requirements;
▪ 4 recent passport size photographs (Must be
colored with a white background)
▪ Certified Final Academic transcripts/
Certificates of qualification
▪ Photocopy of identity card of school where
one trained from
▪ ‘O’ level and/ or A’ level certificates
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 Process of registration a Dispenser
➢ On submission of required documents, the registrar
shall enter the name of the applicant into the register.
➢ Then the registration number shall be issued to the
applicant.
➢ The registrar shall cause a list of all the pharmacy
Assistants whose names appear in the register to be
published in gazette after three months.
➢ If the council is satisfied that the applicant is of good
character, the registrar shall direct the applicant to
collect the certificate of registration.
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 National Drug Policy and Authority
Act

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 National drug policy and authority act,
1993
 Commenced on 3rd December, 1993
 It establishes the NDP and a NDA; to ensure
the availability at all times, of essential,
efficacious and cost-effective drugs to the
entire population of Uganda, as a means of
providing satisfactory health care and
safeguarding the appropriate use of drugs.

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 National drug authority

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 National drug authority (NDA)
➢It is established by the National drug
authority and policy act, 1993.
➢It is mandated by the law to regulate
products i.e medicines/drugs,
manufacturing Facilities, and Distribution
outlets (Importers, Wholesalers, Retailers)

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 Functions of the National drug authority.
1. Deals with the development and regulation of the
pharmacies and drugs in the country
2. Approves the national list of essential drugs and
supervise the revisions of the list in a manner
provided by the Minister
3. Estimates drug needs to ensure that the needs are
met as economically as possible
4. Controls the importation, exportation and sale of
pharmaceuticals
5. Controls the quality of drugs

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 Functions of the drug authority…
6. Promotes and controls local production of essential
drugs.
7. Encourages research and development of herbal
medicines.
8. Promotes rational use of drugs through appropriate
professional training.
9. Establishes and revises professional guidelines and
disseminates information to health professionals and
the public.
10. Provides advice and guidance to the Minister and
bodies concerned with drugs on the implementation of
the national drug policy
11. Performs any other function that is connected with the
above or that may be accorded to it by law.
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 Composition of National drug authority
The drug authority consists of ;
➢ The chairperson
➢ the director of medical services;
➢ the commissioner for veterinary services;
➢ the commissioner for commissioner for trade;
➢ the director, criminal investigation department;
➢ the chief of medical services, Ministry of Defense;
➢ the chief of pharmaceuticals and health supplies;
➢ the head of the Natural Chemotherapeutics
Laboratory;
➢ the director, Mulago Hospital;

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 Composition of National drug authority…..
A representative of each of the following;
 the National Medical Stores
 the Uganda Medical Association
 the Pharmaceutical Society of Uganda
 the Uganda Veterinary Association
 the head of the School of Pharmacy, Makerere University;
 the Uganda herbalists; (vii)
 the Uganda Dental Association
 the Joint Medical Stores
 the director general of the Uganda AIDS Commission
 two other persons appointed from the public
The chairperson and the members appointed from the public
are appointed by the Minister. The members appointed in
office serve for three years but are eligible for
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reappointment.
 THE NATIONAL DRUG AUTHORITY COMMISSION
➢One of the bodies of the NDA is the
National Drug Authority Commission
➢It consists of the chairperson and four
other members appointed by NDA from
among them.
➢The chairperson of NDA is the chairperson of
the commission.

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 The functions of the NDA
commission
 to exercise the functions of the drug authority which
may require exercising when the drug authority is
not sitting
 to monitor and supervise the implementation of the
decisions of the drug authority
 to establish and revise from time to time, the
working procedure of the drug authority
 To perform any other function relating to the
functions of the drug authority as the authority may
direct.
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 COMMITTEES OF THE NATIONAL DRUG
AUTHORITY
 The committee on essential drugs
 The committee on the national formulary.

The membership of the committee on essential

drugs is as follows—
 a chairperson appointed by the NDA
 the commissioner of curative services of the Ministry of
Health;
 the chief of pharmaceuticals and health supplies
 the chief of medical services, Ministry of Defense
 the head of the School of Pharmacy
 a member from the Private Medical Practitioners
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Association;
The membership of the committee on
essential drugs is as follows -
 A non–government organization pharmacist
from the Joint Medical Stores.
 A representative of each of the following
specialties—
➢physician;
➢pediatrician;
➢gynecologist/obstetrician
➢surgeon;
➢psychiatrist
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The membership of the committee on the
national formulary includes ;
 a chairperson appointed by the drug authority on
the recommendation of the appropriate professional
bodies;
 a member of the faculty of medicine of the
universities in Uganda;
 a member of the faculty of veterinary sciences;
 a member from the School of Pharmacy;
 a member from the Pharmaceutical Society of
Uganda;
 a member from the Private Medical Practitioners
Association;
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 The membership of the committee on
the national formulary includes ;-------
 a member from the Uganda Medical
Association;
 the executive director of the National
Bureau of Standards;
a representative of each of the
following specialties such ;
 physician;
 surgeon,
 pediatrician,
 gynecologist/obstetrician and
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 The following categories of people may
apply for Drug registration/ Drug
promotion
➢The patent holder
➢The drug manufacturer
➢The licensed person
➢Any person selected / appointed by the
Patent holder
➢Any person appointed/ selected by the
manufacturer
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Directorates of the NDA
The national drug authority is made up of five
directorates each with its own roles, namely;
1. Directorate of inspectorate and
enforcement services
2. Directorate of product assessment and
registration
3. Directorate of product safety
4. Directorate of corporate services
5. Directorate of laboratory services
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 Directorate of Inspectorate &
Enforcement Services
Key Activities/ Roles
➢Inspections of manufacturing facilities
➢Inspection and licensing of pharmaceutical
Premises
➢Support supervision
➢Compliance verifications and investigations
(including recalls and public advisories)
➢Control imports of medicines &healthcare
products in collaboration with the Uganda
Revenue Authority (URA)
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 Directorate of product safety
Key Activities/ Roles
➢Pharmacovigilance
➢Regulation of pharmaceutical promotional
materials
➢Provision of medicine information to the
public.
➢Monitoring drug related aspects of Clinical
trials
➢Sensitization of herbalists
➢Conducting research.
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 Directorate of product assessment and
registration
Key Activities/ Roles
➢ Evaluation of drug registration applications
➢ Handling of post-registration amendments to drug
applications
➢ Archiving information on drug products (new
applications, registered and suspended/de-registered)
➢ Preparation and regular update of the National Drug
Register
➢ Assesses dossiers prior to issuing marketing
authorization in Uganda.
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 Directorate of laboratory services
Key Activities/ roles:
 Conducting quality assessment through
laboratory analysis of medicines (human and
veterinary), medical devices, surgical
instruments.
 Field testing of regulated products using
screening techniques.
 Generating scientific evidence and reports on
the quality and safety status of the regulated
products in order to inform and facilitate
regulatory decision making.
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 Directorate of laboratory
services
Key Activities/ roles:
 Providing technical support to local
manufacturers and building their capacity in
matters pertaining to quality control of
regulated products through on site and off site
training and laboratory assessments.
 Conducting investigations into the quality and
safety status of regulated products for
purposes of pursing legal or regulatory action.
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 Licensing Class C Drug shops.
➢ The following individuals (in-charge) can be
licensed to operate Class C Human drug shops
 Dispenser/ Pharmacy Technician

 Enrolled Nurse

 Registered Nurse

 Comprehensive Nurse

 Enrolled midwife

 Registered midwife

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 Procedure for opening a Human Drug shop business
 Identify the location and premise where to locate
the business.
 Approach DHO’s office or nearest NDA regional
office
 Fill pre-inspection request form as directed (Forms
are free).
 NDA team will schedule and carry out inspection as
per guidelines and provide formal feedback (
inspection is free).
 If feedback positive , fill license application forms
and pay required fees to the bank
 Submit complete application form to DHO’s office or
NDA regional office consisting of the following;
1.Duly filled in application form for certificate of
suitability of premises.
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2.Duly filled in application form for license to
operate a drug shop.
3.Proof of payment of prescribed fees.
4. A certified copy of certificate of qualification/
enrollment of full-time in-charge.
5. A letter of commitment from the full-time in-
charge
6. A sketch plan of the premises for a
Drugshop.
7. Two recent colored clear passport size
photographs of the full time in-charge
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8. A copy of in-charge’s national identity card
9. A copy of TIN certificate issued by URA
indicating the Drug shop as a registered
business with URA.
10. A copy of the National ID of the owner
 Instill good dispensing practices e.g shelves,
reference books
 Issuing of the operating License by NDA

 Stock the premise and start operations

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 Procedure for opening a pharmacy
business
 Identify the location and premise where to locate the
business.
 Approach the nearest NDA regional office
 Fill pre-inspection request form as directed.
 NDA team will schedule and carry out inspection as per
guidelines and provide formal feedback ( inspection is
free).
 If feedback positive , fill license application forms . This
is done online via NDA – management information system
by the supervising pharmacist.

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▪ Submit a complete application accompanied by the
following attachments;
1.Cetificate of incorporation of the company
2.Company Form 20 which shows that one of the
directors is a pharmacist
3.A copy of memorandum and Articles of Association of
the company
4. A sketch plan of the premises.
5.Certificate of registration of the supervising pharmacist
6.PSU Annual membership certificate of the pharmacist.
7.Commitment letter of the pharmacist
8.Certificate of registration/ enrollment of Auxiliary staff

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 9.Commitment letter of the Auxiliary staff
10.TIN certificate of the company opening up the
pharmacy.
 The application is then submitted
 The application is then reviewed by the NDA.
 Upon satisfaction , an invoice is sent by NDA via
NDAMIS, which can be downloaded by the pharmacist.
 Make payment in the Bank.
 Instill good dispensing practices e.g shelves, reference
books, etc
 NDA will schedule for re-inspection and the
notification is received online.
 The inspecting NDA officer will generate a report after
inspection, which approves the premises for Licensure.
 License is then issued by NDA
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 Classification of Drugs
 Classified drug
Means a class A, B, or C drug.
 Restricted drug
Means a classified drug or any other drug
which is not an exempted drug.
 Exempted drug
Means a drug in the fourth schedule of the
NDP & A

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 Schedules of the NDP/A act, 1993
1. First Schedule; Class A drugs or narcotics.
2. Second Schedule; Class B drugs or controlled drugs.
3. Third Schedule; Class C licensed drugs.
4. Fourth Schedule; Exempted drugs and articles.
5. Fifth Schedule; Diseases as to which publication of
descriptive matter is restricted or prohibited.
6. Sixth Schedule; Preparations that may be
manufactured by, or under the supervision of, a duly
qualified medical practitioner.
7. Seventh Schedule; Requirements as to the storage of
classified drugs.
8. Eighth Schedule; Consignment and transportation of
classified drugs.
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 First schedule
 Also called Class A drugs or narcotics
➢They may be sold by retail only on the
prescription of a duly qualified medical
practitioner, dentist or veterinary surgeon, but
only for medical, dental or veterinary purposes
and may be supplied only by a registered
pharmacist or licensed pharmacy.
 They include; Cocaine, Codeine, Heroin,
Opium, Pethidine, Morphine, Fentanyl, etc.

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 Second Schedule
 Also called Class B drugs or controlled
drugs
➢These drugs may be supplied by retail only
on the prescription of a duly qualified medical
practitioner, dentist or veterinary surgeon,
but only for medical, dental or animal
treatment respectively.
 They include: majority of antibiotics,
antineoplastic agents, barbiturates, CNS
drugs, antihypertensive agents, steroid
drugs, antidiabetic drugs, phenothiazines,
65 antiarrhythmic drugs, etc.
 Third Schedule
 Also Class C or licensed drugs.

➢They may be sold by retail only by a person

or company operating a licensed pharmacy
or a licensed drug seller, but in the case of
the latter, only in accordance with the terms
of his or her license.
Examples include: Ibuprofen, Diclofenac,
paracetamol, Antibiotics in animal feeds,
Antihistamines in external preparations,
etc
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 Fourth Schedule
 This List Exempted drugs and articles.

 They include: Adhesives, Dentifrices,

Distempers, Dressings on seeds or bulbs,
Electrical valves, Fluorescent lamps,
Formaldehyde, Glazes, Glue, Inks, Lacquer
solvents, Medicated soap, Nitrobenzene,
when contained in polishes, etc.

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 Fifth schedule
 It Lists diseases as to which publication
of descriptive matter is restricted or
prohibited.
 These diseases include: gonorrhea,
syphilis, cancer, hernia, goiter, etc.

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 Sixth Schedule
 It lists Preparations that may be
manufactured by, or under the
supervision of, a duly qualified
medical practitioner.
 These include: preparations containing
extracts of pituitary, suprarenal,
thyroid, liver, pancreas or
parathyroid glands, or stomach.
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 Seventh Schedule
 It lists Requirements for the storage of
classified drugs.
 The drugs should be kept in a place accessible only
to the person in charge of the drugs, or to some
person under his or her immediate supervision.
 All class A drugs and preparations should be stored
in an immovable $ lockable place/locker.
 Class A, class B and class C drugs should be kept in
a part to which the general public does not normally
have access.
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 Eighth Schedule
❖Describes Consignment and transportation of
classified drugs.
 Outside package of classified drugs should be
labelled conspicuously with the name or description
of the drug and a notice indicating that it is to be
kept separate from food and from empty food
containers.
 Classified drugs should be prevented from
contaminating foods if transported in the same
vehicle.

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 The Allied Health Professionals Act.

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 The Allied Health Professionals Act.
 Chapter 268 of the constitution

 Commenced on 17 May, 1996.

 It is an Act to provide for the regulation,

supervision and control of the allied health
professionals, and to provide for the
establishment of a council to register and
license the allied health professionals and for
other connected matters.
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 The functions of the AHPC
1. Regulates the standards of allied health professionals
in the country.
2. Regulates the conduct of allied health professionals
and exercises disciplinary control over them.
3. Approves courses of study for allied health
professionals.
4. Supervises and regulates the training institutes for the
different categories of allied health professionals.
5. Approves the qualifications awarded by the different
institutes in respect of the different categories of the
allied health professionals.

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 The functions of AHPC………..
6. Supervises the registration of allied health professionals
and the publication of the names of registered allied
health professionals in the Gazette.
7. Advises and makes recommendations to the
Government on matters relating to the allied health
professions.
8. Exercises general supervision and control over the
allied health professions and performs any other
function relating to those professions or incidental to
their practice.
9. Performs any other functions conferred upon it under
the Act or referred to it from time to time.
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 Composition of the AHPC
1. a chairperson who should be a senior allied health professional
appointed by the Minister.
2. a representative of the director general of the health
services.
3. the assistant commissioner of health services responsible
for allied health professionals.
4. one person representing each of the following professions
i) Dentistry ii) Pharmacy
iii) Clinical medicine iv) Physiotherapy
v) Public health vi) Radiography
vii) Medical laboratory technology viii) Orthopaedic
technology
5. a representative of the Medical and Dental Practitioners
Council;
6. a representative of the Nurses and Midwives Council;
7. one representative of all faculties of medicine of all
universities established in Uganda by law
8.
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a representative of the National Drug Authority.
 Advisory boards of AHPC
❖ They include;
 A pharmacy board, catering for dispensers;
 A dentistry board catering for public health
dental officers and dental technologists.
 A medical clinical officers board, catering for
medical clinical officers, anesthetic clinical officers,
ophthalmic clinical officers and psychiatric clinical
officers.
 A medical laboratory technology board,
catering for laboratory technologists and laboratory
technicians.
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 Advisory boards of AHPC……
 An orthopedic technology board, catering
for orthopedic clinical officers and orthopedic
technicians.
 A physiotherapy board, catering for
physiotherapists and occupational therapists.
 A public health board, catering for health
inspectors, health assistants and assistant
field officers for entomology.
 A radiography board, catering for
radiographers.
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Functions of the registrar.
The registrar shall be the chief executive officer of the AHPC
and the head of the secretariat and as such shall;
(a) keep and maintain the registers of the allied health
professionals
(b) make necessary alterations and corrections in the
registers in relation to any entry as may be directed by
AHPC from time to time
(c) remove from the register;
➢ the name of any person ordered to be removed under AHP
Act.
➢ the name of a deceased professional.
➢ any entry which may have been incorrectly or fraudulently
made in the register.
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 Functions of the registrar
(d) reinstate a name removed from the
register for a specified period and at the
request of the person concerned, after
payment of the prescribed fee;
(e) inspect and have full access, on behalf of
the council, to all allied health units licensed
under AHP Act;
(f) implement the decisions of the council;
(g) perform any other duty or function that
may be required AHPC
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 Removal from the register
 The council may, after inquiry, cause to be
removed from the register the name of any
person;
➢who is convicted by a court of law of a
criminal offence involving moral turpitude
➢who is found guilty of professional
misconduct by the council
➢who is suspended from practice.
➢Who is deceased.

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 Establishing Suitability of Premises
and Locations

PHA-3204

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 Types of pharmaceutical premises
1. Premises for pharmaceutical
manufacturing
2. Premises for wholesale pharmacy
3. Premises for retail pharmacy
4. Premises for sale of class C drugs

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 Criteria for choosing a location for a
pharmaceutical premise
 Type of pharmaceutical premise to be set up.
 Availability of raw materials or supplies
 Proximity to target market
 Supply of labour
 Transportation networks
 Local regulations(NDA and NEMA regulations)
 Environmental impact, waste disposal and safety
requirements
 Future plans (is there a possibility for expansion?)
 Capital
 Competition
 Cost of utilities
84 security
 Characteristics of a good pharmaceutical
premise
 The Pharmaceutical premise should have adequate
space to ensure proper storage and better work climate
 The layout and fittings in respect of the storage of
medicinal products must facilitate their appropriate
storage and supervision of their sale or supply
 Adequate heating, lighting and ventilation/air
conditioning should be provided to ensure the correct
storage and safe dispensing of medicinal products
within the pharmacy.
 A suitable waiting area with seating option should be
provided for patients, giving consideration to the privacy
of others.
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 Characteristics of a good pharmaceutical
premise……………..
 Pharmacies should have a separate, designated,
conveniently located patient consultation area to ensure
privacy.
 All floors within the registered premises should be
undamaged, intact and with an even surface
 It must be easily identifiable as a healthcare facility and
must reflect the professional nature of the premise.
 Any signage used on the exterior of the pharmacy must
be clear, legible and not misleading
 Must be secure

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 Importance of having a suitable
location for a pharmaceutical premise
 A suitable location of a Pharmaceutical
premises ensure low operating and capital
costs
 Clients can easily access the premise
 Increase of profits for pharmaceutical
enterprise.
 Creates a good relationship with the clients
 A suitable pharmaceutical enterprise can
motivate the employees to work better to
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achieve better outcomes
 Importance of having a suitable
pharmaceutical premise ………
 There is reduction in length of hauls and motions
between operations, which minimize production
time as well as the activities of workers.
 Ensure more labor productivity
 There is more safety and security to workers
from accidents.
 Better working conditions resulting in improved
efficiency
 Can act as form of advertising for the medical
drugs
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 Premises for pharmaceutical
manufacturing

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 Premises for pharmaceutical
manufacturing
 Definition:
➢These are premises that deal in the
production of pharmaceutical products
on large scale.

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 Premises for pharmaceutical manufacturing:
Legal Requirements
❖Premises should be located in a place where
they can not be contaminated from the
external environment.
❖Premises should be of a permanent nature;

❖Premises should they have sufficient space

for the carrying out and supervision of the
necessary operations;

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 Premises for pharmaceutical manufacturing:
Legal Requirements
❖Premises to be in good repair and decoration.

❖Manufacturing and processing areas to be

separate.
❖Premises to be clean and tidy.

❖Regular water supply.

❖Materials to be protected against light.

❖Unprocessed ingredients to be stored

separately from finished products
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 Premises for a wholesale pharmacy

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 Premises for a wholesale pharmacy
 Definition:
➢These are premises that deal in the
sale of all classified drugs and other
pharmaceutical products to retail
outlets in large quantities

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 Premises for a wholesale
pharmacy: Legal Requirements
❖Premises should be of a permanent nature;
❖Premises should have sufficient space for the
carrying out and supervision of the necessary
operations;
❖Premises should have floors and walls made of a
washable and impervious material.
❖The dispensary must be a separate lockable area
with no access to the public
❖There should be a separate office or
administrative area for the pharmacist
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 Premises for wholesale pharmacy:
Legal Requirements
❖Premises should have at least one toilet not
shared with any other premises;
❖Pharmacy-only drugs should be separated from OTC
drugs;
❖Narcotic and psychotropic drugs should be kept in a
secure, fixed and lockable storage place.
❖The minimum floor area shall be at least 41 square
metres
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 Premises for a retail
pharmacy

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 Premises for a retail pharmacy
 Definition:
➢These are premises that deal in the
sale of classified drugs and other
pharmaceutical products to final
consumers in small quantities

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 Premises for a retail pharmacy –legal
Requirements
❖Premises should be of a permanent nature;
❖Premises should have sufficient space for the
carrying out and supervision of the necessary
operations;
❖Premises should have floors and walls made of a
washable and impervious material.
❖The dispensary must be a separate lockable area
with no access to the public
❖There should be a separate office or
administrative area for the pharmacist
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 Premises for a retail pharmacy:
Legal Requirements
❖Premises to be in good repair and
decoration.
❖All materials and finished products should
be protected from light, heat and moisture,
❖Premises should have at least one toilet not
shared with any other premises;

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 Premises for a retail pharmacy…..
❖Premises should have at least one toilet
not shared with any other premises;
❖Pharmacy-only drugs should be separated
from OTC drugs;
❖Narcotic and psychotropic drugs should be
kept in a secure, fixed and lockable
storage place.
❖The minimum floor area shall be at least 20
square metres
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 Premises for sale of class C drugs

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 Premises for sale of class C drugs
 Definition:
➢These are premises that deal in the
sale of only class C drugs to final
consumers in small quantities

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 Premises for sale of class C drugs:
Legal Requirements
❖Premises should be located in a place where they
cannot be contaminated from the external
environment.
❖Premises should have floors and walls made of a
washable and impervious material
❖Premises to be in good repair and decoration.
❖The minimum floor area shall be at least 20
square metres
❖
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 Premises for sale of class C drugs:
Legal Requirements……………..
❖Premises shall be of a permanent nature with
direct access to the public.
❖Premises shall not be shared with similar business.

❖Drugs shall be adequately protected against light,

heat and moisture.

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 Advertising new products / promotion
 Drug promotion: refers to all informational and
persuasive activities by manufacturers and distributers
of drugs to induce the prescription, supply, purchase
and use of medicinal drugs. Its intent is to create
awareness among health professionals.

Characteristic of drug promotion material

 Should not be misleading
 Should be reliable
 Should be accurate
 Should also be up to date
 Should be truthful
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NDA guidelines or regulations on drug
promotion
 Should be consistent with FDA approved
information
 Information should be truthful and non-
misleading
 Information should have a balance of benefit
and risks associated with the product.
 Medical representatives should be qualified
and well trained personnel
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 The following categories of people may
apply for Drug advertising/ Drug
promotion
➢The patent holder of drug
➢The drug manufacturer of drug
➢The licensed person
➢Any person selected or appointed by
the Patent holder or manufacturer of
drug

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 Advertising new products
Type of information that such advertisements should usually
contain, among others:
 The name(s) of the active ingredient(s) using either
international nonproprietary names (INN),
 The brand name;
 Content of active ingredient(s),
 Approved therapeutic uses;
 Dosage form or regimen;
 Side-effects and major adverse drug reactions;
 Precautions,
 Contra-indications and warnings;
 Major interactions;
 Name and address of manufacturer or distributor;
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 END

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