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This law is "THE LAW" that regulates pharmacy profession and practice.
The law is old and there are discussions now to change it. Changing
should improve some items that are now non-applicable. There are some
items that are subject to lengthy debates; like owning chain pharmacies
and the distance between two pharmacies etc.. There are some new
decrees and court decisions that modify some of the items. These will be
discussed later.
Content
Toxic substances that should be
kept and locked in a separate locker
with the sign of toxics drawn on it.
Examples: arsenic, mercuric and
cyanides.
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WHO etc..)
Other laws that encounter the pharmacist in various fields:
2-Ethical Principles
Pharmacists by virtue of their roles have special responsibilities for
ethical conduct and ethical practices that go beyond meeting minimum
legal and regulatory standards. The newly graduated pharmacist has to
take an oath before the syndicate representative in order to be
acknowledged as a pharmacy syndicate member. The oath is derived in
part from the "Hippocratic Oath" which is an oath traditionally taken by
physicians pertaining to the ethical practice of medicine. It is widely
believed that the oath was written by Hippocrates, the father of medicine,
in the 4th century BC.
The ethical principles can be summarized as follows:
Respect for persons : privacy and patient rights
Act with honesty and integrity
Conscience before profit
Non- maleficence (Avoiding Harm)
Beneficence (Doing Good)
Promote caring, compassion, confidence.
Respect for colleagues: physicians and pharmacists
Justice (Fairness)
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4-Pharmaceutical Establishments
What are the pharmaceutical establishments according to Chapter 2 in
the Egyptian 127/1955 law?
1. Public pharmacies
2. Special pharmacies
3. Manufacturing factories for various pharmaceutical products :
pharmaceutical medicinal products, cosmetics, medical devices and
disposables, and veterinary medical products
4. Pharmaceutical products' warehouses
5. Medicinal plants stores
time period of the previous one); then if the full requirements are
not finally met the application will be dismissed and cancelled.
or
any
other
manufacturing
establishment.
non-pharmaceutical
pharmaceutical
establishment
can
only
sell
registered
pharmaceutical products.
12. All products in the pharmaceutical establishment must be stored
according to the established storage conditions.
13. The MoH must be notified 2 weeks in advance before selling a
pharmaceutical establishment. The new owner must be a licensed
pharmacist.
have
the
"Good
Storage
Practice"
(GSP)
requirements as follows:
Keep the optimum temperature and humidity suitable
for storing pharmaceutical products.
Installing a thermometer in a clearly seen place to
measure and monitor the temperature of the pharmacy
during the day. The temperature readings should be
recorded in a written form for different intervals. The
temperature should not exceed 30 C at any time.
Having a refrigerator with a freezer; for storing
pharmaceutical products that require low temperature
(2-8 C). The refrigerator should be provided with a
thermometer to measure and monitor the temperature
inside the refrigerator; the measured temperatures
should be recorded in a written form.
Providing
suitable
psychotropic drugs.
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locked
cabinet
to
store
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B- Special Pharmacies
Special pharmacies are two types:
1. Pharmacies in hospitals or clinics: if the capacity of the hospital is
more than 100 beds, the pharmacy serves the patients of the
hospital. This kind of pharmacies is subject to the law 127/1955
like any other public pharmacy.
2. Pharmacies included in a Co-op Organization. This kind of
pharmacies is licensed according to a request from the CEO (chief
executive officer) of the organization. Again; this kind of
pharmacies is subject to the law 127/1955 like any other public
pharmacy.
6- Pharmaceutical Products Warehouses
MoH grants licenses for warehouses.
Warehouses are allowed to sell in large scale only to pharmacies
and not to the public.
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products
warehouses,
pharmaceutical
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What Is cGMP?
GMP refers to the Good Manufacturing Practice Regulations promulgated
by the US Food and Drug Administration (FDA). These regulations,
which have the force of law, require that manufacturers, processors, and
packagers of drugs, medical devices, some food, and blood take proactive
steps to ensure that their products are safe, pure, and effective. GMP
regulations require a quality approach to manufacturing, enabling
companies to minimize or eliminate instances of contamination, mixups,
and errors. This in turn, protects the consumer from purchasing a product
which is not effective or even dangerous. Failure of firms to comply with
GMP regulations can result in very serious consequences including recall,
seizure, fines, and jail time.
GMP regulations address issues including recordkeeping, personnel
qualifications, sanitation, cleanliness, equipment verification, process
validation, and complaint handling. Most GMP requirements are very
general and open-ended, allowing each manufacturer to decide
individually how to best implement the necessary controls. This provides
much flexibility, but also requires that the manufacturer interpret the
requirements in a manner which makes sense for each individual
business.
GMP is also sometimes referred to as "cGMP". The "c" stands for
"current," reminding manufacturers that they must employ technologies
and systems which are up-to-date in order to comply with the regulation.
Systems and equipment used to prevent contamination, mixups, and
errors, which may have been "top-of-the-line" 20 years ago, may be less
than adequate by today's standards.
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Licensing Procedure:
The company presents a request file to license the pharmaceutical
manufacturing plant to CAPAs "General Administration of Licensing
and Mandatory Pharmacy Service", including the approvals and data
outlined in the following list :
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activity
formulated
in
dosage
form
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2- Pricing of generics: The price given is based on the price of the innovator in
Egypt by the following rules:
A- The price will be 30% lower for pharmaceutical products registered by
companies owning licensed pharmaceutical factories that has acquired
one of the following certificates: European EMEA, US FDA,
Australian TGA, Japanese MHLW or certified by WHOPrequalification or being a member of ICH.
B- The price will be 40% lower for pharmaceutical products registered by
companies owning licensed pharmaceutical factories.
C- The price will be 60% lower for pharmaceutical products registered by
companies not owning a pharmaceutical factory and manufacturing the
product by toll (contract) manufacture at other licensed pharmaceutical
factories.
3- For generics of an innovator that has been priced prior to this decree; the same
rules are applied provided that the granted price is not higher than any other
generic already priced in Egypt.
IV- The High Technical Committee will issue a conditioned approval for
registration of the pharmaceutical product. The High Technical
Committee will issue a marketing authorization and a registration number
after the following steps:
1-The company should manufacture three batches (lots) of the product
and within two years of the conditioned approval. Inspectors from the
General Administration for Inspection (one of CAPAs administrations)
will witness the actual production in the factory and take take random
samples from these three batches and send them to the National
Organization for Drug Control & Research (NODCAR). The company
will submit to NODCAR a file with the following documents:
a- specifications of the finished product
b- analytical certificate of the finished product
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Bioavailability study.
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necessary
for
their
inspection
duties.
The
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Table 1:
Most potent group.
Given to the patient only if he/she has special narcotic prescription
with the medical union stamps on it.
This prescription must have full patients information: name, ID
number and address.
The prescription expires in 5 days.
Any corrections in the prescription void it.
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The written prescription is taken from the patient and kept in the
pharmacy as a record.
The prescription and the product taken are documented in a special
narcotic notebook in the pharmacy.
This table includes the following Examples:
Morphine and derivatives
Dihyrocodeine
Codeine
Amphepramone
Butorphanol
Ketamine
Phenobarbitone sodium 60 mg or more
Dextromethorphane > 10mg/dose
Table 2
This group can be prescribed for maximum one month needs
One prescription can contain maximum two of these products.
The prescription is stamped with the pharmacy stamp to prevent
the patient from repeated buying.
Examples from this table
Benzodiazepines derivatives e.g diazepam
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Paracodeine
Tramadol
Table 3:
Felony
Practicing
pharmacy
without
license, obtaining a license by
forgery or by borrowing a
pharmacist's name and documents.
Pharmacist allowing to use his
name for non pharmacist to practice
pharmacy profession.
Advertising for being a pharmacist
without license.
Opening
a
pharmaceutical
establishment without license
Punishment
Jail for two years or less + fine of
200 pounds or less or one the two
Jail for two years or less + fine of
200 pounds or less or one the two
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The product is applied for patent in the Patent Registration Officeat The Academy of Scientific Research and Technology, which is
the Egyptian site for registering new invention.
The owner of the product cannot apply later than one year from
the first publication about the product.
Innovators cannot apply for new use of an old molecule.
The product was applied after January 1st 1995.
The product is already patented or applied for a patent in the
country of origin after 1/1/95.
The product is marketed as a medicine in the country of origin
after 1/1/95.
The product is registered and priced in Egypt by the MoH
registration procedure as mentioned previously.
Syndicates Laws
Law Number 47 /1969
Law of Establishing the Egyptian Pharmacists Syndicate
The Egyptian Pharmacists Syndicate (EPS) was established 1969 by this
law; the main goals and conditions of establishing a Pharmacists
syndicate are:
The EPS headquarter is located in Cairo with branches in all other
governorates.
The EPS aims to promote high standards of the pharmacy
profession and elevate the scientific and professional levels of the
pharmacists.
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be
useful
for
national
planning
and
estimating
education
for
pharmacists
and
pharmaceutical
professional training,
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reputation and avoid any act that might dishonor the pharmacy
profession.
EPS members should treat patients and public with care and
dignity.
When a pharmacist discovers scientific error in a physician's
prescription; he/she should not dispense it. The pharmacist should
make an effort to contact the physician to correct the error.
The pharmacist must guard the secrets he/she knows by virtue of
his profession unless a legal necessity demands revealing a secret.
Pharmacy owners are obliged to sell medicaments with the MOH
forced pricing (no reductions or increases).
Pharmacy owners are not allowed to make contracts to supply
companies with medicaments offering special price rates or any
kind of reductions.
EPS members are not allowed to make any deals with physicians
i.e. agreeing with certain physician to direct his patients to a certain
public pharmacy or writing the prescription in codes etc..
When EPS member has to take legal action against another EPS
member due to a pharmacy profession matter; the issue must be
first submitted to the EPS board members to resolve it; before
taking the matters to the official legal system.
EPS members have to pay annual fees to the EPS funds
department. The fees should be paid before December each year.
The income of EPS that it gets from the members is divided as
follows:
o 15 % for EPS expenses and scientific activities.
o 10% for EPS branches.
o 70% for pensions and assisting needy EPS members.
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o 5% for HR expenses.
EPS members have to pay fees of the Pharmacists Club.
EPS Board
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EPS Board
Formed of:
Head of Syndicate- EPS member for more than 15 years. The head
is elected for a period of four years; it is not allowed to elect the
same head of syndicate twice.
24 members (must be eligible EPS members) elected for a period
of four years divided into:
o 6 elected from all over ARE that are EPS members for more
than 15 years.
o 6 elected from all over ARE that are EPS members for less
than 15 years.
o 6 elected members EPS members for more than 15 years.one representing each of the following six regions:
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General Assembly
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Also, the family (wife, sons or daughters) of the union's member can
benefit from the pension in cases of death.
Support Money:
Given in following cases:
Medical treatment
Exceptional support in some cases.
As a help in child birth for female union's members.
In case of the death of the member.
As loans for union's members serving in the mandatory military
service.
Good Luck
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