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1- Introduction

What are pharmacy laws for?


To protect the public health. The World Health Organization defines of
health as a state of complete physical, mental, and social well-being, and
not merely the absence of disease or infirmity.
Why do you learn Pharmacy Regulations?

In your career you'll come across situations where you should


understand the legal responsibilities and the rights of a pharmacist; for
example
1.
2.
3.
4.
5.

Working in a private pharmacy.


Starting and owning a private pharmacy.
Working in various departments of the MoH.
Working in a pharmaceutical factory.
Working as registration officer in a pharmaceutical company or a
scientific office
6. Making research and inventing new drugs.
7. Working in pharmaceutical marketing.
What is the main law regulating pharmacy practice in Egypt?

The Law of Practicing Pharmacy no. 127/1955


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.

The law 127/1955 has as Annex a number of tables as follows:


Number of Table

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.

Prescription products- products that


should not be dispensed without
prescription.
This is a limited list that was
suitable for 1955; it cannot be used
as a reference nowadays. The
pharmacist now can depend on the
insert leaflet, when it states: To be
dispensed only with a physician's
prescription
Narcotics- these should be kept in a
separate locker with the word
"Narcotics" written on it.
List of pharmaceutical products that
a licensed midwife can prescribe
and the pharmacist can dispense
with her prescription.
List of simple chemical products
that can be sold outside the
pharmacies.
Flammables,
explosives
and
dangerous chemicals and the
maximum amounts of each allowed
to be in a pharmacy.
List of simple medicinal plants that
can be sold outside the pharmacy.
List of products with specific
decrees from the Minister of
Health; according to specific cases
or updates from internationally
recognized organizations (FDA,

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4

5
6

7
8

WHO etc..)
Other laws that encounter the pharmacist in various fields:

Law of Establishing the Pharmacy Syndicate no. 47/1969


Law of Proprietary Rights no 82/2002


( Derived from TRIPs Trade-Related Aspects of Intellectual Proprietary


Rights)
What are the pharmaceutical regulatory bodies in Egypt that you as a
pharmacist- are expected to deal with?
Egyptian Pharmacists Syndicate (EPS) (http://www.eps-egypt.net).

Ministry of Health and Population (MoH) (http://www.mohp.gov.eg/)

Egyptian Drug Authority (EDA)
http://www.eda.mohealth.gov.eg// including:

Central Administration for Pharmaceutical Affairs (CAPA).



CAPA is a regulatory body includes the following departments:
1-Licensing 2-Registration 3-Importation & Exportation 4- Inspection
and Control
National Organization for Drug Control & Research (NODCAR)

It represents the empowered National Quality Control authority for
marketed locally manufactured and imported pharmaceutical products.

National Organization For Research & Control of Biologicals


(NORCB)

Its role is to ensure the safety, quality and efficacy of all imported and
domestic biologicals in compliance with WHO requirements and the
international organization for standardization known as National
Regulatory Authority (NRA) of biologicals.
Local Medical Districts

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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Achieve this by maintaining professional competence

3-Practice of Pharmacy Profession


Chapter 1 of the 127/1955 law deals with the practice of pharmacy
profession. The main points to be recognized in this aspect are:
Conditions for practicing of pharmacy profession:
1. An Egyptian pharmacist registered in both the MoH and the
Pharmacy Syndicate records.
2. A foreigner pharmacist from a country that allows by law
Egyptians to practice pharmacy profession at his/her country.
3. A pharmacist must have a bachelor of pharmacy from an Egyptian
university or from a foreign university provided that he/she passes
the official recognition exam by a pharmacists committee assigned
by the Minister of Health.

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

General conditions for licensing a pharmaceutical establishment:


MoH is the only licensing authority.
For each pharmaceutical establishment there are certain
requirements that must be fulfilled. These requirements are
explained by the law and certain ministerial decrees.
The license is personal, so changing the licensed person
demands applying to MoH
General steps for licensing a pharmaceutical establishment:
1. An application form (available at MoH), is filled by the applicant.
2. This application form is sent by registered post with return
acknowledgment slip of receipt.
3. With the application, the following documents must be included:
Original birth certificate (or original copy).
Copy of ID
Architectural drawing of the establishment.
Proof of payment of inspection fees
4. When the application and the accompanying documents are
complete, a proof of receipt is given to the applicant in which a
serial number is recorded and the date of application.
5. The architectural blueprint is inspected within 30 days by the
health authority.
6. Inspection of location to verify the requirements will be done by
the corresponding inspector.
7. The license will be issued within 30 days if all requirements are
met.
8. Otherwise; a time-limit is given to complete any missing
requirements. A second and last time-limit can be given (half the

time period of the previous one); then if the full requirements are
not finally met the application will be dismissed and cancelled.

Cancellation of a pharmaceutical establishment license:


A license will be cancelled in any one of the following cases:
1. Continuous closure of the establishment for more than one year.
2. Moving the establishment to another location. Exceptions: fire and
demolishing the building where the establishment is. In that case
the new location must fulfill all the health requirements. The
moving must be done by the approval and the recording of the
MoH.
3. When making any architectural changes in the pharmaceutical
establishment; the owner must apply in advance for the requested
changes with detailed accurate description and a blueprint of the
change. If the changes are within the health requirements; an
approval will be granted; the changes written and recorded on the
license and the owner can carry out the changes.
4. All pharmaceutical establishments are subject to inspection by
MoH inspectors. The inspector inspects the maintenance of all
health requirements. A time-limit of not more than 60 days can be
given for the owner to correct a problem.
5. The name of the pharmaceutical establishment must be written on
the front with clear Arabic script.
6. A pharmaceutical establishment can only be used for the licensed
purpose. It is forbidden to connect the establishment to a private
house

or

any

other

manufacturing

establishment.

non-pharmaceutical

7. A pharmaceutical establishment must have a pharmacist manager


with at lease one year experience; when the manager is changed;
the MoH must be notified.
8. A pharmacist student in an Egyptian university can attend in a
pharmaceutical establishment as a trainee .
9. The pharmaceutical establishment must notify MoH with all the
pharmacists, trainees and assistants.
10. If the owner needs an extra storage store for the pharmaceutical
establishment; he/she must get approval from MoH in advance.
11. A

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.

5-Specific Pharmaceutical Establishments


A- Public Pharmacies
What are public pharmacies?
Pharmacies privately owned by one or more pharmacist(s). They are
commercial establishments in stores open to the public. Public
pharmacies play very important role in the health care system in Egypt.
There are around 45 thousands public pharmacies in Egypt distributed in
all 28 governorates. The doors of public pharmacies are open to all
patients all the day without any fees. The pharmacist should be capable of

helping poor or rich patients; directing them either to OTC product or


towards a GP or a specialized physician.
What are the rules regulating public pharmacies?
A license for a public pharmacy is given solely to pharmacist who
has spent at least one year working as a pharmacist in a private or
governmental pharmaceutical establishment. The pharmacist is
exempted from one experience if he/she got the pharmacy as
inheritance.
A pharmacist can own maximum TWO pharmacies only. This is
checked by the local medical districts by the pharmacist movement
card issued by CAPA.
OLD Rule: governmental pharmacists cannot own pharmacies.
NOW: the High Constitutional Court has ruled on the 8th of May
2005 that it is against the constitution to prevent an Egyptian from
owning a property based on his/her governmental job. So,
governmental pharmacists can own pharmacies.
In the unfortunate event of the death of the owner; the inheriting
family members can keep the pharmacy for 10 years with a
pharmacist manager. The pharmacy will be closed after 10 years
unless it is sold to a pharmacist.
The distance to the nearest pharmacy should not be less than 100
meter.
The following are the main health architectural requirements in the
store to be used as a public pharmacy according to a new decree
from the Minister of Health issued September 2009:
o The store must be built with sturdy fire-resistant building
material.

o The floor area must be 40 m2 at least.


o The height must be 260 cm at least.
o The store walls should be painted or covered with easy to
clean materials.
o The floor level of the store should not be lower than the
street level; unless the owner has made all necessary suitable
precautions to prevent water leakage from the street to the
pharmacy. Any precautions taken should not obstruct the
entrance of customers to the pharmacy. By all means; it is
not allowed to open the pharmacy in a basement,
o The place where the pharmaceutical products are stored
should

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

o Assign a separate well labeled place for storing expired


products. The expired products should be stored away from
normal products until returned to companies or destroyed.
Expired products must have invoices and synchronization
with MoH should be done.
o Pharmacy wastes should be disposed in an environmental
safe manner.
o Assign a suitable place in the pharmacy for discussion of
private issues regarding the use of medicines. The
pharmacist must be sure that the patient has fully understood
the correct way to use the prescribed product including
storage, possible side effects and the safe way to dispose the
remaining un-used portions.
o The pharmacy must have a computer with access to the
internet. Also it must have software for keeping purchases
and sales records and inventory to ease the retrieval of any
information if requested. Also the pharmacy must keep the
invoices for at least 5 years.
o The pharmacy must have a supply of fresh water pipes.
o The pharmacy must have permanent source of electricity.
o The shop sign of the pharmacy must include the commercial
name of the pharmacy and the name of the owner.
o Sinks must be of porcelain and the wall behind the sink must
be covered with ceramic tiles for 60 cm height.
o The pharmacy sewage should be dumped in the public
sewers system. When public sewers system are unavailable
within a circle of 30 meters; the pharmacy should have a
separate septic tank built in a suitable empty ground outside

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the pharmacy. All sewage openings must be covered with


iron sealing covers.
o When having a toilet in the pharmacy, it should have a door
that does not open directly into the pharmacy itself or into
any storage area; but into a corridor. The toilet should have a
window that opens into the street or into an inner
illuminator, and extractor fan can be used.
o The owner of the pharmacy is not allowed to rent or use any
part of the pharmacy for any other purpose.
o Pets are not allowed in pharmacies.
What can be sold in the pharmacy?
Registered pharmaceutical products (medicaments and nutraceuticals )
Registered cosmetics
Registered pesticides
All the above must be registered at the Egyptian MoH and have
registration number printed on them.
Every product must be from a well defined official source (official
distributors) and the invoices of purchase must be available for
inspection; if necessary. This is very important to fight counterfeit
products. It is a global problem; honest pharmacist must exert effort to
fight this problem; for further information about the problem visit:
http://www.who.int/mediacentre/factsheets/fs275/en/ .
The pharmacist can make some simple preparations. The preparations
should be derived from a pharmacopoeia or a prescription from a licensed
physician. The preparations should be well labeled with the pharmacy
label, and all preparations should be recorded in a special notebook.

What are the conditions for selling a pharmaceutical product?


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Prescription products: must be sold after a patient provide a


prescription from a licensed physician.
OTC (over the counter) products: can be sold without prescription.

Working hours of public pharmacies:


The working hours must be clearly written and should be reported to the
MoH. Also, vacations weekly and annually should be reported to MoH.
Generally a public pharmacy must open to the public at least 8 hours
daily.

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.

All products should be sold in the original packages.

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The warehouse must report to the MoH all the pharmaceutical


factories they represent and should have accurate recorded data of
their daily sales.
A warehouse should open at least 8 hours daily.
7- Medicinal Plants Stores
MoH grants licenses for trading medicinal plants. Medicinal plants are
divided into two categories:
Simple plants that can be used for cooking and as condiments or
spices. These are included in the law 127/1955 in a table (Table 7
in the law) and can be sold outside pharmaceutical establishments
(in supermarkets or spice shops).
Medicinal plants with distinctive pharmacological actions. These
are mentioned in pharmacopeias and have definitive specifications.
Rules for these plants are as follows:
o Stores selling these plants must be licensed by MoH.
o These stores are only allowed to sell to pharmacies,
pharmaceutical

products

warehouses,

pharmaceutical

factories and scientific organizations (universities and


institutes).
o The plants must be packaged with labels. The label should
show: name of the plant, name of the pharmacopoeia,
collection date and expiry date.
o Medicinal plants stores should have accurate recorded data
of their daily sales.
8- Pharmaceutical Manufacturing Plants (Factories)

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Licensing manufacturing plants is mentioned in the Law of Practicing


Pharmacy no. 127/1955. This is the base for gettig the license. Since 1955
and until now a lot of developments have occurred in the pharmaceutical
industry locally and internationally. Thus, some other more recent
decrees and laws control the procedure, for example:
Ministerial Decree no. 265 of 1981.
Law no. 159 of 1981 for joint stocks companies or the public
sectors.
Law no. 8 of 1997 Law of Investment Warrantees and Incentives'
cGMP

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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 :

Decrees, Studies and Approvals:


Accreditation decree of the applying company according to Law no. 8 of
1997 Law of Investment Warrantees and Incentives and the amending
laws, or Law no. 159 of 1981 for joint stocks companies or the public
sectors;
Decree to license the initiation of the company as published in the
Egyptian Gazette or the Companies Journal;
Approval of the investment organization and the free zones (concerning
investment projects);
Feasibility studies concerning the manufacturing plant project including:
objectives of the company, its activities, planned production power, types
of pharmaceutical products (dosage forms) and pharmaceutical
ingredients listed in the production plan;
Approval of the Ministry of Agriculture to build the plant on the
specified piece of land (The General Organization for the Executive
System of Land Improvement Projects prohibits industrial building on
land classified as agricultural). Industrial zones are exempted;
Approval of the Habitations Sector of Buildings; and
Approval of the Ministry of Industry, General Organization of
Industrialization.
Licence Request:

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Application form for licence request to initiate a pharmaceutical


organisation, signed and approved by the requesting candidate (president
of the board, management director of the project or representative of the
company authorised by the board of management);
documents to be submitted by the candidate requesting the licence:
police status report;
birth certificate (original or certified copy); and
photocopy of the personal photo ID;
inspection fee of five Egyptian pounds paid by mail transfer.
Architectural Drawing Design (Blueprint) that includes:
all details of the building clarifying the view of the site (plan and cross
section);
detailed drawing for each floor including all data concerning areas of
aeration openings, water supply, sewage drainage, electricity and power
production units, production warehouse, control laboratory, management
offices and services;
three original copies of the design;
the design must be certified by a registered syndicate engineer; and
the drawing must have engineering and width duty stamps.
Technical Personnel:
A minimum of highly qualified responsible pharmacists must be available
to run the plant including:
Director of the Factory: pharmacist with at least fifteen years
experience and fully dedicated to the job;
Director of Production: pharmacist with at least ten years experience
and fully dedicated to the job;
Director of Research and Control: pharmacist with at least ten years
experience and fully dedicated to the job; and

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the company representative should present a list of the responsible


pharmacists with the place of their current job and an attestation from
each that they accept the stated job, details of their job status, and their
curriculum vitae. The CV should include: full name, date of birth,
graduation date, experience, number and date of record in the Pharmacy
Syndicate, number and date of the licence to practice the profession, and
certificate of Pharmacist Status issued by the Administration of
Pharmacist Movements.
After completing the inspection of the request file and insuring coverage
of all the requested data is adequate; the request is registered in the
Record of Licenses for pharmaceutical manufacturing plants and is given
a serial number.
Inspection and evaluation of the activities of the factory is achieved by
the Specialized Technical Committee for Plants Inspection. If the results
of the inspection are satisfactory and matching with the cGMP
requirements. The cGMP specifications are inspected by the General
Administration for Pharmaceutical Manufacturing Plants Inspection, and
a final acceptance is given and the license is issued.

9- Registration of Pharmaceutical Products


A public pharmacy can sell only registered products at the MoH. A
licensed factory can only produce registered pharmaceutical products. In
Egypt the registration procedure has undergone several changes in the last
few years.
General Considerations:
All pharmaceuticals in Egypt are subject to mandatory MoH
pricing by a "Pricing Committee".

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NODCAR : the National Organization for Drug Control &


Research is responsible for analyzing all pharmaceutical products
in Egypt. It is an independent regulatory body.
The "High Technical Committee" is responsible for the final issue
of a registration number. This committee is formed by the
127/1955 law and is formed of: The head of CAPA as the head of
the committee and the following members:
o A professor from one of the faculties of pharmacy.
o A professor from one of the faculties of medicine.
o A pharmacist working at MoH.
o A pharmacist representing the Pharmacy Syndicate.
o A physician representing the Medical Syndicate.
o A NODCAR representative
o The head of a medical research center
o A pharmacist representing importers of pharmaceutical
products
o A physician specialized in biological analyses.

Nutraceuticals are defined as natural products with mild


pharmacological

activity

formulated

in

dosage

form

(tablets/capsules/syrups) and multivitamin preparations that have


quantities of vitamins less than the RDA (Recommended Daily
Allowance)
Nutraceuticals are registered and are subject to mandatory pricing as
well. When introducing a neutraceutical that is new to the Egyptian
market; the applicant must provide all necessary information (origin,
active ingredients, properties etc..) and all scientific data are studied by

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special "Neutraceutical Committee" to evaluate and approve the


registration.
Registration is a slow process; takes average 3 to 4 years.
The most updated procedure is as follows:
Registration procedure:
According to ministerial decree issued on June 28th 2009 (Decree No.
296/2009). This decree outlined registration procedure for pharmaceutical
products. The procedure- which is in accordance with the Pharmacy
Practice Law 127/1955 -is outlined in the decree as follows:
I- In order to register a pharmaceutical product; the applying
pharmaceutical company should submit to the Central Administration for
Pharmaceutical Affairs (CAPA) - a form requesting to register a new
pharmaceutical product. This letter is submitted together with a file with
the following documents:
a- official registration form (this form can be acquired from EDA
website ) that contains the following information about the product:
-

concentration and dosage form of the product

20 suggested trade names ;

photocopy of the reference of the product: PDR, BNF, Rote-Liste,

Vidal, Swiss Compendium etc


-

company name and address;

registration status (local/under-license/imported/toll);

full composition (formula) of the product (active and inactive

ingredients, including composition of the capsule shell in case of


capsules);
-

the packs of the products (size and material);

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shelf life of the product and storage conditions;

indications and dosage;

e- raw material specifications (whether or not included in a


pharmacopoeia);
f- labels for the product (outer and inner packaging) in English and
Arabic;
g- the factory license, stating the presence of the production line suitable
for the dosage form of the product. In case of new companies: include a
report from the General Administration for Licensing (one of CAPAs
administrations) about the current status of the factory and the production
lines; the product will not acquire a marketing authorization until the
factory is licensed.
1) For toll manufactured products: a copy of the agreement between
product owner and the manufacturer
2) For imported products and products manufactured under licence:
A-the original Certificate of Free Sale (CFS) (or any equivalent
certificate, e.g. the WHO certificate) including commercial name of the
product; full composition (formula)-it must be exactly the same as
composition of the product to be launched in Egypt-, name and address of
the foreign company and a statement that this company is manufacturing
according to GMP regulations. The certificate must be legalized by the
Egyptian Embassy or Consulate in the country of origin.
B- imported products: a copy of the agreement between the foreign
(mother) company and the Egyptian company legalized by the Egyptian
Embassy or Consulate in the country of origin, clearly stating the name of
the product under registration

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C- under license products: a copy of the manufacturing agreement


between the foreign (mother) company and the Egyptian company
legalized by the Egyptian Embassy or Consulate in the country of origin,
clearly stating the name of the product under registration
3) Proof of payment of 10000 LE to the MoH
II-The submitted file will be carefully inspected by Head Department of
Registration staff. The possibility of registering will be studied according
to the following rules:
MoH is allowing the registration of 12 similar products (the innovator
plus 11 generic versions, one of which may be imported). A limit of 12
similar products is also imposed for high technology products
(innovator plus 11 generics, of which no more than five may be
imported). An exception to the twelve similar products will be given if
the application is for a line extension.
III- CAPA will inform the applying company with decision of approval
or refusal according to the above mentioned rules.
IV The product is priced according to the following rules:
1- Innovator or brand products:
The applying company should submit a list of prices of the product in the
countries in which it is registered and marketed. CAPA will contact the
governmental bodies in the countries mentioned in the attached list to confirm
the prices. The Minister of Health has the right to choose the appropriate
countries according to the local situation and for achieving public benefit.
Attached list:
The price of the innovator will be granted according to the following rules:
A- The public price will be 10% less than the least price in the submitted list.
B- When the first generic of this product is registered and marketed in Egypt
the innovator's price will be lowered by 2% for each year it was marketed
exclusively in Egypt.

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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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c- test method(s) for the finished product


d- specifications of active and inactive raw material(s) with
reference to the corresponding pharmacopeias- if applicable.
e- analytical certificate(s) of active and inactive raw material(s)
f- test method(s) for the active ingredient(s)
g- stability study
h- proof of payment of 5000 LE to NODCAR as analysis fees.
NODCAR must complete the analysis of the samples within forty five
(45) working days of receiving the samples.
2-Submitting the bioequivalence study (if the study is carried out in
Egypt it must be done at one of the approved centers*). The study must
be approved by the High Technical Committee. Exception to this is the
products with any of the following certifications: FDA, EMEA, WHO.
3-Submitting stability studies to the High Technical Committee; where
the validity period is approved.
V- The decision regarding registering the pharmaceutical product will be
studied by the corresponding scientific committees in the following cases:
A If the product contains a new chemical entity.
B- If the product contains a new combination.
C-If the product contains old molecule with new use, dose or dosage
form.
In these cases the company must submit the following:

Pre-clinical data on animals (toxicological cellular


transformation- teratogenicity- carcinogenicity-etc )

Clinical studies on volunteers and patients..

Bioavailability study.

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VI- Regarding the imported products with any of the following


certifications: FDA, EMEA, WHO. These products will acquire a
temporary registration number from the High Technical Committee
before the import. The product will not be launched until the random
samples from the imported first three batches (lots) they can be in the
same shipment-are analyzed by NODCAR (as mentioned above within
45 days)
VII- For toll manufacturing the following conditions apply:
1. The product owner (or one of the co-owners) must be a pharmacist.
2. The agreement between product owner and the manufacturer must
state clearly the mutual responsibility of both parties for the quality
of the final product -including the import of raw materials
complying with the international specifications, the storage, the
analysis and all the manufacturing steps until the final product is
produced.
3. The product owner must be a member of the Pharmaceutical
Chamber of Industry.
VIII Re-registration procedure, every 10 years, is the same as new
product; omitting the steps of first 3 batches analysis and the pricing.
*Some of approved centers for bioequivalence studies
Bioequivalence Units at: Faculty of Pharmacy -Ain Shams University,
Faculty of Pharmacy -Alexandria University, Faculty of Pharmacy -Cairo
University, Faculty of Pharmacy -Tanta University, National Institute for
Research, NODCAR, Genuine Research Center
Importing Pharmaceutical products

26

Only registered imported pharmaceutical products can be imported


in Egypt by the registering company.
General Administration for Pharmaceutical Control (one of
CAPA's administrations) is responsible for giving permission to
import products after revising the registration and the shipping
documents.
It is permitted for patients to import rare pharmaceutical products
that are not available in Egypt. In that case; only limited number of
units is permitted for personal use only. The patient must apply for
permission from MoH.
Explosive products need extra permission from the Ministry of
Interior.
10- General Rules
Chapter 5 of the 127/1955 law has some general rules:
It is not allowed for a pharmacist to practice another medical
profession (physician-dentist-veterinary) in the same time; even if
he/she got a degree in this profession.
Pharmaceutical medicinal products can be only sold in licensed
pharmacies or warehouses as outlined previously.
It is forbidden to trade in free medical samples. Free medical
sample should be kept in a separate store room at the
manufacturing companies or any intermediate scientific office. The
free medical samples should be well-labeled in clear script: "Free
Medical Sample".
It is not allowed to trade or deal with toxic substances in table 1
between pharmaceutical establishments; unless there is a written

27

request stamped with especial "TOXIC" stamp from the


establishment.
MoH pharmaceutical inspectors (from CAPA) have the right to ask
to scrutinize any invoices or documents in the pharmaceutical
establishments

necessary

for

their

inspection

duties.

The

pharmaceutical establishments should keep accurate organized


invoices, records and documents of their activity for the previous
five years.
Warehouses and medicinal plants stores are not allowed to sell
goods to the public.
It is not allowed for a pharmaceutical establishment to refrain from
selling a pharmaceutical product in order to stock it for any reason.
Imported pharmaceutical products are not released from the
customs unless there is written release from MoH.
11-Rules Regulating Handling of Psychotropic Drugs
These rules are contained in decree 487/1985 as follows:
The psychotropic drugs are included in the following tables.
These products can be only distributed by Egydrug (governmental
pharmaceutical distributor).
The in and out quantities of these products are documented in
Egydrug in notebook with numbered pages issued by CAPA.
Each pharmacy can have only limited number of each product
according to MoH rules.
Pharmacies opening night shifts and public sector pharmacies can
have maximum three times the normal quantities of each product.

28

Special hospital pharmacies will have a specified quantity


determined by CAPA, the products will be in the custody of the
pharmacist.

The manager of the pharmacy must submit a signed and stamped


with "TOXIC" stamp a request to the local medical district in the
geographical area of the pharmacy. The medical district will issue a
letter explaining that the pharmacy can take its share from
Egydrug. This letter is valid for 3 months only.

The invoice for these products should be signed by the manager


and kept for 5 years in the pharmacy. A copy stamped with the
pharmacy stamp will be kept in Egydrug for the same period of
time.
The public sector pharmacies and the pharmacies working night
shifts are committed to have these products available for needy
patients.
It is not permitted to produce free medical samples for these
products.

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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Only the smallest registered package is allowed to be dispensed by


prescription.

It is not allowed to have more than one product of this group in


one prescription.

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:

No maximum limits in the prescription

The prescription is stamped with the pharmacy stamp to prevent


the patient from repeated buying.
Examples from this table:
Clonazepam (Rivotril).
Migranil
12- Punishments
This is the topic of chapter 6 of the 127/1955 law; and the main
punishments are outlined as follows:

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

Jail for two years or less + fine of


200 pounds or less or one the two
Jail for one year or less + fine of
5000 pounds or less and the
establishment is closed.
Doing another non-pharmaceutical Jail + fine of 2000- 5000 pounds
activity in a pharmaceutical
establishment that is not lisenced
for him.
An owner doing another non- Closure of the establishment for 6
31

pharmaceutical activity in a months to 1 year


pharmaceutical establishment.
Selling or manufacturing un- 20000 to 50000 pounds fine- if the
registered pharmaceutical products owner did this felony: closure of
establishment 3 month to 1 year

The Law of Proprietary Rights no 82/2002



( Derived from TRIPs Trade-Related aspects of Intellectual Property
rights)
Egypt as a member of the WTO (World Trade Organization) is
committed to apply TRIPs.
What are the consequences of this commitment?
Item 43 and 44 of the law82/2002.
History: before 1995 there was no patent protection for pharmaceutical
products in Egypt. Meaning; once a new chemical entity (NCE) is
registered in any country in the world, any local company could register a
generic with the same chemical compound and market it in Egypt with no
restrictions. For example Unasyn from Pfizer which is ampicillin +
sulbactam has in Egypt a number of local generic clones for example
Unictam, Ampictam etc.. with the same active ingredients.
Now, by the law the innovator of the drug can have exclusive rights to
register the product in Egypt and no other generic from local companies
can be registered until the patent protection time expires- 20 years from
the date of applying the file.
How can an innovator company get such exclusive right?
By the 82/2002 law there are some conditions:

32

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.

33

Contribute to the providing medicaments for all the Egyptian


population.
Contribute to national democratic and economical development
goals.
Sharing in planning studies for various pharmaceutical projects.
Encourage scientific research and relating the research with the real
pharmaceutical production problems.
Study and promotion of means of improvement and increasing the
production of medicaments and reduce the production costs.

Study and promotion of means of improvement of pharmaceutical


services in public pharmacies and hospitals.

Survey of scientific skilled personnel and experienced pharmacists


according to their expertise and level of experience. These data
should

be

useful

for

national

planning

and

estimating

pharmaceutical research costs.


Contributing to planning, developing and executing programs of
continued

education

for

pharmacists

and

pharmaceutical

professional training,

Sharing in study of projects of international pharmaceutical


interest and co-operating with Arab, African and Asian
pharmaceutical bodies.

Supporting the Arab Pharmaceutical Union and helping the union


for achieving its goals.
Organizing medical and social services for Egyptian pharmacists.

Who has the right to be registered as a member at the EPS?

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Egyptian pharmacists having bachelor of pharmaceutical sciences


from an Egyptian university or from any other equivalent
international university.
Arab pharmacists- on the condition that their country registers
Egyptian pharmacists in their country's pharmacists syndicate
(equivalent treatment).
Having good reputation with no criminal record.

What are the duties of a member of the EPS?


The member has to regard the pharmacy profession ethics.
An EPS member must take an oath in front of a committee formed of
three EPS board members, the oath is as follows:

I swear with Allah the Great that I will be faithful


to my country and that I will perform my duties
with honor and integrity and I will guard the secrets
of my profession and execute the pharmacy laws
and respect the pharmacy profession's ethics.
Duties and ethical principles -which are mentioned in the law as a
separate "List of Ethical Principles of the EPS"- to be guarded by EPS
members:
An EPS member is not allowed to advertise for his profession by
any media or publication except for the working hours.
EPS members should refrain from all kinds of market manipulation
and competition and avoid damaging other EPS member's
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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.

Structure of the EPS


The EPS consists of:
EPS
General Assembly

EPS Board

The General Assembly of EPS:


Formed of all EPS members who paid the fees up to the last year.
Headed by the Head of the Syndicate; when absent the Vice. If
both are absent the assembly will be headed by the oldest EPS
member present in the meeting.
Meetings:
o Normal Meeting: in Cairo annually in March.
o Extraordinary Meeting: when there is kind of emergency
issue that requires some discussion by the EPS. An
extraordinary meeting can be held if more than 200 eligible
EPS members sign a request for holding the meeting
outlining the reason for the meeting. The EPS board must
respond by holding the meeting within thirty days; otherwise
the General Assembly people can hold the meeting without
the EPS board.

37

o A valid meeting must have at least 500 eligible EPS


members. If less than 500 are present (after more than one
hour of the meeting's scheduled time), another meeting
should be held within 21 days; in that case only 200
members are sufficient to make the meeting valid.
o Meeting's decisions are taken by voting. In cases when the
votes are equal; the opinion of the head of the meeting is
followed.
o Invitations to the meetings: by personal invitations
explaining the location, date and time of the meeting and
also the agenda of the topics to be discussed in the meeting.
The invitations should be sent at least 15 days in advance.
Also the EPS board can advertise in some selected
newspapers for the meeting.
o Only the agenda's topics can be discussed in the meeting;
unless some kind of emergency topic needs discussion.
o Any eligible EPS member can suggest adding a topic to the
normal meeting agenda one week in advance.
o In an Extraordinary Meeting the general assembly members
have the right to withdraw the trust from the EPS board. In
that case at least 50% of the eligible EPS members must
attend this meeting and voting is carried out.
Main Roles of General Assembly:
Electing the head and the EPS board.
Discussing the general policy of the syndicate.
Approving list of duties and list of profession's ethics
that are suggested by the EPS board and issued by the
Minister of Health.
Discussing and approving the annual budget of EPS.
38

Discussing and approving the last year's budget after


inspecting the financial observer's accounting report.
Discussing and approving topics presented by the EPS
board.
Appointing financial observer.

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:

Cairo (Cairo & Giza)

Middle Delta (Monofia, Gharbia, Kafr Elsheikh and


Kalyobia)

West Delta (Alexandria, Behera, Marsa Matroh)


East Delta (Dakahlia, Sharkia, Damietta, Port Said,
Canal Suez cities, Red Sea and Sinai)
North Upper Egypt (Fayom, Beni Swef and Menya)

39

South Upper Egypt (Assiut, Sohag, Kena, Aswan and


Wadi Gadid)
o 6 elected members EPS members for less than 15 years- one
representing each of the above mentioned six regions, noting
that it is not allowed to have more than one EPS member
from the same governorate as region's representatives. When
an elected region representative moves to another region the
second in number of votes takes his/her place.
EPS board members should have good records and none of them had any
professions penalties. EPS members are elected by voting and in case of
equal votes a draw is carried out. After two years a draw is made and
50% of the EPS board members are removed from the board and other
members elected.
The EPS board members meet at least once each month and their main
responsibilities are:
Achieving the goals of EPS.
The board represents EPS members with the Medical Union's
Syndicates and with the government. They talk for all the Egyptian
pharmacists and defend their rights.
Negotiate with government and business owners to provide good
job offers for pharmacists.
Achieve the EPS goals and planning methods of executing the
goals and the follow up.
Suggesting and improving list of duties and list of profession's
ethics. Make sure that the lists are executed.
Execute the decisions taken by the General Assembly.
Synchronize the relationship and activities between the EPS board
and the Syndicate's branches. The EPS board can oppose decisions

40

of Syndicate's branches; if they think that a certain decision is not


in accordance with the general policy of EPS.
Keeping records and data of the pharmacy profession.
Approve and put rules for commercial names of pharmaceutical
establishments.
Management of the EPS funds.
Preparation of the annual budget accounting.
Issue of magazines and information leaflets with news and
information for the EPS members
Solving any problems between EPS members.
Execute punishments for EPS members according to the law.

Law No. 13 / 1983


Establishing Union of Medical Syndicates

This union with headquarter in Cairo includes all members of the four
medical field syndicates: Egyptian Medical Syndicate- Egyptian
Pharmacists Syndicate- Egyptian Dentists Syndicate Egyptian
Veterinaries Syndicate.
Main roles of the union:
1. Establishing funds system for pensions and support money for all
members of the union.
2. Investing the funds in useful projects to have profit for the benefit
of the union's members.
3. Deciding and modifying lists for the rules of benefiting from
pensions and support money.
4. Solving disputes that might arise between medical fields'
syndicates.

41

5. Co-operation with medical fields' syndicates in Arab countries.

Structure of the Union


The Union of Medical Syndicates consists of:
Union
Union Board

General Assembly

The Union Board:


The president of the Union Board is the Head of the Medical
Syndicate. The three others are vice presidents of the union board.
By election the following positions are occupied by eligible
syndicates' members:
o Secretary General
o Assistant Secretary General
o Funds Trustee
o Assistant Funds Trustee
The Union Board holds meetings when invited by the president of the
union. The meeting is valid when at least half of the Union Board's
members are present.
The General Assembly:
Includes all eligible members from the four syndicates.

42

The General Assembly meets annually (Normal Meeting) in May.


The meeting is announced two weeks in advance in two different
newspapers and once more one day before the meeting.
Extraordinary meeting can be held in urgent matters or when at
least 400 members (75 members from each syndicate) sign a
request for the meeting explaining the reason for such
extraordinary meeting.
Pensions and Support Money
The Union has established a pension and support money system for the
Union's eligible members, the funds for this system are derived from:
1. Governmental support.
2. 70% of annual fees for the four syndicates' memberships.
3. Medical stamps for services provided by syndicates for
example various certificates issued by the four syndicates and
other documents requested by the industry.
4. Any donations.
5. Investment money resulting from investing the funds in various
useful projects.

Types of Pensions and Support Money:


Retirement pension; when the union member stops working
completely.
Old age pension; when the union member reaches the age of
65.
Disability pension; when an unfortunate disability occurs to
the member before reaching 65 years. The disability must
be verified by medical committee.

43

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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