the para-pharmaceuticals market in egypt · the para-pharmaceuticals market in egypt dr. maged...
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THE PARA-PHARMACEUTICALS MARKET IN EGYPT
DR. MAGED GEORGE AMIN
APRIL 18TH 2015
TOPICS• Market Size
• Marketing Tools
• Custom Duties
• Regulatory Entities
• Laws and Registrations
• Exporting Cosmetics to Egypt
• How to Register Your Product in Egypt?
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TOPICS• Market Size
• Marketing Tools
• Custom Duties
• Regulatory Entities
• Laws and Registrations
• Exporting Cosmetics to Egypt
• How to Register Your Product
• Strategy… ?
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MARKET SIZE• Population in Egypt:
� > 90 million
�Almost 25 million= age of 0 – 15
� Almost 35 million= age of 15 – 35
�Almost 20 million= age of 35 – 55
� Almost 10 million= age above > 55
0 to 15
32%
15 to 35
38%
35 to 55
21%
55+
9%
0 to 15 15 to 35 35 to 55 55+
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MARKET SIZE• Population in Egypt: > 90 million
• Pharmacies :
�Licensed 48,000
�Above 30,000 acting
� licensed pharmacies are the main retail outlet for para-pharmaceuticals
0 to 15
32%
15 to 35
38%
35 to 55
21%
55+
9%
0 to 15 15 to 35 35 to 55 55+
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PARA-PHARMACEUTICALS MARKET SIZE
$[VALUE] B
$[VALUE] B
600
620
640
660
680
700
720
740
760
780
800
2013 2014
ParaParaParaPara----Pharmaceuticals Sales in 2013Pharmaceuticals Sales in 2013Pharmaceuticals Sales in 2013Pharmaceuticals Sales in 2013----2014 (USD billion)2014 (USD billion)2014 (USD billion)2014 (USD billion)
Sales (billion)
15% Increase
in Sales
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KEY PLAYERS
The main multinational manufacturing companies in Egypt are (in alphabetic order):
• Dabur India
• Henkel
• Johnson & Johnson
• L’Oreal
• P&G
• Uniliver
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MARKETING
The main marketing tools used are:
1. Media (TV, Magazines, Newspapers.. Etc)
2. Medical representatives
3. Dermatological conferences
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CUSTOM DUTIES
Customs duties according to various trade agreements:
• EFTA & Turkish partnership: 9% in 2015
• European Union: 4.5% in 2015 and possibly 0% by 2016
• Arabic Union: 0%
• Other countries: 30%
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LAWS & REGUATIONS
Para-Pharmaceuticals in Egypt are regulated by two entities:
1. Egyptian Ministry Of Health (MOH)
2. Egyptian Organization for Standardization & Quality (EOS)
Regulations are also guided by European Regulations
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EXPORTING COSMETICS TO EGYPT
• In order to export finished cosmetics products to Egypt products must be registered for customs clearance and market access
• Registration is done by the Egyptian importer or agent at:
• Ministry of Health
• Egyptian Drug Authority (EDA)
• Central Administration of Pharmaceutical Affairs (CAPA)
• General Directorate of Registration
• Department of Cosmetics Registration
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EXPORTING COSMETICS TO EGYPT
• Duration of validity of the registration is 10 years
• Egypt applies the “European Cosmetics Regulation EEC 1223/2009” and its amendments
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HOW TO REGISTER YOUR PRODUCT IN EGYPT?
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Presentation of initial soft file
Presentation of final hard file
Sampling and Analysis
[ ministry of Health decree 151-2015 on FEB – 2015]
INITIAL SOFT FILEA. An application to be filled with some product data as
product name, purpose of use, manufacturing company name, agent name, package and volume
B. Copy of registration fees receipt : 1800 LE / product
C. Free sale certificate issued by the authorities in the country of origin/manufacture. Free sale must be officially signed, sealed, certified by the respective chamber of commerce or an equivalent authority and finally legalized by the Egyptian Embassy or Consulate.
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INITIAL SOFT FILED. Chemical composition of product, including INCI names
of raw materials, their quantities and functions officially signed, sealed, and certified by the respective chamber of commerce or an equivalent authority
E. Package sample or package photo, including the relevant labelling showing active ingredient and method of application
NB: Product with different colors and fragrances is registered as one product
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INITIAL SOFT FILE
F. Shelf life declaration officially signed, sealed, and certified by the respective chamber of commerce or an equivalent authority
G. Authorization letter from foreign manufacturer to Egyptian agent for the purpose of product registration. It must be officially signed, sealed and certified by the respective chamber of commerce or an equivalent authority and finally legalized by the Egyptian Embassy or Consulate.
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INITIAL SOFT FILEH. Letter of attorney for the registration representative,
officially signed, sealed and certified by the respective chamber of commerce or an equivalent authority and finally legalized by the Egyptian Embassy or Consulate.
• All above documents to be sent by mail or in the form of CD
• After documents are revised, missing documents must be completed by the company and presented again till file is complete and accepted, then final hard file is prepared.
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FINAL HARD FILE
A. Original receipt of registration fees
B. Original Free sale certificate
C. Original Chemical composition of the product
D. A sample of the product
E. Certificate of analysis signed and sealed
F. Original shelf life statement
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FINAL HARD FILE
G. Scientific file for active ingredients describing its effect Authorization of the foreign manufacturer to his Egyptian agent for the purpose of product registration
H. 2 copies of Chemical composition of the formula
I. 2 copies of product label
J. Receipt of file receiving fees : 100 LE
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FINAL HARD FILE
• All official documents must be officially signed and sealed, certified by the respective chamber of commerce or an equivalent authority and finally legalised by the Egyptian Embassy or Consulate.
• The file will be discussed in a technical committee to give final approval and issue a registration certificate
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SAMPLING & ANALYSIS
• Registered product samples must be analyzed via the National Organization of Drug Control And Research (NODCAR)
• Product Analysis cost: 3000 LE/Product
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SAMPLING & ANALYSIS
• If product’s origin is from one of the reference countries, a certain procedure is followed.
• Reference countries include:
• All European Union members
• Australia, USA, Canada, Japan, Iceland, Norway, New Zealand
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SAMPLING & ANALYSISFor reference countries, sampling Is done in the following pattern:
• Samples are taken from one of the batches of the first shipment. Chosen batch is suspended till laboratory result is issued (within 45 days) while rest of shipment is allowed to be launched.
•In case of non conformity, all batches are withdrawn from market and samples are taken from all other batches
•Random samples are taken from every shipment
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SAMPLING & ANALYSISFor non-reference countries, sampling Is done in the following pattern:
• Samples are taken from one of the batches of the first shipment, and all the shipment is suspended till laboratory result is issued (within 45 days)
• In case of non conformity shipment is either executed or return to exporter and samples are taken from all other batches
•Random samples are taken from every shipment
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STRATEGY
•????
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STRATEGY
Can we Barter a market of…
90,000,000
for a market of …
???....
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STRATEGY
Can we Barter a market of…
90,000,000
for a market of …
1,600,000,000…
???....
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NEW STRATEGY
Can we Barter a market of…
90,000,000
for a market of …
1,600,000,000…???...
The answer is:
Yes , we can …!
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EGYPT’S TRADE AGREEMENTS• GAFTA – Greater Arab Free Trade Area
• COMESA – Common Market for Eastern And Southern Africa
• European Partnership
• Agadir
• Turkish Partnership
• EFTA – European Free Trade Association
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GAFTA1. Saudi Arabia
2. Bahrain
3. Qatar
4. Kuwait
5. Iraq
6. Oman
7. UAE
8. Yemen*
9. Syria
10. Lebanon
11. Palestine
12. Sudan*
13. Libya
14. Morocco
15. Egypt
16. Algeria*
17. Jordan
18. Tunisia
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COMESA1. Djibouti
2. Kenya
3. Uganda
4. D.R. Congo
5. Burundi
6. Zambia
7. Zimbabwe
8. Eritrea
9. Madagascar
10. Seychelles
11. Comoros
12. Mauritius
13. Swaziland
14. Rwanda
15. Sudan
16. Ethiopia*
17. Egypt
18. Libya
19. Malawi
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AGADIR
1. Egypt
2. Tunisia
3. Jordan
4. Morocco
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EURO PARTNERSHIP – EFTA – TURKISH PARTNERSHIP
1. EURO Members
2. Switzerland
3. Liechtenstein
4. Iceland
5. Norway
6. Turkey
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EURO PARTNERSHIP
Egypt and the EU signed an Agreement in 2001 that came into force in 2004. The partnership agreement states that:
• A free trade area over a 12-year transitional period by 2016.
• All goods exported from Egypt to the EU were immediately exempt from tariffs
• EU export tariffs will gradually be dismantled over the 12 year period
• By 2015, customs reached 4.5% and expected to diminish in 2016
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EURO PARTNERSHIP – EFTA – TURKISH PARTNERSHIP
1. EURO Members
2. Switzerland
3. Liechtenstein
4. Iceland
5. Norway
6. Turkey
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TRADING ADVANTAGE
Egypt’s trade agreements cover total population of
more than 1.6 billion
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MANUFACTURING COSMETICS IN EGYPT “UNDER LICENSE”
to collect the benefits of a ….<Certificate of EGYPTIAN Origin >
STRATEGY >>>>
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MANUFACTURING COSMETICS IN EGYPT “UNDER LICENSE”
• In order to launch cosmetic products in the Egyptian Market, products must be registered
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MANUFACTURING COSMETICS IN EGYPT “UNDER LICENSE”
• In order to launch cosmetic products in the Egyptian Market, products must be registered
• Registration is to be applied by the Egyptian Manufacturing company at :
• Ministry of Health
• Egyptian Drug Authority (EDA)
• Central Administration of Pharmaceutical Affairs (CAPA)
• General Directorate of Registration
• Department of Cosmetics Registration
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MANUFACTURING COSMETICS IN EGYPT “UNDER LICENSE”
• Duration of validity of the registration is 10 years
• Egypt applies the “European Cosmetics Regulation EEC 1223/2009” and its amendments
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HOW TO REGISTER YOUR “UNDER LICENSE” PRODUCT IN EGYPT?
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Presentation of initial soft file
Presentation of final hard file
Sampling and Analysis
[ ministry of Health decree 151-2015 on FEB – 2015]
INITIAL SOFT FILEA. An application to be filled with some product data as
product name, purpose of use, manufacturing company name, agent name, package and volume
B. Copy of registration fees receipt : 1800 LE / product
C. Factory license
D. Chemical composition of product, including INCI names of raw materials, their quantities and functions officially signed & sealed
NB: Product with different colors and fragrances is registered as one product
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INITIAL SOFT FILEE. Package sample or package photo, including the relevant
labelling showing active ingredient and method of application
F. Shelf life declaration officially signed and sealed
G. Tax Registration Card of manufacturing company
H. Manufacturing contract between mother company and manufacturing company officially signed, sealed and certified by the respective chamber of commerce or an equivalent authority and finally be legalized by the Egyptian Embassy.
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FINAL HARD FILEA. Original receipt of registration fees
B. Original Chemical composition of the product
C. A sample of the product
D. Certificate of analysis signed and sealed
E. Original shelf life statement
F. Scientific file for active ingredients describing its effect authorization of the foreign manufacturer to his Egyptian agent for the purpose of product registration
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FINAL HARD FILE
G. 2 copies of Chemical composition of the formula
H. 2 copies of product label
I. Receipt of file receiving fees : 100 LE
The file will be discussed in a technical committee to give final approval and issue a registration certificate
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SAMPLING & ANALYSIS
• Registered product samples must be analyzed via the National Organization of Drug Control And Research (NODCAR)
• Product Analysis cost: 3000 LE/Product
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SAMPLING & ANALYSISSampling is done in the following pattern:
1. Sample is taken from first produced batch samples are withdrawn and sent to National Organization of Drug Control & Research
NB: batch should be 50% at least from factory production capability
2. Product could be launched till analysis report is issued within 45 days
3. If product was non conforming the batch is withdrawn from the market
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Thank you …. [ 18 April 2015]
Dr. Maged Georges Amin
Vice President
Industrial Chamber for Pharmaceuticals ,Cosmetics & Medical Appliances
Member of the Egyptian Federation of Industries
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