THE PARA-PHARMACEUTICALS MARKET IN EGYPT · THE PARA-PHARMACEUTICALS MARKET IN EGYPT DR. ......

THE PARA-PHARMACEUTICALS MARKET IN EGYPT

DR. MAGED GEORGE AMIN

APRIL 18TH 2015

LAWS & REGULATIONS

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

4/30/2015 DR. MAGED GEORGE AMIN

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


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


HOW TO REGISTER YOUR PRODUCT IN EGYPT?


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.


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


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.


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.


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


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


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


SAMPLING & ANALYSIS

• Registered product samples must be analyzed via the National Organization of Drug Control And Research (NODCAR)

• Product Analysis cost: 3000 LE/Product


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


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


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


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


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


HOW TO REGISTER YOUR “UNDER LICENSE” PRODUCT IN EGYPT?


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


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.


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


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


SAMPLING & ANALYSIS

• Registered product samples must be analyzed via the National Organization of Drug Control And Research (NODCAR)

• Product Analysis cost: 3000 LE/Product


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


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

•[email protected]


THE PARA-PHARMACEUTICALS MARKET IN EGYPT · THE PARA-PHARMACEUTICALS MARKET IN EGYPT DR. ......

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