Article 59 of Law 127 for 1955 states that pharmacies may not sell drugs that are not registered with the Ministry of Health. This restriction applies to drugs either prepared domestically or imported from abroad.
Any medicine should be registered with The Egyptian Drug Authority (EDA) – the pharmaceutical regulatory body of the Egyptian Ministry of Health (MOH) – and given a MOH Registration Number before it can be traded or given to people.
We would like to note that although the process of registering a drug with the Ministry of Health is a long procedure that may take up to 4 years to finalize, as we will further explain, it is irrelevant of the patent protection granted to the drug in question.
The registration process starts by receiving the Registration Submission Request via e-mail as described in the following guidelines:
A. The Request:
1. The Applicant sends an appointment request by e-mail to the Central Administration of Pharmaceutical Affairs (CAPA)
2. CAPA will send back an email informing the applicant with the date and time for application submission within 3 working days.
3. The maximum number of applications that could be submitted by one company (local manufacturer) is four applications per month at four different meetings. Import and toll companies could submit only two applications per month at two different meetings. An exception to this limit is granted to requests to register different concentrations of the same dosage form (each in a separate application). In this case, such requests might be submitted at the same meeting.
4. CAPA will receive a maximum of 10 applications per day (application/company), four days per week (no submission meetings on Thursday)
5. The application may be refused for reasons other than “the box is closed at the present time”.
6. If the company representative was 15 minute late after the pre -determined appointment, the meeting will be cancelled and the company will have to ask for another appointment.
7. Accepting the application doesn’t guarantee a market authorization. Market authorization is considered to be granted only when the company receives the final authorization.
8. The application file might be rejected at any stage and the reason of rejection will be given to the applicant.
9. Companies must make sure that their Company Profile (submitted once) has been received by CAPA before submitting the application.
B. Pricing Committee
Within thirty days of the date of the receipt of the preliminary approval of the technical committee, the applicant must submit its file to the pricing committee which in turn will reply within 60 days of receipt of the file.
C. Technical Committee
The file is then referred to the Technical committee in the following cases:
• If the drug has a new effective substance, or does not have a scientific reference or has a new component.
• If the drug has a new use, takes a new shape or has a different dosage
• If any international warnings have been issued regarding one of the components of the drug
In this event the applicant shall be requested to present scientific studies related to the drug within 30 days of the date of the pricing. This timeframe may be extended once.
Subsequently, the file is then transferred to the Pharmacists’ services Department within 8 months of the date of pricing which will return with any questions within 15 days of the receipt of file. The applicant shall then respond to any questions or concerns of the said department within 60 days of receipt of reply.
D. Stability Committee
Researches on the stability of the testing batch is then performed (R&D) within 60 days of the receipt of the complete file.
E. Naming Committee
The file is transferred to the naming committee to approve a name of the drug.
F. Inspection Committee
The inspection committee then issues a preliminary approval that is valid for 3 years.
G. National Organization for Drug Control & Research (NODCAR)
The company then produces the first batch of product that is not less than 50% of the total production batch. This is then presented to NODCAR along with the necessary studies performed on the produced drug. NODCAR replies within 45 days of the receipt of the file with the results of said studies.
H. Bioequivalence Committee
If the product is of the type that requires a bioequivalence test to be undertaken according to the international standards, a specimen of the drug is collected and dispatched to the designated bioequivalence laboratories approved by the Minister of Health, which in turn must issue its results within 30 days of receipt of the studies.
I. Further Stability studies
The applicant then performs stability studies on the first production batch, results of which must be presented to the authorities within 8 months of its production date.
After the first batch is released, the production of the second batch is effected which in turn will not be released until the equivalence studies for it have been performed and approved by NODCAR. Then the third batch is produced and the same procedures are applied.
The applicant shall perform the above steps for the 2nd and 3rd batch. The preliminary approval may be extended for another 3 years until the long term stability studies have been provided and approved.
J. Final Approval
After the approval on the stability studies has been obtained and the final validity date for the product has been determined, the applicant is then issued the final approval which is valid for 10 years from the date of the issuance of the preliminary approval.
Renewal of Registration
The Ministerial Decree number 147 of 1974 states that the duration for the registration of drugs for medical use is 10 years and food supplements is 5 years. Renewal procedures should be undertaken in advance of the expiry of the registration to avoid any cancelation of registration of said drug.
The process of renewal of registration of a drug does not go through all the above mentioned committees, unless there is a change in the composition of the drug.
Eurofast Egypt
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