Pharmaceutical Registration in Egypt

user Merna G. Saad calender 17 Jun 2016 views 9826 Views

The Egyptian Pharmaceutical market is facing a vital crisis of drug deficiency. Egyptian Pharmaceutical production has been impacted by the economic deficiency and the pharmacists warn that some drug supplies such as those of cancer treatment and diabetes are tapering off.

Also, the sharp shortages in monetary currencies has affected the pharmaceutical companies letting them face dual obstacle of this drop in the foreign currency which reserves making imports harder as well as governmental fixed prices.

Accordingly, Egyptian Law set a number of price ceilings which are forbidden to exceed, medicines are grouped to price category with the lowest starting at 0.64$, these rates are designed to make drugs available especially to those of limited financial means and prices have been stable for the past 25 years.

And to ease the pressure on the importers and consumers, the Ministerial Decree No. 296 of 2009 has been issued to identify the General Steps for Registering Medicinal Products which are as follows:

Step 1:

You have to Send an e-mail to “Reserve a date” to submit the “Application Form”, by filling the Submission Request Inquiry Form:
– Only One e-mail per day for each Company.
–  E-mails to “reserve date” will be sent to the following address:
–   E-mails must include the following items: Company name, Company e-mail, Telephone & Fax, Authorized Person name. Use the Submission Request Inquiry Form.

Step 2:

You will receive an e-mail giving you a date & time for the submission of your “Application Form” and the other “Submission Request Inquiry Form” within three working days.
–  E-mails will include both Date & Time to submit the “Application Form”
–  only  10 dates are given per day for 10 different companies.
–  Dates are given all working days except Thursdays.

Step 3: 

The Company submit the “Application Form” at the right date & time. Use the following “Application Form” and the other “Submission Request Inquiry Form” You will receive a “Receipt of Application” signed by the responsible pharmacist in order to protect your rights.

Step 4: 

Processing Time will take 15 working days after receiving your “Application Form”.

Step 5: 

A reply e-mail will be sent by means of CAPA to inform you by the status. A- In Case the “APPLICATION FORM” was accepted: (i.e.: Opened (unsaturated) box, Appropriate Documents….etc.)
–  E-mails will include the valid period (30 working days) to submit the “Pricing File” to continue the Registration Process.
–  Approval letters will be signed & stamped; you will receive your Original letter from CAPA.
–  Remember that you have to finish the File “NAME” before submitting the “Pricing file”.
–  After receiving the “PRICING FILE”, if there were any additional documentation required, the Pharmacist in charge will contact you.
–  Accepting the application doesn’t guarantee a market authorization, only when the company receives a final authorization.

– In Case the “APPLICATION FORM” was rejected: (i.e.: Closed (saturated) box, Inappropriate Documents….etc.)
–  E-mail will be sent declaring your status.
–  In case of closed (saturated) box, the application form will take a serial number and reserved in a waiting list for a year. The application will be re-activated in case of opening the box.
–  The box is opened in cases of termination of a product registration or discontinuing registration process of some products already exists in the box.
–  The activation occurs by sending E-mail from CAPA to the company next in the waiting list.