What is the MINISTERIAL DECREE 296?
Minister Decree for Human Drugs (296)
Is it necessary to submit the complete "COMPANY PROFILE" to CAPA?
Yes, It is a must to submit the completed "COMPANY PROFILE" Form to CAPA; otherwise all your applications will be disregarded. Use the following COMPANY PROFILE format
Do I have to submit the full "Company Profile" every time I submit the "Application Form"?
No, the complete "COMPANY PROFILE" Form is submitted annually. Otherwise, it is updated only in case of changes.
According to the Minister Decree 296, what are the General Steps for Registering Medicinal Products?
A- The General Steps will take place as follows:
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: Appd@eda.mohp.gov.eg.
E-mails must include the following items: Company name, Company e-mail, Telephone & Fax, Authorized Person name. Use the SUBMISSION REQUEST INQUIRY FORM
you will receive an e-mail diving you a date & time for the submission of your “APPLICATION FORM” and the other “REQUEST INQUIRY REQUIREMENT” within three working days.
E-mails will include both Date & Time to submit the "Application Form"
We only give 10 dates per day for 10 different companies.
Dates are given all working days except Thursdays.
The Company submit the "Application Form" at the right date & time. Use the following “APPLICATION FORM” and the other “REQUEST INQUIRY REQUIREMENT” You will receive a "Receipt of Application" signed by the responsible pharmacist in order to protect your rights.
Processing Time will take 15 working days after receiving your "Application Form".
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.
B- 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.
How many e-mails can I send per day to "Reserve a meeting request"?
Only four e-mails for each local manufacturing company and two e-mails for toll and imported company per month, other e-mails will be disregarded. A confirmation receipt will be sent back to you. The cancelled meeting is also counted
Is there any alternative ways to "Reserve a date" other than e-mails?
No, You can only reserve a date by e-mails because e-mails are dated & timed. Other ways will be disregarded. (I.e. In order to maintain priorities), using the “SUBMISSION REQUEST INQUIRY FORM” on the E- mail address: Appd@eda.mohp.gov.eg
How many "Application Forms" I can submit?
Only four new "APPLICATION FORMS" for each local manufacturer and two “APPLICATION FORMS" for the toll manufacturing and imported company per month. With exceptions to these numbers are given to different concentration of the same dosage form are taken at the same meeting.
Do I have to pay any fees at the first meeting?
Yes, you will pay EGP 1000 for each "Application Form", the fee is non refundable
what happens if I miss the "Reserved appointment" to submit the "APPLICATION FORM"? Can I make another one?
The appointment cancelled if the company representative failed to show up within 15 minutes of the pre – determined time .no makeup appointment are given on the same day. In case of missing the appointment, the company has to send e-mail requesting a new appointment.
What proves that I have submitted the "APPLICATION FORM" at the Right date & time?
In order to protect your rights, you will receive a "Receipt of Application" signed by the responsible CAPA representative.
After submitting the application on the first meeting, How can I know that my "APPLICATION FORM" was accepted or rejected?After 15 working days, you will receive an e-mail from CAPA indicating the current status of your Application.
What happens if I didn't receive a reply within 15 days?You can come to CAPA and ask to meet the head of the receiving deck. Any situation will be resolved and your rights are reserved. You should bring a copy of the e-mail which had sent to you by CAPA & "Receipt of Application" which had given to you.
Can we know in advance all the molecules, Dosage Forms, Concentrations that already have been closed?No, because the boxes changed ever day (no box closed for ever).