The pharmaceutical industry: Imported Drug Registration!

Egypt’s pharmaceutical market is one of the most important attractive countries in the Middle East and North Africa. After having a successful economic and regulatory reform, there has been a great intention in the investment field from multinational drug makers and providers in Egypt’s pharmaceutical markets.

Drug Imports

One of the Egyptian Ministry of health’s executive arms is the Egyptian Drug Authority (“EDA”), a pharmaceutical regulatory body responsible for safeguarding people health by regulating safety and quality of medicines (human and veterinary), biologicals, medical devices, cosmetics, dietary supplements and pesticides, provides extensive and fast track process for registering the pharmaceutical drugs for marketing purposes in Egypt; in order to ease the process of entering the Egyptian Market.

Registration departments are responsible for assessment of all Pharmaceutical products for human use including food supplements, veterinary products, insecticides, medical devices & cosmetics before giving registration license to ensure quality & safety of products with affordable prices by applying a Transparent -Effective -Smooth & Communicable System).

Drugs Registration Procedure

We will shed the light on the general steps and/or processes and main requirements of registering different kinds of drugs in Egypt, as follows:

1. Online Submission Process:

In order for a company to apply for registering its imported product (“Drug”), it has to submit its full and complete profile to CAPA (i.e. Central Administration of Pharmaceutical Affairs) otherwise all of the applications will be disregarded. After that an online application is to be carried out by tracking the following steps:

1.  Sending an email to "Reserve a date" to submit the "Application Form", by filling the submission request inquiry form;
2. Receiving an email setting a date & time for the submission of the “Application Form” and the other “request inquiry requirement” within three working days; and
3. Submitting the “Application Form” at the right date & time. By filling in the “Application Form” and the other “Submission Request Inquiry Form”. After that the applicant will receive a “Receipt of Application” signed by the responsible pharmacist in order to protect the applicant’s rights.

The application will take Fifteen (15) working days after receiving the same. Then a reply email will be sent by means of CAPA to provide the application’s status that should be one of the following:

1. Acceptance (i.e. means that the documents were appropriate)

• Emails will include the valid period (30 working days) to submit the “Pricing File” to continue the Registration Process.
• Approval letters will be signed & stamped; and the original letter from CAPA will be sent.
• Finishing 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 the applicant.
• Accepting the application doesn’t guarantee a market authorization, only when the company receives a final authorization.

2. Rejection (i.e. means that the documents were in appropriate)

• Email will be sent declaring the application 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 email from CAPA to the company next in the waiting list.

2. Main Documents required for the Imported human pharmaceutical products (CTD/FDA/EMA approved products)

First: Inquiry Checklist (Online Submission)

1. Payment Receipt for each product;
2. Reference;
3. Copy of certificate of pharmaceutical product (CPP) issued by competent authorities in country of origin;
4. In case of a line extension product: colored scanned copy of the original:

• Registration license of previous product or;
• Pricing certificate or;
• Receipt for pricing submission and proof for naming and PV submission or;
• Receipt for pricing submission and name approval.

Second: Approval Request Checklist (Originals Submission)

1. Certificate of  pharmaceutical product (CPP) issued by competent authorities in country of origin;

1. GMP Certificate (if applicable);
2. Agency agreement or authorization letter; and
3. List of countries in which product is marked.

3. Main Documents required for registering the Biological Products

To market a biological product in Egypt, the applicant must provide information to the EDA demonstrating that the product is safe and effective for the conditions prescribed, recommended, or suggested in the proposed labeling for the product. The regulations under the ministerial decree No.297/2009 and 820/2016 describe the information required for the required application of biological products; as it states that a five-file is required for the application, as follows:

1. Core File;
2. Inspection File;
3. Quality File;
4. Stability File; and
5. Scientific File.