Apply For Register with Egyptian Drug Authority in Egypt By Yourself
- To be registered to register with Egyptian Drug Authority, the applicant should go to for registration with the Egyptian Drug Authority (EDA) and provide the necessary documents to complete the process. The address is listed in the “Office Contacts and Locations” part of the process.
- Check out this section of the “Required documentation” part of the guideline to for further information.
- If the documents met the EDA specifications, an authorization for the import of samples from the product is issued to the person applying. The applicant must take the specified samples that will be used in vetting and Lab analysis.
- Following this, the products that are that are presented are scrutinized. This includes checking the label, leaflets, and drug details, and labels.
- See”Required Documents” in the “Required document” section to find the required documents that must be provided to be vetted.
- Once the vetting has been completed After vetting is completed, you’re required to submit a few samples for lab analysis. It is required to provide a specified amount of samples as well as copies of the receipt for processing fees and letters of application for the submission of the samples.
- Then, your product(s) is sent to the labs for analysis in order to verify conformance to the standard specifications.
- If, at this point, the product(s) is able to pass the laboratory test requirements, the product is presented during the conference. At this point, decisions are made on whether the product is qualified to be granted an EDA license number or not. They typically sit at least two times the size of the product. If the product is in compliance with all the requirements, a license is issued.
- After the product has been issued a license numbers, you’ll be able to obtain your notification numbers. You’ll need to pay the amount for the certificate of license and then present the receipt. the notice number is handed to you. You’re now able for the import of the merchandise to use commercially while waiting for your certificate to be issued. It can take six months or for the certificate to be in place. The certificate typically lasts for up to five (5) year.
Required Documents For Register with Egyptian Drug Authority
- Authority of Attorney or contract manufacturing agreement;
- Manufacturing license and a free sale certificate
- Trademark registration
- certificate of incorporation/business name
Documents that are to be provided during the VETTING are
- copies of the import permit and the payment receipt
- dossier in accordance with EDA format for pesticides and drugs
- Three samples of each product
- Letter of invitation to inspect.
- A Comprehensive Certificate of Analysis
Office Locations and Contacts
Egyptian Drug Authority (EDA)Address: 21 Abd El-Aziz Al Soud Street, EL-Manial, Cairo, Egypt
Tel: +202 25354100 (30 lines)
Tel: +202 23684288 +202 23648046
Tel: +202 23640368 +202 23648769
E-Mail: info@eda.mohp.gov.eg
Ministry of Finance
Arab Republic of Egypt
Ministry of Finance Towers,
Nasr City.
Extension of Ramsis Street,
Abbassiya, Cairo
Phone: 02/23428830
Fax: 02/23428830
Contact Link: Link
What are all the Eligibility
Companies and individuals who are that are looking to invest to engage in Pharmaceutical Business both in human and animal drugs in Egypt and related products can register with Egyptian Drug Authority.
Validity
The validity is 5 years.
Processing Time
The processing period is about 6-12 months.
The Document is required
The Egyptian Drug Authority (EDA) is the regulatory body for pharmaceuticals within the Egyptian Ministry of Health (MOH) and is accountable for:
- Protection of health and safety by regulating the quality and safety for pharmaceutical products.
- Regulation and legislation of practice in pharmacies.
- High-quality medicine is available at reasonable cost.
- Policy making and strategic planning for the industry.
- Establishing standards for medical services, both in hospitals and community.
- Coordinating and integrating all reviewing and analysis methods to ensure registration of products release, lot releases and monitoring market.
- In educating the public about possible negative effects of medicines as well as the risks of drug misuse and warnings regarding counterfeited medications.
- Helping to support programs that improve the pharmacy education system and the continuous formation of pharmacists.
- Collaboration with relevant international organizations (such like the WHO) in order to raise the standards in the production of drugs and methods of use.