How to Apply For Register with Central Administration of Pharmaceutical Affairs (CAPA) in Egypt

Apply For Register with Central Administration of Pharmaceutical Affairs (CAPA) in Egypt  By Yourself

• To be able to apply for registration with the Central Administration of Pharmaceutical Affairs (CAPA) the applicant must be in agreement in CAPA’s requirements. Central Administration of Pharmaceutical Affairs (CAPA) which is a division within the Egyptian Ministry of Health that manages Egypt’s market for medical devices: URL

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• The process of registering products under CAPA for registration in Egypt is a procedural. Each step required for the registration of a product should be completed to the next. The first step is to know that CAPA classifies registration of products generally into four sections; specifically,
  • Imported goods and locally made products.
  • Registration Department.
  • Licensing & Pharmacists services Department.
  • Inspection & Control Department.
• In order to register with CAPA applicants must provide the necessary documents to complete the process.
• See in the “Required documents” part of the process for more information.
• If the documents conform to the CAPA requirements, a permit for the import of samples from product is granted to the person applying. The applicant must bring in specific samples to be used in vetting and Lab analysis.
• At this point the samples of the products that are that are presented are checked for vetting. This includes checking the labels, leafletsand other information.
  • There are minimal standards for product labelling, for example
  • Name of the brand medicine name,
  • Name and address of the manufacturer’s address,
  • Production and expiry dates,
  • Batch no or provisions for CAPA No and so on.
• Documents to be submitted for the vetting process are
  • copies of import permits and the receipt for payment
  • dossier in accordance with CAPA format for pesticides and other drugs
  • Three samples of each product
  • Letter of invitation to inspect.
  • A Comprehensive Certificate of Analysis
• After vetting has been completed after vetting, you will be required to submit a few samples for lab analysis. You must submit specific amounts of samples along with receipts for the processing fee as well as an request letter for collection of your samples.
• Then, your product(s) is sent to a lab to be analyzed to ensure that it is in line to the standard specifications.
• If the product(s) passes the lab testrequirements, the product is presented in the next meeting. At this point, decisions are made regarding whether the product is eligible to be granted a CAPA license number or not. The license number is usually at least two times the size of the product. If the product meets the specifications, a license number is issued.
• After the product has been issued a the license number, you can proceed to get an email with the number of notification. Then, you’ll have 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 as you wait for your certificate to be issued. It can take up to six months time for your certificate to be issued. The certificate is usually valid for five (5) years.

Required Documents For Register with Central Administration of Pharmaceutical Affairs

• The term “contract manufacturing agreement” refers to a Contract Manufacturing Agreement. This is a legal agreement between the applicant and the manufacturer. It has to be notarized by Notary Public at the place of manufacture , and signed by the manufacturer of the product, and then and signed by the top management.
• Manufacturing License for Manufacturing. It is a permit or certificate granted by the a relevant authorities in the country of manufacture which allows the manufacturer to manufacture pharmaceutical products. It also states that the product is sold within that country, and is able to be sold freely in different countries.
• Certification of Pharmaceutical Products
• The current Good Manufacturing Practice (GMP) Certification of Manufacturing facility. Note: Numbers b, c and d are issued by a regulatory body or health agency and then authenticated with the Egyptian Embassy in the country of the origin. In countries where there isn’t an Egypt Embassy is present, the British High Commission or any Commonwealth or ECOWAS country commission can be authenticated.
• Brand Letter Confirmation of Brand. It is issued by the manufacturer when it is confirmed that their manufacturer’s brand name(s) are owned by the owner of the brand. It also states that the trademark name(s) belongs to the person applying for it, and that the applicant must proceed to register the brand name with CAPA.
• Comprehensive Certificate of Analysis Issued by the manufacturer in the company’s name with the designation of the analyst.
• Certificate of Registration of the brand name with the trademark registry within the ministry of finance in Egypt.
• Certificate of incorporation.
• Current pharmacists license to practice, issued by the council of pharmacists in Egypt.
• Valid pharmacist’s premises permit to practice, issued by the Council of pharmacists of Egypt.

Office Locations and Contacts

Pharmaceutical Affairs Central AdministrationEl-Rawda, Cairo Governorate, Egypt
Phone: +20 2 25354100

Medicines Regulatory Authority
Name of the administrator or contact number
E-mailinfo@eda.mohp.gov.eg
The number to dial: +202 25354100.
Physical address
21.AbdEl-Aziz Al Soud Street, EL-Manial, Cairo, Egypt
Addresses for postal mail
21 . Abd El-Aziz Al Soud Street, EL-Manial, Cairo, Egypt
Contact link: URL

What are all the Eligibility

Any company or individual who are interested in exporting and importing the highest quality of food supplements, human as well as veterinary drugs, and related products from Egypt.

Fees

• There is no payment to be made on an oral contract.
• Consultants’ fees must not exceed the scales that have been approved by the Government rates that are in that time in
• A contract’s interim payment is not required to exceed the cost of the work completed and the products supplied up until date. It is only made against interim certificates, which are authenticated by the Director of the user for the approval of the Chairman.
• For each contract (where applicable) the pre-determined portion of the the contract will be retained to Commission for a pre-determined period of time. Commission for a specified time frame of not more than six months from the date of the taking over of the project;

Prior to the release of the final payment, or retainer money gets released Director will verify that the contract is successfully completed, that each of the Interim charges have been taken and that all faults were rectified satisfactorily.

Documentation is needed

CAPA is an official body for regulatory purposes that carry various assessments and monitoring for veterinary and human medicine including food supplements, insecticides and medical devices, as well as cosmetics to make sure they are of a satisfactory standard , with the intention of ensuring that everyone is able to access reliable, safe, affordable, and safe products.
The purpose for CAPA is to attain the highest level of scientific excellence in assessment and oversight of both veterinary and human medicine including food supplements as well as insectsicides, medical equipment, and cosmetics for protection and enhancement of health for the public. In addition, it provides an environment that encourages transparency, mutual respect and trust.
CAPA includes four Services-related departments that include:

• Registration Department.
• Licensing & Pharmacists services Department.
• Inspection & Control Department.
• Importation & Exportation Department.

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