Registration is a key to introducing drug products in the Egyptian pharmaceutical market. Article 59 of law no.127 of 1955 states that the pharmacies shall not sell drugs without having approval from the ministry of health (MOH) and this article applies to the local drugs and the imported drugs.
The Egyptian authorities have goals to reach from the registration like checking the effectiveness of the medicine and accessibility. Moreover, to provide the consumer with their needs at fixed prices, the Egyptian legislator put a price ceiling that is prohibited to exceed. From this, the registration is important to make the pharmaceuticals available and at fixed prices to make them affordable to the consumers to buy in addition, if Egypt imports medicines from foreign countries, they have to fulfil the requirements of registering the imported drugs, however, the required documents are different according to either the drugs is a local brand that manufactured in Egypt or imported fully finished products.
Registration Process for Pharmaceuticals in Egypt
Before starting the registration process. Egyptian law stipulates that the applicant must be one of the following:
- Licensed pharmacists or doctors or dentists;
- Owners of local pharmaceutical manufacturing facilities;
- Owners or agents of pharmaceutical manufacturing facilities.
The applicants shall follow this process in order to register the pharmaceutical products:
1. Request
The registration process starts with the applicant sending an email to “reserve a date: to submit an application form by filling the “submission request inquiry form” to the central administration of pharmaceutical affairs (CAPA). The email must be for one company only and it shall include the name of the company, company mail, telephone number & fax, and authorised person.
After sending this email, the (CAPA) shall reply to the email and state the time and date to submit the “Application form “while the other “submission request inquiry form” within three working days.
The company must apply on time because if they did not submit it at a specific time then their application form will be cancelled.
2. Pricing committee
After receiving the acceptance of the Application form, the second step is that the company must submit the price of the pharmaceutical product to the price committee and they shall reply within 60 days of receipt of the file.
3. Technical committee
The file may be referred to in this step in the following cases only :
- If the drug has a new component or has a new effective substance or does not have a scientific reference
- If the drug is new whether in the dosage or the shape
- If there is an international warning about the component of the drug
After checking on those cases, the file is then transferred to the pharmacist service department within 8 months from the date of pricing.
4. Stability committee
This committee is for doing research on the drug within 60 days of the receipt of the file.
5. Naming committee
The file is transferred to this committee to approve the name of the drug.
6. Inspection committee
The inspection shall give the preliminary approval for 3 days.
7. National organisation for drug control & research (NODCAR)
This process is one of the important steps as this organisation is affiliated with the Ministry of Health (MOH). This organisation is for quality control authority that ensures the quality, safety and effectiveness of the pharmaceutical product.
They shall reply within 45 days of the receipt of the file.
8. Bioequivalence committee
This step is unnecessary if the product does not require a bioequivalence test that is under the international standard. So the company shall take the approval within 30 days of the receipt of the file.
9. Further stability studies
The applicant shall perform a stability study on the first batch and be presented to the authorities within 8 months from the production date. Moreover, the second batch will not be released until the studies have been made and took approval from (NODCAR). Finally, the applicant got the preliminary approval.
10. Final approval
Before issuing the final approval, the authorities have the right to reject the form at any of those stages that are mentioned above. However, if the applicant got the approval from all of these stages then he shall receive the final approval which shall be valid for 10 years from the date of issuing the preliminary approval.
Requirements to Register an Imported Drug in Egypt
The Egyptian legislator differentiated between the fully imported drug and the semi-finished product which are packaged in Egypt.
- The fully imported drug:
The process is the same as the local drug that is mentioned above but there are extra requirements that the applicant should submit to the central administration of pharmaceutical affairs (CAPA) the following:
- Submit an authenticated certificate of pharmaceutical product (CPP) from the country of origin.
- Authenticated agency agreement or authorization from the owner of the product registration.
- Submit a copy of the manufacturing agreement with the foreign company.
- List of countries where the product is market.
- Semi-finished product:
The semi-finished product is required to submit all the documents that are mentioned above in addition to the packaging agreement that is between the imported company and the packaging company.
After submitting these documents and receiving the approval mail that authorizes them to enter the Egyptian market. The last step that should be taken is the registration of the patent from the intellectual property.
Conclusion
There are 10 steps that should be taken to register pharmaceutical products in Egypt. In addition to the required documents to submit for the imported drug. Moreover, the ministerial decree no.147 of 1974 stipulates that the duration of the medical use is 10 years and after that applicant shall renew the registration otherwise the registration will be cancelled.
