Detailed requirements and procedures for registration of pharmaceutical products, whether locally manufactured or imported, are listed in the Ministerial Decree no. 425 of 2015. Requirements and procedures differ according to the following categories of products:
- Imported fully finished products.
- Imported semi-finished products (Bulk), which are manufactured outside but packaged in Egypt.
- Locally products manufactured by licensed manufacturing factory in Egypt.
For the registration of any of the aforementioned categories of products, the applicant shall inquire about the status of the product in the relevant generic group/box. The price of the product shall be determined within sixty (60) days from the date of submitting the required documents.
For imported fully finished products, the applicant shall submit, among others, (i) an authenticated certificate of pharmaceutical product (CPP) from the country of origin (ii) an authenticated agency agreement or official authorization by the market authorization holder, who is the owner of the product registration; and (iii) a copy of the manufacturing contract with the foreign company (for licensed products).
For semi-finished products (Bulk), same requirements shall apply in addition to the packaging agreement between the importing company and the packaging company (in case the importing company does not have a licensed factory).
Annex 1 of the decree decides the maximum number of products registered for each generic group box including the brand or innovator. In case such number is reached, the registration of additional products shall be subject to a waiting list, unless one of the exceptions listed in the Annex 1 applies.
Annex 2 of the decree lists the generic groups/boxes and their forms. If a new pharmaceutical form is created, it can be added to Annex 2 after getting the approval of Technical Committee for Supervising Drugs at CAPA.
Locally manufactured products can be totally owned by an Egyptian entity or manufactured in Egypt under the license of a foreign market authorization holder. In this last case, the manufacturing can either be done by foreign market authorization holder or via third party manufacturer under a toll manufacturing agreement.
Applying to register a pharmaceutical product is only allowed to:
- Licensed pharmacists, doctors or dentists.
- Owners of local pharmaceutical manufacturing facilities.
- Owners of foreign pharmaceutical manufacturing facilities.
- Agents of foreign pharmaceutical manufacturing facilities.
Registration of a pharmaceutical products is renewable every 10 years. A renewal request shall be submitted to CAPA a year before the expiry date of the registration. If the ingredients of the products have changed, it will be go through the registration procedures of a new product.
An applicant who failed to renew the registration within this last year, will be given a grace period, with a maximum of two years from the expiry date. After the lapse of such grace period without finalizing the renewal procedures, the registration of the product will be cancelled.
According to Ministerial Decree No. 60 of 1998, pharmacies are prohibited from dealing in unregistered pharmaceutical products. They are also required, in case of receiving a prescription with unregistered product, to promptly notify CAPA and the Pharmacists Syndicate and to stamp the prescription with the pharmacy stamp indicating that such product is not traded.
MoH is authorized to ban any registered pharmaceutical product in case it is harmful to the public health as recommended by the Technical Committee for Supervising Drugs. In this case, product shall be deregistered and will be confiscated without any compensation or liability against the MoH.
March 07, 2017
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.