In order to carry out any marketing activities for a local or imported pharmaceutical product in the Egyptian market, a prior approval to this effect must be obtained from the Technical Committee for Pharmaceutical Control at MoH.
The procedures for obtaining such approval are detailed under Ministerial Decree no. 113 of 2004 on Pharmaceutical Marketing.
An application shall be summited to CAPA attached with the required supporting documents, technical information and samples of the product.
The applicant shall also submit the necessary information regarding the cost of such relevant product and its prices at the manufacturing state and other countries in which the product is traded. NODCAR shall analyze a sample of such product and notify CAPA of its result and opinion. Further, a pricing committee will undertake the determination of the price to be offered to public.
The Technical Committee for Pharmaceutical Control will issue its final decision on the requested marketing activity. If approved, the committee will grant the applicant a registration number which is considered as the approval for marketing the product in Egypt.
Advertisement of pharmaceutical products by any means, either in newspapers, magazines, radio, TV or any other modern advertising channels must be preapproved by the Supervisory Committee on Emerging Treatment Systems established by Ministerial Decree 255 for 1998. Whoever breaches the foregoing shall be subject to legal liability and the withdrawal of its professional license. According to Ministerial Decree 76/2000, the content of the advertisement of drugs, pharmaceutical products and dietary supplements will be monitored by the MoH which shall review the accuracy of the data and technical information to be announced in the advertisement. The advertisement shall abide by the rules of the laws, ministerial decrees, morals and traditions. An Arabic version of the package of the product and its labeling and prescription shall be submitted and kept with the MoH.
Violating these requirements can result in deregistration of the product and its withdrawal from the Egyptian market.
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.
