In order to manufacture pharmaceutical product, a company must obtain a prior license from MoH and the Industrial Development Authority ("IDA"). This is in addition to registration at the Industrial Register affiliated to the IDA.
No nationality restriction exits in relation to the owners of the manufacturing company.
In 2007, MoI issued a decision to adopt the WHO Good Manufacturing Practices for Pharmaceutical Products (GMP) as the Egyptian guide for good manufacturing standards. Manufacturer of pharmaceutical products are required by virtue of the Ministerial Decree no. 539 of 2007 to abide by this guide otherwise the violating production line can be suspended.
Within a month from the date of applying for the license, a special committee formed by MoH (formed by virtue of Ministerial Decree 2 of 1994) shall visit and inspect the factory and decide whether it fulfills the technical and health requirements.
Every factory must have a laboratory equipped with the necessary devices to test the raw materials supplied to the factory as well as the final products. This laboratory will be supervised by a pharmacist who will be independent from those pharmacists who prepare the drug at the factory. Both the preparing and the supervisory pharmacists will be liable for ensuring the quality and validity of the products.
A company may manufacture pharmaceutical products at the third party's manufacturing factory under a Toll manufacturing scheme. The manufacturing company must be registered in the toll manufacturing register at CAPA. A toll manufacturing agreement between the company and the third-party manufacturing factory shall be certified and approved by CAPA. According to the internal regulations issued by the MoH, in order for a company to be registered as a toll manufacturer, it must be, among others, owned 51% by Egyptian licensed medical professionals. The company must be managed by licensed pharmacist.
Originally published 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.