With the aim to encourage the pharmaceutical industry, a strategic industry, while exercising effective control over it, the Egyptian Drug Authority (the “EDA”) has recently issued Decree No. 505 for 2021 (the “New Decree”), which sets out new conditions with regard to the registration requirements for pharmaceutical companies who have their products manufactured by means of a toll manufacturing process.
Below are the key highlights of the New Decree:
The New Decree requires pharmaceutical companies who manufacture their products through a toll manufacturing process to renew their registration at a Registry created for that purpose within the EDA every 10 years. The renewal request shall be submitted within the last three months of the registration period. In addition, each company must have its own licensed warehouse measuring at least 100 square meters.
For companies registered before 31 December 2018 and whose registration is more than ten years old, they must renew their registration by 1 January 2024. For companies registered before 31 December 2018 and whose registration took place less than ten years ago, they must renew their registration during their tenth year of registration.
Any company that does not abide by the above registration requirements shall have its registration cancelled.
The head of the Central Administration of Operations at the EDA (the “CAO”) should issue a Regulatory Manual within five working days of the publication of the New Decree, organizing the registration process for companies in the pharmaceutical sector who manufacture their products through a toll manufacturing process. Companies who violate the provisions set forth in the Manual can have their registration suspended for up to six months. If they fail to rectify the violation within such six-month period, the registration shall be cancelled.
A company’s registration may also be cancelled in any of the following cases:
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- If it changes its name, address, object or license owner in its Commercial Registration form and fails to notify the CAO within three months.
- If it receives a license from the EDA to operate its own factory to manufacture pharmaceuticals.
- If it owns registered pharmaceutical products and fails to show evidence of manufacturing and supplying a single pharmaceutical product in the market upon renewing its registration.
Market Reaction
The EDA has stated that the New Decree is expected to open up more prospects for development and support of the local pharmaceutical industry. It will provide an increase in products for licensed companies and will encourage the Egyptian pharmaceutical industry to supply the market with pharmaceutical products at the highest level of safety and efficacy.
