On 25 August 2019, Law No. 151 of 2019 was issued for the establishment and regulation of two new public authorities in the pharmaceutical sector, namely, the Egyptian Drug Authority ("EDA") and the Egyptian Authority for Unified Procurement, Medical Supply and Technology Management ("AUPP").
The law will enter into effect 6 months from the date of its issuance, i.e., 24 February 2020. Below is a summary of the role of each authority.
The Egyptian Drug Authority (EDA)
The Egyptian Drug Authority (EDA) is established as a public service authority affiliated to the Prime Minister to be responsible for all drug related matter.
EDA will be the regulatory authority responsible solely for the registration, licensing, inspection and supervision of all pharmaceutical and cosmetic products, medical equipment and raw materials used in their manufacturing.
EDA has replaced following entities:
- National Organization for Drug Control and Research (NODCAR).
- National Organization for Research and Control of Biological (NORCB).
- Central Administration of Pharmaceutical Affairs (CAPA) in relation to the registration and licensing or pharmaceutical products.
The main responsibilities of EDA will be, among others, the following:
- Issuance of the necessary licenses for all pharmaceutical entities.
- Issuance of the operation licenses for factories of pharmaceutical products and medical equipment.
- Licensing private laboratories that are working in the pharmaceutical field.
- Examination of all pharmaceutical, biological products like medicines, cosmetics, insecticides, vaccines, serums, pharmaceutical devices, tools, medical lenses, diagnostic indicators in order to insure their quality, safety, effectiveness and compliance with the approved.
- Setting the rules and procedures for importation, exportation and pricing of all pharmaceutical products and medical equipment.
- Customs release of all imported pharmaceutical products and medical equipment.
- Licensing locally manufactured products and equipment.
- Issuance of the Egyptian Pharmacopeia.
- Inspection of all pharmaceutical entities and their officers and taking necessary legal actions against violations.
The Egyptian Authority for Unified Procurement, Medical Supply and Technology Management (AUPP)
AUPP as an exclusive medical procurement authority AUPP is established as a public economic authority to report directly to the Prime Minister.
AUPP will be the exclusive authority to carry out purchase transactions of pharmaceutical products and medical equipment on behalf of all governmental and public entities in Egypt.
UAPP will receive a fee up to 7% of the value of the procured products from the requesting governmental and public entities (“Requesting Entities”) in consideration of the procurement services it provides thereto.
According to the law, Governmental and public entity will be prohibited from making any direct purchase of pharmaceutical products or medical equipment except in case of emergency and after obtaining the approval of the Cabinet of Ministers. They are also prohibited from taking any loans to purchase pharmaceutical products or medical equipment without obtaining the approval of the Cabinet of Ministers.
Other authorities of AUPP
AUPP will be responsible, among others, for:
- Preparing the plan and the setting rules of the unified procurement from inside and outside Egypt.
- Preparing an annual budget for the unified procurement in collaboration with the Ministry of Finance.
- Reviewing, evaluating and approving the purchase requests submitted by the Requesting Entities.
- Coordinate with the pharmaceutical and medical equipment companies, whether Egyptian or foreign, to enhance the strategic storage of the products to face any unforeseen circumstances.
- Preparing annual reports on the expected procurement needs of the Requesting Entities.
- Entering into contracts with all companies and entities inside and outside Egypt to procure the needed pharmaceutical products and medical equipment.
- Conducting periodical inspection of the stock of the products and equipment at the Requesting Entities.
- Managing the transportation, distribution and storage system of the products and the equipment and inspecting the warehouses of the Requesting Entities.
- Managing a unified maintenance system of the medical equipment to ensure the after-sale services.
AUPP is given the authority to establish joint stock companies either solely or in partnership with other entities to achieve its purposes.