The following elements should be taken into consideration when developing the executive regulations of Law No. 151 of 2019.
- Amend Article 1 of Chapter 1, Definitions, by including the following: “Medical products and devices are the medical products and medical devices as defined in Clauses 2 and 3 of Article 1 of the law”.
- The fee schedule included in Law 151 of 2019 should make reference to medical devices.
- Ensure making reference to the European standards that are adopted by medical equipment and laboratory reagents manufacturers, who have ben l under the supervision of the Ministry of Health for the past 20 years.
- Licensing local factories and warehouses: Factories should obtain their licenses from IDA and EDA to ensure that they adhere to GMPs, which are included in ISO 22716 or its equivalent.
- Oversight, inspection and market surveys: EDA must assume the responsibility to overseeing, and periodically inspecting cosmetics establishments, including factories, warehouses and places of sale. In carrying out their responsibilities, inspectors should be vested with law enforcement authority and powers. To ensure product compliance, EDA’s inspector may enter cosmetics factories, warehouses and places of sale for the purpose of inspection; they have the right to review the relevant records and documents, as well as collect samples of cosmetics products for inspection and analysis in the EDA’s laboratories or other accredited laboratories.
- Adopt an Egyptian system for cosmetic products that aligns with international practices adopted in EU countries, Saudi Arabia, as well as all East Asian countries; adopting such a system promises to expand Egypt’s cosmetics exports.
- Cosmetic products should not be subject to registration requirements; a notification system, which is adopted worldwide, should be used instead.
- Use international standards as a reference for setting the mandatory standard specifications for cosmetics.
- Institute an in-market control system for cosmetic products instead of requiring that products be tested prior to being placed on the market. In-market control system, which relies heavily on carrying out the needed testing while the product is on the market, is more appropriate to the nature of the cosmetic products, their volume of circulation, and the degree of potential health risks associated with using cosmetics, which is drastically lower than that of other medicinal and pharmacological products. This system will ensure the safety of customers, especially that many cosmetic products reach the Egyptian market in an illegal manner.
- Include representatives from the Cosmetics Sub-Chamber of FEI’s Pharmaceutical Chamber in the technical committee that will be set up for developing the executive regulations of the law.
- Exceptional Measure: Take advantage of the existing production capacity in the cosmetics sector to meet urgent needs; allow cosmetics manufacturers to obtain alcohol in order produce disinfectants for hospitals and other facilities.