According to Ministerial Decree no. 174 of 1999, pharmaceutical products, medical requirements, cosmetics, home pesticides, diagnostic materials, food therapeutic and vaccines, may not be imported or released by the customs unless registered and approved by MoI in accordance with the Pharmacy Law.
According to Pharmacy Law, such products may neither be imported into Egypt nor released from the customs unless the following conditions are met:
The registration of the importing company with the Importers Register at the General Organization for Export and Import Control (GOEIC). In order to register in the Importers Register, an importation company must be fully owned and managed by Egyptian nationals.
The registration of the importing company at the Importers Register at the MoH and the registration of the relevant pharmaceutical products with the MoH. The products must be properly packaged. They cannot be imported individually or by piece.
The label must indicate the necessary information about the pharmaceutical product (i.e. the name of the factory which has prepared the pharmaceutical product or carried out its packaging, usage instructions, dosage, etc.).
Importation of pharmaceutical products are allowed only from the manufacturing company which are registered at MoI.
To ensure meeting the local market needs, importers are required to import enough quantities of the product on a regular basis according to a plan approved by the MoH.
Article 66 of the Pharmacy Law provides that any pharmaceutical product listed in a pharmacopeia may not be released from the Egyptian customs unless such product: (i) indicates the name of the pharmacopeia under which it is listed, (ii) indicates the date of its preparation and assembly, (iii) indicates that it follows the conditions laid down under such pharmacopeia, and (iv) is securely packaged. Imported products may not be released from customs without approval of MoH.
According to Article 68 of the Pharmacy Law, any imported pharmaceutical product (whether special or by virtue of a pharmacopeia) can only be released to the persons licensed to trade in such products. Individuals may import certain pharmaceutical products for personal use after acquiring the necessary exceptional permit from the MoH.
Without prejudice to any severer penalties provided under any other law, whoever imports, produces for trade, sells or offers for sale any pharmaceutical products or medical devices which the MoH has not issued a license for their use or trading shall be subject to fine not less than EGP 20,000 and not more than EGP 50, 000. Further, in case such crime was committed by the owner or manager of the pharmaceutical institution, the latter shall be closed for a period not less than one month and not more than one year. In case of recurrence of violation, the abovementioned penalties shall be doubled.
Originally published March 07, 2017
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