Pharmaceutical entities, as defined under the Pharmacy Law include:

  • Public pharmacies.
  • private pharmacies.
  • Factories of pharmaceutical products.
  • Drug warehouses.
  • Drug agent's warehouses.
  • Stores trading in medicinal plants and its proceeds.

Before establishing a pharmaceutical entity, a license must be obtained from MoH. A pharmaceutical entity may not be used for any purpose other than that specifically provided under its license. Any changes or amendments to the pharmaceutical entity must be approved in advance and will be reflected in the entity's license. The license is personal, and may not be transferred to a third party without the prior approval of MoH which will ensure that the transferee fulfills the requirements set out by the law.

A license may be cancelled if the licensed entity (i) does not commence its activities within 6 months from the issuance date of the license, (ii) is closed in a continuous manner for a period exceeding 1 year, and (iii) changed its the licensed location without prior approval of MoI.

The manager of a pharmaceutical entity must be a pharmacist with at least one-year practical experience in a governmental or national pharmaceutical entity. However, for private pharmacies and pharmaceutical intermediary warehouses, the manager may be an assistant pharmacist who is registered with the MoH. The manager may not manage more than one entity.

Establishing, operating, managing a pharmaceutical entity without a valid license is penalized by imprisonment for a period not less than one year and a fine not less than EGP 5,000 and not exceeding EGP 10,000. This is beside closure of the entity itself

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.