The Ministry of Pharmaceutical Industry has defined the new conditions to be met by importers of pharmaceutical products and medical devices, repealing the order dated 30 October 2008 adopted by the Ministry of Health.
The order of 14 February 2021 setting out the new technical conditions for the import of pharmaceutical products and medical devices for use in human medicine was published in the Official Gazette of 2 March 2021. The full document can be downloaded below.

The highlights of the new specifications are summarized below:

• The import of pharmaceutical products and medical devices is allowed to pharmaceutical establishments duly approved for import;

• The importing pharmaceutical establishment undertakes to demonstrate the exercise of a manufacturing activity of pharmaceutical products when the import related to pharmaceutical products;

• The importing pharmaceutical establishment shall procure the pharmaceutical products and medical devices only from authorized manufacturing sites in their countries of origin;

• The importing pharmaceutical establishment shall hold for each batch of imported pharmaceutical products and medical devices, the certificates of analysis and release of the batches from the various stakeholders involved in their manufacturing;

• The importing pharmaceutical establishment shall comply with the control procedures for pharmaceutical products and medical devices;

• The importing pharmaceutical establishment and the manufacturer will have to take a joint and several commitment and provide for specific clauses for the replacement of expired products or the granting of a credit note equivalent to their value;

• The importing pharmaceutical establishment shall carry out the imports in accordance with the issued import schedules and the submitted shipment schedule;

• The annual provisional imports are subject to a technical approval issued each year by the Ministry of Pharmaceutical Industry;

• Multi-year import programs may be granted for certain essential and specific pharmaceuticals and medical devices which are experiencing international tensions (under certain conditions);

• The technical visa takes into account data relating to the quantification of national needs, the availability of essential pharmaceutical products and medical devices and products of high therapeutic value, and is granted, as the case may be, to complement national production;

• The order defines the criteria that the packaging of drugs and medical devices shall meet, in particular the information that must be included, the information in the leaflet, etc.

However, some uncertainties remain and would benefit from clarification by the Ministry of
Pharmaceutical Industry; for instance:

• How does the importer have to demonstrate that he is engaged in the manufacturing of pharmaceutical products? Does the importer have to be the holder of a manufacturer’s license?

• Is an importing pharmaceutical establishment entitled to import raw materials to give them to a toll manufacturer without being the holder of a manufacturer’s license?

Other texts should be published by the Ministry of Pharmaceutical Industry in the coming weeks.

Summary prepared by Rym Loucif