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27 October 2025

Algeria establishes new requirements for licensing pharmaceutical import establishments

  • On 1 October 2025, the Ministry of the Pharmaceutical Industry issued decree No. 24, which sets out the requirements, procedures and compliance obligations for the licensing of pharmaceutical import establishments in Algeria.
  • This updated framework replaces the decree of 20 December 2021, modernizing the application process and strengthening oversight of pharmaceutical import activities.
  • The new decree defines the content of the application file, processing and inspection procedures, and the rules governing substantial modifications, renewal and withdrawal of authorizations granted.
  • Authorized import establishments must align with the new requirements within 12 months of the decree's publication in the Official Journal.
 

Executive summary

On 1 October 2025, the Ministry of the Pharmaceutical Industry issued decree No. 24, which sets out the requirements, procedures and compliance obligations for the licensing of pharmaceutical import establishments in Algeria. The ministerial decree aims to regulate elements of an application file seeking approval for a pharmaceutical establishment to import pharmaceutical products and medical devices, the procedures for processing the file, as well as the list of substantial modifications.

The new framework standardizes the issuance, renewal and publication of authorizations that grant these applications, reinforcing regulatory oversight, transparency and compliance with national and international manufacturing standards. Authorizations will now be valid for two years, subject to renewal following inspection, and the Ministry will publish a list of certified facilities online.

Key provisions

Competent authorities

The Ministry of the Pharmaceutical Industry delivers an authorization only after a thorough inspection by the National Agency for Pharmaceutical Products.

Validity, renewal and withdrawal

The authorization is valid for a period of two years. Renewal is subject to a new inspection verifying continued compliance.

The Technical Director Pharmacist's authorization to practice is also valid for two years and renewable.

Obligations and reporting

Import establishments must maintain records of all purchase and sales transactions and submit an annual import report by 31 January of the following year.

Modifications

Substantial and non-substantial modifications (e.g., change of headquarters, warehouse site or expansion) must be declared within 15 days to the competent services at the level of the Ministry of the Pharmaceutical Industry.

Requests for substantial modifications are processed within two months starting from the date of reception of the modification file.

Implications

Pharmaceutical establishments must align with the new requirements to be compliant and avoid withdrawal of non-obtention of their authorization.

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Contact Information

For additional information concerning this Alert, please contact:

Ernst & Young Advisory Algérie

Published by NTD’s Tax Technical Knowledge Services group; Carolyn Wright, legal editor

Document ID: 2025-2172

 

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