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09 October 2025

Algeria issues regulation on good manufacturing practices certification for pharmaceutical establishments

  • Ministerial Decree No. 21 dated 30 September 2025 establishes the procedures for issuing the Certificate of Good Manufacturing Practices for pharmaceutical manufacturing establishments in Algeria.
  • The certificate is valid for two years and requires renewal through an on-site inspection to ensure ongoing compliance with national and international manufacturing standards.
  • The Ministry of the Pharmaceutical Industry will maintain and regularly update an online list of certified facilities, enhancing transparency and regulatory oversight in the pharmaceutical sector.
  • Entities involved in the importation of pharmaceutical products should prepare for compliance with the new certification requirements and ensure their facilities are ready for inspections to obtain or renew their certificates.
 

Executive summary

On 30 September 2025, the Ministry of the Pharmaceutical Industry (Ministry) issued the decree No. 21, establishing the procedures for granting the Certificate of Good Manufacturing Practices to pharmaceutical manufacturing establishments in Algeria.

The new framework standardizes the issuance, renewal and publication of the certifications, reinforcing regulatory oversight, transparency and compliance with national and international manufacturing standards. The certificate is now valid for two years, subject to renewal following inspection. The Ministry will publish online a list of certified facilities.

Key provisions

Competent Authority

The certificate is issued by the Ministry based on an on-site inspection conducted as part of the facility's licensing (agrément) process.

Validity and renewal

The Good Manufacturing Practices certificate is valid for two years. Renewal is subject to a new inspection verifying continued compliance.

Transparency and publication

The Ministry will regularly publish and update the list of certified establishments on its official website

Transitional provisions

Existing Good Manufacturing Practices certificates issued before the entry into force of the present decree will remain valid until the expiry of their assigned validity period.

Implications

Entities involved in the importation of pharmaceutical products should prepare for compliance with the new certification requirements and ensure their facilities are ready for inspections to obtain or renew their certificates.

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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: 2025-2046

 

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