Executive summary

On 22 September 2025, the Ministry of Pharmaceutical Industry published the Ministerial Decree No. 17, which updates the legal framework governing the authorization process for pharmaceutical manufacturing establishments.

Ministerial Decree No. 17 modifies the decree of 22 June 2021, and introduces new requirements regarding:

• Documentation to be submitted when applying for approvals
• Procedures for file processing
• Treatment of renewals
• The definition of substantial modifications and the approval process.

All pharmaceutical manufacturers in Algeria must align with the new provisions within 24 months from publication in the Official Gazette.

Key provisions

Two-stage authorization process

Pharmaceutical manufacturing establishments must obtain two separate authorizations.

First, they must obtain preliminary approval ("agrément préalable de réalisation"), authorizing the acquisition of equipment and initiation of the project. This is valid for two years and is renewable.

Second, they must obtain activity launching approval ("agrément d'ouverture") authorizing the effective start of operations. This is valid for five years and is renewable).

Both applications must be filed electronically by the pharmacist technical director (i.e., technical director of the pharmaceutical company).

Documentation requirements and timeline

Preliminary approval

An application for preliminary approval must be filed and must include:

• A request under an administrative form to create a pharmaceutical manufacturing establishment
• Corporate documents (statutes, commercial register, property/lease documents), including the appropriate activity codes
• The prior agreement for creating a classified establishment
• The technical file (e.g., site plans, environmental and safety approvals, equipment layout, air and water treatment systems, production flows, quality systems and the envisaged pharmaceutical operations)
• The file of the pharmacist technical director, including a work permit in case of foreigners
• The list of different pharmaceutical forms of drugs or classes of medical devices
• Production capacity details, product ranges, technology transfer agreements and subcontracting contracts
• Designation of the type of medical radiopharmaceutical, the risk management and radiation protection approach, proof of the technical director's competence in radiation protection and authorization from the Atomic Energy Commission for radiopharmaceutical products

Once the preliminary approval is requested, the requesting establishment will be notified within five days.

The file will then go through a technical review conducted by National Agency of Pharmaceutical Products inspectors. The review usually takes 15 days to two months, depending on the nature of the file. The documents and attached reports will then be submitted to the technical commission at the Ministry of Pharmaceutical Industry, which holds its ordinary session every 15 days to examine and decide on requested agreements. Once the technical commission has examined the request, the ministry will notify the requester of its decision within eight days.

Activity launching approval

To obtain the activity launching approval, the requester must submit:

• A request under an administrative form to open a pharmaceutical manufacturing establishment
• The site Master File
• The pharmacist assistant file
• Authorization of exploitation of a classified establishment
• The notice of compliance with safety standards established by civil protection services
• The document related to the conditions of securing the premises and pharmaceutical documents
• Proof of payment of royalties for the expertise request of the establishment
• The document justifying the withdrawal of reservations issued by the competent services of the ministry during the realization phase, if any

Once the activity launching approval is requested, the Ministry of the Pharmaceutical Industry must screen the applicable files within five days. The file is then submitted to the manufacturing site for a technical evaluation, which will be performed by the National Agency of Pharmaceutical Products inspectors. The evaluation report will be reverted within 15 days to three months. The documents and attached reports will then be submitted to the technical commission at the Ministry of the Pharmaceutical Industry, which holds its ordinary session every 15 days to examine and decide on the requested agreements.

Once the commission has examined the request, the Ministry will notify the requester of its decision within eight days.

Incomplete or noncompliant dossiers will be rejected when received by the Ministry of the Pharmaceutical Industry.

Renewal obligations

The technical director must submit renewal requests electronically to the Ministry of the Pharmaceutical Industry within two months (preliminary approval) or four months (opening approval/activity launching approval) before expiry.

Renewal requires evidence of project progress, absence of substantive changes and clearance of any prior reservations.

Substantial modifications

Certain changes require prior authorization from the Minister in charge of pharmaceutical industry, after the technical commission review. These include:

• New pharmaceutical forms or therapeutic classes
• Manufacturing of hazardous active substances
• Addition/removal of equipment, production lines or premises
• Changes to air/water treatment systems

The authorized pharmaceutical establishment must also declare to the Minister in charge of the pharmaceutical industry any modifications having a non-significant impact relating to the information stated in the authorization, within 15 days, as well as any other modification that is not of a substantial nature, in particular:

• The name change of the establishment
• The change of the legal form of the pharmaceutical manufacturing establishment
• The transfer of the registered office of the pharmaceutical manufacturing establishment
• The appointment of a new technical director, within 30 days after the resignation of the previous technical director

Non-substantial modifications only require notification to the appropriate services at the level of the Ministry of the Pharmaceutical Industry.

Special provisions

The decree also includes special provisions. Accelerated review is possible for high-value or emergency-use medications and devices.

In addition, specific rules apply to subcontracting arrangements that require quality agreements and detailed risk management procedures. Finally, noncompliance with dossier completeness, regulatory obligations or project timelines could result in applications being rejected.