Five Types of Pharmaceutical Establishments under Executive Decree 21-82

1. Key takeaways

Article 2 of Décret exécutif n° 21-82 divides pharmaceutical establishments into five categories: production establishments, operation (distribution) establishments, import establishments, wholesale establishments, and export establishments. Article 5 provides that a single establishment may carry out one or several of these activities, provided that it complies with the rules specific to each activity, including BPF (good manufacturing practice), storage, distribution, pharmacovigilance and materiovigilance requirements. Articles 6 through 12 then define the duties of each category in detail.

The practical conclusion reached by GRZAN in partner due diligence is straightforward: when searching for a local partner in Algeria, look first at the categories of activity recorded on the agrément, and only then assess whether the establishment genuinely has the operational capability to perform them. A certificate that lists a category on paper is not the same as an establishment that can actually run import logistics, batch release, or post-market vigilance. The five-category structure of Article 2, read together with Article 5 and Articles 6 to 12, therefore forms the baseline checklist for evaluating any Algerian pharmaceutical establishment that intends to handle medical devices.

2. Legal basis

1. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021 on pharmaceutical establishments and the conditions of their agrément, JORADP No. 14, published 28 February 2021, pages 9–12, 29 articles in total): Article 2 (five categories of establishments), Article 5 (multiple activities permitted subject to compliance with applicable rules), Article 6 (production establishments), Article 9 (operation establishments), Article 10 (import establishments), Article 11 (wholesale establishments), Article 12 (export establishments).
2. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 2 July 2018 on health, JORADP No. 46, published 29 July 2018): Article 219 (establishments classified into the five categories of production, operation, import, export and wholesale).
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles in total): Article 18 (only establishments recognised under Articles 218 and 219 may submit homologation applications).
4. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021, JORADP No. 14, published 28 February 2021, pages 9–12, 29 articles in total): Article 3 (establishments must take the corporate forms provided by commercial law and are subject to authorisation by the Minister of Pharmaceutical Industry).

3. Expert insights

Insight 1: the five-category division mirrors Article 219 exactly, but the duties are newly drafted. Article 219 of Loi 18-11 lists only the names of the five categories; Articles 6 to 12 of Executive Decree No. 21-82 assign concrete duties to each category. This two-layer structure of name plus duties means that a category label alone is never sufficient evidence of competence. When assessing a partner, the reviewing team must verify that the establishment actually possesses the conditions needed to discharge the duties attached to that category — premises, qualified staff, procedures, and systems for storage, release and traceability.

Insight 2: operation establishments under Article 9 are the most critical category for device projects. Article 9 provides that operation establishments are responsible for the commercial operation of registration and homologation decisions. They must assume all operations related to registration, homologation, pharmacovigilance, materiovigilance, release and batch tracking, as well as recall where necessary. In effect, this single article places almost every post-market obligation of a device project on the shoulders of the operation establishment. A partner who holds an operation agrément but lacks vigilance and traceability systems will become the weak point of the entire compliance chain.

Insight 3: the role of import establishments under Article 10 is resale in the same state after import. Article 10 provides that import establishments import products and/or devices and resell them as such (en l’état) to wholesale establishments and public institutions, or make them available for clinical research, while satisfying the conditions for storage, quality and batch release. Note carefully that import establishments do not face the end market directly: their resale counterparties are wholesale establishments and public institutions. This channels the distribution flow through controlled, licensed intermediaries.

Insight 4: wholesale establishments under Article 11 expressly exclude investigational medicinal products. Article 11 provides that wholesale establishments handle the procurement, storage and transport of products and devices (with the exception of investigational medicinal products), and distribute them as such to other wholesale establishments, retail pharmacies, and private and public healthcare institutions. This exclusion signals that clinical trial samples do not travel through the wholesale channel and must be arranged separately, under the applicable clinical trial framework.

4. Practical recommendations

1. In partner due diligence, first request the original agrément and verify the categories of activity recorded on it.
2. For device projects, give priority to establishments that hold both the operation and import qualifications.
3. If a partner holds only a production agrément, do not assign import or operation functions to it.
4. In the agreement, allocate each of the six duties enumerated in Article 9 on an item-by-item basis.
5. Arrange a separate channel for clinical trial samples; do not route them through wholesale establishments.
6. Periodically re-verify whether the scope of activity on the partner’s agrément has changed.

5. Verification checklist

• □ The partner’s original agrément has been obtained and the activity categories verified.
• □ Establishments holding both operation and import qualifications have been given priority.
• □ No establishment lacking an import qualification has been assigned import functions.
• □ The agreement allocates the six duties of Article 9 item by item.
• □ A separate channel for clinical trial samples has been arranged.
• □ A re-verification mechanism for changes in the partner’s scope of activity is in place.

Further reading in this series: Who can submit the homologation application: the Article 18 threshold of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/who-can-submit-homologation-application/ ; Obtaining, lapse and transition of the agrément: Articles 19 to 27 of Executive Decree 21-82 — https://www.grzanglobal.com/algeria-medical-device-registration/agrement-obtaining-lapse-transitional/ ; Joint liability of holder and operator: Articles 4 and 9 of Executive Decree 21-82 — https://www.grzanglobal.com/algeria-medical-device-registration/joint-liability-holder-and-operator/

Regulatory information verified as of 30 October 2026.

GRZAN supports medical device manufacturers entering Algeria with the appointment of a qualified local authorised representative and importer, the drafting of operation agreements aligned with the agrément categories of Executive Decree n° 21-82, and complete fee budgeting in Algerian dinars (DZD). For assistance with partner qualification or any question on this topic, contact info@grzanglobal.com.