Foreign Manufacturers as Detenteur and the Local Exploitant

1. Key takeaways

Algeria splits market responsibility in two with two French terms: the détenteur (holder) and the exploitant (operator). Under Article 4 of Décret exécutif n° 21-82, the holder may be a local production-type pharmaceutical establishment or a foreign establishment holding device certification or a homologation decision in its country of origin; but the second paragraph makes clear that a foreign holder must entrust exploitation to a local exploitation-type pharmaceutical establishment.

Article 9 further provides that the two bear joint responsibility for entrusted matters. GRZAN’s recommendation is that the foreign manufacturer retain the holder role to keep sovereignty over the product, while the local partner takes the operator role to hold the executive capability for importation and vigilance.

This division of labor is not optional drafting style; it is written into the approval documents themselves. The names of both roles appear on the homologation decision, and any change to either one is a regulated event requiring a new decision rather than a contractual amendment alone.

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 11 Rajab 1442 corresponding to February 23, 2021 on pharmaceutical establishments and the conditions of their agrément, JORADP No. 14, published 2021-02-28, pages 9–12, 29 articles), Article 4 (eligibility of the holder and entrustment of exploitation) and Article 9 (duties of exploitation establishments and joint responsibility).
2. 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 6 Rabie Ethani 1442 corresponding to November 22, 2020 on the modalities of homologation of medical devices, JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Article 18 (only recognized pharmaceutical establishments may submit the application).
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Article 33 (the homologation decision must state the name and address of the holder and the name and address of the operator).
4. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Article 32 (the decision is issued only to establishments referred to in Article 18) and Article 43 (transfer or assignment requires a new decision).

3. Expert insights

Insight one: both role names are written into the homologation decision — they are public facts.

Article 33 requires the decision to state 9 items, of which the fifth is the name and address of the holder and the sixth is the name and address of the operator. The role division is therefore not an internal commercial arrangement but a statutory record printed on the certificate, and any later change goes through Article 43 with a new decision. Treat the certificate as a mirror of your architecture: if the certificate looks wrong, the architecture is wrong.

Insight two: the foreign holder’s qualification is certification or a homologation decision from the country of origin.

The wording of Article 4, second paragraph, refers to an entity holding device certification or a homologation decision in its country of origin. In practice GRZAN typically prepares the market authorization or free sale certificate issued by the competent authority of the country of origin, together with corporate documents proving that the foreign entity is the holder of that certificate, and completes consular legalization. Without the proof-of-identity chain, the second paragraph cannot be invoked.

Insight three: the joint responsibility clause turns the entrustment contract into a regulatory document.

The final sentence of Article 9 on joint responsibility means the ANPP can pursue both parties simultaneously on vigilance, recall and batch release matters. The entrustment contract therefore cannot be a generic distribution agreement; it must map item by item to the duties enumerated in Article 9: registration, homologation, pharmacovigilance, device vigilance, release and batch tracking, and where necessary withdrawal. Each mapped duty should name the responsible party and the cooperation duty of the other.

Insight four: Article 32 locks the issuance of the decision to Article 18 establishments.

Even though the holder may be a foreign entity, the homologation decision itself is issued only to the pharmaceutical establishment referred to in Article 18. What the foreign holder obtains is the status of being recorded on the decision, not the status of receiving the original. Practical consequences follow: certified copies, records references and correspondence routes should all be planned around the local establishment’s custody of the document.

4. Practical recommendations

1. Map the agreement clause by clause to the six duties enumerated in Article 9, stating the division of labor and the cooperation obligations on each.
2. The foreign holder prepares the country-of-origin market authorization or free sale certificate and completes legalization and translation.
3. After the certificate is issued, verify the 9 items of Article 33 word by word, focusing on the holder, the operator, the manufacturer and the site address.
4. Plan role changes in advance and apply under Article 43 for the ANPP to issue a new decision; never execute first and report later.
5. Build a two-way vigilance information transmission mechanism between holder and operator to satisfy the joint responsibility requirement.
6. Include in the agreement an internal recourse path should one party be held liable by the ANPP.

5. Verification checklist

• □ The agreement maps the six duties of Article 9 clause by clause.
• □ The foreign holder’s country-of-origin market authorization or free sale certificate is ready and legalized.
• □ The 9 items of Article 33 have been verified word by word after issuance of the certificate.
• □ Role changes are planned through the Article 43 new-decision procedure.
• □ A two-way holder–operator vigilance transmission mechanism is in place.
• □ An internal recourse path is written into the agreement.

Related reading in this series

• Article 07, Who can submit the application: the entity threshold of Article 18 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/who-can-submit-homologation-application/
• Article 34, The 9 items that must appear on the homologation decision: Article 33 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/nine-items-on-homologation-decision/
• Article 33, 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 October 30, 2026.

GRZAN structures holder and operator arrangements for foreign manufacturers entering Algeria, including certificate verification, legalization support and vigilance cooperation frameworks. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.