Joint Liability of the Certificate Holder and the Operator

1. Key takeaways

The final sentence of Article 9 of Décret exécutif n° 21-82 carries the greatest weight in Algerian device compliance: the certificate holder and the operator bear joint responsibility (responsabilité conjointe) for the delegated operations of the homologation decision. This clause elevates the commercial delegation between the holder and the operator into a statutory duty. Read together with the qualification rules of Article 4 and the duty list of Article 9, the recommendation of GRZAN is clear: the delegation contract must map onto Article 9 clause by clause; a generic distribution agreement is not sufficient.

In practice, this means the contract between the foreign manufacturer and its Algerian partner is not merely a commercial instrument. It is the document that fixes the boundary of who answers to the regulator for which operations. Every obligation that is left vague in the contract automatically widens the zone of shared exposure for both parties, because the statute attaches joint responsibility to whatever has been delegated, and delegation is construed from the contract itself.

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 4 (holder qualification and delegation of operation), Article 9 (duties of the operation establishment 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 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 (persons entitled to submit), Article 33 (the decision must state the names and addresses of the holder and the operator), Article 43 (transfer or assignment requires a new decision).
3. 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 4 (the six categories of operations listed in Article 9: registration, homologation, pharmacovigilance, materiovigilance, release and batch tracking, recall).
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 5 (establishments must comply with BPF, storage, distribution, pharmacovigilance and materiovigilance rules).

3. Expert insights

Insight 1: the scope of joint responsibility is the delegated operations, not everything. The closing words of Article 9 limit the duty to responsibility sur les opérations déléguées, that is, for the operations that have been delegated. The boundary of liability is therefore determined by the border drawn in the delegation contract. The vaguer the contract, the wider the zone in which both parties can be pursued jointly; the more specific the contract, the more predictable the allocation of responsibility. Drafting precision is thus a direct liability-management tool, not a stylistic preference.

Insight 2: the six categories of operations listed in Article 9 are the minimum clause set for the contract. The second paragraph of Article 9 requires the operation establishment to assume all operations related to registration, homologation, pharmacovigilance, materiovigilance, release and batch tracking, and, where necessary, recall. These six categories should become the top-level headings of the delegation contract, with concrete actions, deadlines and cooperation duties spelled out beneath each heading. A contract built on this skeleton will map naturally onto the statute and survive regulatory scrutiny.

Insight 3: when the holder is a foreign entity, joint responsibility becomes the local lever for the ANPP. Under the second paragraph of Article 4, the establishment holding the certificate in the country of origin may act as the détenteur. Enforcement against a foreign entity faces practical difficulties, and the joint responsibility of Article 9 allows the ANPP to pursue the local operation establishment directly. This is precisely why local partners care intensely about the wording of each contract clause, and it is the point where negotiations most often stall. Foreign manufacturers should anticipate this and arrive with a balanced liability matrix already drafted.

Insight 4: the division of roles becomes public because it appears on the homologation decision. Article 33 requires the decision to state the name and address of the holder and the name and address of the operator. Once the roles are printed on the certificate, they are no longer a purely internal arrangement; any change must follow the procedure of Article 43, under which a new decision is issued. Companies should therefore treat role changes as regulatory projects with lead time, not as paper amendments that can be executed overnight.

4. Practical recommendations

1. Structure the delegation contract around the six categories of Article 9 as top-level clauses, specifying actions, deadlines and cooperation duties for each.
2. Define an explicit boundary list of delegated operations and exclude non-delegated matters from joint responsibility.
3. Where the holder is a foreign entity, agree on a reasonable liability cap and recourse rights for the local operation establishment.
4. Establish a bidirectional vigilance-information transfer mechanism between holder and operator, with defined time limits.
5. Plan role changes in advance and apply to the ANPP for a new decision under Article 43.
6. Attach a responsibility matrix to the contract, marking the responsible party and the supporting party for each category of operations.

5. Verification checklist

• □ The delegation contract is structured around the six categories of Article 9.
• □ A boundary list of delegated operations has been defined.
• □ Liability cap and recourse rights are agreed for the foreign-holder scenario.
• □ Bidirectional vigilance-information transfer and time limits are written into the contract.
• □ Role changes are planned under Article 43.
• □ A responsibility matrix is attached to the contract.

Further reading in this series: Can a foreign manufacturer be the certificate holder: the dual-track design of détenteur and exploitant — https://www.grzanglobal.com/algeria-medical-device-registration/foreign-manufacturer-detenteur-exploitant/ ; Five types of pharmaceutical establishments: Article 2 of Executive Decree 21-82 — https://www.grzanglobal.com/algeria-medical-device-registration/five-types-of-pharmaceutical-establishments/ ; The nine items required on the homologation decision: Article 33 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/nine-items-on-homologation-decision/

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 holder-operator delegation agreements aligned with Articles 4 and 9 of Executive Decree n° 21-82, and complete fee budgeting in Algerian dinars (DZD). For assistance with contract structuring or any question on this topic, contact info@grzanglobal.com.