Who Can Submit a Homologation Application in Algeria

1. Key takeaways

Article 18 of Décret exécutif n° 20-324 is unusually direct: only pharmaceutical establishments recognized under Articles 218 and 219 of Loi 18-11 may submit a homologation application. This means a foreign manufacturer cannot file a dossier with the ANPP in its own name.

But Article 4 of Décret exécutif n° 21-82 opens a door at the same time: the holder (détenteur) of the homologation decision may be a foreign entity that holds device certification or a homologation decision in its country of origin — provided it entrusts exploitation (exploitation) to a locally established exploitation-type pharmaceutical establishment in Algeria.

GRZAN summarizes the rule as three clauses: the right to submit is local, the right to hold the certificate can be kept abroad, and the right to operate must be local. These three clauses define the entire market-entry architecture, and every agreement, license check and filing in the project should be traceable back to one of them.

Foreign manufacturers who ignore the first clause waste months attempting direct submissions; those who ignore the third clause discover at customs that their certificates do not authorize anyone to import. The architecture must be fixed before the dossier is drafted, not after the first rejection.

2. Legal basis

1. 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 production and exploitation establishments may submit).
2. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 18 Chaoual 1439 corresponding to July 2, 2018 on health, JORADP No. 46, published 2018-07-29), Article 218 (pharmaceutical establishments require a license) and Article 219 (five categories of pharmaceutical establishments).
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 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 the operator and the entrustment arrangement) and Article 9 (duties of exploitation establishments and joint liability).
4. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 28 Ramadhan 1442 corresponding to May 10, 2021 fixing the composition of the homologation dossier and of the renewal dossier, JORADP No. 55, published 2021-07-14, pages 21–24, 13 articles), Article 3 (the dossier is submitted by the pharmacien directeur technique).

3. Expert insights

Insight one: Article 18 restricts submission; Article 4 restricts holding. The two sentences must be read separately.

What Article 18 prohibits is a foreign manufacturer filing directly. The second paragraph of Article 4 of Décret exécutif n° 21-82, in contrast, recognizes that an entity holding device certification or a homologation decision in its country of origin may act as détenteur. On architecture, GRZAN usually recommends that the foreign manufacturer retain the détenteur role to protect brand control and pricing power, while the local partner acts as exploitant handling importation, vigilance and batch release. Splitting the roles this way keeps strategy in the manufacturer’s hands and execution in the licensed local channel.

Insight two: the wording of Article 4, second paragraph, is an either-or.

The holder is either a domestic production-type pharmaceutical establishment or a foreign establishment certified in its country of origin. This either-or structure means that if the foreign manufacturer wants to hold the certificate itself, it cannot simultaneously designate a local producer as holder. Choosing the branch is a strategic decision with long-term consequences for control of the certificate.

Insight three: joint liability is a hard constraint, written in the last sentence of Article 9.

The final sentence of Article 9 provides that the holder of the homologation decision and the operator bear joint responsibility (responsabilité conjointe) for entrusted matters. That sentence upgrades the entrustment contract from a commercial document to a compliance document: whatever the contract fails to spell out, the ANPP will pursue with both parties at once. Vague distributor agreements are therefore a latent regulatory exposure, not just a legal inconvenience.

Insight four: even the identity of the filer is constrained — it is the pharmacien directeur technique.

Article 3 of the May 10, 2021 Ministerial Order provides that the dossier is submitted by the pharmacien directeur technique of the pharmaceutical establishment. Stacked on Article 18, this forms two entity thresholds: the establishment must be on the register, and the pharmacist must be in post. A licensed establishment without its pharmacist is, for filing purposes, indistinguishable from no establishment at all.

4. Practical recommendations

1. Decide the détenteur and exploitant roles at the architecture design stage and write them into the formal agreement between the parties.
2. List the entrusted matters item by item in the agreement — importation, vigilance, batch release, recall — matching the scope of joint liability in Article 9.
3. Verify that the activity types on the local partner’s agrément cover the roles it will perform.
4. Verify that the partner’s pharmacien directeur technique is in post and that the appointment was approved by a ministerial decision (Article 12 of the June 22, 2021 ministerial order).
5. If the foreign manufacturer holds the certificate itself, prepare the certification or homologation decision documents from the country of origin and complete legalization.
6. When the entity changes, follow the transfer or assignment procedure of Article 43 with a new decision issued by the ANPP; do not arrange a private handover.

5. Verification checklist

• □ The détenteur and exploitant roles are defined in a formal agreement.
• □ The agreement lists the entrusted matters item by item, covering importation, vigilance, batch release and recall.
• □ The activity types of the partner’s agrément cover its role.
• □ The pharmacien directeur technique is in post and the appointment has ministerial approval.
• □ The foreign holder has prepared the country-of-origin certification documents and completed legalization.
• □ Entity changes are planned through the Article 43 transfer procedure.

Related reading in this series

• Article 09, 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/
• Article 31, Five categories of pharmaceutical establishments: Article 2 of Executive Decree 21-82 — https://www.grzanglobal.com/algeria-medical-device-registration/five-types-of-pharmaceutical-establishments/
• 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 designs compliant market-entry structures for Algeria, including détenteur and exploitant arrangements, partner qualification reviews and submission channel management. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.