Transfer and Assignment Require a New Homologation Decision

1. Key takeaways

Article 43 of Décret exécutif n° 20-324 provides that the transfer or assignment (cession ou transfert) of the homologation decision requires the ANPP to issue a new decision. This article, together with Article 33 (the decision must state the holder and the operator), Article 32 (the decision is issued only to establishments under Article 18) and Article 4 of Executive Decree n° 21-82 (holder qualification), forms a closed loop: when the party changes, the certificate must change. The fee is set by Article 2 of Executive Decree n° 21-551 at 100.000 DA.

Because the operator and holder are printed on the face of the decision, a change of commercial partner is never a private matter between two companies. Until the ANPP signs the new decision, the old decision continues to name the old parties, and any activity conducted under it by the new parties lacks a legal basis. Transaction timelines must therefore be built around the regulatory procedure, not around the signing ceremony.

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 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 43 (transfer or assignment requires a new decision), Article 32 (the decision is issued only to establishments under Article 18), Article 33 (9 items stated on the decision).
2. Décret exécutif n° 21-551 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités de recouvrement et d’affectation du produit de la redevance des produits pharmaceutiques et des dispositifs médicaux (Executive Decree No. 21-551 of 30 December 2021 on the collection and allocation of the redevance on pharmaceutical products and medical devices, JORADP No. 02, published 5 January 2022, pages 14–15): Article 2 (fee of 100.000 DA for transfer of a device homologation decision between 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 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: a locally manufacturing establishment or the establishment holding the certificate in the country of origin), Article 9 (joint responsibility).
4. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 23 June 2021 on the procedures for modification of the homologation decision for medical devices for human medicine, JORADP No. 62, published 15 August 2021, pages 21–22, 16 articles in total): Article 3 (the scope of modification includes the information stated on the decision under Article 33), Article 6 (submission by the pharmacien directeur technique).

3. Expert insights

Insight 1: Article 43 requires a new decision, not a modification, which is procedurally heavier. Compare Article 36 (changes must be declared) with Article 43 (transfer or assignment requires a new decision): the legislature chose two different verbs. A transfer is not a routine modification but the cancellation of the original decision and the issuance of a new one. This means the decision number will change, and whether the validity period restarts must be confirmed with the ANPP at the time of application. Deal valuations and commercial warranties should account for this uncertainty explicitly.

Insight 2: the transfer fee of 100.000 DA is the lowest of the three tiers. Article 2 of Executive Decree No. 21-551 sets the three device tiers as modification 150.000 DA, renewal 300.000 DA, transfer 100.000 DA. Transfer is the cheapest, which is consistent with its nature: it changes only the party and does not re-evaluate the technology. The low fee, however, does not mean low effort — the qualification review of the incoming party is where the real work lies.

Insight 3: the assignee must first clear the qualification thresholds of Article 18 and Article 4. The precondition for the ANPP to issue a new decision under Article 43 is that the new party is itself qualified to hold the certificate: under Article 18 it must be a recognised pharmaceutical establishment; under Article 4, the holder must be either a locally manufacturing establishment or the establishment holding the device certification or homologation decision in the country of origin. The first step of transfer negotiations is therefore qualification due diligence, not price negotiation. A bargain price for an unqualified assignee is worth nothing.

Insight 4: the 9 items of Article 33 must be updated in step with the transfer. On the new decision, item 5 (name and address of the holder) and item 6 (name and address of the operator) will change. If the manufacturer is unchanged, item 7 remains; if the operator changes as well, it must be handled in the same application. GRZAN recommends completing all required amendments to the stated items in one single application, since piecemeal filings multiply review cycles and fees.

4. Practical recommendations

1. Before starting negotiations, conduct qualification due diligence: is the assignee a pharmaceutical establishment recognised under Article 18, or a qualified foreign holder under Article 4.
2. Make the issuance of the new ANPP decision a closing condition in the agreement; do not execute first and report afterwards.
3. Complete all updates to the stated items of Article 33 in one single application.
4. Budget the transfer at 100.000 DA; if a modification occurs at the same time, add 150.000 DA separately.
5. Confirm in writing with the ANPP how the validity of the new decision is calculated (fresh start or continuation of the original term).
6. After completion, update the register of matters requiring immediate declaration under Article 36.

5. Verification checklist

• □ The assignee’s qualification has been due-diligenced against Articles 18 and 4.
• □ The agreement lists the new ANPP decision as a closing condition.
• □ All stated items of Article 33 requiring updates have been changed in one application.
• □ The budget includes the 100.000 DA transfer fee and any possible modification fee.
• □ The validity start method of the new decision has been confirmed in writing with the ANPP.
• □ The register of immediate declarations under Article 36 has been updated.

Further reading in this series: 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/ ; 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/ ; Fee anchors: modification 150,000, renewal 300,000, transfer 100,000 dinars — https://www.grzanglobal.com/algeria-medical-device-registration/fee-anchors-modification-renewal-transfer/

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, transfer and assignment procedures under Article 43 of Executive Decree n° 20-324, and complete fee budgeting in Algerian dinars (DZD). For assistance with transaction structuring or any question on this topic, contact info@grzanglobal.com.