CLV, CPP and country-of-origin authorisations in the Algerian dossier

1. Key takeaways

The foreign evidence in an Algerian homologation dossier runs along three main lines: the certificate of free sale (CLV), the certificate of a pharmaceutical product (CPP), and the marketing authorisation in the country of origin. In addition, the dossier must include copies of the marketing authorisations obtained in all other countries. Article 4 of the Ministerial Order of 10 May 2021 gives the CLV a deliberately broad formulation — the certificate, or a document issued by the pharmaceutical regulatory authority or any other recognised authority, must certify that the device is registered and marketed in the country of origin.

The combination principle applied by GRZAN can be stated in one sentence: the CLV is the base layer, the CPP and the country-of-origin marketing authorisation are complements, and the other-country authorisations are corroborating evidence. None of the three lines can be skipped, because each answers a different reviewer question: the CLV answers whether the product is registered and sold at home; the CPP and the home authorisation answer whether a formal national approval exists; the other-country copies answer whether the product has a credible regulatory track record abroad.

The renewal stage raises the bar again: the CLV must then prove the maintenance of registration and marketing, not merely their historical existence, and the country-of-origin authorisation must be the renewed version.

2. Legal basis

1. 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 10 May 2021 on the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (the CLV or alternative document, the country-of-origin marketing authorisation and the CPP, copies of other-country marketing authorisations, the conformity certificate).
2. 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 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 10 (at renewal, the CLV must certify the maintenance of registration and marketing, and the country-of-origin marketing authorisation must be renewed).
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 the homologation of medical devices, JORADP N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 22 (the acceptance review verifies the authenticity of the documents).
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 on pharmaceutical establishments and the conditions of their approval, JORADP N° 14, published 2021-02-28, pages 9–12, 29 articles in total): Article 4 (the holder may be an establishment in the country of origin holding the device certification or homologation decision).

3. Expert insights

Insight one: the statutory function of the CLV is to prove registration and marketing in the country of origin.

The wording of Article 4 refers to a device that is registered and marketed in the country of origin — in the French text, enregistré et commercialisé. Both actions must be covered: a registration certificate alone is not enough, and sales invoices alone are not enough either. If the home-country certificate only evidences registration, supplementary evidence of marketing must be added. This dual test is where many dossiers fail, because applicants assume that a registration number speaks for itself and forget that the Algerian legislator asked for two distinct facts to be certified in a single document line.

Insight two: at renewal, the CLV requirement upgrades from registration and marketing to the maintenance of registration and marketing.

Article 10, governing the renewal dossier, requires the CLV or equivalent document to prove the maintien de l’enregistrement et de la commercialisation — the maintenance of registration and of marketing in the country of origin — and requires the country-of-origin marketing authorisation to be the renewed version. In other words, an old CLV cannot be recycled at renewal. The certificate must speak to the present state, and the home authorisation must itself have been kept alive. Planning the renewal therefore means planning the reissue of foreign certificates months in advance, since issuing authorities often have their own lead times.

Insight three: other-country marketing authorisations must be copied in full, not selectively.

The wording of Article 4 refers to a copy of any marketing authorisation for the device obtained in the other countries — une copie de toute autorisation de mise sur le marché obtenue dans les autres pays. This is a complete-submission obligation, not a best-foot-forward exercise. GRZAN recommends maintaining a global marketing status table, country by country, to ensure nothing is missed; an omission discovered by the reviewer directly affects the authenticity assessment under Article 22 of Executive Decree No. 20-324, which is a far worse outcome than an honest disclosure of every authorisation held.

Insight four: the CLV and the holder qualification under Article 4 of Executive Decree No. 21-82 corroborate each other.

The second paragraph of Article 4 of Executive Decree No. 21-82 allows an establishment in the country of origin holding the device certification or homologation decision to act as the détenteur. The practical consequence is that the holder recorded on the CLV should match the holder recorded in the dossier and on the homologation decision. Where the two differ, an additional explanation of the legal relationship between them is needed. This consistency check costs nothing at preparation time and prevents an identity query during review that can freeze the file for weeks.

4. Practical recommendations

1. Maintain a global marketing status table recording, country by country, the registration status, certificate number, issuing authority and validity period.
2. Make sure the CLV evidences both registration and marketing; add sales evidence where necessary.
3. Before renewal, obtain fresh versions of the CLV and the country-of-origin marketing authorisation; never reuse old certificates.
4. Submit other-country marketing authorisations against the full-submission standard, and attach an index list in the dossier.
5. Check whether the CLV holder matches the proposed détenteur, and attach a legal-relationship explanation where they differ.
6. Legalise and translate all foreign documents into French, allowing at least 1 month of lead time.

5. Verification checklist

• □ The global marketing status table has been created and completed country by country.
• □ The CLV evidences both registration and marketing.
• □ The CLV and country-of-origin authorisation used for renewal have been updated.
• □ Other-country marketing authorisations have been submitted in full, with an index attached.
• □ The consistency of the CLV holder and the détenteur has been checked.
• □ Legalisation and translation of the foreign documents are complete.

• Article 22 — The 22-item initial homologation dossier, item by item: https://www.grzanglobal.com/algeria-medical-device-registration/initial-dossier-22-items-breakdown/
• Article 30 — The 21-item renewal dossier and the two formats: the consolidated version rule of Article 11: https://www.grzanglobal.com/algeria-medical-device-registration/renewal-dossier-21-items-consolidated-format/
• Article 24 — BPF, BPL, BPC and ISO: compliance evidence for manufacturing and trial activities: https://www.grzanglobal.com/algeria-medical-device-registration/bpf-bpl-bpc-iso-compliance-evidence/

Regulatory information verified as of 30 October 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Algerian market, including CLV and CPP strategy, global marketing status mapping and foreign document legalisation. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.