Packaging mock-ups and the mandatory Arabic labelling requirements

1. Key takeaways

The language requirements for packaging mock-ups in Algeria are set by Article 4 of the Ministerial Order of 10 May 2021. The dossier must include the mock-up proposals for the secondary and primary packaging, with text that is conspicuous, easily legible, in the Arabic language, and also presented in any foreign language used in Algeria, in compliance with the regulations in force, and prepared in accordance with Annex I attached to the original of this ministerial order. Combined with the classification requirements of Article 17 of Executive Decree No. 20-324, the packaging and labelling are a common checkpoint for both the acceptance review and the record of the decision.

Two structural facts follow. First, Arabic is the primary language of the label; any foreign language is additional, not substitutive. Second, the mock-up is submitted as a proposal, which means the approved version becomes a controlled document, and any later change to it must go through the modification procedure. The practical estimate applied by GRZAN is that labelling should be locked as a bilingual Arabic-plus-French layout at the design stage, because retrofitting Arabic artwork onto a finished pack is the most expensive way to comply.

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 (mock-up proposals for the secondary and primary packaging; Arabic and any foreign language used in Algeria; Annex I).
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 (the renewal dossier likewise requires the packaging mock-up proposals, in accordance with Annex I).
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 33 (the homologation decision must state the storage conditions and period of validity); Article 36 (modifications must be declared).
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 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (the dossier must state the storage conditions and the period of conservation).

3. Expert insights

Insight one: Arabic holds the primary position; foreign languages run alongside it, not instead of it.

The syntax of Article 4 reads: en caractères apparents, aisément lisibles en langue arabe et en toute langue étrangère usitée en Algérie — in conspicuous, easily legible characters, in the Arabic language and in any foreign language used in Algeria. Arabic plus the foreign languages in use in Algeria. In practice this is generally understood to mean Arabic alongside French. An English-only label does not satisfy the requirement. The grammatical point matters: the conjunction et joins Arabic and the foreign language as coexisting requirements, so a single-language solution in any language other than Arabic fails the text of the article, however good the translation quality.

Insight two: mock-up proposals are required for both the primary and the secondary packaging, not just one.

Article 4 explicitly requires proposals for the conditionnement secondaire and the conditionnement primaire — two mock-up sets. Article 10 repeats the same requirement for the renewal dossier, which shows that this is a document refreshed at every submission, not a one-time deliverable. Teams that only mock up the outer carton leave the primary packaging — the blister foil, the pouch, the vial label — unevidenced, and that gap is visible to any reviewer comparing the two sets side by side.

Insight three: the mock-up is a proposal (proposition de la maquette), and once approved it becomes a controlled version.

Both Article 4 and Article 10 use the phrase proposition de la maquette. The term means that what is submitted is a design awaiting approval; the approved version then becomes a controlled document, and any subsequent change must follow the modification procedure under Article 3 of the Ministerial Order of 23 June 2021. Labelling changes are among the most frequent modifications in practice, so the controlled status should be anticipated from the start: version numbers, change history and an owner for the artwork file.

Insight four: the storage conditions and conservation period on the packaging must match the dossier and the decision.

Article 4 requires the dossier to state the storage conditions and period of conservation of the device, and Article 33 of Executive Decree No. 20-324 requires the homologation decision to state the storage conditions and period of validity. These three places — the dossier, the packaging mock-up and the homologation decision — must be mutually consistent, and this is the point where contradictions are most easily detected during review. A mismatch between the shelf life printed on the label and the figure declared in the dossier is a trivially visible defect that nonetheless triggers a regularisation cycle, so the three values should be reconciled once, in writing, before submission.

4. Practical recommendations

1. Lock the bilingual Arabic-plus-French layout at the packaging design stage; do not add languages by late-stage stickers.
2. Produce one mock-up proposal for the primary packaging and one for the secondary packaging, laid out in accordance with Annex I.
3. Check the storage conditions and conservation period on the mock-ups against the values declared in the dossier under Article 4.
4. Enter approved mock-ups into the controlled-document list, and route every subsequent change through the modification procedure.
5. At renewal, prepare fresh mock-up proposals; do not reuse the first-filing versions.
6. Verify that the product name, model and manufacturer name are identical in the dossier, on the label and on the homologation decision.

5. Verification checklist

• □ The packaging uses a bilingual Arabic-plus-French layout.
• □ One mock-up proposal each for the primary and secondary packaging, prepared per Annex I.
• □ The storage conditions and conservation period on the mock-ups match the dossier values.
• □ Approved mock-ups are entered in the controlled-document list.
• □ Fresh mock-up proposals have been prepared for renewal.
• □ The product name, model and manufacturer name have been checked for consistency across all three records.

• 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 26 — The four special device categories: medicinal substances, active implantables, IVDs, custom-made: https://www.grzanglobal.com/algeria-medical-device-registration/special-device-categories-declarations/
• Article 34 — The 9 items that must appear on the homologation decision: Article 33 of Executive Decree No. 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 manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Algerian market, including bilingual labelling review, Annex I mock-up layout and controlled-version artwork management. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.