Obtaining, Lapse and Transition of the Pharmaceutical Establishment Agrément

1. Key takeaways

The agrément (operating licence) of pharmaceutical establishments is governed by Articles 19 to 27 of Décret exécutif n° 21-82. Article 19 lists the 7 items of the licence application file; Article 20 sets out the verification content. Article 23 provides that the licence lapses if the establishment does not commence operation within 2 years of approval, with a possible single extension of 1 year upon justified request. Article 24 provides that when an establishment ceases operation it must notify the Minister and the licence is withdrawn. Articles 25 and 26 establish a two-tier sanction system of inspection and temporary closure of up to 1 year or permanent withdrawal. Article 27 grants existing establishments a 12-month transition period to reach compliance.

Taken together, these articles define the full life cycle of the agrément: application, verification, lapse, withdrawal, sanctions and transition. For any manufacturer selecting an Algerian partner, the most decisive dates are the approval date of the agrément and the date the establishment actually started operating, because the 2-year lapse rule of Article 23 operates automatically and cannot be negotiated away.

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 19 (7 items of the application file), Article 20 (verification content), Article 23 (lapse after 2 years and one extension of 1 year), Article 24 (withdrawal upon cessation of operation), Articles 25 and 26 (inspection, temporary closure of 1 year, permanent withdrawal), Article 27 (12-month transition).
2. 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 3 (authorisation by the Minister of Pharmaceutical Industry required), Article 14 (at least 1 pharmacien directeur technique and 1 assistant pharmacist).
3. Arrêté du 11 Dhou El Kaâda 1442 correspondant au 22 juin 2021 fixant les missions et les qualifications du pharmacien directeur technique et des pharmaciens assistants de l’établissement pharmaceutique de fabrication (Ministerial Order of 22 June 2021 on the missions and qualifications of the pharmacien directeur technique and assistant pharmacists of the manufacturing establishment, JORADP No. 62, published 15 August 2021, pages 18–21, 19 articles in total) (missions and qualifications of the pharmacien directeur technique).
4. 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 (only agréd establishments may submit homologation applications).

3. Expert insights

Insight 1: the 2-year lapse rule of Article 23 is the hardest fact in partner due diligence. Article 23 provides that if the establishment does not commence operation within 2 years of approval, the licence becomes lapsed (caduque). However, the applicant may submit justifications before the deadline expires and request one extension of up to 1 year. A newly licensed establishment therefore has a realistic usable window of 2 years plus 1 year, i.e. 3 years at most. Any partner whose agrément is older than two years without documented operation or extension should be treated as a serious red flag until documentation proves otherwise.

Insight 2: among the 7 items of Article 19, items 6 and 7 are the ones that cause delays. Article 19 enumerates: the application form, a copy of the company statutes, a copy of the commercial register, the employment contract of the pharmacien directeur technique, proof of ownership or the lease contract, the operating licence for classified premises issued by the environment authorities, and the safety compliance opinion issued by the civil protection authorities. The last two items require applications to two other ministries and are typically the slowest steps of the entire licensing process. Planning should therefore start these applications first.

Insight 3: the sanction system is two-tier, with temporary closure capped at 1 year. Under Article 26, upon finding a violation the authorities first serve a formal notice (mise en demeure) requiring correction within a set period. If the establishment does not comply, it faces temporary closure of up to 1 year (reopening only after reservations are cleared) or permanent withdrawal of the licence. This structure of notice before sanction creates a genuine window for remediation, and the arrival of a mise en demeure is the earliest observable warning signal for a partner.

Insight 4: the 12-month transition of Article 27 has long expired. Article 27 provides that establishments legally existing on the date of publication of the decree must reach compliance within 12 months. The decree was published on 28 February 2021, so the transition deadline fell in February 2022. Every establishment operating today should therefore already be fully compliant with Executive Decree No. 21-82, and due diligence can be conducted directly against the new standards without transitional tolerances.

4. Practical recommendations

1. In due diligence, request the issue date of the agrément and apply the 2-year rule of Article 23 backwards to determine whether it remains valid.
2. If a partner’s licence is approaching 2 years without operation, confirm whether it has applied for the 1-year extension under Article 23.
3. Verify that all 7 items of Article 19 are complete, focusing on the environment licence and the civil protection opinion.
4. Verify staffing against Article 14: at least 1 pharmacien directeur technique plus 1 assistant pharmacist.
5. Include a clause on substitute arrangements in case the licence is withdrawn in the cooperation agreement.
6. Regularly confirm whether the partner has received a mise en demeure, which is the upstream signal of sanctions.

5. Verification checklist

• □ The issue date of the partner’s agrément has been obtained and the 2-year rule applied.
• □ For licences near 2 years without operation, the 1-year extension status has been confirmed.
• □ The 7 items of Article 19 have been checked, with the two critical items confirmed.
• □ Pharmacist staffing meets the minimum of Article 14.
• □ The agreement contains substitute arrangements for licence withdrawal.
• □ A tracking mechanism for mise en demeure signals is established.

Further reading in this series: 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 pharmacien directeur technique system: why the applicant must be a pharmacien directeur technique — https://www.grzanglobal.com/algeria-medical-device-registration/pharmacien-directeur-technique-role/ ; Who can submit the homologation application: the Article 18 threshold of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/who-can-submit-homologation-application/

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, due diligence on agrément validity under Executive Decree n° 21-82, and complete fee budgeting in Algerian dinars (DZD). For assistance with licence verification or any question on this topic, contact info@grzanglobal.com.