The Role of the Pharmacien Directeur Technique

1. Key takeaways

Algeria places the technical direction of every pharmaceutical establishment in the hands of the pharmacien directeur technique. The institution is established by Article 218 of Loi 18-11, detailed by Article 14 of Décret exécutif n° 21-82, and given dedicated rules on duties and qualifications by the ministerial order of June 22, 2021 (19 articles).

Three sets of numbers define the regime. The pharmacien directeur technique must have 2 years of experience in the pharmaceutical industry (waived with a postgraduate diploma in the pharmaceutical industry); assistant pharmacists are staffed at one per 30 employees, with one more for every additional 40 persons; substitution may not exceed 1 month, extendable with approval by up to 6 months; and substitution records are kept for 5 years.

For a foreign manufacturer choosing a local partner, this single person is the hinge of the whole operation. The pharmacist signs the dossier, certifies batches, and anchors the establishment’s legal capacity to act. If the pharmacist is absent, everything downstream — filings, imports, releases — stops with them.

2. Legal basis

1. 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 (technical direction is the responsibility of the pharmacien directeur technique, assisted by assistant pharmacists).
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 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 14 (each establishment must have at least one pharmacien directeur technique and one assistant pharmacist) and Article 19 (the license dossier must include the pharmacists’ employment contracts).
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 11 Dhou El Kaâda 1442 corresponding to June 22, 2021 fixing the missions and qualifications of the pharmacien directeur technique and the assistant pharmacists of the pharmaceutical manufacturing establishment, JORADP No. 62, published 2021-08-15, pages 18–21, 19 articles), Articles 2 to 19 (duties, qualifications, staffing ratios, substitution and departure).
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 homologation dossier is submitted by the pharmacien directeur technique) and Article 9 (the same applies to the renewal dossier).

3. Expert insights

Insight one: the filing signature and responsibility are bound together; it is not a formal rubber stamp.

Article 2 of the June 22, 2021 ministerial order requires the pharmacien directeur technique to ensure that every batch of pharmaceutical products or devices is manufactured and tested in accordance with current regulations and the requirements retained in the registration or homologation decision. Article 4 further requires the pharmacist, after reviewing the dossier, to sign the registration or homologation application submitted by the establishment. The signature therefore means the dossier has been read and its contents owned — not a procedural stamp. This is why GRZAN insists on direct contact with the partner’s pharmacist before filing, so the signature reflects genuine review.

Insight two: the 1-month substitution cap is an easily missed compliance risk point.

Article 16 provides that when the pharmacien directeur technique is absent, substitution must be notified to the competent department of the Ministry of Pharmaceutical Industry and may not exceed 1 month; with an approved application it may be extended, with a total length not exceeding 6 months. The identity of the substitute and the start and end dates must be kept within the establishment for 5 years. If the partner’s pharmacist is chronically absent, both the establishment’s agrément and the homologation decisions in hand are exposed.

Insight three: the notice period for departure runs in both directions, up to 3 months.

Article 17 provides that when the pharmacist permanently ceases practice, a new pharmacien directeur technique or assistant pharmacist must be designated within 15 days. Article 18 provides that the establishment must notify the competent department and the pharmacist ethics committee at least 3 months before the pharmacist’s departure date. Together these two numbers define the shortest feasible handover window when replacing a pharmacist, and contracts should anticipate it.

Insight four: establishments manufacturing medical devices carry an additional competence requirement.

The final paragraph of Article 11 provides that a pharmacien directeur technique practicing in a medical device manufacturing establishment must be assisted by a person possessing competence in the manufacture of medical devices. This provision separates knowing pharmacy from knowing devices: a pharmacy credential alone does not cover the technical side of device production, and the assistante role is a legal requirement, not a convenience.

4. Practical recommendations

1. In due diligence on a local partner, make the appointment decisions and employment contracts of the pharmacien directeur technique and assistant pharmacists mandatory review documents.
2. Stipulate in the agreement an advance-notice obligation for pharmacist changes, reserving a 3-month handover window.
3. Check whether the partner is a device-manufacturing establishment; if so, confirm that an assistant with device manufacturing competence has been appointed.
4. Establish a quarterly confirmation mechanism for pharmacist presence to prevent any gap exceeding 1 month.
5. Before filing, confirm that the signatory is the incumbent pharmacien directeur technique and that the dossier review has been completed.
6. Require the partner to keep substitution records for the full 5 years and include this in the compliance file.

5. Verification checklist

• □ The appointment decisions of the partner’s pharmacien directeur technique and assistant pharmacists have been examined.
• □ The pharmacists’ employment contracts have been verified as a license-dossier requirement.
• □ The agreement contains an advance-notice obligation for pharmacist changes.
• □ Device-manufacturing establishments have confirmed an assistant with device manufacturing competence.
• □ A quarterly confirmation mechanism for pharmacist presence is in place.
• □ The 5-year retention requirement for substitution records is embedded in the partner’s compliance file.

Related reading in this series

• Article 07, Who can submit the application: the entity threshold of Article 18 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/who-can-submit-homologation-application/
• 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 32, Obtaining, lapse and transition of the exploitation license agrément: Articles 19 to 27 of Executive Decree 21-82 — https://www.grzanglobal.com/algeria-medical-device-registration/agrement-obtaining-lapse-transitional/

Regulatory information verified as of October 30, 2026.

GRZAN assists manufacturers in evaluating and managing the pharmacien directeur technique requirement in Algeria, from due diligence and appointment verification to continuity planning. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.