当地授权代表：定义、资格与法律责任边界

1. Key Takeaway

The Local Authorised Representative (LAR) is defined expressly in Article 2(d) of the AMDD: a person located within the member state, designated explicitly by the product owner, who can be contacted by the regulatory authority on behalf of the product owner.

In Cambodia, an overseas manufacturer or product owner may appear on the registration certificate as the licence holder and the manufacturer, but the applicant filing the submission must be a locally licensed Cambodian company. In practice, the local licensed importer — which must employ a registered Cambodian pharmacist — therefore acts as the applicant and carries the representative functions: preparing, signing and submitting the application documents, communicating with the DDF on the dossier, and collecting the product registration certificate.

GRZAN note: the LAR definition is in Article 2(d) of the AMDD; Cambodia imposes 2 hard conditions on the filer — status as a locally licensed company and a Cambodian registered pharmacist; overseas entities can retain 2 identities on the certificate (licence holder, manufacturer).

2. Regulatory Basis

3. Expert Commentary

1. An authorised representative is a “legal channel”, not a commercial agent. The key phrase in the definition is “can be contacted by the authority on behalf of the product owner”. It answers whether the regulator can find a responsible person within the jurisdiction when something goes wrong. Changing the authorised representative is therefore not just changing a service provider; it is changing a legal channel — a node that must be handled at the regulatory level in parallel.

1. Cambodia’s distinctiveness is that the “filer” and the “licence holder” can be separated. The DDF allows the overseas manufacturer to be named as licence holder on the certificate, while the filer must be a locally licensed company. This separation gives companies flexibility: once the certificate is obtained, the licence holder can in principle change the local importer that actually runs import and distribution. Note, however, that the local entity at the filing stage remains the signatory of, and the responsible party for, the dossier as it stood at that time.

1. “The licence holder can change the importer” does not mean “no representative is needed”. After the registration certificate is obtained, import and distribution can be delegated to any licensed importing company, but the post-market obligations (adverse event and FSCA reporting, complaints, import and export records) must still be reported to the DDF by someone, and in practice this still falls to the local authorised representative. Teams that do a one-off import and arrange no follow-up surveillance are the ones most likely to break the chain at this point.

4. Practical Recommendations

1. Spell out the list of rights and duties in the authorisation agreement. Cover at least: submissions and communication, collection and custody of the registration certificate, cooperation on import and customs clearance, adverse event and FSCA reporting, complaints and record-keeping, and handover of the dossier and certificate on termination. An independent third-party LAR arrangement is recommended, so that changing the distribution network does not affect the product registration certificate.
2. Verify the representative’s two hard qualifications. First, the company registration certificate and the pharmaceutical import and export enterprise licence are within their validity; second, the employed registered pharmacist is a member of the Pharmacy Council of Cambodia in good standing. The former can be checked against Ministry of Commerce and Ministry of Health documents; for the latter, request proof of membership.
3. Make a change of authorised representative a controlled process. Changing the representative changes the regulator’s contact channel; the power of attorney in the dossier and the local responsible-party information on the labelling must be updated in parallel, and the change notified to the DDF.

5. Verification Checklist

• □ Legal position of the authorised representative understood under AMDD Article 2(d)
• □ Confirmed the overseas entity may be named on the certificate as licence holder and manufacturer
• □ Confirmed the applicant filing the submission is a locally licensed company
• □ Verified the pharmacist employed by the local entity is a member of the Pharmacy Council of Cambodia
• □ Authorisation agreement covers the six items, from submission and communication through post-market reporting and termination handover
• □ Controlled process for changes of authorised representative and DDF notification mechanism in place

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities concentrate on three areas. First, distinguishing the legislative progress of dedicated medical device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established a written device regulatory framework, whereas Cambodia still has no dedicated Medical Device Law; its current rules are assembled from three layers — the registration-number legal basis provided by the 1996 Law on the Management of Pharmaceuticals and its 2007 amendment, the classification and procedures provided by Prakas No. 1258 of 2012, and the technical framework provided by the ASEAN Medical Device Directive — leaving regulatory certainty materially lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN can act as the manufacturer’s statutory representative in Cambodia, undertaking registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist requirement and the pharmaceutical import and export enterprise licence. Third, quality system and testing support: helping establish a quality management system meeting ISO 13485 requirements and organising the technical dossier according to the ASEAN Common Submission Dossier Template (CSDT).

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