Local Pharmaceutical Representative Services

What we do: Many regulators in the region require pharmaceutical manufacturers to operate through a locally licensed entity to hold the marketing authorization, act as the regulatory point of contact, or import the product. PKCS provides this local representative function in Iraq, the UAE, and Saudi Arabia for foreign manufacturers without their own in-country presence.

When is a local pharmaceutical representative required?

Each major regional regulator requires foreign manufacturers to appoint a locally licensed entity in some capacity. The exact role differs by country: in some markets the local entity must hold the marketing authorization; in others the local entity is the regulatory point of contact and the named importer; in still others the local entity carries the pharmacovigilance responsibility. The UAE Federal Decree-Law 38/2024 framework, the Saudi SFDA marketing authorization regulations, and Iraqi MOH practice each define the local representative role differently.

Local representation is administrative on its surface but consequential in practice. The local representative is the entity that receives regulatory correspondence, signs declarations on behalf of the manufacturer, fronts inspections, and answers when adverse events are reported. Choosing the wrong representative — especially a distributor whose interests may not align with the manufacturer’s regulatory strategy — can complicate everything from marketing authorization transfers to product withdrawals.

What does PKCS deliver as a local representative?

• Marketing authorization holder of record in markets that require a locally licensed MA holder.
• Regulatory point of contact — Receipt and management of regulatory correspondence in Arabic and English.
• Importer of record for finished products and investigational medicinal products where required.
• Pharmacovigilance contact — Coordination with PKCS’s pharmacovigilance services for adverse event reporting and PSURs.
• Authority interactions — Representation in pre-submission meetings, deficiency response cycles, GMP inspections, and PV inspections.
• Lifecycle management on the manufacturer’s behalf — Variations, renewals, and withdrawals submitted under the local entity.
• Distributor coordination — Where the manufacturer uses a separate commercial distributor, PKCS coordinates between the regulatory function and the commercial channel.

Why separate the regulatory and commercial functions?

A common misstep is to appoint the in-country distributor as both commercial partner and local regulatory representative. The two functions have different incentives: the distributor wants the broadest possible commercial freedom; the regulatory representative needs to enforce compliance, even when that limits commercial activity. Separating the roles — with PKCS as the regulatory representative and an independent commercial distributor — preserves the manufacturer’s ability to switch distributors without losing the registration history, and avoids regulatory conflicts of interest.

Related services

• Regulatory Affairs — Dossier preparation and lifecycle management.
• Pharmacovigilance Services — PV obligations carried by the local representative.
• UAE MOHAP & EDE Registration — UAE-specific local representative requirements.

Frequently asked questions

Why not just use our distributor as the local regulatory representative?

Distributors and regulatory representatives have different incentives. Combining the two creates conflicts when commercial pressure clashes with regulatory compliance, and complicates distributor changes — the registration is held by the distributor, who can leverage it commercially. PKCS provides independent regulatory representation while the manufacturer retains commercial flexibility.

Is PKCS the marketing authorization holder of record for clients?

In markets where the regulator requires a locally licensed entity to hold the MA, yes — PKCS holds the MA on the manufacturer’s behalf, with a contractual framework that ensures the manufacturer retains all underlying rights to the registration.

Can we transition from one local representative to PKCS mid-cycle?

Yes. PKCS regularly handles MA holder transfers from outgoing distributors or representatives, including the regulatory authority notifications and renewal of supporting documentation in the new representative’s name.