Medicine sponsors, brand owners and businesses holding relevant pharmaceutical rights or regulatory responsibilities.

Where the sector’s exposures differ

Tell us what your business does, including brand ownership, outsourcing, manufacture, importation and distribution. We can discuss how those activities are described in the proposed insurance. Your regulatory adviser should confirm any licence or sponsor obligations.

Insurance covers to assess

Potential covers include products liability, recall, professional indemnity for services, management liability and cyber insurance. Insurers need to understand your products and activities, and which entities are proposed for cover. Legal interpretation of licence agreements, indemnities or territorial rights should be addressed with your legal adviser.

Policy features to discuss

We can discuss the insured activities, insured entities, territorial limits, defence costs, excesses and aggregate limits offered by insurers. If a customer requests particular insurance, let us know so we can consider the available cover. Legal interpretation, drafting and negotiation of contracts should be handled by your legal adviser.

An illustrative exposure

A brand owner faces an allegation about supplied medicine and a claim under its distribution agreement, despite using an external manufacturer.

This is a hypothetical example to explain cover questions, not a Mercantile client case or a paid claim. The proposed policy must be assessed before assuming any response.

Information needed for a quotation

Exact licence or sponsor role; ARTG details where relevant; licensed products and countries; manufacturing and quality agreements; pharmacovigilance arrangements; indemnity obligations.

Also provide turnover, wages, subcontractor and labour-hire costs, the legal entities to insure, existing schedules and wordings, claims or known circumstances, and planned changes. A clear activity breakdown helps us approach suitable markets and compare the terms offered.

Common questions

Does holding a commercial licence make the company the manufacturer?

A business label alone is not enough for an insurance submission. Describe the work actually undertaken and provide any existing product or sponsor records requested by the insurer.

Can Mercantile review existing insurance?

Yes. Send the schedule and wording together with a description of your activities and key contracts. We can examine significant gaps and approach suitable insurers, subject to their appetite and acceptance. We assist Australian businesses from our Norwest NSW office.

Related insurance sectors

Our service focuses on insurance placement and policy cover. Product classification, approvals and regulatory compliance are matters for your regulatory adviser or the relevant authority.

Return to pharmaceutical insurance or explore all Life Science insurance sectors.

• Pharmaceutical Manufacturer and Importer Insurance
• Pharmaceutical Distributor Insurance
• Pharmaceutical Contract Manufacturer Insurance

Prepared by Mercantile Insurance Brokers. Updated 30 September 2026. General information for Australian businesses. Availability and cover depend on insurer acceptance, policy terms, exclusions, limits and deductibles.