A number of options for product sponsorship
Manufacturers of medicines and medical devices who are not located in Australia must have an in-country representative, a Sponsor, to enable Marketing Authorisation by Australia’s Therapeutic Goods Administration (TGA). (see previous post).
For manufacturers entering the Australian market for the first time a number of options are available, including
- establishing their own legal entity
- Partner with a distribution company and utilize that entity to hold the product sponsorship
- Partner with a third party product sponsorship to act solely as your regulatory representative in Australia.
Strategic options – maintaining control of your registration
A number of considerations are relevant in making a decision on how to support product sponsorship. For example, the manufacturer may not be ready to establish a local legal entity, or have no intention of doing so for the foreseeable future. A distributor often has a core competency on sales and distribution, and may not have a depth of expertise in the regulatory environment that affects your products. A clear understanding, and the capabilities to meet ongoing obligations of product sponsorship are also a primary concern, including incident reporting and post-market surveillance.
To maintain direct control of the registration of your therapeutic good, it is recommended that you appoint a “third party” Sponsor who is not commercially involved in the sale of your products and acts solely as your regulatory representative in Australia.
Case study – change of distributor delayed due to product sponsorship change
A pharmaceutical manufacturer had initially entered the Australian market via a distribution agreement with a company that had the sales and marketing capability required at product launch. Some years later, at the expiry of the distribution agreement, the product manufacturer had decided to establish their own legal entity in Australia and distribute the product themselves.
Despite the expiration of the agreement, the manufacturer was forced to continue working with the local distributor for a lengthy transition period whilst product registrations were changed, which included product packaging and labelling.
Separating distribution from product sponsorship in the first instance would have maintained all of the benefits of working with the local distributor, but kept control of the registrations with the manufacturer, and enabled a seamless transition under the control of the manufacturer.
Maxx Pharma provides sponsorship services for manufacturers not based in Australia.
To maintain direct control of the registration of your therapeutic good, it is recommended that you appoint a “third party” Sponsor who is not commercially involved in the sale of your products and acts solely as your regulatory representative in Australia.
In acting as a product sponsor in Australia, Maxx Pharma:
- Sponsors products for manufacturers that do not have an established legal entity in Australia
- Acts as a local primary point of contact with the TGA
- Submit applications to add a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
- Maintains sponsorship after registration or listing on the ARTG
- Undertakes ongoing legal responsibilities once the therapeutic good is on the ARTG and fulfilling the obligations of the sponsor
About Maxx Pharma
As a provider of Sponsorship Services, Maxx Pharma is a wholly owned subsidiary of Commercial Eyes Pty Ltd.
Commercial Eyes is Australia’s leading pharmaceutical and medical device commercialisation company. With a team of over 100 people, with expertise in Regulatory, Quality & Compliance, Access, Research & Intelligence, Patient Safety & Risk Management, Medical Information and Patient Programs.
Contact us at [email protected] to discuss your sponsorship needs, or options for entering the Australian market.
Maxx Pharma: https://maxxpharma.com.au/
Commercial Eyes: https://commercialeyes.com.au/