Maxx Pharma NZ Limited (Maxx) provides companies with a compliant and efficient pathway to enter the New Zealand market, without needing to establish a physical presence in the country, or for those within New Zealand not wanting to become a sponsor themselves, to outsource this activity. It also offers companies the flexibility to change distributors without the need to change your local sponsor.
When it comes to distribution/3PL/4PL, Maxx can work with your partners, or we can recommend one for you based on your needs. Maxx offers flexible business arrangements ranging from a full service offering (sponsorship plus all of the services offered by expert teams at Commercial Eyes) to a partial service offering if you have some expertise in-house/with other partners.
“I am always happy to talk with clients about how we can best tailor our services to their needs”
Maxx is a related company of Commercial Eyes Pty Ltd; a leading Australian-based consultancy with expertise in Regulatory, Quality & Compliance, Medical Information, Patient Safety & Risk Management, Patient Programs, Market & Patient Access and Research & Intelligence. This affiliation offers potential clients a “one-stop-shop” solution of seamless support across both the Australian and New Zealand markets.
Contact us at [email protected] to discuss your sponsorship needs, or options for entering the market in Australia or New Zealand.
After successful operations in Australia continue to grow, it is with excitement that the launch of Maxx Pharma NZ Limited is announced.
This launch now allows the offering of therapeutic product sponsorship to the New Zealand market.
Why choose Maxx Pharma NZ Limited?
While the launch of this company may be new, our team have extensive knowledge and experience navigating the unique landscape of the New Zealand market, and have established positive working relationships with Medsafe, the New Zealand Medicines and Medical Devices Safety Authority.
The expansion into the New Zealand market also offers companies who utilise Maxx Pharma Pty Ltd in Australia to consider the many benefits of having the same sponsor in both markets; namely:
Less administrative burden
Simpler solutions to assist in potential stock shortages
Shared packs between markets
Consistent and streamlined preparation of regulatory submissions
Established basis of product knowledge
About Maxx Pharma
As a provider of Sponsorship Services, Maxx Pharma Pty Ltd (in Australia) and Maxx Pharma NZ Limited (in New Zealand) are a wholly owned subsidiaries of Commercial Eyes Pty Ltd.
Contact us at [email protected] to discuss your sponsorship needs, or options for entering market in Australia or New Zealand.
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.
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).
A Sponsor is required by law if your company:
Exports or arranges the export of therapeutic goods from Australia
Imports or arranges the import of therapeutic goods into Australia
Manufactures therapeutic goods for supply in Australia or elsewhere
Your Sponsor plays an important role in the registration process and post-market compliance.
With a physical office in Melbourne, Australia, Maxx Pharma acts as an established provider of Sponsorship Services for manufacturers of medicines and medical devices located throughout the world.
Sponsors have ongoing legal responsibilities once a therapeutic good is on the ARTG
Your Sponsor in Australia acts as a liaison between you and the TGA, as specified by the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. Your Sponsor assumes regulatory representation for your product in the Australian market and is responsible for registration with the TGA.
Ongoing legal obligations for sponsors include:
Obtaining information from the manufacturer when requested by the TGA
Providing information to the TGA on request and within required legislative timeframes
Ensuring all manufacturers hold a relevant manufacturing license, clearance, certification or conformity assessment certificate, as required
Ensuring the information supplied to the TGA is complete and correct
Paying annual charges to maintain the ARTG entry while the therapeutic good is supplied on the ARTG
Applying to, or notifying, the TGA of any changes to the therapeutic good, if required
Complying with:
any conditions imposed on the supply of the therapeutic goods
the requirements for advertising therapeutic goods
requirements for records of distribution and supply
pharmacovigilance requirements
Notifying the TGA of adverse events or problems with the therapeutic goods they sponsor
Notifying the TGA of an issue that requires corrective action, such as a recall
Undertaking recall actions relevant to the therapeutic goods supplied, where necessary
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.
