Proposal 3 – Improving reliability of supply for known shortages
14. Would implementation of a new TGA process that provided faster evaluation times and lower fees encourage you to make an application to register one of the medicines that are subject to longstanding section 19A approvals?
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Yes
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No
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Not sure
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The decision to register a product is based on cost recover plus profit. Many of the products that have S19A approvals, only have low sales and therefore not viable to register. However, without knowing the revised ARTG listing fees it is difficult to comment.
15. What value do you see in having a designation step to confirm the eligibility of an application before it is formally submitted to the TGA?
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Yes, as this will save time and money for the sponsors working with the manufacturer.
16. Do you think introduction of the proposed process will assist in supporting a more reliable supply of overseas-registered medicines currently imported under section 19A?
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Yes
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No
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The proposed suggestions would reduce some of the supply chain risks and therefore make it more viable to import product under S19A.
17. Do you have any other suggestions to encourage ARTG registration of medicines currently supplied under section 19A?
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The suggestions made, would make the decision to register products currently on S19A more economically viable.