A2M 0.54% $5.56 the a2 milk company limited

FDA Approval, page-195

  1. 4,217 Posts.
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    My interpretation is a little different but probably much the same outcome.

    From what I can tell the grace period means that companies have two years to adapt to the new registration requirements without these being enforced, including where existing registrations expire. Companies could have been at all different stages of existing registration when the new guidelines came out. Some actually have to cancel existing registrations if they need to make ingredient changes in order to comply. Others nearing the end of their existing registration may have delayed in order to have clarity on the new guidelines before initiating the re-registration process. So I guess the idea is to standardise things for everyone.

    There have been similar grace period during previous regulatory changes and during this times companies already in the market were able to continue to sell their product (without a registration) while undergoing the transition. The key date is the implementation date in Feb 23 which is why i mentioned that to begin with.

    Believe it or not, I'm not seeking to minimise the actual risk of non renewal, which is a genuine one. I think renewal is likely but not an absolute given.

    For instance, this is all noted as a source of potential risk by A2M in their risk management section of the annual report (p.34) last year:

    - a failure to renew the company’s China label infant formula SAMR product registration beyond its expiry in September 2022, with this expiry date potentially being subject to a grace period.

    However, the company confirmed it had completed and submitted its dossiers by February. Technical review is the responsibility of SAMR. On site audit is MPI on behalf of SAMR. So I don't see how any delay is the company's fault at this point, unless of course they stuffed the paperwork. But the delays don't matter either provided these other parties do their bit by the implementation date.

    All IMO, DYOR, etc.
    Last edited by werdplaya58: 04/07/22
 
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