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  • 1.  international change assessment

    This message was posted by a user wishing to remain anonymous
    Posted 10-May-2021 08:36
    This message was posted by a user wishing to remain anonymous

    Dear All,
    I am a bit confused in new company regarding international change assessment. The fact is that we have every week so many product changes and somehow unnessessary hours are spent to assess them whether it ishould be notified at international authority. Actually there are since years toning unsolved changes.
    In my knowledge in most countries there is no guidance as in US and Europe, perhaps one sentence in regulation about when to change. For me it is easy either to have new registration or a kind lof etter to file in drawer. Ask authority whether to new registration makes no sence. What is your system to control change assessment in international RA? It helps even if you could reveal in whcih country is worthy to notify change at authority.

    Maybe you can also address other thoughts:
    QMS related items (change of one manufactuering site, change of one ciritical supplier), wait for next renewal or notify?
    Product change (Labelling, new component list,) besides obviours significant change
    If significant change in how country, would you have another tactic in term of product variant without this change in related international market? How to deal home country certificate?

    Thanks for your effort and feedback.


  • 2.  RE: international change assessment

    Posted 12-May-2021 10:12
    I believe, it is very important to notify about changes... In Russia and many othere countries of ex-USSR it is obligatory to notify about many changes during very limited period of time. Mostly changes require regulator's approval. Manufacturing site change is actually crucial (must be notified in advance, so by the time new product arrives you already have a renewed license).
    Normally working in RA I would get some notification about upcoming (or planned) changes from my collegues in International RA, so I would give them information on how long it will take to implement that change and what documentation is required. Sometimes they decided not to change someting after getting feedback form all the countries, as RA expenses would be too big. Sometimes you also need to have a stock of old products in order not to disrupt supply while waiting for regulator's approval.

    Oksana Kolosova
    F. Hoffman-LaRoche

  • 3.  RE: international change assessment

    Posted 13-May-2021 11:49
    Very good discussion.
    I had good experience to discuss about change in Japan. As Oksana said, it is nessessary to notify QMS change especially in country where there is a QMS process for overseas change.

    About internal change, in my former company, were all happened. So you have to decide for , no notification, notification, or a new registration.

    Often manufacturer are more active or aware than authority. if you ask authority whether to new registration in term of any change in gray zone, they will anwser with yes. 

    Antonio Lee
    Beijing, China