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EDQM PA/PH/CEP (04) 1, 6 R

Discussion in 'Other Medical Device Regulations World-Wide' started by athenna_mk, Aug 15, 2019.

  1. athenna_mk

    athenna_mk New Member

    Aug 15, 2019
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    Hi everybody,

    I am not sure where to post my question. Sorry for the basic question but nobody seems to be able to answer my question. I already asked all People I know, online and offline as well Helpdesks. No answer till now.

    I tried to understand following:

    Manufacturer(s) (3.2.S.2.1):

    Names and addresses of each manufacturer involved in the manufacturing process from the introduction of starting material(s) to the final substance should be listed in the application and their role explained.

    Situation: a company buys material and sell it after (only) storing and packing it (retailer). In the sentence quoted, is the Company the manufacturer or must the Company start to look for Information at the supplier? In my case final substance is the same as the starting material if I consider the retailer as the manufacturer. But it is not the same if a consider the supplier as a manufacturer. He produces the product.

    I would appreciate your help.
  2. Atul Khandekar

    Atul Khandekar Administrator Staff Member

    Jul 24, 2015
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    Pune, India
    Any takers ?