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FAQs for the page Manufacturing

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Question
A "Responsible Person" is required to be appropriately qualified. It is preferable for this person to have a degree in pharmacy? Would it be correct to say that the RP should be someone with wholesaler's licence experience? What other areas of expertise should an RP have?
A company holds an API GMP certificate and wants to include another API – is an inspection required?
A company intends to renew their API GMP Certificate – is an inspection required?
Are there circumstances where the IMB may change the date of an inspection?
Can a licence / export certificate application be submitted by email?
Can companies contact the IMB to discuss changes to their manufacturing/ wholesale facility or licence?
Can companies request a change to the date of an inspection?
Can companies request to meet with the IMB to discuss plans for a new manufacturing facility?
Does a veterinary wholesaler importing Torbugesic/ Butador require an import licence?
Does a wholesaler supplying controlled drug veterinary medicinal products e.g. Dolethal, Somulose, require a controlled drug licence?
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Date Printed: 10 September 2010

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