FAQs

Below you will find a list of all IMB FAQs. You can filter this list by choosing from the Categories on the left or the Years and Letters below. You can select multiple categories if you wish, to remove any filters you have applied click Remove Filters.

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Question
How much does it cost to register medical devices with the Irish Medicines Board?
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?
A company wants to market their clinical nutrition products in Ireland. What steps must they follow in order to achieve the registry and reimbursement of their products?
Are all clinical trials covered by the current regulations?
Are cosmetic products only applied to the skin?
Are preparations intended for use in hamsters, aquarium fish or caged birds exempt from the requirements of a marketing authorisation and if so, how do I go about gaining an exemption?
Are there circumstances where the IMB may change the date of an inspection?
Are there restrictions on medical devices containing mercury?