What information is required for the registration of any manufacturers, importers and distributors of active substances in the EU?
The information required of the applicant for the registration is defined in Art. 52a, No 2 of Directive 2011/62/EU:
• name or corporate name and permanent address,
• the active substances which are to be manufactured imported or distributed,
• particulars regarding the premises and the technical equipment for their activity.
[GMP Compliance Adviser, Chapter 20.B]
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