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Answer:

Certificates of suitability (CEPs) are accepted in all EU member states and in member states of the Convention on the elaboration of a European Pharmacopoeia except Ukraine. In some non EU states there may be additional requirements. A full current list of the Ph. Eur. members is available on EDQM website.  CEPs may be accepted in other countries (outside the EU or Ph. Eur. members) at the discretion of the authorities in those countries. In such cases the competent authorities in these countries will decide on the scope of the acceptance of CEPs and the conditions which they may apply, e.g. in addition to the CEP there may be a requirement for provision of a Drug Master File (open part or full content) or other documents.  It is therefore important to verify in advance, the acceptability and conditions associated with the use of a CEP in such countries. It is recommended to contact the competent authority in the country concerned for details of their current requirements as the information is subject to change without prior notice by the competent authorities.

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