What is confirmed by the written confirmation for imported APIs?
The written confirmation confirms the following:
• The GMP standards applicable to the third-country active substance manufacturer are at least equivalent to those laid down by the European Union.
• The manufacturing plant in the third country is subject to regular, strict and transparent controls and to repeated and unannounced inspections, so as to ensure the effective implementation of GMP standards by the competent authority in the third country and to assure supervision by the competent authority that is at least equivalent to EU requirements.
• Any reports of non-compliance shall be communicated to the European Union without delay.
[GMP Compliance Adviser, Chapter 20.B]
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