Product Coverage. 1. These provisions apply to marketed finished pharmaceuticals for human or animal use, intermediates (for the EU as defined in EU legislation) and in-process materials (for the United States as defined under U.S. law), certain marketed biological products for human use, and active pharmaceutical ingredients, only to the extent they are regulated by the authorities of both Parties as listed in Appendix 2 and subject to Article 20. 2. Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of this Annex. 3. Appendix 3 contains the list of products covered by this Annex.
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Samples: Agreement on Mutual Recognition Between the European Community and the United States of America, Agreement on Mutual Recognition Between the European Community and the United States of America, Agreement on Mutual Recognition Between the European Community and the United States of America
