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1.The Member States shall ensure that the manufacturing operations are carried out by manufacturers in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export.
2.For medicinal products imported from third countries, the Member States shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union and that such products have been manufactured by manufacturers duly authorised to do so.