These changes shall be subject to the approval of the competent authority of the Member State concerned.
Home› Food & Health Safety› Community Code on Medicinal Products
Article 23
After an authorization has been issued, the authorization holder must, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.
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