The Authorized Holder shall notify the Board of the product's approval and its decision about whether to supply the product in accordance with Article 34, or provide any further information about the process of marketing the product in accordance with the provisions of Article 33, as well as information about potential adverse consequences of the approval of a medicinal product and on the measures taken by the Authorized Holders if they should come under any of those consequences.
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ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, MARKETING Authorization HOLDERS, PACKAGING AND PACKAGE SIZES OF THE MEDICINAL PRODUCT IN THE MEMBER STATES 1 Article
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