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Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification) article 7 CELEX: 32016R0793 A product approved as a tiered-priced product and listed in Annex I shall remain on that list for as long as the conditions set out in Article 4 are fulfilled and annual sales reports have been submitted to the Commission in accordance with Article 12. The applicant shall submit information to the Commission on any change which has occurred with respect to the scope or conditions set out in Article 4 in order to ensure that those requirements are met. |