S.L. 458.34 Art. 31Informing the Agency of the actions taken.

(1) The Medicines Authority shall take all the appropriate measures to ensure that decisions authorising marketing, refusing or revoking a marketing authorization, cancelling a decision refusing or revoking a marketing authorization, prohibiting supply, or withdrawing a product from the market, together with the reasons on which such decisions are based, are brought to the attention of the Agency forthwith.

(2) The marketing authorisation holder shall be obliged to notify the Medicines Authority forthwith of any action taken by the holder to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is based on any of the grounds set out in article 28(1) of the Medicines Act.

(3) The marketing authorisation holder shall also make the notification pursuant to sub-regulation (2) in cases where the action is taken in a third country and where such action is based on any of the grounds set out in article 28(1) of the Medicines Act.

(4) The marketing authorisation holder shall furthermore notify the Agency where the action referred to in sub-regulation (2) is based on any of the grounds referred to in article 28 of the Medicines Act.

(5) The Medicines Authority shall ensure that appropriate information about action taken pursuant to sub-regulations (1) and

(2) which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organization, with a copy to the Agency.

(6) The marketing authorisation holder shall notify the Medicines Authority before the commencement of any recall of medicinal product from the local market, and to submit all pertinent and required information. SCHEDULE Added L.N. ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS

TABLE OF CONTENTS Introduction and general principles Part I: Standardised marketing authorisation dossier requirements