(b)the terms of the decision granting the marketing authorisation for a medicinal product for human use, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics;
(c)the terms of the decision granting the marketing authorisation for a veterinary medicinal product, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet.’;
(b)paragraph 8 is replaced by the following:‘8.“Urgent safety restriction” means an interim change in the terms of the marketing authorisation due to new information having a bearing on the safe use of the medicinal product.’;
(c)the following paragraph 9 is added:‘9.“Purely national marketing authorisation” means any marketing authorisation granted by a Member State in accordance with the acquis outside the mutual recognition or decentralised procedure and that has not been subject to a complete harmonisation following a referral procedure.’;