1. ‘variation to the terms of a mar

1. ‘variation to the terms of a marketing authorisation’means an amendment to the contents of the documentsreferred to in Article 6(1) and (2) or Article 28(1) and (2)of Regulation (EEC) No 2309/93, such as they existed atthe moment the decision on the marketing authorisationwas adopted, in accordance with Article 10 or Article 32of that Regulation or after approval of any previousvariations;2. a ‘minor variation’ of type IA or type IBmeans a variationlisted in Annex I which fulfils the conditions set outtherein;3. a ‘major variation’ of type II means a variation that cannotbe deemed to be a minor variation or an extension of themarketing authorisation;4. ‘urgent safety restriction’ means an interim change, dueto new information having a bearing on the safe useof the medicinal product, to the product informationconcerning particularly one or more of the followingitems in the summary of product characteristics: theindications, posology, contraindications, warnings, targetspecies and withdrawal periods.