Article 12 11

11.   This Article shall not apply to immediate and outer packaging as defined in Regulations (EU) 2017/745, (EU) 2017/746 and (EU) 2019/6 and Directive 2001/83/EC, if there is no space on the packaging due to other labelling requirements as defined in those Union legislative acts or if the labelling of the packaging could jeopardise the safe use of medicinal products for human use or of veterinary medicinal products.