This section has no associated Explanatory Memorandum
8. The list mentioned in paragraph 7 must—
(a)take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);
(b)mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; and
(c)list any excipients—
(i)if knowledge of the excipients is important for the safe and effective use of the product, and
(ii)the excipients are included in the guidance published pursuant to Article 65 of the 2001 Directive.