1 Amendments of Theodoros SKYLAKAKIS related to 2008/0256(COD)
Amendment 143 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way that is comprehensible to the general public or members thereof without compromising the quality and reliability of the information. The reason for presenting the information in a different way much be clearly justified;