1 Amendments of Mairead McGUINNESS related to 2008/0260(COD)
Amendment 119 #
Proposal for a directive – amending act
Article 1 – point 7
Article 1 – point 7
Directive 2001/83/EC
Article 21 – paragraph 3
Article 21 – paragraph 3
“3. The national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet, summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised.