1 Amendments of Mario PIRILLO related to 2008/0261(COD)
Amendment 328 #
Proposal for a directive – amending act
Article 1 – point 13 b (new)
Article 1 – point 13 b (new)
Directive 2001/83/EC
Article 84 a (new)
Article 84 a (new)
(13b) the following Article 84a is inserted: 'Article 84a The Commission shall publish guidelines on specific good manufacturing practices for active pharmaceutical ingredients and specific good manufacturing practices for excipients. To this end, it shall consult the Committee for Proprietary Medicinal Products established under Council Directive 75/319/EEC and the Pharmaceutical Committee established by Council Decision 75/320/EEC, taking into account the GMP equivalent systems in force such as HACCP and ISO9001/ISO22000 and the voluntary rules such as the EFfCI GMP and the IPEC PQG Guide for pharmaceutical excipients.'