1 Amendments of Herbert REUL related to 2008/0261(COD)
Amendment 82 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 54 – point o
Article 54 – point o
(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI, other than radiopharmaceuticals and medicinal products which due to their specific characteristics are not suitable for distribution through a wholesaler and pharmacy and therefore are sold directly by the producer to a clinical establishment where they are directly administered to the patient.