6 Amendments of Pilar AYUSO related to 2008/0261(COD)
Amendment 66 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the unique identification, authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 82 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Safety features should be grouped so as to reflect the particularities of certain products or categories of products. They should be considered equivalent when they offer the same level of efficiency for ascertaining unique identification, authentication, traceability and absence of tampering, as well as the same level of technical difficulty for duplication. When removing, replacing or covering the safety feature an equivalent safety feature should be replaced.
Amendment 208 #
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 unique identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.
Amendment 218 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a - paragraph 1 – point b
Article 54a - paragraph 1 – point b
(b) identify individual packs by means of a unique machine-readable serialisation code;
Amendment 236 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 - point b - subparagraph 1 a (new)
Article 54a – paragraph 2 - point b - subparagraph 1 a (new)
Safety features shall be considered equivalent where they are equally efficient in identifying, authenticating, tracing and preventing tampering with medicinal products, and where they are equally technical difficult to duplicate.
Amendment 311 #
Proposal for a directive – amending act
Article 1 – point 13 – point -a a (new)
Article 1 – point 13 – point -a a (new)
Directive 2001/83/EC
Article 80 – point c a (new)
Article 80 – point c a (new)
(-aa) The following point (ca) is added: (ca) they must check that the medicinal products they have purchased are not falsified by authenticating the unique identification feature on the outer packaging;