10 Amendments of Patrizia TOIA related to 2008/0261(COD)
Amendment 49 #
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 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 50 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, together with interested parties, should be free to determine the particular aspects of technologies for combating counterfeiting of pharmaceuticals which they consider most appropriate for their pharmaceutical distribution systems, taking account of the authentication seal adopted by this Directive.
Amendment 59 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) In particular, information campaigns should be promoted at both national and European level. The Commission and Member States should adopt effective measures to improve public awareness of the risks arising from purchases of pharmaceuticals over the Internet.
Amendment 64 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Member States should cooperate, including with Europol, to step up the existing restrictions on the illegal supply of pharmaceuticals over the Internet.
Amendment 78 #
Proposal for a directive – amending act
Article 1 – point 3 - point b a (new)
Article 1 – point 3 - point b a (new)
Directive 2001/83/EC
Article 46 – point h (new)
Article 46 – point h (new)
(ba) The following point (h) is added: ''(h) to make the importation of the active principles from third countries subject to specific and stringent monitoring, in order to check whether good manufacturing practices have been adhered to and the intrinsic quality of the active principles.'
Amendment 84 #
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.’
Amendment 92 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4
Article 54 a – paragraph 4
4. The Commission shall adopt the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article. Before formulating a specific proposal as provided for by Article 54(o), the Commission shall perform an impact assessment of the costs and benefits of the anti-counterfeiting systems currently in force and consult interested parties about the implementation and use of such authenticating seals. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a)
Amendment 95 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5
Article 54 a – paragraph 4 – subparagraph 5
The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights.’ Member States shall ensure that the ownership and confidentiality of the data generated by using technology to combat counterfeiting of pharmaceutical products are respected.'
Amendment 108 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Article 88 – paragraph 1 a (new)
Article 88 – paragraph 1 a (new)
14a) In Article 88, the following paragraph 1a is inserted after paragraph 1: '1a. Member States, in cooperation with the Commission and after consulting interested parties, shall devise an information strategy concerning the reliability of suppliers of pharmaceuticals. This strategy should take into account the various national legislations regulating the supply of pharmaceuticals and the risk attendant upon certain methods of supply of pharmaceuticals, such as illegal Internet channels.'
Amendment 111 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111 b – paragraph 2
Article 111 b – paragraph 2
2. The Commission, in accordance with the procedure set out in Article 121(2), shall adopt guidelines defining in detail the requirements set out in points (a) to (d) of paragraph 1, performing by means of the appropriate instruments, and possibly also by means of extraordinary measures, the verification and subsequent monitoring of the quality of the principles and safety.