6 Amendments of Miroslav OUZKÝ related to 2008/0256(COD)
Amendment 55 #
Proposal for a directive - amending act
Recital 9
Recital 9
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to prescription-only medicinal products, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions. This Directive requires Member States to permit, via certain channels and subject to appropriate monitoring, the provision by a marketing authorisation holder or a third party acting on its behalf of certain information on authorised medicines subject to prescription to the general public. Communications that do not fall within the proposed Title VIIIa are permitted, provided that they do not constitute advertising.
Amendment 91 #
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 2
Article 86 – paragraph 2 – indent 2
- factual, informative announcements (including announcements or statements such as those made to media organisations either in response to a direct enquiry or by dissemination of such information via conferences or written releases and announcements or reports to shareholders and/or regulators) and reference material relating to a medicinal product, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they and reimbursement, provided that such announcements and reference material they include no product promotional claims;
Amendment 94 #
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 3
Article 86 – paragraph 2 – indent 3
- information relating to human health or diseases, provided that there is no reference, even indirect, to individual medicinal products;
Amendment 161 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d
Article 100 b – point d
d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treatedother information on medicinal products provided under this title that meets the criteria set out in Article 100d and does not intend to promote an individual product.
Amendment 176 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point a
Article 100 c – point a
a) booklets, leaflets, audiovisual information and other categories of printed information, including health- related publications as defined by the Member State of publication, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 180 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
b) internet websites on medicinal productsand other electronic repositories containing information, to the exclusion of unsolicited material actively distributedion to the general public or members thereof;citizens through mass communications such as e-mails and telephone text messages to multiple recipients.