10 Amendments of Corinne LEPAGE related to 2008/0256(COD)
Amendment 39 #
Proposal for a directive - amending act
Recital 4
Recital 4
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the CommunityEU, and that this has given rise to situations where the general public is exposed to disguised advertising.
Amendment 52 #
Proposal for a directive - amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 60 #
Proposal for a directive - amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminatedis accessible. The information should take into account patients needs and expectations in order to empower patients allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteria.
Amendment 69 #
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake only high-quality information and to distinguish non-promotional information from advertisingaccessible, the types of information which may be disseminated should be defined. It is appropriate to allow marketing authorisation holders to disseminate the contents of the approvedmake accessible the most recent summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationapproved by the competent authorities.
Amendment 109 #
Proposal for a directive - amending act
Article 1 – point 2
Article 1 – point 2
2001//83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
4. The prohibition set outreferred to in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.
Amendment 138 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
Amendment 181 #
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) marketing authorisation holders’ internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 213 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1
Article 100 e – paragraph 1
1. Member States shall ensure that marketing authorisation holders' Internet websites for the dissemination of information on medicinal products subject to medical prescription faithfully reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised.
Amendment 266 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TV, podcasts or any other information in video format.
Amendment 280 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allow marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall clearly identify the national competent authority monitoring the website concerned and the marketing authorisation holder responsible for the website. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.