13 Amendments of Linda McAVAN related to 2008/0256(COD)
Amendment 68 #
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allowclarify that marketing authorisation holders tocan disseminate the contents of the approved 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 informationand public assessment report.
Amendment 84 #
Proposal for a directive – amending act
Article 1 – point – 1 a (new)
Article 1 – point – 1 a (new)
Directive 2001/83/EC
Article 86 – paragraph 1 – indent 7 a (new)
Article 86 – paragraph 1 – indent 7 a (new)
Amendment 105 #
Proposal for a directive - amending act
Article 1 – point 2
Article 1 – point 2
Directive 2001/83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
Amendment 132 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part
Article 100 b – introductory part
The following types of information on authorised medicinal products subject to medical prescription may be disseminatedmade available by the marketing authorisation holder to the general public or members thereof, via their websites:
Amendment 133 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point a
Article 100 b – point a
a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities; . This information should be presented in the form of a list classified in alphabetical order or by therapeutic class and should not be accompanied by pictures or additional information. It should include a statement regarding the availability of the same information on website of the national competent authority and the website of the European Medicines Agency. The documents should be made available in a pdf format that faithfully represents the officially approved information drawn up by the competent authorities.
Amendment 137 #
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 156 #
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 treated.eleted
Amendment 173 #
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
Amendment 184 #
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 200 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point d a (new)
Article 100 d – paragraph 2 – point d a (new)
da) a mail or e-mail address allowing members of the general public to send comments to the national competent authorities;
Amendment 201 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
db) a statement indicating that members of the general public are encouraged to report all suspected adverse reactions of medicinal products to their doctor, pharmacist, healthcare professional, or to the national competent authority, and indicating the name and web-address, postal address and / or telephone number of that national competent authority.
Amendment 217 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 a (new)
Article 100 e – paragraph 1 a (new)
1a. Member States shall ensure that each webpage from a marketing authorisation holders' website referring to a medicinal product subject to medical prescription includes a link to the corresponding webpage of the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation EC 726/2004, and the national or Community safety web portal referred to in Article 106 of the Directive, and Article 26 of Regulation (EC) No 726/2004.
Amendment 252 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 2
Article 100 h – paragraph 1 – subparagraph 2
After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other Internet websites throughout the Community if the contents are identicalany amendments to the content relating to medicinal products subject to medical prescription shall be subject to monitoring in accordance with paragraph 3.