Activities of Jiří MAŠTÁLKA related to 2008/0256(COD)
Shadow reports (1)
REPORT Report on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use PDF (693 KB) DOC (1020 KB)
Amendments (27)
Amendment 30 #
Proposal for a directive - amending act
Recital 1
Recital 1
(1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use establishes harmonised rules on the advertising of medicinal products for human use. In particular, it prohibits the advertising to the general public of medicinal products subject to medical prescription in order to protect public health.
Amendment 62 #
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 to disseminatcan make available 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 information and the public assessment reports.
Amendment 80 #
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that the information made available by marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective and efficient monitoring mechanisms and allowing effective enforcement in cases of non-compliance and redress mechanisms for consumers. Monitoring should be based on the control of information prior to its dissemination, unless the substancecontent of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring.
Amendment 85 #
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)
(-1a) In Article 86 (1), the following indent shall be added: - drawing the general public's attention to a specific medicinal product or to a therapeutic class of medicinal products using therapeutic indications or signs and symptoms
Amendment 104 #
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 118 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1
Article 100 a – paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminate, either directly or indirectly through a third party,make available information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII.
Amendment 120 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 2
Article 100 a – paragraph 2
Amendment 134 #
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 to the exclusion of a statement regarding the availability of the same information in the website of the national competent authority or the European Medicines Agency. It should be available in a pdf format that faithfully represents the officially approved information drawn up by the competent authorities.
Amendment 142 #
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 150 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point c
Article 100 b – point c
c) information on the environmental impact of the medicinal product, prices and factual, informative announcements and reference material relating, for example, to pack changes or adverse- reaction warnings;relating to the disposal of unused medicinal product or waste derived from medicinal products as well as reference to any collection system in place.
Amendment 158 #
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 171 #
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 195 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point c
Article 100 d – paragraph 2 – point c
c) a statement indicating that the information is disseminated by a[name of the marketing authorisation holder];
Amendment 199 #
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) mail address or e-mail address allowing members of the general public to send comments to the national competent authorities;
Amendment 203 #
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 b (new)
Article 100 d – paragraph 2 – point d b (new)
(db) a statement indicating that members of the general public are encouraged to report negative side effects of prescription drugs to their doctor, pharmacist or to the national competent authorities.
Amendment 215 #
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 222 #
Proposal for a directive - amending act
Article 1 – point 5 (new)
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100e – paragraph 1 b (new)
Article 100e – paragraph 1 b (new)
1b. Member States shall make available on the website of the national competent authorities the approved and updated version of the summary of product characteristics, labelling and package leaflet of the medicinal product, the publicly accessible version of the assessment report and its summary where applicable. The website of the national competent authorities shall include a link to the Eudrapharm website.
Amendment 243 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
The methods may include the voluntary control of information on medicinal products by self-regulatory or co- regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.
Amendment 249 #
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
Amendment 257 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 1
Article 100 h – paragraph 2 – subparagraph 1
2. Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holderwebsites, with the exclusion of the competent authorities' websites, unless they have also been registered in accordance with that paragraph. Those websites shall identify the competent authority which granted the marketing authorisation and its website address.
Amendment 260 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2
Article 100 h – paragraph 2 – subparagraph 2
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, pod casts, video streaming or any other digital information format not strictly authorised in accordance with this Directive.
Amendment 272 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 3
Article 100 h – paragraph 3
3. The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website. The marketing authorisation holder shall remain fully responsible and liable for all the information it disseminates to the general public.
Amendment 282 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5 a
Article 100 h – paragraph 5 a
Amendment 285 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 i – paragraph 1 – point c a (new)
Article 100 i – paragraph 1 – point c a (new)
ca) the obligation to put in place complaint-handling systems and efficient redress mechanisms to deal with consumer complaints and to ensure fair compensation of victims.
Amendment 286 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 i – paragraph 1 – subparagraph 1 a (new)
Article 100 i – paragraph 1 – subparagraph 1 a (new)
Member States shall provide for the possibility to publish the name of a marketing authorisation holder responsible for disseminating non- compliant information on a medicinal product.
Amendment 290 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point c
Article 100 j – point c
c) supply the authorities or bodies responsible for monitoring information on medicinal products with the information, the financial resources and assistance they require to carry out their responsibilities;
Amendment 293 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 k
Article 100 k
Information on homeopathic and herbal medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title.