Activities of Anja WEISGERBER related to 2008/0256(COD)
Shadow opinions (1)
OPINION 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
Amendments (56)
Amendment 28 #
Proposal for a directive – amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product’s packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non -promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 29 #
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 providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 30 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) Those disparities in the interpretation of the Community rules on advertising, and between national provisions on information have a negative impact on the uniform application of Community rules on advertising, and on the effectiveness of the provisions on product information contained in the summary of products’ characteristics and the package leaflet. Although those rules are fully harmonised to ensure the same level of protection of public health across the Community, this objective is undermined if widely divergent national rules on the disseminationmaking available of such key information are allowed. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 31 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non -promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics and the package leaflet in electronic and printed form.
Amendment 32 #
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. MWithout prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be a valuablen additional source of non -promotional information on their medicinal products. This Directive should therefore establish a legal framework for the disseminationmaking available 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 34 #
Proposal for a directive - amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 34 #
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 allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 36 #
Proposal for a directive – amending act
Recital 12 a (new)
Recital 12 a (new)
(12a) The Internet is a major source of information for a growing number of patients. This trend is likely to increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via national health Internet websites. These websites should be monitored by competent authorities in the Member States. Member States in cooperation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 37 #
Proposal for a directive – amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Directive 2001/83/EC
Article 59 – paragraph 3 a (new)
Article 59 – paragraph 3 a (new)
(-1a) The following paragraph shall be inserted: “3a. The package leaflet shall correspond to the real needs of patients. To this end, patient organisations should be involved in developing and reviewing the information on medicinal products by national regulatory authorities and the European Medicines Agency. The package leaflet entails a short paragraph which sets out the benefit and potential harm of a medicinal product as well as a short description of further information aiming at a safe and effective use of a medicinal product.”
Amendment 39 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
– information made available by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 41 #
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 disseminatmake available, either directly or indirectly through a third party, 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. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 42 #
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 providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 44 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1 a (new)
Article 100 a – paragraph 1 a (new)
Amendment 45 #
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: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 46 #
Proposal for a directive - amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics, and the package leaflet in electronic and printed form.
Amendment 46 #
Proposal for a directive – amending actArticle 1 – point 5 Directive 2001/83/EC
Article 100 b – introductory part
Article 100 b – introductory part
1. The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription, may be disseminated by the marketing authoriske available to the general public or members thereof a summary of the 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 made available both in electronic and in printed form and in a format accessible to people with disabilities. 2. In addition, the following types of information may also be made availabler to the general public or members thereof by the marketing authorisation holder:
Amendment 47 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Amendment 49 #
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 authorisatWhile there is already a lot of independent information on pharmaceuticals, for example by national authorities or health care professionals, the situation differs very much between Member States and among the different products available. Member States and Commission shoulders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained take much more efforts to facilitate the access of citizens to high-quality information through appropriate channels.
Amendment 49 #
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
(ba) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different wayway that is comprehensible to the general public or members thereof without jeopardising the quality or reliability of the information;
Amendment 51 #
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
(cb) information on the environmental imparelating to the disposal of unused medicinal products of ther waste derived from medicinal products, as well as reference to any collection system in place; information on prices and factual, informative announcements and reference material on a medicinal product, relating, for example, to pack changes or adverse- reaction warnings;
Amendment 52 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d a (new)
Article 100 b – point d a (new)
(da) the pharmaceutical and pre-clinical tests or clinical trials of the medicinal product concerned that are contained in the publicly accessible version of the assessment report referred to in paragraph 1.
Amendment 53 #
Proposal for a directive - amending act
Recital 8 a (new)
Recital 8 a (new)
(8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available 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 54 #
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 the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
Amendment 54 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedmade available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or ra, radio or in the printed medioa. It shall only be made available through the following channels:
Amendment 57 #
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) health-related publications as defined by the Member State of publicCommission’s guidelines concerning the information allowed, such as booklets, leaflets, and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 58 #
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 disseminated. 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 criteriabe approved in advance by the competent authorities und should be supplied only in the approved form.
Amendment 58 #
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) imarketing authorisation holders’ Internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 60 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c a (new)
Article 100 c a (new)
Article 100ca 1. Member States shall ensure that the mandatory information as referred to in Article 100b(1) shall be made available through national health Internet websites in the official language(s) of the Member State where the website is registered. Such websites shall be monitored by a competent authority of the Member State or by a body assigned by the competent authority in accordance with Article 100g. The websites shall be administered and managed in cooperation with stakeholders such as health care professionals and patient organisations. 2. The information shall communicate both benefits and risks in a clear descriptive manner that is patient friendly and linked to the national medicinal products safety website. The Internet websites shall provide patients with the mandatory information on all available medicinal products in that Member State both centrally approved by the European Medicines Agency and locally approved in that Member State. 3. The Internet websites should also include general information about medicinal and non-medicinal treatment of various diseases, including rare diseases, in order to promote a high level of public health. They may also contain other information as referred to in Article 100b(2) and as defined by the Commission’s guidelines concerning information allowed.
Amendment 63 #
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 a (new)
Article 100 h – paragraph 2 – subparagraph 2 a (new)
Without prejudice to this prohibition, Internet websites registered in accordance with paragraph 1 can provide video content when it is aimed at supporting the safe and effective use of medicinal products in general and provided that it does not contain any promotional claims relating to medicinal products. Compliance with these two conditions shall be subject to monitoring in accordance with Article 100g.
Amendment 64 #
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 allow marketing authorisation holders to disseminatmake 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. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 64 #
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 b (new)
Article 100 h – paragraph 2 – subparagraph 2 b (new)
The registered Internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorisation holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 67 #
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information andcompetent authority- approved high-quality information in approved form and in order to distinguish non-promotional information from advertising, 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 approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationcluding the "drug-fact-box".
Amendment 72 #
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.
Amendment 74 #
Proposal for a directive - amending act
Recital 12 a (new)
Recital 12 a (new)
(12 a) The internet is a major source of information for a growing number of patients. This trend is likely increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 75 #
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its dissemination, unless the substance of thesupply. Only such information thas already been agreedt has been approved in advance by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringshould be provided, and it should be provided in the approved form only.
Amendment 88 #
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 1a (new)
Article 86 – paragraph 2 – indent 1a (new)
– correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 95 #
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
- information by the marketing authorisation holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 111 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a (new), to be inserted before Article 100a
Article 100 - a (new), to be inserted before Article 100a
Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission shall grant financial support to independent drug information centres, encourage the development of independent, continuing education programmes for health professionals and the development of their critical appraisal skills.
Amendment 112 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a a (new), to be inserted before Article 100a
Article 100 - a a (new), to be inserted before Article 100a
Amendment 116 #
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 disseminatmake available, either directly or indirectly through a third party, information that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied 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. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.
Amendment 129 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part and point a
Article 100 b – introductory part and point a
The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription may be disseminated by the, marketing authorisation holder available to the general public or members thereof: 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;. A drug-fact-box shall be added to the package leaflet. The information provided in the drug-fact-box shall be presented in a form that is clearly legible, prominent and clearly distinguishable from the rest of the text. This drug-fact-box shall contain a short description of the necessary facts of the medicinal product in order to enable the patient to understand the utility and the possible risks of the medicinal product and in order to apply the medicinal product safely and in the right way. It shall also contain a short summary of the results of the clinical trials. Before supplying it, the drug-fact-box shall be approved by the competent authorities; and prior to such approval, patient organizations shall be heard in an appropriate way in order to guarantee a form that is suitable to the patients. This information shall be made available both in electronic and printed form in all languages of the EU and in a format accessible to people with disabilities.
Amendment 145 #
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
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way; way that is comprehensible to the general public or member thereof without jeopardising the quality or reliability of the information;
Amendment 162 #
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. Such information which presents the medicinal product in the context of the condition to be prevented or treatedshall be vetted by the Agency prior to its being made available in accordance with Article 20 b (1) of Regulation EC (No) 726/2004.
Amendment 165 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedthat has been approved by the competent authorities and is made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It, radio or newspapers, magazines and similar publications. The marketing authorisation holder shall be allowed to supply the information approved in Article 100b on the internet. This information shall not be supplied to the general public or members thereof unasked or actively and shall only be made available through the following channels:
Amendment 177 #
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) health-related publications as defined by the Member State of publicationCommission's guidelines concerning the information allowed, such as booklets, leaflet, and other categories of printed information including peer reviewed medical journals, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 182 #
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 190 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1 a (new)
Article 100 d – paragraph 1 a (new)
1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 231 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 1
Article 100 g – paragraph 1 – subparagraph 1
1. Member States shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereofmisuse is avoided by securing that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the dissemination to the general public or members thereof. By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31.12.2008. The Commission verifies and approves these systems.
Amendment 248 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 1
Article 100 h – paragraph 1 – subparagraph 1
1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.
Amendment 259 #
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 without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVInternet websites may provide video content if it is useful for the safe and effective use of the medicine. Video contents shall only reflect the package leaflet, the summary of the characteristics and the drug-fact-box and hints how to use this medicine safe and effectively. Before publication video contents must be approved by the competent authorities.
Amendment 267 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 a (new)
Article 100 h – paragraph 2 a (new)
2a. The registered internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 274 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point a
Article 100 h – paragraph 4 – point a
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Amendment 275 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point b
Article 100 h – paragraph 4 – point b
(b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
Amendment 279 #
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 identify the national competent authority monitoring the website concerned. 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.
Amendment 288 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point a
Article 100 j – point a
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,
Amendment 295 #
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l
Article 100 l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.