19 Amendments of Anne DELVAUX related to 2008/0260(COD)
Amendment 37 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product isFor newly authorised medicinal products and for medicinal products that are authorizsed subject to the requirement to conduct a post-authorisation safety study or where there areare subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal productsall newly authorised medicinal products on the market for less then 3 years, identified as such by a black triangle and a corresponding explanatory sentence on the summary of product characteristics and on the patient information leaflet, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 51 #
Proposal for a directive – amending act
Recital 10 a (new)
Recital 10 a (new)
(10a) Without any delay, the Commission shall, in collaboration with EMEA, and following consultations with organisations representing patients, consumers, doctors and pharmacists, social health insurers, and Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability 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 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 70 #
Proposal for a directive – amending act
Recital 28
Recital 28
(28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities. It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of fees. However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence.
Amendment 87 #
Proposal for a directive – amending act
Article 1 – point 1 – point c
Article 1 – point 1 – point c
Directive 2001/83/EC
Article 1 – point 15
Article 1 – point 15
Amendment 92 #
Proposal for a directive – amending act
Article 1 – point 1 – point d
Article 1 – point 1 – point d
Directive 2001/83/EC
Article 1 – point 28b
Article 1 – point 28b
(28b) Risk management system: a set of specific pharmacovigilance activities and interventions designed to idequantify, characterise, prevent or minimise or prevent risks relating to a medicinal product, including the assessment of the effectiveness of those interventions, or to ensure early identification of new risks.
Amendment 109 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 – paragraph 3
Article 11 – paragraph 3
“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal productfollowing statement, preceded by the symbol : “This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”
Amendment 124 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21a - introductory words
Article 21a - introductory words
Amendment 130 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21a – paragraph 2
Article 21a – paragraph 2
The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary. If the conditions included in the marketing authorisation are not fulfilled by the relevant deadline, the competent authorities shall have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.
Amendment 139 #
Proposal for a directive – amending act
Article 1 – point 14 – point a
Article 1 – point 14 – point a
Directive 2001/83/EC
Article 27 – paragraph 1
Article 27 – paragraph 1
1. ATwo coordination groups shall be set up: (a) a coordination group for mutual recognition and decentralised procedures shall be responsible for the following purposes: (atasks: (i) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), with the exception of all questions relating to pharmacovigilance. For the fulfilment of its tasks, the coordination group for mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 5(1) of Regulation (EC) No 726/2004. (b) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (cii) the examination of questions relateding to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1). The Agency shall provide the secretariat of this coordination group, for all questions relating to pharmacovigilance. For the fulfilment of its pharmacovigilance tasks, the coordination group for pharmacovigilance risk assessment shall be assisted by the European Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004. The Agency shall provide the secretariat for these coordination groups.
Amendment 157 #
Proposal for a directive – amending act
Article 1 – point 18 b
Article 1 – point 18 b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3
Article 59 – paragraph 1 – subparagraphs 2 and 3
“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended textNew important safety warnings shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “‘New information”mportant safety warnings’. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product, preceded by the symbol ▼ : ‘This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name and, web-address, postal address and/or telephone number of the national competent authority>”’.”
Amendment 158 #
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3
Article 59 – paragraph 1 – subparagraphs 2 and 3
“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended textNew important safety warnings shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”text “New important safety warnings “. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product, preceded by the symbol : ‘This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name and, web-address, postal address and/or telephone number of the national competent authority>”’.”
Amendment 175 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing author. Those measures shall include training for health professionals and for patients and a public information campaign for patients. Patients’ organisation s shoulder be involved in providing information and training to patients and in developing public information campaigns in cooperation with regulatory bodies.
Amendment 179 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)
Article 102 – paragraph 1 – point 1 a (new)
(1a) conduct public awareness campaigns on the importance of reporting adverse reactions;
Amendment 186 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 2
Article 102 – paragraph 1 – point 2
(2) ensure that adverse reaction reports and the databases contain the highest quality information possible;
Amendment 193 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)
Article 102 – paragraph 1 – point 3 a (new)
(3a) ensure that the public is given important information in good time on pharmacovigilance concerns relating to the use of a medicinal product and that the data is permanently accessible to the public;
Amendment 207 #
Proposal for a directive – amending act
Article – point 21
Article – point 21
Directive 2001/83/EC
Article 105 – paragraph 2
Article 105 – paragraph 2
Amendment 228 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraph 1 and 2
Article 107 – paragraph 3 – subparagraph 1 and 2
3. Marketing authorisation holders shall be required to submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’)national competent authorities information on all serious suspected adverse reactions that occur in the Community and in third countries within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the Eudravigilance databasenational competent authorities information on all non-serious suspected adverse reactions that occur ion the Communitymarkets in which they operate, within 9045 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event.
Amendment 229 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 4
Article 107 – paragraph 4
4. Member States shall access reports on adverse reactions through the Eudravigilance database and shall assess the quality of the data received from marketing authorisation holders. They shall, as appropriate, involve patients and health- care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders. The marketing authorisation holders shall be required to report any follow up information received to the Eudravigilance database.
Amendment 241 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a
Article 107a
1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention fromby healthcare professionals and patient, patients, marketing authorisation holders and programmes for the reporting and prevention of medication errors. Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals, as well as by mail, telephone and fax. 2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database. Marketing authorisation holderselectronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all adverse reactions that occur within their territory within 15 days following the receipt of the report or, in the absence of a report, following the day on which the competent authority gained knowledge of the event. Marketing authorisation holders, healthcare professionals and the public shall access those reports through the Eudravigilance database, which must be made permanently accessible without delay. 3. The Member States shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and, to any authorities responsible for patient safety within that Member State and to independent programmes for the reporting and prevention of medication errors. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.