Activities of Philippe JUVIN related to 2008/0260(COD)
Shadow opinions (1)
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Amendments (36)
Amendment 26 #
Proposal for a directive – amending act
Recital 10
Recital 10
Amendment 28 #
Proposal for a directive – amending act
Recital 13
Recital 13
(13) With a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Agency’s Pharmacovigilance Risk-Benefit Balance Assessment Advisory Committee of the Agency.
Amendment 30 #
Proposal for a directive – amending act
Recital 22
Recital 22
(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products. Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routinethe intervals between reportings should not be necessarybe extended for generic, well- established use, informed consent, homeopathic, or traditional use registered herbal medicinal products. However, in the interest of public health the authorities should require periodic safety update reports for such products at specific intervals when there is a need to assess their risk or review the adequacy of product information.
Amendment 32 #
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2001/83/EC
Article 11
Article 11
Amendment 36 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21 a – introductory part
Article 21 a – introductory part
Amendment 41 #
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 – subparagraph 3
Article 27 – paragraph 1 – subparagraph 3
For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk Assessment Advisory CommitteAgency’s advisory committee to assess the risk-benefit balance as regards pharmacovigilance referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.”
Amendment 45 #
Proposal for a directive – amending act
Recital 10
Recital 10
Amendment 47 #
Proposal for a directive – amending act
Article 1 – point 18
Article 1 – point 18
Directive 2001/83/EC
Article 59 – paragraph 1
Article 59 – paragraph 1
Amendment 51 #
Proposal for a directive – amending act
Article 1 – point 20
Article 1 – point 20
Directive 2001/83/EC
Article 65 – point g
Article 65 – point g
Amendment 52 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – point 1
Article 102 – point 1
1) take all appropriate measures to encourage doctors, pharmacists and, other health-care professionals and patients to report suspected adverse reactions to the national competent authority or the marketing authorisation holder;
Amendment 53 #
Proposal for a directive – amending act
Recital 13
Recital 13
(13) With a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Pharmacovigilance Risk-Benefit Ratio Assessment Advisory Committee of the Agency.
Amendment 63 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 1 – subparagraph 1
Article 107 – paragraph 1 – subparagraph 1
1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, stating that they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study.
Amendment 64 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 2
Article 107 – paragraph 2
2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other suitable means from patients and health-care professionals.
Amendment 65 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraphs 1 and 2
Article 107 – paragraph 3 – subparagraphs 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’) information on all serious suspected adverse reactions that occur in the Community and in third countries, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, within 15 days following the receipt of the report or, in the absence of a report, followingwithin 15 days of the dayte on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Community, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, within 90 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 66 #
Proposal for a directive – amending act
Recital 22
Recital 22
(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products. Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reportings should not be necessarybe required at longer intervals for generic, well- established use, informed consent, homeopathic, or traditional use registered herbal medicinal products. However, in the interest of public health the authorities should require periodic safety update reports for such products at specific intervals when there is a need to assess their risk or review the adequacy of product information.
Amendment 66 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 1
Article 107a – paragraph 1 – subparagraph 1
1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics.
Amendment 67 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 2
Article 107a – paragraph 1 – subparagraph 2
Member States shall ensure that reports of such reactions are submitted by means of the national medicines safety web-portalweb portals or by any other appropriate means.
Amendment 68 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 2– subparagraph 1
Article 107a – paragraph 2– subparagraph 1
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, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics.
Amendment 69 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107b – paragraph 3 – introductory wording
Article 107b – paragraph 3 – introductory wording
3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only every three years, save in the following cases:
Amendment 71 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107k – paragraph 2 – subparagraph 1
Article 107k – paragraph 2 – subparagraph 1
2. The Pharmacovigilance Risk-Benefit Balance Assessment Advisory Committee shall assess the matter which has been submitted. Fconsider the situation concerned. It may hold a public hearing for theat purposes of that assessment, it may hold a public hearing in connection with a risk-benefit analysis.
Amendment 72 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107k – paragraph 2 – subparagraph 4 a (new)
Article 107k – paragraph 2 – subparagraph 4 a (new)
In cases where a public hearing is held, a preliminary report shall be published following the hearing.
Amendment 73 #
Proposal for a directive – amending act
Article 2 – paragraph 1
Article 2 – paragraph 1
Amendment 104 #
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a – and Article 11 – paragraph 3
Article 11 – paragraph 1 – point 3a – and Article 11 – paragraph 3
Amendment 140 #
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 – subparagraph 3
Article 27– paragraph 1 – subparagraph 3
For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk- Benefit Assessment Advisory Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 145 #
Proposal for a directive – amending act
Article 1 – point 18
Article 1 – point 18
Directive 2001/83/EC
Article 59 – paragraph 1
Article 59 – paragraph 1
Amendment 162 #
Proposal for a directive – amending act
Article 1 – point 20
Article 1 – point 20
Directive 2001/83/EC
Article 65 – point g
Article 65 – point g
Amendment 172 #
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 doctors, pharmacists and other health-care professionals as well as patients to report suspected adverse reactions to the national competent authority or the marketing authorisation holder;
Amendment 219 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 1 – subparagraph 1
Article 107 – paragraph 1 – subparagraph 1
1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention and to specify whether they occurred at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function, as a result of a medication error or following off-label use, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study.
Amendment 225 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 2
Article 107 – paragraph 2
2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other appropriate means from patients and health-care professionals.
Amendment 227 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraphs 1 and 2
Article 107 – paragraph 3 – subparagraphs 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’) information on all serious suspected adverse reactions that occur in the Community and in third countriesUnion and in third countries, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics, 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 database information on all non-serious suspected adverse reactions that occur in the CommunityUnion, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics,, within 90 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 232 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 1
Article 107 a – paragraph 1 – subparagraph 1
1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics.
Amendment 233 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 2
Article 107 a – paragraph 1 – subparagraph 2
Member States shall ensure that reports of such reactions are submitted by means of the national medicines safety web-portals, or by any other appropriate means.
Amendment 237 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 2 – subparagraph 1
Article 107 a – paragraph 2 – subparagraph 1
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. , specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics.
Amendment 243 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 b – paragraph 3 – introduction
Article 107 b – paragraph 3 – introduction
3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only every three years, except in the following cases:
Amendment 253 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 k – paragraph 2
Article 107 k – paragraph 2
2. The Pharmacovigilance Risk/Benefit Assessment Advisory Committee shall assess the matter which has been submitted. For the purposes of that assessment, it may hold a public hearing as part of a risk/benefit analysis. Public hearings shall be announced by means of the European medicines safety web-portal. The announcement shall include information on how marketing authorisation holders and the public can participate. The Agency shall provide the opportunity, to all those who request it, to participate in the hearing either in person or through the use of web-based technology. Where a marketing authorisation holder or another person intending to submit information has commercially confidential data relevant to the issue of the procedure, he may request to present those data to the Pharmacovigilance Risk Assessment Advisory Committee in a non-public hearing. Where a public hearing is organised, a preliminary report shall be published at its conclusion.
Amendment 267 #
Proposal for a directive – amending act
Article 1 – point 28
Article 1 – point 28
Directive 2001/83/EC
Article 2 – paragraph 1
Article 2 – paragraph 1