45 Amendments of Michèle RIVASI related to 2008/0260(COD)
Amendment 35 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) The planning of pharmacovigilance for each individual medicinal product by the marketing authorisation holder should also take place in the context of a risk management system and should be proportionate to the identified risks, potential risks, and the need for additional information on the medicinal product. It should also be foreseen that any key measures contained in a risk management system are included in the marketing authorisation as conditions. If the conditions included in the marketing authorisation are not fulfilled by the relevant deadline, competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.
Amendment 36 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where, in the case of an unmet medical need, a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are 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 products, which should be identified by a specific symbol on the outer packaging and by a corresponding explanatory sentence in the 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 47 #
Proposal for a directive – amending act
Recital 10
Recital 10
(10) In order to make it possible for the healthcare professionals anWithin five years of the entry into force of this Directive, the Commission shall, following consultations with organisations representing patients, consumers and healthcare professionals, Member States and other interested parties, presents to identify easily the most relevant information about the medicines they use,the European Parliament and the Council an assessment report regarding the readability of the summary of theies of product characteristics and the packageing leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits. Following an analysis of such 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 health care professionals.
Amendment 55 #
Proposal for a directive – amending act
Recital 17
Recital 17
(17) To further increase the coordination of resources between the Member StatesEach Member State should be responsible for the oversight of the adverse reactions occurring in its territory. To further increase the level of expertise in pharmacovigilance, Member States should be authorised to delegate certain pharmacovigilencouraged to organise training and to regularly exchancge tasks to another Member Statinformation and expertise.
Amendment 57 #
Proposal for a directive – amending act
Recital 18
Recital 18
(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders should report those reactions only to the competent authorities of the Member States where it occurred and the Member States should report those reactions ondirectly to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’). Any change in the national database should be immediately and automatically reflected in the Eudravigilance database.
Amendment 62 #
Proposal for a directive – amending act
Recital 19
Recital 19
(19) In order to increase the level of transparency on the processes of pharmacovigilance, the Member States should create and maintain medicines safety web-portals. To the same end, the marketing authorisation holders should provide the authorities with prior warning about safety announcements and the authorities should provide each other with such a warningbe required to submit to the authorities the safety announcements which they plan to disseminate for prior authorisation. Without delay following such authorisation, the authorities should provide each other with a prior warning about these safety announcements.
Amendment 69 #
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 71 #
Proposal for a directive – amending act
Recital 29 a (new)
Recital 29 a (new)
Amendment 72 #
Proposal for a directive – amending act
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2001/83/EC
Article 1 – point 11
Article 1 – point 11
Amendment 86 #
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
“(15) Post-authorisation safetypharmacovigilance study: Any study with an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product medicinal product authorised early for reasons of public health in the absence of a therapeutic alternative, or carried out at the request of the health authorities once a medicinal product has been placed on the market, with the aim of identifying, characterising or quantifying adverse reaction risks or of assessing the adverse reaction profile of the medicinal product, or of reassessing its risk/benefit balance, or of measuring the effectiveness of risk management measures.”
Amendment 91 #
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 94 #
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 28c
Article 1 – point 28c
(28c) Pharmacovigilance system: a system utilized byenabling marketing authorisation holders and by Member States, with a view to fulfilling the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and: (a) to collect information useful for the surveillance of medicinal products, with particular reference to adverse reactions in human beings, including misuse and abuse of medicinal products and medication errors; and (b) to evaluate such information scientifically in order to detect any change to their risk- benefit-risk balance of authorised medicinal products.
Amendment 96 #
Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)
Article 1 – point 1 – point d a (new)
Directive 2001/83/EC
Article 1 – points 32 a, 32 b and 32 c (new)
Article 1 – points 32 a, 32 b and 32 c (new)
(da) The following points 32a, 32b and 32c are inserted: “(32a) Medication error: a non- intentional, preventable omission or action relating to a medicinal product which can be the cause of a risk or of an adverse event for the patient, and which can concern one or more stages in the medicinal product’s cycle, such as formulary selection, prescription, dispensing, validation, preparation, storage, delivery, administration and therapeutic monitoring and information, but also its interfaces, such as communications and transcriptions. (32b) Medication misuse: use of a medicinal product not in compliance with the recommendations in the summary of the product characteristics (SPC). (32c) Medically justified use outside the approved indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the SPC but based on the assessment data.”
Amendment 106 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a
Article 11 – paragraph 1 – point 3a
Amendment 114 #
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 summaryleaflet shall include the statement: “This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“. The statement shall be accompanied by an inverted black triangle . The black triangle shall also appear on the outer packaging.”
Amendment 121 #
Proposal for a directive – amending act
Article 1 – point 7
Article 1 – point 7
Directive 2001/83/EC
Article 21 – paragraph 4 – subparagraph 1
Article 21 – paragraph 4 – subparagraph 1
4. The national competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials and the risk management system and the pharmacovigilance system of the medicinal product concerned. The assessment report shall detail the natural development of the disease, existing treatments for the indication requested, where appropriate, and whether the medicinal product produces tangible therapeutic progress in comparison to existing treatments (‘added value’ or ‘improvement in the medical service provided’). The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned.
Amendment 125 #
Proposal for a directive – amending act
Article 1 – paragraph 8
Article 1 – paragraph 8
Directive 2001/83/EC
Article 21a - introductory words
Article 21a - introductory words
Amendment 133 #
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2
Article 21a – point 4 – subparagraph 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 136 #
Proposal for a directive – amending act
Article 1 – point 11
Article 1 – point 11
Directive 2001/83/EC
Article 23– paragraph 4 – subparagraph 1
Article 23– paragraph 4 – subparagraph 1
4. In order that the risk-benefit balance may be continuously assessed, the national competent authority may at any time ask the holder of the marketing authorisation to forward data demonstrating that, through its pharmacovigilance system, the data necessary for a reassessment of the risk- benefit balance remains favourable.
Amendment 138 #
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: tasks: (ai) 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 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 141 #
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 Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Amendment 142 #
Proposal for a directive – amending act
Article 1 – point 14 – point b
Article 1 – point 14 – point b
Directive 2001/83/EC
Article 27– paragraph 2 – subparagraphs 1a and 1b
Article 27– paragraph 2 – subparagraphs 1a and 1b
Members of the coordination groups for mutual recognition and decentralised procedures and for pharmacovigilance risk assessment and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to the national marketing authorisation bodiesbodies responsible for, respectively, issuing marketing authorisations and pharmacovigilance. Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts. Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination groups as regards the transparency and independence of its members. their members. A member of one coordination group may not simultaneously be a member of the other group. The members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies.
Amendment 143 #
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27– paragraphs 4, 5 and 6
Article 27– paragraphs 4, 5 and 6
4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination groups. 5. The members of the coordination groups for mutual recognition and decentralised procedures and for pharmacovigilance risk assessment shall ensure that there is appropriate coordination between the tasks of thateir respective group and the work of national competent authorities, including, respectively, the consultative bodies concerned with the marketing authorisation and those concerned with the surveillance of medicinal products. 6. Save where otherwise provided for in this Directive, the coordination groups shall use itstheir best endeavours to take decisions by consensus. If such a consensus cannot be reached, the position of the majority of members shall prevail.
Amendment 144 #
Proposal for a directive – amending act
Article 1 – point 14 – point c
Article 1 – point 14 – point c
Directive 2001/83/EC
Article 27– paragraph 6 a (new)
Article 27– paragraph 6 a (new)
6a. A detailed agenda of coordination group meetings shall be made public on the day before the meeting at the latest. Detailed minutes of coordination group meetings, containing, in particular, details of votes and explanations of votes, including minority opinions, shall be made public in the month following the meeting.
Amendment 146 #
Proposal for a directive – amending act
Article 1 – point 18 – point a
Article 1 – point 18 – point a
Directive 2001/83/EC
Article 59 – paragraph 1 – point aa
Article 59 – paragraph 1 – point aa
Amendment 156 #
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 informationhe following 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 newly authorised medicinal product is under intensive monitoring in order to increase knowledge of its adverse effects. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>”’. The statement shall be accompanied by an inverted black triangle, which shall also appear on the outer packaging.”
Amendment 163 #
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 178 #
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 to report suspected adverse reactions to the national competent authority or the marketing authorisation holder;
Amendment 185 #
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 187 #
Proposal for a directive – amending act
Article 1 – point 2
Article 1 – point 2
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 192 #
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 196 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 103
Article 103
Amendment 208 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 - introductory words
Article 106 - introductory words
Each Member State shall set up and maintain a national medicines web-portal, including a dedicated medicine safety web- portalage, which shall be linked to the European medicines safety web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines safety web- portals, the Member States shall make public at least the following:
Amendment 210 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point -1 (new)
Article 106 – point -1 (new)
Amendment 211 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point -1 a (new)
Article 106 – point -1 a (new)
(-1a) the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised;
Amendment 212 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point -1 b (new)
Article 106 – point -1 b (new)
(-1b) the assessment reports together with the periodic safety update reports submitted by marketing authorisation holders to the health authorities;
Amendment 214 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point - 1
Article 106 – point - 1
(1) risk management systemdetailed descriptions of risk management systems, and detailed protocols for post-authorisation studies for medicinal products authorised in accordance with this Directive;
Amendment 217 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 a (new)
Article 106 – point 3 a (new)
(3a) agendas for meetings of the Pharmacovigilance Committee and of the coordination group and records of their meetings, accompanied by the decisions taken and by details and explanations of the votes, including minority opinions;
Amendment 218 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 b (new)
Article 106 – point 3 b (new)
(3b) requests from the national competent authority to the marketing authorisation holder to operate a risk management system or to conduct a post-authorisation study, together with the explanations provided by the marketing authorisation holder to the national competent authority where necessary, and the final decision of the competent authority.
Amendment 221 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107
Article 107
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, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study. Marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the Community. By way of derogation to the first subparagraph, sclinical trial or a post-authorisation safety study. Suspected adverse reactions occurring in the context of a clinical trial shall also be recorded and reported in accordance with Directive 2001/20/EC. 2. The marketing authorisation holder may not refuseshall forward to the national competent authorities any reports of suspected adverse reactions received electronically from patients and health-care professionals. 3. M within 45 days of receiving the reports. The 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’)inform the patient and healthcare professional that their report has been forwarded to the competent authorities who will be in charge of following it up. The national competent authorities may not refuse reports of suspected adverse reactions received by post, telephone, facsimile transmission or in electronic format from patients and healthcare professionals. 3. Marketing authorisation holders shall be required to submit electronically to the 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 Community, 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 knowledgemarkets in which they operate, within 45 days following the receipt of the evenreport. For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report to the Eudravigilance database the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions. 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 240 #
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 1530 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 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. 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.
Amendment 244 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107b – paragraph 3 - introductory words
Article 107b – paragraph 3 - introductory words
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 16 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 in the following cases: –
Amendment 258 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 108 – point 3
Article 108 – point 3
(3) the use of internationally agreed terminologies, formats and standards for the conduct of pharmacovigilance allowing the clinical significance of reported case to be preserved;
Amendment 261 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 108 – paragraph 2
Article 108 – paragraph 2
Those guidelines shall be based on patient needs from a scientific perspective, shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress.
Amendment 269 #
Proposal for a directive – amending act
Article 2 – paragraph 1
Article 2 – paragraph 1
1. With regard to the requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectivelymedicinal product’s adverse reaction profile in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.