14 Amendments of Jiří MAŠTÁLKA related to 2008/0260(COD)
Amendment 46 #
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 package 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 analysis of the above data, the Commission shall, if appropriate, put forward proposal to improve the layout and the content of the summaries of product characteristics and of the package leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 56 #
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 detection and follow- up of adverse events occurring on its territory. To further increase the level of expertise on pharmacovigilance, Member States should be authorised to delegate certain pharmacovigilencouraged to organise training and regular exchancge tasks to another Member Statof information and expertise.
Amendment 59 #
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 Member States 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. The Eudravingilance database and the national database should be fully interoperable.
Amendment 61 #
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 providesubmit to the authorities with prior warning about safety announcementssafety announcements for prior authorisation and the authorities should provide each other with such a warning.
Amendment 68 #
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 134 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 22
Article 22
In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to meet certain conditionintroduce specific procedures, in particular concerning the safety of the medicinal product, notification to the national competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC. Continuation of the authorisation shall be linked to the annual reassessment of these conditions.”
Amendment 165 #
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 171 #
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 182 #
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) facilitate direct patient reporting through the provision of alternative reporting formats (email, telephone, fax and letter) in addition to web-based formats;
Amendment 195 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 103
Article 103
Amendment 206 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 105 – paragraph 2
Article 105 – paragraph 2
Amendment 209 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106
Article 106
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: (1) the leaflets of the medicines available on the national market in the national language (and where applicable the link to the EMEA EudraPharm database), (2) 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, and (3) the assessment report. By means of the national medicines web- pages, the Member States shall make public at least the following: (1) risk management systems for medicinal products authorised in accordance with this Directive; (2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004; (3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004; (4) agendas for meetings of the pharmacovigilance committee and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.
Amendment 224 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – point 2
Article 107 – point 2
2. The marketing authorisation holders may not refuseust forward to the national competent authorities any reports of suspected adverse reactions received from patients and health-care professionals within 7 days following the receipt of the report. The marketing authorisation holder must inform the patient and health-care professional that their report has been forwarded to the competent authorities who will be in charge of the follow up. Member States shall, as appropriate, involve patients and health-care professionals in the follow up of any reports they receive. The national competent authorities may not refuse any reports of suspected adverse reactions received via post, telephone, fax or in electronically format from patients and health-care professionals.
Amendment 230 #
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
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.