14 Amendments of Cristina GUTIÉRREZ-CORTINES related to 2008/0261(COD)
Amendment 85 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) The use of technologies that allow the authentication and tracing of medicinal products at the level of individual dosage forms (e.g. the capsule, tablet or tamper-evident immediate packaging of liquids) can also be very valuable in terms of allowing better monitoring of products on the market.
Amendment 100 #
Proposal for a directive – amending act
Recital 12
Recital 12
(12) Falsified active pharmaceutical ingredients pose the risk of sub-standard active pharmaceutical ingredients. This risk should be addressed. In particular, manufacturers of medicinal products should ensure either by themselves of through a body accredited for that purpos by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients. In particular, manufacturers of medicinal products should themselves ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices.
Amendment 101 #
Proposal for a directive – amending act
Recital 13
Recital 13
(13) TIn order to ensure sufficient protection of public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices and should comply with the information submitted within, or supplied to, the Marketing Authorisation Application, irrespective of whether those ingredients were manufactured in the Community or imported. WTherefore, with regard to the manufacture of active pharmaceutical ingredients in third countries, it should be ensured that the rul intended for medicinal products marketed in the Union, it should be ensured through repeated, mandatory inspections and enforcement by the Union’s competent authorities for the manufacture of active pharmaceutical ingredients intended for export to the Community, including inspection and enforcement, provide for a level of protection of public health equivalent to that provided for by Community legislationby authorities with mutual recognition agreements covering active pharmaceutical ingredients in force, that manufacture is taking place in compliance with both of the above- mentioned requirements.
Amendment 169 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
Amendment 187 #
Proposal for a directive – amending act
Article 1 – point 3 – point b a (new)
Article 1 – point 3 – point b a (new)
Directive 2001/83/EC
Article 46 – point h
Article 46 – point h
(ba) The following point (h) is added: (h) to assume legal liability for the accuracy of the findings of inspections and checks he has carried out or commissioned, without it being possible to delegate that liability.
Amendment 189 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – introductory part
Article 46b – paragraph 2 – introductory part
2. Active substances used as starting material shallmay only be imported if:
Amendment 190 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – point b
Article 46b – paragraph 2 – point b
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community, and that the planthave, in the past three years, successfully passed an inspection specifically covering active pharmaceutical ingredients carried out by a competent Community authority or an authority of a country with which a mutual recognition agreement is in force. The passing of the inspection shall be documented by a certificate is subject to control and enforcement ensuring that thoseed by a competent authority, attesting compliance with good manufacturing practices cannot be circumvented.
Amendment 200 #
Proposal for a directive – amending act
Article 1 - point 7
Article 1 - point 7
Directive 2001/83/EC
Article 52 c (new)
Article 52 c (new)
Article 52c The Commission shall study the possibilities for the authentication of individual dosage forms, as a method of detecting falsified medicinal products.
Amendment 313 #
Proposal for a directive – amending act
Article 1 – point 13 – point a a (new)
Article 1 – point 13 – point a a (new)
Directive 2001/83/EC
Article 80 – point g
Article 80 – point g
(aa) Point (g) is replaced by the following: '(g) they must comply with the principles and guidelines of good distribution, trading and brokering practice for medicinal products as laid down in Article 84.'
Amendment 342 #
Proposal for a directive – amending act
Article 1 – point 15 – point -a (new)
Article 1 – point 15 – point -a (new)
Directive 2001/83/EC
Article 111 – paragraph 1
Article 111 – paragraph 1
(-a) Paragraph 1 is replaced by the following: '1. The competent authorities of the Member State concerned shall, under the Agency's coordination, ensure by means of repeated, and where necessary unannounced, inspections, that the legal requirements governing medicinal products are complied with, and shall, where appropriate, commission an official medicinal product test laboratory, or another laboratory designated for that purpose, to carry out sampling tests. Such inspections shall be carried out by officials representing the competent authority who shall be empowered to: (a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20; (b) take samples; (c) examine any documents which relate to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975, and which place restrictions on these powers with regard to the descriptions of the method of preparation.'
Amendment 343 #
Proposal for a directive – amending act
Article 1 – point 15 – point a a (new)
Article 1 – point 15 – point a a (new)
Directive 2001/83/EC
Article 111 – paragraph 1 – subparagraph 2
Article 111 – paragraph 1 – subparagraph 2
(aa) In Article 111(1), subparagraph 2 is replaced by the following: '2. The competent authorities shall carry out repeated, and where necessary unannounced, inspections of the premises of producers, distributors or importers of active ingredients used as starting materials, the premises of manufacturing authorisation holders, the premises of medicinal product traders and brokers or the premises of excipient producers, importers and distributors where there are sound grounds for suspecting, on the basis of information available to the authorities or of previous cases, that legal obligations or the guidelines are not being complied with. Such inspections may also be carried out at the request of a Member State, the Commission or the Agency.'
Amendment 352 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111a
Article 111a
The Commission shall adopt detailed guidelines laying down the principles for inspections referred to in Article 111 and, in particular, the Union or national bodies responsible for carrying out inspections.
Amendment 354 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 1 – introductory part
Article 111b – paragraph 1 – introductory part
1. The Commission shall, following a request from a third country and the satisfactory conclusion of the inspection by the body responsible pursuant to Article 111a, list that country by way of a Decision if its regulatory framework for active substances exported to the Community and the respective control and enforcement ensure a protection of public health equivalent to that in the Community. Particular account shall be taken of:
Amendment 357 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 3
Article 111b – paragraph 3
3. The Commission, in cooperation with the Agency and competent authorities of the Member States, shall verify regularly whether the conditions set out in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the country has been listed in accordance with paragraph 1be conducted with a view to confirming compliance with the criteria set out in paragraph 1 and shall be followed by regular verifications at intervals of no less than 3 years.