Activities of Judith A. MERKIES related to 2008/0261(COD)
Plenary speeches (1)
Falsified medicinal products (debate)
Shadow opinions (1)
OPINION Proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
Amendments (26)
Amendment 42 #
Proposal for a directive – amending act
Citation 1
Citation 1
Having regard to the Treaty establishingon the Functioning of the European CommunityUnion, and in particular Article 95s 114 and 168 thereof,
Amendment 43 #
Proposal for a directive – amending act
Recital 4 b (new)
Recital 4 b (new)
(4b) The new draft Convention of the Council of Europe on counterfeiting of medicinal products and similar crimes involving threats to public health, which is expected to be open for signature in 2010, should be supported by the Commission and the Member States.
Amendment 44 #
Proposal for a directive – amending act
Recital 4 c (new)
Recital 4 c (new)
(4c) A considerable number of medicines purchased over the internet come from sites that conceal their actual physical address. Therefore, a distinction should be made between legitimate mail-order or internet pharmacies and the illegal supply chain through non-controlled internet purchasing. Member States should ensure that the internet sale of medicinal products is continuously monitored by designated bodies.
Amendment 45 #
Proposal for a directive – amending act
Recital 4 d (new)
Recital 4 d (new)
(4d) European citizens should be made aware of the danger to their health from ordering products from non-controlled internet websites or from the illegal supply chain. The Commission together with the Member States and in cooperation with the patients' and consumers' organisations should adopt measures to increase awareness among the general public on the risks related to purchasing medicinal products on the internet. Public awareness campaigns should inform citizens whether their internet pharmacy is officially registered and controlled by public authorities.
Amendment 46 #
Proposal for a directive – amending act
Recital 4 e (new)
Recital 4 e (new)
Amendment 61 #
Proposal for a directive – amending act
Recital 4 c (new)
Recital 4 c (new)
(4c) It is useful to introduce a definition of the concept of ‘falsified medicinal product’ in order to distinguish such products from legal but unauthorised medicinal products. Furthermore, authorised or otherwise legitimate products with quality defects and medicinal products that due to mistakes in the manufacturing or subsequent handling do not comply with the requirement of Good Manufacturing Practices or Good Distribution Practices should not be confused with falsified medicines.
Amendment 61 #
Proposal for a directive – amending act
Recital 13 a (new)
Recital 13 a (new)
(13a) Pharmaceutical excipients, other than active pharmaceutical ingredients, used in drug product manufacturing should be subject to appropriate controls by the manufacturing authorisation holder such that the excipients are checked and verified by the manufacturing authorisation holder to be suitable for use in the production of drug products in accordance with good manufacturing practices and that the verification provides for an adequate level of protection of public health.
Amendment 65 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Amendment 67 #
Proposal for a directive – amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Directive 2001/83/EC
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
(-1a) In Article 1, the following point 3a is inserted after point 3: (3a) Excipient: “Excipients are the constituents of a pharmaceutical form apart from the active substance. Excipients include, for example, fillers, disintegrants, lubricants, colouring matters, antioxidants, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, solubilisers, permeation enhancers, flavouring and aromatic substances, as well as the constituents of the outer covering of the medicinal products, for example gelatine capsules.”
Amendment 75 #
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 a (new)
Article 46 – point f – subparagraph 1 a (new)
The manufacturing authorisation holder should ensure that starting materials other than active pharmaceutical ingredients are assessed as being suitable for use in pharmaceutical products. The manufacturing authorisation holder shall ensure that the process by which the assessment is achieved is described in a quality system which is available for inspection by competent authorities.
Amendment 80 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 47 – paragraph 2 a (new)
Article 47 – paragraph 2 a (new)
Amendment 86 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 2 – point b – subparagraph 1 a (new)
Article 54 a – paragraph 2 – point b – subparagraph 1 a (new)
Amendment 89 #
Proposal for a directive – amending act
Article 1 – point 9
Article 1 – point 9
Directive 2001/83/EC
Article 54 a – paragraph 2 – subparagraph 1 a (new)
Article 54 a – paragraph 2 – subparagraph 1 a (new)
The safety features referred to in point (o) of Article 54 shall be applied without discriminating between distribution channels.
Amendment 103 #
Proposal for a directive – amending act
Recital 13
Recital 13
(13) The manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the Community or imported. With regard to the manufacture of active pharmaceutical ingredients in third countries, it should be ensured that the rules 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 legislation. Pharmaceutical excipients, other than active pharmaceutical ingredients, used in drug product manufacturing should be subject to appropriate controls by the manufacturing authorisation holder such that the excipients are checked and verified by the manufacturing authorisation holder to be suitable for use in the production of drug products in accordance with Good Manufacturing Practices and that the verification provides for an adequate level of protection of public health.
Amendment 107 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)
Title VII a (new) – Article 85 c (new)
Amendment 113 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118 c a (new)
Article 118 c a (new)
Article 118ca The Commission and the Member States shall cooperate closely with the Council of Europe on the establishment of a European Convention on the suppression of the falsification of medicinal products and trafficking in falsified medicines. The Convention covers the civil and criminal law aspects of falsification and trafficking of falsified medicinal products.
Amendment 125 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - introductory part (new)
Article 1 – point 2 a - paragraph 1 - introductory part (new)
-1) In Article 1, the following point 2a is inserted after point 2: 2a. Falsified medicinal product: Any medicinal product that has been deliberately falsified in relation to its:
Amendment 131 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point a (new)
Article 1 – point 2 a - paragraph 1 - point a (new)
(a) identity, including its packaging, labelling, name and composition in terms of components, including packaging components, excipients, active ingredients, and the dosage thereof; and/or
Amendment 142 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point b (new)
Article 1 – point 2 a - paragraph 1 - point b (new)
(b) source, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder; and/or
Amendment 146 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point c (new)
Article 1 – point 2 a - paragraph 1 - point c (new)
(c) history, including the records and documents enabling the distribution chain to be identified.
Amendment 151 #
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 2 (new)
Article 1 – point 2 a - paragraph 2 (new)
The Commission shall, in cooperation with the Agency and Member State authorities, update this definition on the basis of technical and scientific progress and international agreements. This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights. This definition does not include non- intentional manufacturing errors.
Amendment 158 #
Proposal for a directive – amending act
Article 1 – point - 1 b (new)
Article 1 – point - 1 b (new)
Directive 2001/83/EC
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
(-1b) In Article 1, the following point 3a is inserted after point 3: 3a. Excipient: The constituent of a pharmaceutical form apart from the active substance. Excipients include fillers, disintegrants, lubricants, colouring matters, antioxidants, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, solubilisers, permeation enhancers, flavouring and aromatic substances, as well as the constituents of the outer covering of the medicinal products, for instance gelatine capsules.
Amendment 174 #
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
(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State. The manufacturing authorisation holder should ensure that starting materials other than active pharmaceutical ingredients are assessed as being suitable for use in pharmaceutical products. The manufacturing authorisation holder must ensure that the process by which the assessment is achieved is described in a quality system which will be available for inspection by competent authorities.’
Amendment 196 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 47 – paragraph 3
Article 47 – paragraph 3
‘The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 and in Article 46b shall be adopted in the form of detailed guidelines.’ The principles by which the manufacturing authorisation holder ensures that excipients are suitable for use in manufacturing operations, carried out using risk based analyses under the principles of good manufacturing practices, shall be adopted in the form of guidelines.
Amendment 235 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Safety features shall be considered equivalent where they are equally efficient in identifying, authenticating, tracing and preventing tampering with medicinal products, and where they are equally technical difficult to duplicate. This paragraph shall also apply to the removal, replacement or covering up of new safety features.
Amendment 242 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point c a (new)
Article 54a – paragraph 2 – point c a (new)
(c a) The safety features referred to in point (o) of Article 54 shall be applied without discrimination between distribution channels.