23 Amendments of Michèle RIVASI related to 2008/0261(COD)
Amendment 54 #
Proposal for a directive – amending act
Recital 3 a (new)
Recital 3 a (new)
(3a) The Commission should submit every year to the European Parliament and to the Council a report on the current situation and trends in the falsification of medicinal products, and update the measures on the application of the safety features accordingly.
Amendment 67 #
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 128 #
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 with a false or misleading representation of:
Amendment 134 #
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) its identity, including its packaging and labelling, name, composition in respect of any of its components and strength; and/or
Amendment 141 #
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) its source, including the manufacturer, country of manufacturing, country of origin, marketing authorisation holder; and/or
Amendment 150 #
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) its history, including the records and documents relating to distribution channels.
Amendment 156 #
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)
This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights.
Amendment 183 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 46 – point g
Article 46 – point g
(b) The following point (g) is added: ‘(g) to inform the competent authority of products he gets knowledge of which are or which are suspected to be falsified in relation to the identity, history or source of products manufactured by him in the legal or illegal supply chain, including on the internet.’
Amendment 184 #
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
Amendment 204 #
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.
Amendment 250 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1
Article 54a – paragraph 4 – subparagraph 1
Amendment 282 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5
Article 54 a – paragraph 4 – subparagraph 5
The measures referred to in this paragraph shall comply with relevant provisions of Union law with regard to protection of personal data and shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights.
Amendment 288 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5 a (new)
Article 54 a – paragraph 4 – subparagraph 5 a (new)
The measures referred to in this paragraph shall be updated every year on the basis of the Commission report pursuant to Article 46(h).
Amendment 293 #
Proposal for a directive – amending act
Article 1 - point 9 a (new)
Article 1 - point 9 a (new)
Directive 2001/83/EC
Article 55 – paragraph 2
Article 55 – paragraph 2
(9a) In Article 55, paragraph 2 is replaced by the following: 2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62. - the name of the medicinal product as laid down in point (a) of Article 54, - the name of the holder of the authorization for placing the product on the market, - the expiry date, - the batch number, - the INN name."
Amendment 298 #
Proposal for a directive – amending act
Article 1 – point 11
Article 1 – point 11
Directive 2001/83/EC
Title VII – Heading
Title VII – Heading
Wholesale distribution and trad, trading and brokering of medicinal products’; (Horizontal amendment (if adopted, the whole proposal should be modified accordingly))
Amendment 304 #
Proposal for a directive – amending act
Article 1 – point 12 b (new)
Article 1 – point 12 b (new)
Directive 2001/83/EC
Article 77 – paragraph 6
Article 77 – paragraph 6
(12b) In Article 77, paragraph 6 is replaced by the following: ‘6. The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization, after having notified the holder thereof, if the conditions of authorization cease to be met or if the authorisation has not been used for more than three years. That Member State shall forthwith inform the other Member States and the Commission thereof.’
Amendment 306 #
Proposal for a directive – amending act
Article 1 – point 12 d (new)
Article 1 – point 12 d (new)
Directive 2001/83/EC
Article 79 a (new)
Article 79 a (new)
(12d) The following Article 79a is inserted: ‘Article 79a The Commission shall, in cooperation with the Agency and Member State authorities, lay down rules and criteria for obtaining trade and brokerage authorisations. Applicants must fulfil the following minimum requirements: (a) they must have a permanent address or contact details, so as to ensure accurate identification and location of their official place of business; (b) they must undertake to ensure that they conduct their activities only with those persons or entities that are able to fulfil their obligations under the terms of Article 80.’
Amendment 309 #
Proposal for a directive – amending act
Article 1 – point 13 – point -a (new)
Article 1 – point 13 – point -a (new)
Directive 2001/83/EC
Article 80 – introductory sentence
Article 80 – introductory sentence
(-a) The introductory sentence is replaced by the following: ‘Holders of the authorisation for distributing, trading or brokering medicinal products must fulfil the following minimum requirements:’
Amendment 325 #
Proposal for a directive – amending act
Article 1 – point 13 – point c
Article 1 – point 13 – point c
Directive 2001/83/EC
Article 80 – subparagraph 1 b
Article 80 – subparagraph 1 b
Where the product is obtained from the manufacturer or importerthrough trading or brokering, holders of the wholesale distribution, trading or brokering authorisation must verify that the manufacturer or importer holds a manufacturing authorizationpersons or entities involved hold the necessary authorizations through the Community database, as referred to in Article 111(6).
Amendment 327 #
Proposal for a directive – amending act
Article 1 – point 13 a (new)
Article 1 – point 13 a (new)
Directive 2001/83/EC
Article 84
Article 84
(13a) Article 84 is replaced by the following: ‘Article 84 The Commission shall publish guidelines on good distribution, trading and brokering practice for medicinal products. To this end, it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee established by Council Decision 75/320/EEC1. 1 OJ L 147, 9.6.1975, p. 23.’
Amendment 339 #
Proposal for a directive – amending act
Article 1 – point 14 d (new)
Article 1 – point 14 d (new)
Directive 2001/83/EC
Article 85 f (new)
Article 85 f (new)
(14d) The following Article 85f is inserted: 'Article 85f Nothing in this Directive shall affect the right of Member States to restrict or prohibit the sale of prescription medicines through the internet.'
Amendment 345 #
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: The competent authority shall also carry out routine or unannounced inspections at the premises of manufacturers, distributors or importers of active substances used as starting materials, at the premises of marketing authorisation holders and at the premises of manufacturers or importers or distributors of excipients, whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47. These inspections shall also be carried out if so requested by a Member State, the Commission or the Agency. The competent authority shall also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials and of excipients based in third countries.
Amendment 350 #
Proposal for a directive – amending act
Article 1 – point 15 – point c
Article 1 – point 15 – point c
Directive 2001/83/EC
Article 111 – paragraph 6
Article 111 – paragraph 6
(6) Member States shall enter the certificates of good manufacturing practice and, good distribution practice, good trading practice and good brokering practice which they issue in a Community database managed by the Agency on behalf of the Community. (Horizontal amendment (if adopted, the whole proposal should be modified accordingly))