19 Amendments of Milan CABRNOCH related to 2008/0261(COD)
Amendment 162 #
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 17 b (new)
Article 1 – point 17 b (new)
(1a) In Article 1, the following point 17b is inserted after point 17a: 17b. Persons authorised to supply medicinal products: Persons or entities in possession of a wholesale distribution authorisation without prejudice to persons or entities exempt from holding an authorisation to supply medicinal products.
Amendment 297 #
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”
Amendment 301 #
Proposal for a directive – amending act
Article 1 – point 11 b (new)
Article 1 – point 11 b (new)
Directive 2001/83/EC
Article 77 – paragraph 1
Article 77 – paragraph 1
(11b) In Article 77, paragraph 1 is replaced by the following: ‘1. Member States shall take all appropriate measures to ensure that the wholesale distribution, trade and brokerage of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler, trader or broker in medicinal products, stating the place for which it is valid.’
Amendment 302 #
Proposal for a directive – amending act
Article 1 – point 12 a (new)
Article 1 – point 12 a (new)
Directive 2001/83/EC
Article 77 – paragraph 5
Article 77 – paragraph 5
(12a) In Article 77, paragraph 5 is replaced by the following: 5. Checks on the persons authorized to engage in the activity of wholesaling, trading or brokering in medicinal products and the inspection of their premises, as applicable, shall be carried out under the responsibility of the Member State which granted the authorization.
Amendment 303 #
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 authorisation, after having notified the holder thereof, if the conditions of authorisation cease to be met or if the authorisation has not been used for more than three years, except in cases where the authorisation was not used on account of the time reasonably necessary to comply with the obligations under this Directive. That Member State shall forthwith inform the other Member States and the Commission thereof.
Amendment 305 #
Proposal for a directive – amending act
Article 1 – point 12 c (new)
Article 1 – point 12 c (new)
Directive 2001/83/EC
Article 78
Article 78
(12c) Article 78 is replaced by the following: Member States shall ensure that the time taken for the procedure for examining the application for the distribution, trade or brokerage authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application. The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.’
Amendment 307 #
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 308 #
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 310 #
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 c a (new)
Article 80 – point c a (new)
(-a a) The following point (ca) is added: '(ca) they must randomly verify that the medicinal products they have purchased are not falsified by checking the safety feature on the outer packaging, as referred to in point (o) of Article 54;'
Amendment 312 #
Proposal for a directive – amending act
Article 1 – point 13 – point a
Article 1 – point 13 – point a
Directive 2001/83/EC
Article 80 – point e
Article 80 – point e
(e) they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or, traded or brokered at least the following information: - date, - name of the medicinal product, - quantity received, supplied or trad, traded or brokered, - name and address of the supplier or consignee, as appropriate;’;, - national identification number, where appropriate,
Amendment 314 #
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 practice, or principles and guidelines of good trade practices, or principles and guidelines of good brokerage practices for medicinal products as laid down in Article 84.’
Amendment 316 #
Proposal for a directive – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Directive 2001/83/EC
Article 80 – point i – paragraph 1
Article 80 – point i – paragraph 1
(i) they must inform the competent authority of products they receive, trade or broker which they identify as infringing, or they suspect of infringing, either of the following:
Amendment 323 #
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 a
Article 80 – subparagraph 1 a
Amendment 326 #
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 347 #
Proposal for a directive – amending act
Article 1 – point 15 – point b
Article 1 – point 15 – point b
Directive 2001/83/EC
Article 111 – paragraph 3
Article 111 – paragraph 3
3. After every inspection as referred to in paragraph 1, the competent authority shall report on whether the manufacturer, importer, or wholesale distributor, trader or broker complies with the principles and guidelines of good manufacturing practice and, good distribution practices, good trading practice, or good brokerage practice referred to in Articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in Title IX. The competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer, importer, marketing authorization holder, or to the wholesale distributor, trading authorisation holder or brokerage authorisation holder who has undergone the inspection. Before adopting the report, the competent authority shall give the manufacturer, importer, marketing authorization holder, or wholesale distributor, trader or broker concerned the opportunity to submit their comments.’
Amendment 348 #
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 5 – subparagraph 1
Article 111 – paragraph 5 – subparagraph 1
5. Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice or, good distribution practice, good trading practices, or good brokerage practice shall be issued to the manufacturer, importer, or wholesale distributor, trader or broker if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or, good distribution practice, good trading practices, or good brokering practice as provided for by CommunityUnion legislation.
Amendment 349 #
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.
Amendment 351 #
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 7
Article 111 – paragraph 7
7. If the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices, good trading practices or good brokering practices as provided for by Community legislation, the information shall be entered in the Community database referred to in paragraph 6.
Amendment 359 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118a
Article 118a
The competent authorities shall issue the accreditation referred to in Articles 46(f) and 80(b) if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or, in the case of wholesale distributors, good distribution practices or, in the case of traders, good trading practices or, in the case of brokers, good brokering practices.