15 Amendments of Andrés PERELLÓ RODRÍGUEZ related to 2008/0261(COD)
Amendment 159 #
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 1 – point 17 a
Article 1 – point 17 a
17a. Tradhird party intermediation in the trading and brokering of medicinal products: All activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products, or billing or brokering medicinal products, apart from supplying medicinal products to the public, and not falling under the definition of whorelating to the buying and selling of medicines, except for the supply of medicinal products to the public and wholesale distribution, as defined in paragraph 17 of this Article, which do not include the physical handling of such products and take the form of independent negotiation on behalf of another natural or lesgale distribution person or of a body provided for in national law.
Amendment 176 #
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 Commission shall draw up a list of certain categories of excipients on the basis of risk criteria, taking into account their origin and intended use. Those acts, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the procedure referred to in Article 290 of the Treaty on the Functioning of the European Union. The manufacturer shall apply, for those competent authority of a Member Stateategories of excipient, the relevant good manufacturing practices on the basis of a risk analysis conducted in accordance with the Directives referred to in Article 47(2), taking into account other quality system requirements that may be applicable; they shall properly document this.
Amendment 202 #
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 is possible to ascertain identification, and authenticity and traceability of medicinal products other than radiopharmaceuticals, subject tomake it possible to detect any tampering with the packaging of medicinal products other than radiopharmaceuticals which are at risk of being falsified or tampered with. . The decision to require these safety features for medicinal prescription as defined in Title VIoducts or categories thereof shall be based on a risk assessment carried out under the provisions of paragraph (4) of Article 54a’.
Amendment 215 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 1 - introductory part
Article 54a – paragraph 1 - introductory part
1. The safety features referred to in point (o) of Article 54 shall allow wholesale distributors or pharmacists orand persons authorised or entitled to supply medicinal products to the public to perform all of the following:
Amendment 216 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 1 – point a
Article 54a – paragraph 1 – point a
a) verify authenticity by assessing overt, covert or forensic devices;
Amendment 229 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b
Article 54a – paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceabilityinviolability of the external packaging of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);
Amendment 245 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 3
Article 54a – paragraph 3
(3) Manufacturing authorisation holders engaged in the activities referred to in paragraph (2) of Article 54a shall be liable for damages in accordance with Council Directive 85/374/EEC caused by medicinal products which are falsified in terms of their identity. . .
Amendment 269 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 3 – point e a (new)
Article 54a – paragraph 4 – subparagraph 3 – point e a (new)
(ea) other potential public health hazards.
Amendment 271 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 4
Article 54a – paragraph 4 – subparagraph 4
Amendment 291 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 a (new)
Article 54a – paragraph 4 a (new)
4a. Five years from the entry into force of this Directive, the Commission shall present a report to the European Parliament and the Council concerning the implementation thereof. In this report the Commission shall assess the effectiveness of the provisions adopted further to Article 54 concerning measures to prevent falsified medicinal products entering the legal distribution chain.
Amendment 292 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 b (new)
Article 54a – paragraph 4 b (new)
4b. Any Member State may extend the scope of the safety features referred to in paragraph (o) of Article 54 to other medicinal products and to other relevant areas of national policy such as reimbursement.
Amendment 295 #
Proposal for a directive – amending act
Article 1 – point 10
Article 1 – point 10
Directive 2001/83/EC
Article 57
Article 57
In Article 57, the fourth indent of the first paragraph is replaced by the following: ‘- without prejudice to point (o) of Article 54, identification and authenticity.’
Amendment 324 #
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
‘For the purpose of point (b), in the case where the product is obtained from another wholesale distributor, holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a Member State, including checking that the latter is an authorised wholesale distributor.
Amendment 346 #
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) The second subparagraph of paragraph 1 is replaced by the following: The competent authority shall have a supervisory system responsible for: - regular inspections in the Union of the premises of the manufacturers and importers of active substances employed as starting materials, and - the effective follow-up of said inspections. The competent authority shall be able to inspect the premises of manufacturers or importers of excipients whenever it considers that there are grounds for suspecting non-compliance with the law or the guidelines on good manufacturing practice referred to in Article 47. Inspections may also be carried out on the premises of marketing authorisation holders, distributors and brokers in the medicinal products trade. Inspections in the Community and in non-EU countries may be requested by a Member State, the Commission or the Agency.
Amendment 358 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118a
Article 118a