BETA

Activities of Oreste ROSSI related to 2008/0261(COD)

Plenary speeches (2)

2016/11/22
Dossiers: 2008/0261(COD)

2016/11/22
Dossiers: 2008/0261(COD)

Amendments (12)

Proposal for a directive – amending act
Recital 4 a (new)

(4a) It is well known that the internet represents one of the main routes for falsified medicinal products to enter the European market. In view of the difficulty of pinpointing the actual physical address of internet sites and, therefore, of granting them certification of authenticity with complete certainty and of verifying the quality, safety and efficacy of the pharmaceutical, the internet sale of all types of medicinal product should be prohibited, unless they have been authorised under national legislation in force on the date of entry into force of this Directive.

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
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.

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 – point -1 (new)

Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - introductory part (new)

~~Addition of a reference to the package leaflet, in the interests of greater precision and thoroughness~~-1) In Article 1, the following point 2a is inserted: 2a. Falsified medicinal product: Any medicinal product with a false representation of: Or. it Justification.

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 – point -1 (new)

Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point a (new)

a) its identity, including its packaging and labelling and package leaflet, name, composition in respect of any of its components and strength; and/or

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 – point -1 (new)

Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point b (new)

b) its source, including the manufacturer, country of manufacture, country of origin and marketing authorisation holder; and/or

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 – point -1 (new)

Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point c (new)

c) its history, including the records and documents relating to distribution channels.

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 – point -1 (new)

Directive 2001/83/EC
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.

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 - point 9

Directive 2001/83/EC
Article 54a - paragraph 2 – introductory part

~~(2) The safety features referred to in point (o) of Article 54 shall not be partly or fully removed or covered-up, unless the following conditions are fulfilled:~~ 2. Member States shall ensure that the holder of a manufacturing authorisation does not exchange, partly or fully remove, or cover up the safety features referred to in point (o) of Article 54, unless that holder has a marketing authorisation for the relevant medicinal product in accordance with Article 6(1) or has obtained written authorisation from the marketing authorisation holder.

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 - point 9

Directive 2001/83/EC
Article 54a - paragraph 2 – point a

~~(a) The manufacturing authorisation holder verifies, prior to partly or fully removing or covering-up the safety feature, the authenticity of the product;~~deleted

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 - point 9

Directive 2001/83/EC
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 traceability of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);deleted

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 - point 9

Directive 2001/83/EC
Article 54a - paragraph 2 – point c

~~(c) The replacement of the safety feature is subject to supervision by the competent authority.~~deleted

2010/03/12
Committee: ENVI

Proposal for a directive – amending act
Article 1 – point 14 a (new)

Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)

14a. The following Title VIIa and Article 85c are inserted after Article 85b: "TITLE VIIa INTERNET SALES Article 85c 1. Internet sales of all medicines and medicinal products shall be prohibited, without prejudice to any national regulations to the contrary that are in effect on the date this Directive enters into force. 2. The Commission shall adopt measures to increase awareness among the general public of the health risks linked to purchasing medicinal products on the internet. The Commission shall adopt these measures by means of delegated acts in accordance with Articles 121a to 121c. 3. Member States which allow internet sales on the date this Directive enters into force shall ensure that they are continuously monitored by a designated body, and shall take legal action in the event of non-compliance with this Directive.

2010/03/12
Committee: ENVI