BETA

4 Amendments of Jolanta Emilia HIBNER related to 2012/0267(COD)

Amendment 146 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
2a. Service providers providing means of distance communication shall be obliged, upon receiving a request from the competent authority, to disclose the details of entities engaging in distance selling.
2013/05/13
Committee: ENVI
Amendment 147 #
Proposal for a regulation
Article 5 – paragraph 2 b (new)
2b. There shall be a prohibition on the marketing, placing in use, distribution, delivery and making available of products whose names, labelling or instructions for use may mislead with regard to the product’s characteristics and effects by: a) ascribing characteristics, functions and effects to the product which the product does not have; b) creating the false impression that treatment or diagnosis using the product is sure to be successful, or failing to inform of a likely risk associated with the use of the product in line with its intended use or for a longer-than-anticipated period; c) suggesting uses or characteristics of the product other than those declared when the conformity assessment was carried out. Promotional materials, presentations and information about the products may not mislead in the manner referred to in the first sentence.
2013/05/13
Committee: ENVI
Amendment 157 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
10a. The manufacturer of the product shall be responsible for the product, for carrying out a conformity assessment on the product before it is placed on the market, and for placing the product on the market. If the manufacturer is neither resident nor based in a Member State, this responsibility shall be borne by the authorised representative for that product. Where the manufacturer has not designated an authorised representative, or where the manufacturer or authorised representative is not responsible for placing the product on the market, responsibility shall be borne by the entity that placed the product on the market.
2013/05/13
Committee: ENVI
Amendment 276 #
Proposal for a regulation
Article 45 – paragraph 3
3. Upon request by a Member State and where this is in the interest of public health or patient safety in more than one Member State, the Commission may, by means of implementing acts, extend for a determined period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 84(4).deleted
2013/05/13
Committee: ENVI