5 Amendments of Catherine STIHLER related to 2013/0049(COD)
Amendment 118 #
Proposal for a regulation
Article 2 – paragraph 3 – point a
Article 2 – paragraph 3 – point a
(a) medicinal products and medical devices for human or veterinary use;
Amendment 163 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point d
Article 6 – paragraph 1 – subparagraph 1 – point d
(d) the categories of consumers at risk when using the product, in particular vulnerable consumers; such as children, the elderly and the disabled, while taking into account vulnerability based on specific risks by the product.
Amendment 246 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Manufacturers shall ensure that they have procedures in place for taking corrective action, withdrawing or recalling their products. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 296 #
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it, if appropriate. Distributors shall ensure that they have procedures for taking corrective action, withdrawing or recalling products that they have made available on the market. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 333 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The system of traceability shall consist of the collection and storage of data by electronic means enabling the identification of the product and of the economic operators involved in its supply chain as well as of the placement of a data carrier on the product, its packaging or accompanying documents enabling access to that data. The system of traceability shall include facilities to extend traceability of products out to the consumer through voluntary opt-in measures.