Activities of Gesine MEISSNER related to 2016/0023(COD)
Plenary speeches (1)
Mercury (debate) DE
Amendments (3)
Amendment 119 #
Proposal for a regulation
Recital 11
Recital 11
(11) The export, import and manufacturing of a range of mercury-added products accounting for a significant share of the use of mercury and mercury compounds within the Union and globally should be prohibited; continued use should be strictly monitored and meet the conditions set out in Articles 3 and 4 of this Regulation.
Amendment 169 #
Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 2 a (new)
Article 3 – paragraph 1 – subparagraph 2 a (new)
The first subparagraph shall not apply to the export of mercury and of mercury compounds and mixtures listed in Annex I used as starting material for active pharmaceutical ingredients in homeopathic preparations manufactured in accordance with the European Pharmacopeia, if the following conditions are met: - the manufacturer compiles and submits an annual compliance report in relation to any activities involving mercury to the national competent authority; - the medicinal product is authorised by a national competent authority to be marketed as a medicinal product; and - the manufacturer complies with the safety-assessment requirements for such products set out by the competent national authority.
Amendment 173 #
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
The import of mercury and of mercury compounds and mixtures listed in Annex I shall be permitted if used as starting material for active pharmaceutical ingredients in homeopathic preparations manufactured in accordance with the European Pharmacopeia, if the following conditions are met: - the manufacturer compiles and submits an annual compliance report in relation to any activities with mercury to the national competent authority; - the medicinal product is authorised by a national competent authority to be marketed as a medicinal product; and - the manufacturer complies with the safety-assessment requirements for such products set out by the competent national authority.