Article 3 4

(a)

paragraph 3, point (b), of this Article, by adding chemicals data relating to substances contained in medicinal products other than active substances or relating to active substances contained in medicinal products with properties other than those referred to in paragraph 3, point (b) (i) and (ii), of this Article, where relevant to the objectives of this Regulation or if, in view of scientific progress, there is new knowledge about the hazards or risks to the environment or human health;

(b)

paragraph 3, point (c), of this Article, by adding new categories of data types relevant to the objectives of this Regulation or, if, in view of scientific progress, there are new data on the hazard or risk to the environment or human health.