+Article 3 3

Article 3 3

3.   By way of derogation from paragraph 2, the common data platform shall provide access to chemicals data related to human and veterinary medicinal products as part of the implementation of the Union legal acts listed in Annex I, Part 2, only if such data:

(a)

are held by the EMA; and

(b)

relate to active substances:

(i)

that are subject to regulatory processes under other Union legal acts listed in Annex I, Part 1; or

(ii)

that have particular persistent, bio-accumulative and toxic properties; or

(iii)

for which a high level of residues has been identified in the environment; and

(c)

fall into at least one of the following categories:

(i)

non-clinical safety data, including data related to environmental risk assessments, compiled pursuant to Directive 2001/83/EC of the European Parliament and of the Council (17) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (18); or

(ii)

data related to environmental risk assessments, compiled pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council (19); or

(iii)

maximum residue levels and the data from which they were derived, compiled pursuant to Regulation (EC) No 470/2009 of the European Parliament and of the Council (20).

1. Resumen

,

1.1 Referencias

1.2 Requisitos identificados

1.3 Estándares relacionados

2. Requisitos identificados

Requisitos

3. Estándares relacionados

Estándares