(d)
the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation;
← art_33__para_3__point_c__text_1 · All articles · art_33__para_3__point_d__text_1 →
Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.