6.
The competent authority or authorities shall organise inspections and carry out control measures as appropriate whenever there is any serious adverse reaction or serious adverse event. In addition, such an inspection shall be organised and control measures shall be carried out at the duly justified request of the competent authority or authorities in another Member State in any such case.
← 5. · All articles · 7. →
Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.