Article 22: Urgent safety restrictions

Location:

Chapter IV, section 1

Source:

1. Where, in the event of a risk to public health in the case of medicinal products, the holder takes urgent safety restrictions on its own initiative, it shall forthwith inform all relevant authorities and, in the case of a centralised marketing authorisation, the Agency.

If the relevant authority or, in the case of a centralised marketing authorisation, the Agency has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions shall be deemed accepted.

2. In the event of a risk to public health in the case of medicinal products, relevant authorities or, in the case of centralised marketing authorisations, the Commission may impose urgent safety restrictions on the holder.

3. Where an urgent safety restriction is taken by the holder or imposed by a relevant authority or the Commission, the holder shall submit the corresponding application for variation within 15 days following the initiation of that restriction.