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What are Urgent Safety Restrictions?

Article 2(8), "Urgent Safety Restriction"
"Urgent safety restriction" means an interim change in terms of marketing authorisation due to new information having a bearing on the safe use of the medicinal product.

Article 22, Urgent Safety Restrictions
1. Where, in the event of a risk to public health in the case of medicinal products for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, the holder takes urgent safety restrictions on its own initiative, it shall forthwith inform all relevant authorities and, in the case of centralised marketing authorisation, the Agency. If the relevant authority or, in the case of 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 for human use or, in the case of veterinary medicinal products, in the event of a risk to human or animal health or to the environment, 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.

Uploaded files:
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Documentation:

- The completed USR procedure submission form (Annex 1)
- Proposed revised SmPC and package leaflet (if applicable)
- A DHPC (if applicable)
- A proposal for actions relating to recall and distribution of the new packaging information and distribution of DHPC together with corresponding timelines
- A proposal for the timing of the release of public communication
- An Investigator's Letter (if applicable for clinical trials)
- The timetable for the 24-hour USR
- The preliminary assessment report of the USR
- Any draft communication texts
- Any other relevant information relating to the matter in question