Where a Member State or Switzerland finds that, although an instrument that an economic operator has been made available on the EU and on the Swiss market is in compliance with Directive 2014/31/EU or Directive 2014/32/EU, respectively the relevant Swiss legislation, presents a risk to aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Pour ce qui concerne l'Union européenne, la procédure officielle de libération de lots est précisée dans le document “Control Authority Batch Release of Vaccination and Blood Products, 2001” ou ses versions ultérieures, ainsi que dans diverses procédures spécifiques de libération de lots.