Records of literature searches should be maintained in accordance with the requirements described in Article 12 of the Commission Implementing Regulation (EU) No 520/2012. Marketing authorisation holders should demonstrate due diligence in searching published medical literature. It is always good practice to retain a record of the search construction, the database used and the date the search was run. In addition, it may be useful to retain results of the search for an appropriate period of time, particularly in the event of zero results. If decision making is documented on the results, it is particularly important to retain this information.