Advisory on the Use of Open Text Fields in APS

Open text fields may be used in APS provided that they do not relate to healthcare products, healthcare product issues, diseases/conditions, outcomes/endpoints, corporate messages or service messages. They may be used solely for personalized greetings or transactional elements (e.g. date and time of meeting). Open text fields must not include other messages, even if they echo messages reviewed and accepted elsewhere in the current or previous APS.

In order to employ open text fields, the manufacturer must confirm:

  1. Representatives will be adequately trained on proper use of open text fields
  2. There is an audit-type mechanism in place to monitor and ensure compliance with this directive
Advisory on the use of open text fields in APS E 05.2020.pdf



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