The Portuguese Health Regulatory Authority (ERS) must carry out inspections and audits on a regular basis, in accordance with previously inspection plans, and whenever circumstances indicate potential disruptions within the relevant sector of activity.

Employees mandated by ERS to carry out surveillance and inspection activities, or audits are equated to law enforcement agents and may:

a) Access all premisses of the facilities, lands or vehicles of companies and or other entities, subject to ERS’s activity, including those collaborating with them;

b) Inspect books, and other records held by companies and or other entities subject to ERS’s activity, as well those collaborating with them, regardless of theirformat. This excludes access to patients' clinical records.

c) Obtain, by any means, copies or extracts of the documents under review;

d) Request from any legal representative, worker, or collaborator of the company or of other entities subject to ERS’s activities as well those collaborating with them,clarifications regarding facts or documents related to the object and purpose of the inspection activity or audit and record their responses;

e) Identify, for the purposes of any subsequent proceedings, any Entities or individuals whowho infringe the Law and regulations subject to ERS’s supervision;;

f) Request the assistance of police or administrative authorities whenever deemed necessary for the due performace of their duties.