Regulation 11 Disclosure of confidential information
A person who in the course of enforcing compliance with these Regulations gains access to commercially sensitive or other confidential information shall be guilty of an offence if without lawful authority he discloses that information.
A person may disclose commercially sensitive or confidential information to which he has had access in the course of enforcing compliance with these Regulations to—
the European Commission;
a monitoring authority;
a regulatory authority;
a laboratory or sponsor concerned with the inspection or study audit during the course of which that person gained access to that information.
For the purposes of this regulation—
the names of laboratories which are or have been subject to an inspection as part of the United Kingdom’s good laboratory practice compliance programme;
the level of adherence of a laboratory to the principles of good laboratory practice as assessed by the United Kingdom’s monitoring authority; and
the dates upon which laboratory inspections or study audits have been conducted,
shall not be considered to be confidential.