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The Good Laboratory Practice Regulations 1999

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This is the original version (as it was originally made).

Disclosure of confidential information

10.—(1) 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.

(2) A person may disclose commercially sensitive or other confidential information to which he has had access in the course of enforcing compliance with these Regulations to—

(a)the European Commission;

(b)a monitoring authority;

(c)a regulatory authority;

(d)a police force;

(e)a test facility or sponsor concerned with the inspection or study audit during the course of which the GLPMA gained access to that information.

(3) For the purposes of this regulation—

(a)the names of test facilities or test sites which are or have been subject to an inspection as part of the UK GLP compliance programme;

(b)the level of adherence of a test facility or test site to the principles of good laboratory practice of those laboratories as assessed by the GLPMA; and

(c)the dates upon which study audits or test facility or test site inspections have been conducted,

shall not be considered to be confidential.

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