Ordinance
on Good Laboratory Practice
(OGLP)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 18 May 2005 (Status as of 1 December 2012)


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Art. 9 Duties and powers of the authority

1 The au­thor­ity shall carry out in­spec­tions and study audits ac­cord­ing to the guidelines in Sec­tions A and B of An­nex I of European Dir­ect­ive 2004/9/EC of the Par­lia­ment and of the Coun­cil of 11 Feb­ru­ary 20046.

2 On re­quest, the es­tab­lish­ment must sub­mit to the au­thor­it­ies all doc­u­ments and all oth­er evid­ence re­quired to as­sess its com­pli­ance with GLP Prin­ciples.

3 The au­thor­it­ies must be al­lowed to ac­cess the test fa­cil­it­ies at all times.

4 If an es­tab­lish­ment with test fa­cil­it­ies has been ac­cred­ited by the Swiss Ac­cred­it­a­tion Ser­vice pur­su­ant to Art­icle 14 of the Or­din­ance of 17 June 19967 on Ac­cred­it­a­tion and Iden­ti­fic­a­tion, the au­thor­ity shall take these res­ults in­to ac­count.

6 Dir­ect­ive 2004/9/EC of the European Par­lia­ment and of the Coun­cil of 11 Feb. 2004 on the in­spec­tion and veri­fic­a­tion of good labor­at­ory prac­tice (GLP); OJ No. L 050 of 20 Feb. 2004, pp. 28-43. The European Com­munity le­gis­la­tion men­tioned in this Or­din­ance can be ordered for a fee or con­sul­ted free of charge at the no­ti­fic­a­tion au­thor­ity for chem­ic­al products, 3003 Bern; it can also be con­sul­ted at www.cheminfo.ch.

7 SR 946.512

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