Ordinance
on Protection against Dangerous Substances and Preparations
(Chemicals Ordinance, ChemO)


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Art. 38 Additions to the documents

1 If the No­ti­fic­a­tion Au­thor­ity de­term­ines that the doc­u­ments are ob­vi­ously in­com­plete, it shall in­form the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive ac­cord­ingly without delay.

2 If an as­sess­ment au­thor­ity de­term­ines that the doc­u­ments are in­com­plete or in­ac­cur­ate, or that fur­ther data or tests are re­quired for an as­sess­ment of the haz­ards and risks as­so­ci­ated with the sub­stance, it shall in­form the No­ti­fic­a­tion Au­thor­ity ac­cord­ingly. The No­ti­fic­a­tion Au­thor­ity shall re­quest the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive to sub­mit ad­di­tions or cor­rec­tions.

3 If a ro­bust study sum­mary in ac­cord­ance with Art­icle 27 para­graph 2 let­ter b num­bers 7–9 does not per­mit an in­de­pend­ent as­sess­ment of a spe­cif­ic test, the No­ti­fic­a­tion Au­thor­ity may re­quest the full study re­port.

4 The No­ti­fic­a­tion Au­thor­ity shall con­firm to the man­u­fac­turer or ex­clus­ive rep­res­ent­at­ive the date of re­ceipt of ad­di­tions and cor­rec­tions.

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