Ordinance
on the Placing on the Market and Handling of Biocidal Products
(Ordinance on Biocidal Products, OBP)

¹ For a biocid­al product which is au­thor­ised in an EU or EFTA Mem­ber State (state of ori­gin), the No­ti­fic­a­tion Au­thor­ity, in con­sulta­tion with the as­sess­ment au­thor­it­ies, shall, on re­ceiv­ing an ap­plic­a­tion to this ef­fect, grant an au­thor­isa­tion for par­al­lel trade if it de­term­ines that the biocid­al product is identic­al to a biocid­al product which it has already au­thor­ised (ref­er­ence product).

^1bis For a biocid­al product that is placed on the mar­ket in the state of ori­gin with a no­ti­fied act­ive sub­stance in ac­cord­ance with the na­tion­al pro­vi­sions there, the No­ti­fic­a­tion Au­thor­ity shall, on re­ceiv­ing an ap­plic­a­tion to this ef­fect, grant an au­thor­isa­tion for par­al­lel trade provided the ap­plic­ant can demon­strate that the biocid­al product is identic­al to a ref­er­ence product.⁹⁷

² A biocid­al product shall be con­sidered identic­al to the ref­er­ence product if the fol­low­ing re­quire­ments are met:

a.

It has been man­u­fac­tured by the same com­pany, by an as­so­ci­ated un­der­tak­ing or un­der li­cence in ac­cord­ance with the same man­u­fac­tur­ing pro­cess.

b.

The products are identic­al in spe­cific­a­tion and con­tent in re­spect of the act­ive sub­stances and the type of for­mu­la­tion.

c.

The products are identic­al in re­spect of the non-act­ive sub­stances present.

d.

The products are either the same or equi­val­ent in pack­aging size, ma­ter­i­al or form, in terms of the po­ten­tial ad­verse im­pact on hu­man health, an­im­al health or the en­vir­on­ment.

³ The au­thor­isa­tion for par­al­lel trade shall con­tain the same con­di­tions for pla­cing on the mar­ket and use as in the au­thor­isa­tion for the ref­er­ence product.⁹⁸