Unless there is appropriate justification, the maximum acceptable deviation in the active substance content of the finished product shall not exceed ± 5 % at the time of manufacture.
Mura bhfuil údar iomchuí leis, ní rachaidh an t-uasdiallas inghlactha d’ábhar substainte gníomhaí an táirge chríochnaithe thar ± 5 % tráth an mhonaraithe.