40Information for active constituents

40 Information for active constituents

If the application relates to an active constituent, the application must contain, or be accompanied by, the following information: (a) the name of the relevant chemical product for the active constituent; (b) the following names of the constituent: (i) the common name; (ii) the IUPAC name (if applicable); (iii) the chemical abstracts name (if applicable); (c) the CAS number of the constituent (if applicable); (d) the minimum purity or pharmacopoeial standard of the constituent; (e) the following information about the manufacturer of the constituent: (i) the manufacturer’s name; (ii) if the manufacturer has an ACN—the ACN; (iii) if the manufacturer is an overseas company and has a number equivalent to an ACN—that number; (iv) the name and street address of the site at which the active constituent is manufactured; (v) the country in which the active constituent is manufactured.