sec.86Manufacturing licence for hazardous poisons

sec.86 Manufacturing licence for hazardous poisons

No licensing fee is payable for an initial application or renewal application for a manufacturing licence for a hazardous poison (each a later application ) if— an initial application or renewal application for a manufacturing licence for an S4 medicine (each a first application ) has been made, and not withdrawn or refused, under the Medicines and Poisons (Medicines) Regulation 2021 ; and the site the subject of the later application is the same as the site the subject of the first application; and the term proposed for the later application ends no later than the last month of— the term proposed for the first application; or if the chief executive has granted the first application—the term of the substance authority granted on the first application; and all fees payable under the Act for the first application have been paid.

• (a) an initial application or renewal application for a manufacturing licence for an S4 medicine (each a first application ) has been made, and not withdrawn or refused, under the Medicines and Poisons (Medicines) Regulation 2021 ; and
• (b) the site the subject of the later application is the same as the site the subject of the first application; and
• (c) the term proposed for the later application ends no later than the last month of— (i) the term proposed for the first application; or (ii) if the chief executive has granted the first application—the term of the substance authority granted on the first application; and
• (i) the term proposed for the first application; or
• (ii) if the chief executive has granted the first application—the term of the substance authority granted on the first application; and
• (d) all fees payable under the Act for the first application have been paid.
• (i) the term proposed for the first application; or
• (ii) if the chief executive has granted the first application—the term of the substance authority granted on the first application; and