Medicines and Poisons (Medicines) Regulation 2021
sec.240Manufacturing licence for S2, S3 or S4 medicines
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sec.240 Manufacturing licence for S2, S3 or S4 medicines
No licensing fee is payable for an initial application or renewal application for a manufacturing licence for an S2, S3 or S4 medicine (each a later application ) if— an initial application or renewal application for a manufacturing licence for an S7 poison (each a first application ) has been made, and not withdrawn or refused, under the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 ; and the site the subject of the later application is the same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or renewal application for a manufacturing licence for an S7 poison (each a first application ) has been made, and not withdrawn or refused, under the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 ; and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