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australian capital territory medicines poisons and therapeutic goods regulation 2008 sl2008 42 made under the medicines poisons and therapeutic goods act 2008 republication no 45 effective 1 october 2022 republication ...

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                                                                                                                        Australian Capital Territory 
                                                           Medicines, Poisons and Therapeutic 
                                                           Goods Regulation 2008     
                                                           SL2008-42 
                                                           made under the 
                                                           Medicines, Poisons and Therapeutic Goods Act 2008 
                                                           Republication No 45 
                                                           Effective:  1 October 2022 
                                                           Republication date: 1 October 2022 
                                                           Last amendment made by SL2021-28 
                                                           (republication for expiry of provision (s 632)) 
                                                            
                                                                                                                                     
                                                                                   Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au 
                      
                     About this republication 
                     The republished law 
                     This is a republication of the Medicines, Poisons and Therapeutic Goods Regulation 2008, made 
                     under the Medicines, Poisons and Therapeutic Goods Act 2008 (including any amendment made 
                     under the Legislation Act 2001, part 11.3 (Editorial changes)) as in force on 1 October 2022.  It 
                     also includes any commencement, amendment, repeal or expiry affecting this republished law to 
                     1 October 2022.   
                     The legislation history and amendment history of the republished law are set out in endnotes 3 
                     and 4.  
                     Kinds of republications 
                     The Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT 
                     legislation register at www.legislation.act.gov.au): 
                     •  authorised republications to which the Legislation Act 2001 applies 
                     •  unauthorised republications. 
                     The status of this republication appears on the bottom of each page. 
                     Editorial changes 
                     The Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial 
                     amendments and other changes of a formal nature when preparing a law for republication.  
                     Editorial changes do not change the effect of the law, but have effect as if they had been made by 
                     an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117).  The 
                     changes are made if the Parliamentary Counsel considers they are desirable to bring the law into 
                     line, or more closely into line, with current legislative drafting practice.   
                     This republication does not include amendments made under part 11.3 (see endnote 1). 
                     Uncommenced provisions and amendments 
                     If a provision of the republished law has not commenced, the symbol  U  appears immediately 
                     before the provision heading.  Any uncommenced amendments that affect this republished law 
                     are  accessible  on  the  ACT  legislation  register  (www.legislation.act.gov.au).  For  more 
                     information, see the home page for this law on the register. 
                     Modifications 
                     If  a  provision  of  the  republished  law  is  affected  by  a  current  modification,  the 
                     symbol  M  appears immediately before the provision heading.  The text of the modifying 
                     provision appears in the endnotes.  For the legal status of modifications, see the Legislation 
                     Act 2001, section 95. 
                     Penalties 
                     At the republication date, the value of a penalty unit for an offence against this law is $160 for an 
                     individual and $810 for a corporation (see Legislation Act 2001, s 133). 
                              Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au 
                           
                                                                                  
                                                     Australian Capital Territory 
                          Medicines, Poisons and Therapeutic 
                          Goods Regulation 2008 
                          made under the 
                          Medicines, Poisons and Therapeutic Goods Act 2008 
                               
                          Contents 
                                                                                                           Page 
                          Chapter 1             Preliminary 
                             1       Name of regulation                                                       2 
                             3       Dictionary                                                               2 
                             4       Notes                                                                    2 
                             5       Offences against regulation—application of Criminal Code etc             3 
                             6       Overview of things to which medicines and poisons standard does not 
                                     apply                                                                    3 
                           
                           R45                     Medicines, Poisons and Therapeutic Goods          contents 1 
                           01/10/22                            Regulation 2008 
                                                              Effective:  01/10/22  
                                     Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au 
                                                                      
                                            Contents 
                                                                                                                                                                             Page 
                                          Chapter 2                           Medicines—authorisations generally 
                                          Part 2.1                            Overview of medicines authorisations 
                                             10             General overview of authorisations for medicines                                                                      5 
                                             11             Overview of medicines authorisations under this regulation                                                            6 
                                             12             General overview of authorisation conditions for medicines                                                            9 
                                          Part 2.2                            Relationship with registration laws 
                                             20             Medicines authorisations subject to Health Practitioner Regulation 
                                                            National Law (ACT) restrictions                                                                                     10 
                                             21             Medicines authorisations subject to Veterinary Practice Act 2018 
                                                            restrictions                                                                                                        10 
                                          Chapter 3                           Medicines—supply authorities 
                                          Part 3.1                            Prescribing medicines 
                                          Division 3.1.1                      Authorisation to prescribe medicines 
                                             30             Authorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b), 
                                                            (2) (b) and (3) (b)                                                                                                 11 
                                             31             Authorisation conditions for prescribing medicines—Act, s 44 (1) (b) 
                                                            and (2) (b)                                                                                                         12 
                                           31A              Variation of authorisation condition during Commonwealth special 
                                                            arrangement period                                                                                                  14 
                                             32             Additional requirements for prescribing controlled medicines for human 
                                                            use                                                                                                                 15 
                                          Division 3.1.2                      Prescriptions 
                                             40             General requirements for written prescriptions                                                                      16 
                                             41             Particulars for prescriptions                                                                                       16 
                                          Part 3.2                            Requisitioning medicines 
                                          Division 3.2.1                      Authorisation to issue requisitions 
                                             50             Authorisation under sch 1 to issue requisitions for medicines—Act, 
                                                            s 41 (b)                                                                                                            19 
                                             51             Authorisation conditions for issuing requisitions for medicines—Act, 
                                                            s 44 (1) (b) and (2) (b)                                                                                            19 
                                           
                                            contents 2                       Medicines, Poisons and Therapeutic Goods                                                        R45 
                                                                                                Regulation 2008                                                       01/10/22 
                                                                                              Effective:  01/10/22  
                                                            Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au 
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