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Licence to manufacture [SEPI] [Top-up SEPI] 1965 2008 2019 Acquisition Acronyms Act act as a distributor act as a wholesaler Act No. 101 of 1965 Act No. 72 of 2008 Adverse event reporting advertisements Advertising Advertising of medicines Advisory committee agent alcohol-based hand-rubs allowing international tendering Amended Amendment Amendment of Amendment of entries Amendment of Schedules amendment to the register Analysts and Scheduled Substances animals Annexure 1 Annexure 2 Annexure 3 Annexures Annual Single Exit Price Adjustment any aircraft Appeal against Appeal against decision Appeal against the decision Appeals Appendix A Applicant Information Application Application Fee Application for Application for a Licence Application for registration applications received for registration Appointment as Amended authorisation Authorisation of sale Authority authorize sale Batch release biological medicines Board Bonusing by wholesalers cancellation of licence Cancellation of registration cancellation thereof Categories categories A and D categories C and D Category A medicines Category C medicines Category D medicines certain alcohol-based hand-rubs certain information certain provisions certain provisions of Regulation 12 certain purposes certain veterinary medicines Certificate of registration certificate to be issued Certificates certificates of registration Chairman chairman casting vote chairperson Chief Executive Officer Class A Medical Classes of Medicines classification of medicines Classifications clinical investigations Clinical Trials Commencement committees Compliance with Compliance with requirements components Composition Compound compounding medicine Conditions for Conduct of Conduct of clinical trials considering applications Control Act Control of medicines Council Custom made custom made medical devices decision of decision of Authority declaration of interest Definitions Delegation of powers Deputy Registrar of Medicines Desktop inspection Destruction of Destruction of medicines Director-General Dispense Medicines Disposal Disqualification from membership Disqualifications Dissolution Dissolution of Board distribute medicines distribution distributor donated to the State efficacy employee engineers entries in register Establishment evidence Exclusion Exclusion of Exclusion of certain Exclusion of COVID-19 Vaccines Exclusion of Medicines Exclusion of Medicines from the application Exclusion of Schedule 0 Medicines executive committee Exemption Exemption of Exemption of Manufacturers Exemption of Medical Devices exhibition purposes export exportation Extension to false advertisements Fee for New Licences Fees Fees for Fees for Inspections Fees Payable filling of vacancies Form from the Operation from the operation of from the requirement in Functions Funds of Authority furnished furnishing of information General General Regulations Generic substitution hospitals How to complete How to complete template columns human complementary medicine Human medicines human use humans implantable medical devices import Importation Importation of Importation of medicines in case of prosecutions In respect of licences in terms of In Vitro Diagnostic Medical Devices In Vitro Diagnostics In Vitro Diagnostics (IVDs) Information Information that must appear Information to be furnished annually Information to be provided Inspections to assess Inspectors Instructions Instructions for use into the Republic Investigation Investigations In-Vitro Diagnostics (IVDs) IVD IVDs IVDs register Labelling Labelling of medicines Labels Licence to Compound Licence to dispense Licence to manufacture licences Licensing made in terms of the Act majority decision Management of Medicines manager manner and conditions Manufacturers and or Importers Marketing of products masters of ships Measures to ensure supply medical device Medical Devices medicine medicines Medicines and Related Substances Act Medicines and Related Substances Act, 1965 Medicines and Related Substances Amendment Act Medicines and Related Substances Control Act Medicines and Scheduled Substances medicines for human use Medicines manufactured medicines or scheduled substances medicines to the council Meetings Meetings of the council members Method of taking samples more affordable medicines No. 101 of 1965 not registered Notice No. 1002 of 1965 Notice No. 1256 of 2017 Notice No. 1502 of 2021 Notice No. 1515 of 2016 Notice No. 1581 of 2021 Notice No. 252 of 2021 Notice No. 29 of 2019 Notice No. 2940 of 2023 Notice No. 3382 of 2023 Notice No. 3800 of 2023 Notice No. 3801 of 2023 Notice No. 4406 of 2024 Notice No. 514 of 2020 Notice No. 5361 of 2024 Notice No. 695 of 2019 Notice No. 696 of 2019 Notice No. 758 of 2003 Notice No. 759 of 2003 Notice No. 784 of 2015 Notice No. 859 of 2017 Notice No. R 685 of 2019 Notice No. R. 1102 of 2005 Notice No. R. 1379 of 2020 Notice No. R. 1632 of 2021 Notice No. R. 164 of 2021 Notice No. R. 481 of 2020 Notice No. R. 585 of 2020 Notice No. R. 721 of 2020 Notice No. R. 756 of 2021 Notices Notification Notification of registration Objects Obtaining pain control medicines of certain provisions of the Act of medicines or scheduled substances of Section 22C of the Act of the provisions Offences officers in charge omission operation of Operation of Act operation of certain operations of order for medicine other committees other staff Particulars to be published Particulars which must appear Parts pathologists Patient information leaflet Patient-ready packs Penalties Period of Period of validity permanent record Permits Personal medicinal use persons entering Republic pharmacologists Powers of inspectors Preamble prescribed requirements Prescription book prescription for medicine Preservation of secrecy Pricing Committee Privileges Procedure Proclamation No. 20 of 2017 Proclamations products Professional information prohibit the manufacture Prohibition Prohibition on sale Provisions provisions of Provisions of Sections 18A and 18B provisions of the Act Publication Publication of information Purchase quality quality of medicines quality, safety and efficacy Quorum Record of Register register for medical devices register for medical devices or IVDs register for medical devices or IVs register for medicines registered midwives Registers Registrar Registration Registration certificate registration of a medicine Registration of Medicines regulation 23 regulation 24 Regulations Regulations regarding Regulations relating to Related Substances relation to other laws renewal of licence renewal of licence issued Repackaging of medicines Repeal Repeal of Laws Repealed reporting of analysis results Republic requirements Requirements for Retention Fee Payment Returns to be furnished safety sale sale of medicines Sampling of Schedule Schedule 0 Schedule 1 Schedule 2 Schedule 2, 3 and 4 substances Schedule 3 Schedule 4 Schedule 5 Schedule 6 Schedule 7 Schedule 8 Schedule Zero (0) Medicines scheduled substance scheduled substances Schedules Schedules 2, 3 and 4 Schedules 2, 3 and 4 substances Second Single Exit Price Increase section 14(3) section 15C Section 18A Section 18A and 18B Section 18B section 22A Section 22A(6)(f) of the Act section 22H Section 35(1)(xxxi) and (xxxii) Section 9 Sections 22G and 18A Seizure of medicines SEPA Short Title Single Exit Price Adjustment Single Exit Price Adjustment for 2023 Skills of staff South African Health Products Regulatory Authority Special defences specified specified provisions specified Schedule 5 State bound Submissions for 2019 submitting for substances substances from Supply of Medicines Suspension technicians template columns the Act the Authority the operation the year 2023 therapeutic equivalence through Republic through the Republic Time frames to assess to assess the Transfer from register Transfer of Transitional arrangements Transmission of medicines Transparent Pricing System undesirable products unlicensed manufacturer unregistered medical devices unregistered medicine unregistered medicines unregistered products Use of Use of medicines Use of unregistered medicines vacation of office validity of licence issued veterinary complementary medicines Veterinary medicine veterinary medicines vice-chairman vice-chairperson Vigilance wholesaler Wholesalers and Distributors of Withdrawal of Notice year 2023