medicines and related substances control act 101 of 1965

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1015A Amendment of entries in register(1) The entry made in the register with respect to any medicine may on application by the holder of thecertificate of registration issued in respect of such medicine be amended by the registrar with the approvalof the council.(2) Application for the amendment of an entry in the register shall be made to the registrar on the prescribedform and shall be accompanied by the prescribed application fees.(3) The registrar shall as soon as possible after the receipt of any such application submit the application tothe council for consideration.(4) If the council grants its approval in respect of any application submitted to it in terms of subsection (3) theregistrar shall make the required amendments in the register and, if necessary, cancel the existingcertificate of registration in respect of such medicine and issue a new certificate of registration on theprescribed form to the applicant in respect of such medicine.15BTransfer of certificates of registration(1) A certificate of registration may with the approval of the council be transferred by the holder thereof toany other person.(2) Application for approval of the transfer of a certificate of registration shall be made to the registrar on theprescribed form and shall be accompanied by the certificate of registration in question and the prescribedapplication fees.(3) The registrar shall as soon as practicable after the receipt of any such application submit the application tothe council for consideration.(4) If the council grants any application submitted to it in terms of subsection (3) the registrar shall make thenecessary entries in the register relating to the person to whom the certificate of registration is transferred,cancel the existing certificate of registration and issue a new certificate of registration on the prescribedform to such person in respect of the relevant medicine.15C - Measures to ensure supply of more affordable medicinesThe Minister may prescribe conditions for the supply of more affordable medicines in certain circumstances soas to protect the health of the public, and in particular may-(a)(b)(c)notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act 57 of 1978), determinethat the rights with regard to any medicine under a patent granted in the Republic shall not extend to actsin respect of such medicine which has been put onto the market by the owner of the medicine, or with hisor her consent;prescribe the conditions on which any medicine which is identical in composition, meets the same qualitystandard and is intended to have the same proprietary name as that of another medicine already registeredin the Republic, but which is imported by a person other than the person who is the holder of theregistration certificate of the medicine already registered and which originates from any site ofmanufacture of the original manufacturer as approved by the council in the prescribed manner, may beimported;prescribe the registration procedure for, as well as the use of, the medicine referred to in paragraph (b).
1116. Cancellation of registration(1) If the council-(a)(b)(c)is of the opinion that any person has failed to comply with any condition subject to which anymedicine has been registered; oris of the opinion that any medicine does not comply with any prescribed requirement; oris of the opinion that it is not in the public interest that any medicine shall be available to thepublic,the council shall cause notice in writing to be given accordingly by the registrar to the holder of thecertificate of registration issued in respect of that medicine.(2) Any such notice shall specify the grounds on which the council's opinion is based, and shall indicate thatthe person to whom it is directed may within one month after receipt thereof submit to the registrar anycomments he may wish to put forward in connection with the matter.(3) If no such comments are so submitted, or if after consideration of any comments so submitted the councilis of the opinion that the registration of the medicine in question should be cancelled, the council maydirect the registrar to cancel the registration thereof.(4) If the person who is the holder of the certificate of registration issued in respect of any medicine fails topay the prescribed annual fee in respect of the retention of the registration of that medicine before or onthe prescribed date or such later date as the registrar may with the approval of the council determine onapplication by that person, the registrar shall cancel the registration of that medicine.17. Notification of registration or cancellation of registration in GazetteThe registrar shall give notice in the Gazette of the registration or cancellation of the registration of any medicinein terms of this Act, and shall in such notice specify-(a)(b)in the case of a registration of any medicine, the name under which such medicine is registered, the activecomponents of such medicine, the name of the person who applied for the registration of such medicine,the number allocated to it in terms of section 15 and the conditions (if any) subject to which it isregistered;in the case of a cancellation of the registration of any medicine, the name under which such medicine wasregistered, the name of the holder of the certificate of registration issued in respect of such medicine andthe number which was allocated to it in terms of section 15.18. Labels and advertisements(1) No person shall sell any medicine or Scheduled substance unless the immediate container or the packagein which that medicine or Scheduled substance is sold bears a label stating the prescribed particulars.(2) No person shall advertise any medicine or Scheduled substance for sale unless such advertisementcomplies with the prescribed requirements.(3) The label referred to in subsection (1) shall be approved by the council.(4) The council may authorise a deviation from the prescribed format and contents of any label.
Page 2 and 3: 21. Definitions(1) In this Act, unl
Page 4 and 5: 4'regulation' means a regulation ma
Page 6 and 7: 6(e)if the Minister is satisfied th
Page 8 and 9: 8(3) In the case of a medicine whic
Page 12 and 13: 12(5) The Minister may prescribe ad
Page 14 and 15: 14(4) Any Schedule 1 substance shal
Page 16 and 17: 16(j)in an emergency in which the h
Page 18 and 19: 18(i)(ii)(iii)(iv)(v)the Director-G
Page 20 and 21: 20(b)the council may, on applicatio
Page 22 and 23: 22(2) The Minister may, on the reco
Page 24 and 25: 2427. Analysts, pharmacologists and
Page 26 and 27: 26(m)manufactures, sells or uses a
Page 28 and 29: 28(6) The records and annual financ
Page 30 and 31: 30(xxi)(xxii)(xxiii)(xxiv)(xxv)(xxv
Page 32: 3236A Minister may prohibit the man

medicines and related substances control act 101 of 1965

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