Medicines and Related Substances Amendment Act
This section publishes an amendment Act and inserts or substitutes several product definitions, including cosmetics, foodstuffs, IVDs, medical devices, medical device establishments, medicine, and products.
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- South Africa
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- Act 72 of 2008
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About this statute
This section publishes an amendment Act and inserts or substitutes several product definitions, including cosmetics, foodstuffs, IVDs, medical devices, medical device establishments, medicine, and products. The South African Health Products Regulatory Authority is established and must act without fear, favour or prejudice; it may exercise powers and perform functions given by the Act. The Minister must appoint a suitably qualified Chief Executive Officer, and certain people cannot be appointed to that role. The Minister must establish an advisory committee, and the committee and its members have rules about size, appointment, disclosure, remuneration, and non-interference. This section repeals sections 5, 6, 7, 8, 9 and 12 of the principal Act.
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Provisions of Medicines and Related Substances Amendment Act
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April 2009
AI-assisted research summary: This section publishes an amendment Act and inserts or substitutes several product definitions, including cosmetics, foodstuffs, IVDs, medical devices, medical device establishments, medicine, and products.
21 April 2009 No. 32148 THE PRESIDENCY No. 434 21 April 2009 It is hereby notified that the President has assented to the following Act, which is hereby published for general information:– No. 72 of 2008: Medicines and Related Substances Amendment Act, 2008. AIDS HELPLINE: 0800-123-22 Prevention is the cure 4 (c) by the insertion after the definition of ‘‘certificate of registration’’ of the following definition: ‘‘ ‘cosmetic’ means a cosmetic as defined in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), which contains a Scheduled substance;’’; (d) by the deletion of the definition of ‘‘council’’; (e) by the insertion after the definition of ‘‘export’’ of the following definition: ‘‘ ‘foodstuff’ means a foodstuff as defined in the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), which contains a Scheduled substance;’’; (f) by the insertion after the definition of ‘‘interchangeable multi-source medicine’’ of the following definition: ‘‘ ‘IVD’ (in vitro diagnostic medical device) means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes;’’; (g) by the substitution for the definition of ‘‘medical device’’ of the following definition: ‘‘ ‘medical device’ means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article— (a) intended by the manufacturer to be used, alone or in combination, for human beings for— 5 10 15 20 (i) diagnosis, prevention, monitoring, treatment or alleviation of 25 disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensa- tion for an injury; (iii) investigation, replacement, modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) control of conception; (vi) disinfection of medical devices; or (vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means;’’; (h) by the insertion after the definition of ‘‘medical device’’ of the following definition: (i) ‘‘ ‘medical device or IVD establishment’ means a facility used by a manufacturer, wholesaler, distributor, retailer, service provider or an importer of medical devices or IVDs for conducting business;’’; by the substitution for the definition of medicine of the following definition: ‘‘ ‘medicine’ means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in— (a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in [man] humans; or restoring, correcting or modifying any somatic or psychic or organic function in [man] humans, and includes any veterinary medicine’’; (b) 30 35 40 45 50 (j) by the insertion after the definition of ‘‘prescribed’’ of the following definition: 55 ‘‘ ‘product’ means a medicine, a Scheduled substance or a cosmetic or foodstuff which contains a scheduled substance;’’; (k) by the deletion of the definition of ‘‘registrar’’. 6 Substitution for section 2 of Act 101 of 1965, as substituted by section 2 of Act 65 of 1974 and amended by section 2 of Act 90 of 1997 - 2 Verify source ↗
The following section is hereby substituted for section 2 of the principal Act:
AI-assisted research summary: The South African Health Products Regulatory Authority is established and must act without fear, favour or prejudice; it may exercise powers and perform functions given by the Act.
2. The following section is hereby substituted for section 2 of the principal Act: ‘‘Establishment, powers and functions of South African Health Products Regulatory Authority 5 2. (1) The South African Health Products Regulatory Authority is hereby established as an organ of state but outside the public service. (2) The Authority is— (a) a juristic person; (b) subject to the Public Finance Management Act, 1999 (Act No. 1 of 1999); and accountable to and reports to the Minister. 10 (c) (3) The Authority may exercise the powers and shall perform the functions conferred upon or assigned to it by this Act. (4) In performing its functions, the Authority shall act without fear, 15 favour or prejudice.’’. Substitution of section 3 of 101 of 1965, as substituted by section 3 of Act 90 of 1997 - 3 Verify source ↗
The following section is hereby substituted for section 3 of the principal Act:
AI-assisted research summary: The Minister must appoint a suitably qualified Chief Executive Officer, and certain people cannot be appointed to that role.
3. The following section is hereby substituted for section 3 of the principal Act: ‘‘Chief Executive Officer and other staff of Authority 3. (1) The Minister must appoint a suitably qualified person as the Chief 20 Executive Officer of the Authority. (2) A person may not be appointed as the Chief Executive Officer if such is an unrehabilitated insolvent; is mentally unfit; or person— (a) (b) (c) has been convicted of an offence committed after the Constitution of the Republic of South Africa, 1993 (Act No. 200 of 1993) took effect and sentenced to imprisonment without the option of a fine. (3) The Chief Executive Officer may be removed from office for— (a) serious misconduct; (b) permanent incapacity; or (c) engaging in any activity that is reasonably capable of undermining the integrity of the Authority. (4) The Chief Executive Officer— (a) (b) (c) (d) (e) is appointed for a term of five years and may be reappointed for one additional term of five years; is appointed subject to the conclusion of a performance agreement with the Minister; is accountable to and reports to the Minister; is entitled to the benefits as may be determined by the Minister in consultation with the Minister for the Public Service and Administra- tion; is responsible for the general administration of the Authority and for the carrying out of any functions assigned to the Authority by this Act and the Minister; (f) must manage and direct the activities of the Authority; (g) must appoint and supervise staff of the Authority; and (h) must compile business and financial plans and reports in terms of the Public Finance Management Act, 1999 (Act No. 1 of 1999). (5) The Chief Executive Officer shall appoint suitably qualified staff and may contract other suitably qualified persons to assist the Authority in carrying out its functions. (6) (a) The Minister shall, after consultation with the Minister for Public Service and Administration, determine the structure and the human resources policy for the Authority. 25 30 35 40 45 50 55 8 (b) The human resources policy shall include a code of conduct and provisions on conflict of interests applicable to the Chief Executive Officer and the staff of the Authority. (7) The Authority may utilise persons seconded or transferred from the public service, and such transfer must be in accordance with the Labour Relations Act, 1995 (Act No. 66 of 1995). (8) The Chief Executive Officer and the staff of the Authority become members of the Government Employees’ Pension Fund contemplated in section 2 of the Government Employees Pension Law, 1996 (Proclamation No. 21 of 1996). (9) The Chief Executive Officer shall appoint committees, as he or she may deem necessary, to investigate and report to the Authority on any matter within its purview in terms of this Act.’’. 5 10 Substitution of section 4 of Act 101 of 1965 - 4 Verify source ↗
The following section is hereby substituted for section 4 of the principal Act:
AI-assisted research summary: The Minister must establish an advisory committee, and the committee and its members have rules about size, appointment, disclosure, remuneration, and non-interference.
4. The following section is hereby substituted for section 4 of the principal Act: 15 ‘‘Advisory committee 4. (1) The Minister shall establish an advisory committee to advise or act as a consultative body for the Minister and the Authority on matters concerning corporate governance of the Authority. (2) The advisory committee contemplated in subsection (1) shall consist of not more than 5 persons who shall be appointed from persons outside the Authority. (3) The Minister shall appoint a chairperson for the advisory committee from among the members after having consulted the members. (4) Members of the advisory committee shall— (a) be appointed for a term not exceeding five years, which is renewable; (b) be fit and proper persons; and (c) have appropriate expertise, skills, knowledge or experience and the ability to perform effectively as a member. (5) The advisory committee shall determine procedures for its meetings. (6) An advisory committee member who has a personal or financial interest in any matter on which the advisory committee gives advice shall disclose that interest and where the advisory committee deems it necessary withdraw from the discussions. (7) The Authority shall remunerate a member mentioned above and compensate the member for expenses, as determined by the Minister after consultation with the Minister of Finance. (8) The advisory committee or its members shall not interfere with the powers assigned to the Chief Executive Officer or the Authority in terms of this Act in so far as those powers relate to the safety, efficacy and quality of products, medical devices or IVDs.’’. 20 25 30 35 40 Repeal of sections 5, 6, 7, 8, 9 and 12 of Act 101 of 1965 - 5 Verify source ↗
Sections 5, 6, 7, 8, 9 and 12 of the principal Act are hereby repealed.
AI-assisted research summary: This section repeals sections 5, 6, 7, 8, 9 and 12 of the principal Act.
5. Sections 5, 6, 7, 8, 9 and 12 of the principal Act are hereby repealed. Substitution of section 13 of Act 101 of 1965, as substituted by section 3 of Act 20 of 1981 45 - 6 Verify source ↗
The following section is hereby substituted for section 13 of the principal Act:
AI-assisted research summary: Section 13 of the principal Act is being replaced with a new section titled “Registers”.
6. The following section is hereby substituted for section 13 of the principal Act: ‘‘Registers - 13 Verify source ↗
The Chief Executive Officer shall keep separate registers for
AI-assisted research summary: The Chief Executive Officer must keep separate registers for products, medical devices, or IVDs and record specified registration details in them.
13. The Chief Executive Officer shall keep separate registers for products, medical devices or IVDs; in which he or she shall record— (a) the registration of products, medical devices or IVDs by the Authority; and 50 10 (b) such particulars in regard to the products, medical devices or IVDs and the holder of certificate of registration in respect of such products, medical devices or IVDs as are required by this Act.’’. Substitution of section 14 of Act 101 of 1965, as amended by section 7 of Act 94 of 1991 5 - 7 Verify source ↗
The following section is hereby substituted for section 14 of the principal Act:
AI-assisted research summary: Unregistered products, medical devices or IVDs subject to registration may not be sold, subject to stated exceptions.
7. The following section is hereby substituted for section 14 of the principal Act: ‘‘Prohibition on the sale of [medicines] products, medical devices or IVDs which are subject to registration and are not registered 14. (1) Save as provided in this section or sections 21 and 22A, no person shall sell any [medicine] product, medical device or IVD which is subject to registration by virtue of a [resolution] declaration published in terms of subsection (2) unless it is registered. (2) (a) The [council] Authority may from time to time [by resolution approved by the Minister,] determine that a [medicine] product, medical device or IVD, or class or category of [medicines] product, medical device or IVD or part of any class or category of [medicines] product, medical devices or IVDs mentioned in the [resolution] declaration, shall be subject to registration in terms of this Act. (b) Any such [resolution] declaration may also relate only to [medi- cines,] products, medical devices or IVDs which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to [medicines] products, medical devices or IVDs which were not then so available. (c) Any such [resolution] declaration shall be published in the Gazette by the [registrar] Chief Executive Officer and shall come into operation on the date on which it is so published. (3) In the case of a [medicine] product, medical device or IVD which was available for sale in the Republic immediately prior to the date of publication in the Gazette of the [resolution] declaration by virtue of which it is subject to registration in terms of this Act, the provisions of subsection (1) shall come into operation— (a) if no application for the registration of such [medicine] product, medical device or IVD is made within the period of six months immediately succeeding that date, on the expiration of that period; or if application for the registration of such [medicine] product, medical device or IVD is made within the said period, on the date one month after the date on which a notice in respect of such [medicine] product, medical device or IVD is published in the Gazette in terms of section 15(10) 15(9) or section 17(a). (b) 10 15 20 25 30 35 (4) The provisions of subsection (1) shall not apply in respect of the sale 40 of any medicine— (a) compounded in the course of carrying on his or her professional activities by a pharmacist, veterinarian or person who is the holder of a licence contemplated in section 22C(1)(a), for a particular patient in a quantity not greater than the quantity required for treatment as determined by the medical practitioner, pharmacist, practitioner or veterinarian; or (b) compounded by a pharmacist in a quantity not greater than that prescribed by regulation for sale in the retail trade, subject to the conditions likewise prescribed or in a quantity for a particular person or animal as prescribed by a medical practitioner or a dentist or a veterinarian or a practitioner or a nurse or other person registered under the Health Professions Act, 1974, and referred to in section 22A, as the case may be, 45 50 11 (b) die besonderhede rakende die produkte, mediese toestelle of IVD’s en die houer van ’n registrasiesertifikaat ten opsigte van sodanige produkte, mediese toestelle of IVD’s wat by hierdie Wet vereis word.’’. Vervanging van artikel 14 van Wet 101 van 1965, soos gewysig deur artikel 7 van Wet 94 van 1991 5 - 7 Verify source ↗
Artikel 14 van die Hoofwet word hierby deur die volgende artikel vervang:
AI-assisted research summary: Sale of unregistered registered-only medicine products, medical devices, or IVDs is prohibited, subject to stated exceptions.
7. Artikel 14 van die Hoofwet word hierby deur die volgende artikel vervang: ‘‘Verbod op verkoop van [medisyne] produkte, mediese toestelle of IVD’s wat aan registrasie onderhewig is en nie geregistreer is nie 14. (1) Behoudens die bepalings van hierdie artikel of artikels 21 en 22A, mag niemand enige [medisyne] produk, mediese toestel of IVD wat aan registrasie onderhewig is uit hoofde van ’n [besluit] verklaring ingevolge subartikel (2) gepubliseer, verkoop nie tensy dit geregistreer is. (2) (a) Die [raad] Owerheid kan van tyd tot tyd [by besluit deur die Minister goedgekeur,] bepaal dat ’n in die [besluit] verklaring vermelde [medisyne] produk, mediese toestel of IVD of klas of kategorie van [medisyne] produk, mediese toestel of IVD of gedeelte van ’n klas of kategorie van [medisyne] produk, mediese toestel of IVD aan registrasie ingevolge hierdie Wet onderhewig is. (b) So ’n [besluit] verklaring kan ook betrekking hê slegs op [medisyne] produkte, mediese toestelle of IVD’s wat onmiddellik voor die datum waarop dit ingevolge paragraaf (c) in werking tree in die Republiek vir verkoop beskikbaar was, of slegs op [medisyne] produkte, mediese toestelle of IVD’s wat nie toe aldus beskikbaar was nie. (c) So ’n [besluit] verklaring moet deur die [registrateur] Hoof- Uitvoerende Beampte in die Staatskoerant gepubliseer word en tree in werking op die datum waarop dit aldus gepubliseer word. (3) In die geval van [medisyne] produkte, mediese toestelle of IVD’s wat onmiddellik voor die datum van publikasie in die Staatskoerant van die [besluit] verklaring uit hoofde waarvan dit aan registrasie ingevolge hierdie Wet onderhewig is, in die Republiek vir verkoop beskikbaar was, tree die bepalings van subartikel (1) in werking— (a) indien daar nie binne die tydperk van ses maande onmiddellik na daardie datum om registrasie van daardie [medisyne] produkte, mediese toestelle of IVD’s aansoek gedoen word nie, by verstryking van daardie tydperk; of indien daar binne daardie tydperk om die registrasie van bedoelde [medisyne] produkte, mediese toestelle of IVD’s aansoek gedoen word, op die datum een maand na die datum waarop ’n kennisgewing met betrekking tot die [medisyne] produkte, mediese toestelle of IVD’s ingevolge artikel [15(10)] 15(9) of artikel 17(a) in die Staatskoerant gepubliseer word. (b) (4) Die bepalings van subartikel (1) is nie van toepassing nie ten opsigte van die verkoop van enige medisyne wat— (a) deur ’n apteker, veearts of ’n persoon wat die houer is van ’n lisensie in artikel 22C(1)(a) beoog in die loop van die verrigting van sy of haar professionele bedrywighede aangemaak word vir ’n bepaalde pasiënt in ’n hoeveelheid nie groter nie as die hoeveelheid nodig vir behandeling soos deur die geneesheer, apteker, praktisyn of veearts bepaal; of (b) deur ’n apteker aangemaak word in ’n hoeveelheid nie groter nie as wat by regulasie voorgeskryf word vir verkoop in die kleinhandel onderworpe aan die voorwaardes insgelyks voorgeskryf, of in ’n hoeveelheid vir ’n bepaalde persoon of dier soos deur ’n geneesheer of tandarts of veearts of praktisyn of ’n verpleegkundige of ander persoon wat kragtens die Wet op Gesondheidsberoepe, 1974, geregistreer is en in artikel 22A bedoel, na gelang van die geval, voorgeskryf, 10 15 20 25 30 35 40 45 50 55 12 if such medicine does not contain any component the sale of which is prohibited by this Act or any component in respect of which an application for registration has been rejected, and is not or has not been advertised: Provided that the active components of such medicine appear in another medicine which has been registered under this Act.’’. 5 Substitution of section 15 of Act 101 of 1965, as substituted by section 9 of Act 90 of 1997 - 8 Verify source ↗
The following section is hereby substituted for section 15 of the principal Act:
AI-assisted research summary: This section sets out how products, medical devices, and IVDs are registered, including what an applicant must file and how the Chief Executive Officer and Authority must handle the application.
8. The following section is hereby substituted for section 15 of the principal Act: ‘‘Registration of products, medical devices or IVDs 15. (1) Every application for the registration of a product, medical device or IVD shall be submitted to the Chief Executive Officer in the prescribed form and shall be accompanied by— (a) the prescribed particulars; (b) samples of the relevant products; (c) where practicable, samples of medical devices or IVDs; and (d) the prescribed registration fee. (2) As soon as possible after receipt by the Chief Executive Officer of an application contemplated in subsection (1), he or she shall inform the applicant in writing that the application is being considered. (3) (a) If after consideration of any such application and after any investigation or enquiry which it may consider necessary the Authority is satisfied that the product, medical device or IVD in question— is suitable for the purpose for which it is intended; (i) (ii) complies with the prescribed requirements; (iii) (iv) the Authority shall issue the applicant with a certificate of registration to that effect. is safe and of good quality; and in the case of products, also efficacious, (b) If the Authority is not satisfied as contemplated in paragraph (a), it shall cause the applicant to be notified in writing of the reasons why it is not so satisfied and cause the applicant to be informed that he or she may within a period of 30 days after the date of the notification furnish the Chief Executive Officer with his or her comments on the Authority’s reasons for not being so satisfied. (c) If no such comments are submitted by the applicant within the said period, or if after consideration of any comments so submitted the Authority is still not satisfied as aforesaid, it shall not issue the certificate of registration. (4) Every product, medical device or IVD shall be registered under such name as the Authority may approve. (5) The Chief Executive Officer shall allocate to every product, medical device or IVD registered under this Act a registration number which shall be recorded in the register opposite the name of such product, medical device or IVD and which shall be stated in the certificate of registration issued in respect of such product, medical device or IVD. (6) Any registration under this section— (a) may be made subject to such conditions as may be determined by the (b) Authority; and shall in the case of medicines, be valid for a period of five years. (7) No condition shall be imposed under subsection (6) whereby the sale of the medicine in question by any person other than a pharmacist is prohibited or until after the applicant has in writing been notified by the Chief Executive Officer that the imposition of such condition is contem- plated and invited to submit written representations to the Authority in regard to the matter. (8) If no such representations are lodged by the applicant concerned within a period of 30 days after the receipt by him or her of any notification 10 15 20 25 30 35 40 45 50 55 14 referred to in subsection (7), or if after consideration of any such representations the Authority is still of the opinion that the condition in question should be imposed, the Authority shall register the product, medical device or IVD concerned subject to the said condition. (9) Notice of the rejection of an application for registration under this section in respect of a product, medical device or IVD referred to in subsection (3) of section 14 shall be given in the Gazette by the Chief Executive Officer. (10) The Chief Executive Officer shall as soon as possible after the date of expiry of the appropriate period referred to in section 14(3) publish in the Gazette the prescribed particulars in respect of all applications for registration received by him or her prior to such date. Substitution of section 15A of Act 101 of 1965 - 9 Verify source ↗
The following section is hereby substituted for section 15A of the principal Act:
AI-assisted research summary: The Chief Executive Officer may amend certain register entries for products, medical devices, or IVDs on application by the certificate holder, and may cancel the existing registration and issue a new certificate if necessary.
9. The following section is hereby substituted for section 15A of the principal Act: ‘‘Amendment of entries in register 15A. (1) The entry made in the register in respect of any product, medical device or IVD may on application by the holder of a certificate of registration issued in respect of such product, medical device or IVD be amended by the Chief Executive Officer. (2) An application for the amendment of an entry in the register shall be made to the Chief Executive Officer in the prescribed form and shall be accompanied by the prescribed application fee. (3) The Chief Executive Officer may, if necessary, cancel the existing registration in respect of such product, medical device or IVD and issue a new certificate of registration.’’. Substitution of section 15B of Act 101 of 1965 - 10 Verify source ↗
The following section is hereby substituted for section 15B of the principal Act:
AI-assisted research summary: A certificate of registration may be transferred only with the Chief Executive Officer’s approval, and the holder must apply on the prescribed form with the certificate and fee.
10. The following section is hereby substituted for section 15B of the principal Act: ‘‘Transfer of certificate of registration 15B. (1) A certificate of registration may with the approval of the Chief Executive Officer be transferred by the holder thereof to any other person. (2) An application for approval of the transfer of a certificate of registration shall be made to the Chief Executive Officer on the prescribed form and shall be accompanied by the certificate of registration in question and the prescribed application fee. (3) If the Chief Executive Officer grants any application submitted to him or her in terms of subsection (2), the Chief Executive Officer shall make the necessary 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 one in the prescribed form to such person.’’. Amendment of section 15C of Act 101 of 1965 - 11 Verify source ↗
Section 15C of the principal Act is hereby amended by the substitution for
AI-assisted research summary: The Authority may prescribe conditions for importing certain medicines that match an already registered medicine and come from approved manufacturing sites.
11. Section 15C of the principal Act is hereby amended by the substitution for paragraph (b) of the following paragraph: ‘‘(b) prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the Republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the [council] Authority in the prescribed manner, may be imported;’’. 5 10 15 20 25 30 35 40 45 50 16 Substitution of section 16 of Act 101 of 1965, as amended by section 14 of Act 65 of 1974 and section 4 of Act 20 of 1981 - 12 Verify source ↗
The following section is hereby substituted for section 16 of the principal Act:
AI-assisted research summary: The Authority must notify the certificate holder before cancelling certain product, medical device, or IVD registrations, and the Chief Executive Officer must cancel registration for non-payment of the prescribed annual fee.
12. The following section is hereby substituted for section 16 of the principal Act: ‘‘Cancellation of registration 16. (1) If the Authority— (a) (b) is of the opinion that a holder of a certificate of registration has failed to comply with any condition subject to which any product, medical device or IVD was registered; or is of the opinion that any product, medical device or IVD does not comply with any prescribed requirement; the Authority shall cause notice in writing to be given accordingly by the Chief Executive Officer to the holder of the certificate of registration issued in respect of that product, medical device or IVD. (2) Any such notice shall specify the grounds on which the Authority’s opinion is based, and shall indicate that the person to whom it is directed may within one month after receipt thereof submit to the Chief Executive Officer any comments he or she 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 Authority is of the opinion that the registration of the product, medical device or IVD in question should be cancelled, the Authority may cancel the registration thereof. (4) If the person who is the holder of the certificate of registration issued in respect of any product, medical device or IVD fails to pay the prescribed annual fee in respect of the retention of the registration of that product, medical device or IVD before or on the prescribed date or such later date as the Chief Executive Officer may determine on application by that person, the Chief Executive Officer shall cancel the registration of that product, medical device or IVD.’’. 5 10 15 20 25 Substitution of section 17 of Act 101 of 1965, as substituted by section 5 of Act 20 of 1981 30 - 13 Verify source ↗
The following section is hereby substituted for section 17 of the principal Act:
AI-assisted research summary: This substituted section is titled “Notification of registration or cancellation thereof.”
13. The following section is hereby substituted for section 17 of the principal Act: ‘‘Notification of registration or cancellation thereof - 17 Verify source ↗
The Chief Executive Officer shall give notice in the Gazette of the
AI-assisted research summary: The Chief Executive Officer must publish notice in the Gazette when a product, medical device, or IVD is registered or its registration is cancelled.
17. The Chief Executive Officer shall give notice in the Gazette of the registration or cancellation of registration of any product, medical device or IVD in terms of this Act, and shall in such notice specify— (a) in the case of registration of any product, medical device or IVD, the name under which such product, medical device or IVD is registered, the active components of such product, if any, the name of the person who applied for registration of such product, medical device or IVD, the number allocated to it in terms of section 15 and the conditions (if any) subject to which it is registered; in the case of a cancellation of the registration, the name under which such product, medical device or IVD was registered, the name of the holder of the certificate of registration issued in respect of such product, medical device or IVD and the number which was allocated to it in terms of section 15.’’. (b) 35 40 45 18 Substitution of section 18 of Act 101 of 1965, as substituted by section 7 of Act 17 of 1979 and amended by section 11 of Act 90 of 1997 - 14 Verify source ↗
The following section is hereby substituted for section 18 of the principal Act:
AI-assisted research summary: Products cannot be sold or advertised unless labeling and advertising requirements are met, and the Authority or Minister can set or approve deviations and additional requirements.
14. The following section is hereby substituted for section 18 of the principal Act: ‘‘Labels and advertisements 18. (1) No person shall sell any [medicine or Scheduled substance] product unless the immediate container or the package in which that [medicine or Scheduled substance] product is sold bears a label stating the prescribed particulars. (2) No person shall advertise any [medicine or Scheduled substance] product, medical device or IVD for sale unless such advertisement complies with the prescribed requirements. (3) The label referred to in subsection (1) shall be approved by the [council] Authority. (4) The [council] Authority may authorize a deviation from the prescribed format and contents of any label. (5) The Minister may prescribe additional requirements for the labelling of [medicines] products, medical devices or IVDs.’’. Substitution of section 18A of Act 101 of 1965 - 15 Verify source ↗
The following section is hereby substituted for section 18A of the principal Act:
AI-assisted research summary: A person must not supply products, medical devices, or IVDs under a bonus, rebate, or similar incentive scheme.
15. The following section is hereby substituted for section 18A of the principal Act: ‘‘Bonusing 18A. (1) No person shall supply any product, medical device or IVD according to a bonus system, rebate system or any other incentive scheme. (2) Notwithstanding subsection (1), the Minister may prescribe accept- able and prohibited acts in relation to subsection (1).’’. Substitution of section 18B of Act 101 of 1965 - 16 Verify source ↗
The following section is hereby substituted for section 18B of the principal Act:
AI-assisted research summary: A person may not sample products, medical devices, or IVDs, and exhibition or appraisal use must follow prescribed rules.
16. The following section is hereby substituted for section 18B of the principal Act: ‘‘Sampling of products, medical devices or IVDs 18B. (1) No person shall sample any product, medical devices or IVD. (2) Use of products, medical devices or IVDs for exhibition or appraisal purposes shall be as prescribed. (3) For the purposes of this section ‘sample’ means the free supply of products, medical devices or IVDs by a device or IVD establishment, manufacturer or wholesaler or to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974 (Act No. 56 of 1974), or any professional or person authorized to use the device.’’. its agent 5 10 15 20 25 30 35 Substitution of section 18C of Act 101 of 1965 - 17 Verify source ↗
The following section is hereby substituted for section 18C of the principal Act:
AI-assisted research summary: This section replaces section 18C of the principal Act with a new section about marketing products, medical devices, or IVDs.
17. The following section is hereby substituted for section 18C of the principal Act: ‘‘Marketing of products, medical devices or IVDs - 18C Verify source ↗
The Minister shall, after consultation with the relevant industries
AI-assisted research summary: The Minister must, after consulting relevant industries and other stakeholders, make regulations about marketing products, medical devices, or IVDs.
18C. The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of products, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries.’’. 40 20 Substitution of section 19 of Act 101 of 1965, as amended by section 17 of Act 65 of 1974 - 18 Verify source ↗
The following section is hereby substituted for section 19 of the principal Act:
AI-assisted research summary: A person must not sell a medicine product, medical device, or IVD unless it meets prescribed requirements. The Authority may also require specified people to provide information by written notice and may extend the deadline if asked.
18. The following section is hereby substituted for section 19 of the principal Act: ‘‘Prohibition on sale of [medicine] products, medical devices or IVDs which do not comply with prescribed requirements and furnishing of information regarding [medicines] products, medical devices or IVDs to the [council] Authority 19. (1) No person shall sell any [medicine] product, medical device or IVD unless it complies with the prescribed requirements. (2) The [council] Authority may by notice in writing require any person who manufactures or sells [medicines] products, medical devices or IVDs or administers or prescribes any medicine or on whose direction any medicine is administered to furnish it, within a period stipulated in such notice, with any information which such person has in his or her possession or which such person is in a position to obtain regarding such [medicine or] product, medical device or IVD. (3) The [council] Authority may, if so requested by any person to whom a notice under subsection (2) is addressed, extend the period stipulated in such notice.’’. 5 10 15 Substitution of section 20 of Act 101 of 1965, as amended by section 18 of Act 65 of 1974 20 - 19 Verify source ↗
The following section is hereby substituted for section 20 of the principal Act:
AI-assisted research summary: It prohibits false or misleading advertisements about products, medical devices, or IVDs, and bars advertisements from making unsupported claims about their therapeutic effect or use.
19. The following section is hereby substituted for section 20 of the principal Act: ‘‘Publication or distribution of false advertisements concerning [medi- cines] products, medical devices or IVDs 20. (1) No person shall— (b) (a) publish or distribute or in any other manner whatsoever bring to the notice of the public or cause or permit to be published or distributed or to be so brought to the notice of the public any false or misleading advertisement concerning any [medicine] product, medical device or IVD; or in any advertisement make any claim to the effect that the therapeutic efficacy and effect of any [medicine] product is other than that stated by the [council] Authority in terms of sub-paragraph (ii) of paragraph (a) of section twenty-two or state or suggest that any [medicine] product, medical device or IVD should be used for a purpose or under circumstances or manner other than that stated by the [council] Authority in terms of subparagraph (iii) of paragraph (a) of that section. (2) It shall be a sufficient defence in any prosecution for an offence under paragraph (a) of sub-section (1) if it is proved to the satisfaction of the court that the accused, not being a person selling the [medicine] product, medical device or IVD to which the false or misleading advertisement which is the subject of the prosecution relates, did not know, and could not reasonably be expected to have known, that the advertisement was in any respect false or misleading [, unless it is proved that the accused failed on demand by the registrar or an inspector or a member of the South African Police to furnish the name and address of the person at whose instance the advertisement was published, distributed or so brought to the notice of the public].’’. 25 30 35 40 45 22 Substitution of section 21 of Act 101 of 1965, as amended section 6 of Act 20 of 1981 - 20 Verify source ↗
The following section is hereby substituted for section 21 of the principal Act:
AI-assisted research summary: The Authority may authorize sales of unregistered products, medical devices, or IVDs for a specified period and may later withdraw that authority in writing.
20. The following section is hereby substituted for section 21 of the principal Act: ‘‘Authority may authorize sale of unregistered products, medical devices or IVDs for certain purposes 21. (1) The Authority may in writing authorize any person to sell during a specified period to any specified person or institution a specified quantity of any particular product, medical device or IVD which is not registered. (2) Any product, medical device or IVD sold in pursuance of any authority granted under subsection (1) may be used for such purposes and in such manner and during such period as the Authority may in writing determine. (3) The Authority may at any time by notice in writing withdraw any authority granted in terms of subsection (1) if effect is not given to any determination made in terms of subsection (2).’’. 5 10 Substitution of section 22 of Act 101 of 1965, as amended by section 6 of Act 20 of 1981 15 - 21 Verify source ↗
The following section is hereby substituted for section 22 of the principal Act:
AI-assisted research summary: The Chief Executive Officer must arrange for certain people to be told when a product, medical device, or IVD is registered or cancelled.
21. The following section is hereby substituted for section 22 of the principal Act: ‘‘[Director-General] Authority to cause certain information to be furnished 22. (1) [The Director-General shall after consultation with the council,] The Chief Executive Officer shall cause, in such manner as [the Director-General] he or she considers most suitable— (a) as soon as practicable after any [medicine] product, medical device or IVD, other than a veterinary medicine, has been registered, medical practitioners, dentists, pharmacists and the person who applied for the registration of such [medicine] product, medical device or IVD to be informed— (i) of the name and number under which such [medicine] product, medical device or IVD is registered and the conditions, if any, subject to which such [medicine] product, medical device or IVD is registered; (ii) of the therapeutic efficacy and effect of such [medicine] product; (iii) of the purpose for which, the circumstances under which and the manner in which such [medicine] product, medical device or IVD should be used; and regarding any other matter concerning such [medicine] product, medical device or IVD which, in the opinion of the [council] Chief Executive Officer, may be of value to them; (iv) (b) as soon as practicable after the registration of any [medicine] product, medical device or IVD, other than a veterinary medicine, has been cancelled in terms of section 16, medical practitioners, dentists, pharmacists, the public in general and the holder of the certificate of registration issued in respect of such [medicine] product, medical device or IVD to be informed of the cancellation of such registration. (2) The provisions of subsection (1) shall apply mutatis mutandis in respect of any veterinary medicine, and for the purposes of such application the reference in that subsection to medical practitioners and dentists shall be deemed to be a reference to veterinarians. 20 25 30 35 40 45 Amendment of section 22A of Act 101 of 1965, as substituted by section 13 of Act 90 of 1997 and amended by section 5 of Act 59 of 2002 50 - 22 Verify source ↗
Section 22A of the principal Act is hereby amended—
AI-assisted research summary: This section lets the Minister prescribe scheduled substances on the Authority’s recommendation, and lets the Director-General issue permits for specified scheduled substances to health-service providers, subject to conditions.
22. Section 22A of the principal Act is hereby amended— (a) by the substitution for subsection (2) of the following subsection: 24 ‘‘(2) The Minister may, on the recommendation of the [council] Authority, prescribe the Scheduled substances referred to in this section.’’; (b) by the substitution in subsection (4) for paragraph (b) of the following paragraph: ‘‘(b) to any person apparently under the age of [14] 12 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist’s assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C(1)(a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of [14] 12 years’’; (c) by the substitution in subsection (6) for paragraph (e) of the following paragraph: ‘‘(e) in the case of a Schedule 2 substance, such substance may not be supplied to any person apparently under the age of [14] 12 years except upon a prescription issued by an authorised prescriber and intern or pharmacist’s dispensed by a pharmacist, pharmacist assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C(1)(a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of [14] 12 years’’; (d) by the substitution in subsection (13) for paragraph (a) of the following paragraph: ‘‘(a) to the applicant’s furnishing the [registrar] Chief Executive Officer annually with the prescribed information;’’; and (e) by the substitution for subsection (15) of the following subsection: ‘‘(15) Notwithstanding anything to the contrary contained in this section, the Director-General may, after consultation with the [Interim Pharmacy Council of South Africa] South African Pharmacy Council as referred to in section 2 of the Pharmacy Act, 1974 (Act No. 53 of 1974), issue a permit to any person or organisation performing a health service, authorising such person or organisation to acquire, possess, use or supply any specified Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance, and such permit shall be subject to such conditions as the Director-General may determine.’’. Substitution of section 22B of Act 101 of 1965 - 23 Verify source ↗
The following section is hereby substituted for section 22B of the principal Act:
AI-assisted research summary: The Authority may disclose certain product-related information, and the Director-General may publish or release that information to the public.
23. The following section is hereby substituted for section 22B of the principal Act: ‘‘Publication of information relating to [medicine, Scheduled sub- stance] products, medical devices or IVDs 22B. (1) Notwithstanding the provisions of section 34 the [council] Authority may, if it deems it expedient and in the public interest, disclose information in respect of the prescribing, dispensing, administration and use of a [medicine, Scheduled substance or medical device] product, medical device or IVD. (2) The Director-General may publish the information referred to in section (1) or release it to the public in a manner which he or she thinks fit.’’. Amendment of section 22C of Act 101 of 1965 - 24 Verify source ↗
Section 22C of the principal Act is hereby amended—
AI-assisted research summary: This section lets the Director-General or the Authority issue certain licences on application and payment of the prescribed fee, and it bars listed medical device/IVD businesses from operating without the required licence.
24. Section 22C of the principal Act is hereby amended— (a) by the substitution for subsection (1) of the following subsection: ‘‘(1) Subject to the provisions of this section— (a) the Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, 5 10 15 20 25 30 35 40 45 50 55 26 (b) dentist, [practitioner] nurse or other person registered under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions; the [council] Authority may, on application in the prescribed manner and on payment of the prescribed fee, issue to a medical device or IVD establishment, manufacturer, wholesaler or distribu- tor of a [medicine] product, medical device or IVD a licence to manufacture, act as a wholesaler of or distribute, as the case may be, such [medicine] product, medical device or IVD upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the [council] Authority may determine.’’; (b) by the substitution for subsection (2) of the following section: ‘‘(2) A licence referred to in subsection (1)(a) shall not be issued unless the applicant has successfully completed a supplementary course determined by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa[, the Allied Health Professions Council of South Africa] and the South African Nursing Council.’’; (c) by the substitution for subsection (3) of the following subsection: ‘‘(3) The Director-General or the [council] Authority, as the case may be, may require an applicant contemplated in subsection (1) to furnish such information, in addition to any information furnished by the applicant in terms of the said subsection, as the Director-General or the [council] Authority may deem necessary.’’; (d) by the substitution in subsection (4) for the words preceding paragraph (a) of the following words: ‘‘When the Director-General or the [council] Authority, as the case may be, grants or refuses an application for a licence—’’; and (e) by the substitution for subsection (6) of the following subsection: ‘‘(6) No medical device or IVD establishment, manufacturer, whole- saler or distributer referred to in subsection (1)(b) shall manufacture, act as a wholesaler of or distribute, as the case may be, any [medicine] product, medical device or IVD unless he or she is the holder of a licence contemplated in the said subsection.’’. Substitution of section 22D of Act 101 of 1965 - 25 Verify source ↗
The following section is hereby substituted for section 22D of the principal Act:
AI-assisted research summary: This section substitutes section 22D of the principal Act and is titled “Period of validity and renewal of licence.”
25. The following section is hereby substituted for section 22D of the principal Act: ‘‘Period of validity and renewal of licence - 22D Verify source ↗
A licence issued under section 22C shall be valid for the prescribed
AI-assisted research summary: A licence issued under section 22C is valid for the prescribed period and may be renewed if an application is made in the prescribed way, on time (or later if allowed), and the prescribed fee is paid.
22D. A licence issued under section 22C shall be valid for the prescribed period but may be renewed on application in the prescribed manner and before the prescribed time or such later time as the Director-General or the [council] Authority, as the case may be, may allow and on payment of the prescribed fee.’’. Amendment of section 22E of Act 101 of 1965 - 26 Verify source ↗
Section 22E of the principal Act is hereby amended—
AI-assisted research summary: A licence applicant or renewal applicant must not give information that is knowingly untrue or misleading in a material way.
26. Section 22E of the principal Act is hereby amended— (a) by the substitution in subsection (1) for paragraph (a) of the following paragraph: ‘‘(a) has in or in connection with an application for a licence or renewal of a licence furnished the Director-General or the [council] Authority, as the case may be, with any information which to the knowledge of such holder is untrue or misleading in any material respect;’’; (b) by the substitution in subsection (1) for the words following paragraph (d) of the following words: ‘‘the Director-General or the [council] Authority, as the case may be, may by way of a notice in writing call upon him or her to show cause within the period specified in the notice, which period shall not be less 5 10 15 20 25 30 35 40 45 50 55 28 than 20 days as from the date of the notice, why the licence in question should not be suspended or revoked.’’; and (c) by the substitution for subsection (2) of the following subsection: ‘‘(2) The Director-General or the [council] Authority, as the case may be, may after considering the reasons furnished [to him or her] in terms of subsection (1)— (a) suspend the licence in question for such period [as he or she or the council] the Director-General or the Authority may determine; or revoke the license in question.’’. (b) 5 Amendment of section 22F of Act 101 of 1965, as amended by section 7 of Act 59 of 2002 10 - 27 Verify source ↗
Section 22F of the principal Act is hereby amended by the substitution in
AI-assisted research summary: This section amends section 22F so that paragraph (c) now refers to a product declared not substitutable by the Authority.
27. Section 22F of the principal Act is hereby amended by the substitution in subsection (4) for paragraph (c) of the following paragraph: ‘‘(c) where the product has been declared not substitutable by the [council] Authority.’’. Amendment of section 22H of Act 101 of 1965 - 28 Verify source ↗
Section 22H of the principal Act is hereby amended by the substitution for
AI-assisted research summary: Wholesalers may only buy products from the original manufacturer or primary importer, and may only sell products into the retail sector, with a limited exception for Schedule 0 substances.
28. Section 22H of the principal Act is hereby amended by the substitution for subsections (1) and (2) of the following subsections, respectively: ‘‘(1) (a) No wholesaler shall purchase [medicines] products from any source other than from the original manufacturer or from the primary importer of the finished product. (b) A wholesaler shall sell [medicines] products only into the retail sector. (c) Notwithstanding paragraphs (a) and (b), a wholesaler may purchase from or sell to, other wholesalers or the public Schedule 0 substances. (2) Subsection (1) shall not be construed as preventing the return of [medicines] products for credit purposes only, to the manufacturer or wholesaler from which that [medicine] product was initially obtained.’’. Substitution of section 23 of Act 101 of 1965, as amended by section 22 of Act 65 of 1974 15 20 25 - 29 Verify source ↗
The following section is hereby substituted for section 23 of the principal Act:
AI-assisted research summary: The Authority may order unwanted medicine products, medical devices, or IVDs to be returned, delivered, sent, dealt with, or disposed of, and no one may sell items covered by an unblocked notice.
29. The following section is hereby substituted for section 23 of the principal Act: 30 ‘‘Disposal of undesirable [medicines] products, medical devices or IVDs 23. (1) If the [council] Authority is of the opinion that it is not in the public interest that any [medicine] product, medical device or IVD shall be made available to the public, it may— (a) by notice in writing transmitted by registered post to any person direct that person; or (b) by notice in the Gazette direct any person, to return any quantity of such [medicine] product, medical device or IVD which he or she has in his or her possession to the manufacturer thereof or (in the case of any imported [medicine] product, medical device or IVD) to the importer concerned or to deliver or send it to any other person designated by the [council] Authority. (2) The [council] Authority may by notice in writing direct any medical device or IVD establishment, manufacturer or importer of any such [medicine] product, medical device or IVD who has in his or her possession any quantity thereof (including any quantity returned, delivered or sent to him or her in pursuance of a direction under sub-section (1)), or any other person to whom any quantity of such [medicine] product, medical device or IVD has been so returned, delivered or sent, to deal with or dispose of that quantity in such manner as the [council] Authority may determine. (3) No person shall sell any [medicine] product, medical device or IVD which is the subject of a notice under subsection (1) which has not been set aside on appeal.’’. 35 40 45 50 55 30 Substitution of section 24 of Act 101 of 1965, as substituted by section 15 of Act 90 of 1997 and amended by section 9 of Act 59 of 2002 - 30 Verify source ↗
The following section is hereby substituted for section 24 of the principal Act:
AI-assisted research summary: A person aggrieved by the Director-General’s decision may make written representations to the Minister within the prescribed period and manner; the Minister must then decide whether to confirm, set aside, or vary that decision.
30. The following section is hereby substituted for section 24 of the principal Act: ‘‘Appeal against decision of [council or] the Director-General 24. (1) Any person aggrieved by the decision of the Director-General may within the prescribed period and in the prescribed manner make written representations with regard to such decision to the Minister. (2) The Minister shall, after considering representations made in terms of subsection (1), confirm, set aside or vary the decision of the Director- General.’’. 5 10 Insertion of section 24A to Act 101 of 1965 - 31 Verify source ↗
The principal Act is hereby amended by the insertion after section 24 of the
AI-assisted research summary: A person unhappy with the Authority’s decision may appeal by notifying the Chief Executive Officer within 30 days and giving full grounds. The Chief Executive Officer must meet the appellant within 30 days, and if the matter is not resolved, the appellant may ask the Minister to convene an appeal committee after paying a prescribed fee.
31. The principal Act is hereby amended by the insertion after section 24 of the following section: ‘‘Appeal against decision of Authority 24A. (1) Any person aggrieved by the decision of the Authority may appeal against such decision by notifying the Chief Executive Officer within 30 days of becoming aware of such decision of his or her intention to appeal and setting out the full grounds of appeal. (2) Upon being notified the Chief Executive Officer shall meet with the appellant within 30 days of being so notified in the absence of legal representatives to try to resolve the matter, especially if the appeal involves administrative matters. (3) Should the Chief Executive Officer and the appellant fail to resolve the matter as contemplated in subsection (2), the appellant shall within 30 days of being notified by the Chief Executive Officer of the failure to resolve the matter and upon payment of a prescribed fee, request the Minister in writing to convene an appeal committee. (4) The appeal committee contemplated in subsection (3) shall— (a) comprise the chairperson who shall have knowledge of the law and four other persons who shall have knowledge of the subject matter of appeal but with no financial or business interests in the affairs of the parties to the appeal, two of them nominated by the appellant and the other two by the Chief Executive Officer; and (b) conduct the appeal hearing and make a decision within 30 days from the day when it first meets to hear the appeal. (5) A party aggrieved by the decision of the appeal committee may approach the High Court for a judicial review.’’. 15 20 25 30 35 Substitution of section 25 of Act 101 of 1965, as substituted by section 10 of Act 59 of 2002 - 32 Verify source ↗
The following section is hereby substituted for section 25 of the principal Act:
AI-assisted research summary: This section replaces section 25 of the principal Act with a new section titled “Privileges of [council] Authority and committees.”
32. The following section is hereby substituted for section 25 of the principal Act: 40 ‘‘Privileges of [council] Authority and committees - 25 Verify source ↗
The Authority, persons contracted by the Authority to perform work
AI-assisted research summary: The Authority, its contractors, and certain committees or their members are not liable for acts done in good faith under this Act.
25. The Authority, persons contracted by the Authority to perform work for the Authority, committees appointed in terms of this Act or their members are not liable in respect of anything done in good faith under this Act.’’. 45 32 Substitution of section 26 of Act 101 of 1965, as substituted by section 24 of Act 65 of 1974, section 1 of Act 19 of 1976 and section 10 of Act 17 of 1979 - 33 Verify source ↗
The following section is hereby substituted for section 26 of the principal Act:
AI-assisted research summary: The Chief Executive Officer may authorize inspectors. Every inspector must have a signed certificate and must show it before exercising any power or function.
33. The following section is hereby substituted for section 26 of the principal Act: ‘‘Inspectors 26. (1) The [Director-General] Chief Executive Officer may authorize such persons as inspectors[,] as he or she may consider necessary for the proper enforcement of this Act. (2) Every inspector shall be furnished with a certificate signed by the [Director-General] Chief Executive Officer and stating that he or she has been authorized as an inspector under this Act. (3) An inspector shall, before he or she exercises or performs any power or function under this Act, produce and exhibit to any person affected [hereby] by such exercise or performance, the certificate referred to in subsection (2).’’. 5 10 Substitution of section 27 of Act 101 of 1965, as substituted by section 11 of Act 17 of 1979 15 - 34 Verify source ↗
The following section is hereby substituted for section 27 of the principal Act:
AI-assisted research summary: The Chief Executive Officer may grant authority to specified qualified professionals, or other appropriately qualified persons, when needed for proper enforcement of the Act.
34. The following section is hereby substituted for section 27 of the principal Act: ‘‘Analysts, pharmacologists, engineers, technicians and pathologists 27. [The Director-General] Chief Executive Officer may grant such authority to such analysts, pharmacologists, engineers, technicians and pathologists or any other appropriately qualified person as he or she may consider necessary for the proper enforcement of this Act.’’. 20 Amendment of section 28 of Act 101 of 1965 - 35 Verify source ↗
Section 28 of the principal Act is hereby amended—
AI-assisted research summary: This section amends the inspection powers for products, medical devices and IVDs, and lets the owner claim market value for any sample taken.
35. Section 28 of the principal Act is hereby amended— (a) by the substitution in subsection (1)(a) for subparagraph (i) of the following 25 subparagraph: ‘‘(i) any place or premises from which a person, authorized under this Act to compound and dispense medicines or Scheduled substances, handles products, medical devices or IVDs or from which the holder of a licence as contemplated in section 22C(1)(b) conducts a business; or’’; (b) by the substitution in subsection (1) for paragraphs (b) and (c) of the following paragraphs, respectively: (c) ‘‘(b) inspect any product, medical device or IVD, or any book, record or document found in or upon the premises, place, vehicle, vessel or aircraft contemplated in subparagraph (ii) of subsection (1)(a); seize any such product medical device or IVD, any books, records or documents found in or upon such premises, place, vehicle, vessel or aircraft and appearing to afford evidence of a contravention of any provision of this Act;’’; (c) by the addition in subsection (1) of the following paragraph: ‘‘(d) take so many samples of any such product, medical device or IVD as he or she may consider necessary for the purpose of testing, examination or analysis in terms of the provisions of this Act.’’; and (d) by the substitution for subsection (2) of the following subsection: ‘‘(2) (a) Any sample taken in terms of paragraph (d) of subsection (1) shall— (i) be taken in accordance with the prescribed methods and in the presence of the person who is in charge of such [medicine or Scheduled substance,] product, medical device or IVD, or if there is no such person or if he or she is absent for any reason, in the presence of any other witness[, shall]; forthwith be packed and sealed and suitably labelled or marked in such manner as its nature may permit [and shall]; and (ii) 30 35 40 45 50 34 (iii) then be transmitted to an analyst, pharmacologist, technician or pathologist together with a certificate in the prescribed [forms] form signed by such inspector[and a]. (b) A copy of the aforesaid certificate shall be handed or transmitted by registered post to the owner or seller of such [medicine or Scheduled substance] product, medical device or IVD or his or her agent.’’; and (e) by the substitution for subsection (4) of the following subsection: ‘‘(4) The owner of the [medicine or Scheduled substance] product, medical device or IVD from which the sample was taken may claim from the [Director-General] the Authority an amount equal to the market value thereof.’’. Amendment of section 29 of Act 101 of 1965, as amended by section 27 of Act 65 of 1974, section 12 of Act 94 of 1991 and section 17 of Act 90 of 1997 - 36 Verify source ↗
Section 29 of the principal Act is hereby amended—
AI-assisted research summary: This section amends section 29 of the principal Act.
36. Section 29 of the principal Act is hereby amended— (a) by the substitution for paragraph (e) of the following paragraph: ‘‘(e) contravenes or fails to comply with any condition imposed under section [15(7)] 15(6)’’; (b) by the substitution in paragraph (h) for the words preceding subparagraph (i) of the following words: ‘‘makes any false or misleading statement in connection with any [medicine or Scheduled substance] product, medical device or IVD—’’; and (c) by the substitution for paragraph (i) of the following paragraph: ‘‘(i) sells any [medicine or Scheduled substance] product upon the container of which a false or misleading statement in connection with the contents is written; or’’. Amendment of section 30 of Act 101 of 1965, as amended by section 28 of Act 65 of 1974, section 13 of Act 94 of 1991 and section 18 of Act 90 of 1997 - 37 Verify source ↗
Section 30 of the principal Act is hereby amended—
AI-assisted research summary: A convicting court may, on the prosecutor’s application, order forfeiture of certain products, medical devices, or IVDs to the State; forfeited items must then be destroyed or otherwise handled as the Chief Executive Officer directs.
37. Section 30 of the principal Act is hereby amended— (a) by the substitution for subsection (2) of the following subsection: ‘‘(2) The court convicting any person of an offence under this Act may, upon the application of the prosecutor, declare any [medicine or Scheduled substance] product, medical device or IVD in respect of which the offence has been committed to be forfeited to the State.’’; and (b) by the substitution for subsection (3) of the following subsection: ‘‘(3) Any [medicine or Scheduled substance] product, medical device or IVD forfeited under this Act shall be destroyed or otherwise dealt with as the [Director-General] Chief Executive Officer may direct.’’. 5 10 15 20 25 30 35 Amendment of section 31 of Act 101 of 1965, as amended by section 29 of Act 65 of 1974, section 13 of Act 17 of 1979 and section 19 of Act 90 of 1997 40 - 38 Verify source ↗
Section 31 of the principal Act is hereby amended—
AI-assisted research summary: This section amends section 31 of the principal Act, including rules about sampled products and the admissibility of certain books, records, or documents as evidence.
38. Section 31 of the principal Act is hereby amended— (a) by the substitution in subsection (1) for paragraph (a) of the following paragraph: ‘‘(a) any quantity of a [medicine or Scheduled substance] product, medical device or IVD in or upon any premises, place, vehicle, vessel or aircraft at the time a sample thereof is taken pursuant to the provisions of this Act shall, unless the contrary is proved, be deemed to possess the same properties as such sample;’’; and (b) by the substitution for paragraph (d) of the following paragraph: ‘‘(d) any statement or entry contained in any book, record or document kept by any owner of a [medicine product or Scheduled substance,] product, medical device or IVD or by the manager, agent or employee of such owner or found upon or in any premises occupied by, or any vehicle used in the business of, such owner, shall be admissible in evidence against him or her as an admission of the facts set forth in that statement or entry, unless [it is proved] 45 50 55 36 evidence to the contrary which raises a reasonable doubt shows that that statement or entry was not made by such owner, or by any manager, agent or employee of such owner in the course of his or her work as manager, or in the course of his or her agency or employment.’’. 5 Substitution of section 33A of Act 101 of 1965 - 39 Verify source ↗
The following section is hereby substituted for section 33A of the principal Act:
AI-assisted research summary: The Authority must manage its funds through a bank account, keep proper records, and have those records audited; it may accept unconditional donations and invest unused money.
39. The following section is hereby substituted for section 33A of the principal Act: ‘‘Funds of [council] Authority 33A. (1) The funds of the [council] Authority shall consist of— (a) State funds received through the Department of Health; (b) (c) money accruing to the [council] Authority from any other source. fees raised and interest on overdue fees; (2) (a) The [council] Authority may accept money or other goods donated or bequeathed to the [council] Authority, provided no condition is attached to such donation or bequest. (b) Details of any such donation or bequest shall be specified in the relevant annual report of the [council] Authority. (3) The [council] Authority shall utilise its funds for the defrayal of expenses incurred by the [council] Authority in the performance of its functions under this Act. (4) The [council] Authority shall open an account with a bank as defined in section 1(1) of the Banks Act, 1990 (Act No. 94 of 1990), and shall deposit in that account all money referred to in subsections (1) and (2). (5) The [council] Authority shall keep full and proper records of all money received or expended, of its assets and liabilities and of its financial transactions. (6) The records and annual financial statements referred to in subsection (5) shall be audited by the Auditor-General. (7) The [council] Authority may invest money which is deposited in terms of subsection (4) and which is not required for immediate use in any manner as it may deem fit. (8) Any money which at the close of the [council’s] Authority’s financial year stands to the credit of the [council] Authority in the account referred to in subsection (4) and money which has been invested in terms of subsection (7), shall be carried forward to the next financial year as a credit in the account of the [council] Authority.’’. Amendment of section 34A of Act 101 of 1965, as substituted by section 15 of Act 94 of 1991 and section 22 of Act 90 of 1997 - 40 Verify source ↗
Section 34A of the principal Act is hereby amended by the addition of the
AI-assisted research summary: The Chief Executive Officer may authorise Authority staff in writing to exercise or perform the CEO’s powers, duties, or functions under the Act.
40. Section 34A of the principal Act is hereby amended by the addition of the following subsection: ‘‘(3) The Chief Executive Officer may, in writing, authorise any staff member of the Authority to exercise or perform in general or in a particular case or in cases of a particular nature, any power, duty or function conferred or imposed on the Chief Executive Officer in terms of this Act.’’. 10 15 20 25 30 35 40 Amendment of section 35 of Act 101 of 1965, as substituted by section 23 of Act 90 of 1997 and amended by section 12 of Act 59 of 2002 45 - 41 Verify source ↗
Section 35 of the principal Act is hereby amended—
AI-assisted research summary: The Minister may make regulations for the listed matters, after consulting the Authority; for some regulations, the Minister may also amend or repeal existing regulations if it is in the public interest and consultation has occurred.
41. Section 35 of the principal Act is hereby amended— (a) by the substitution in subsection (1) for the words preceding paragraph (i) of the following words: ‘‘The Minister may, in consultation with the [council] Authority, make regulations—’’; 50 38 (b) by the substitution in subsection (1) for paragraph (xii) of the following paragraph: (xii) prescribing the particulars which shall be published in the Gazette in respect of any application for registration referred to in section [15(11)] 15(10);’’; (c) by the substitution in subsection (1) for paragraph (xiii) of the following paragraph: ‘‘(xiii) relating to the responsibilities of both medical device and IVD establishments and users of medical devices and IVDs, in relation to the use, training, maintenance, calibration, post-marketing surveil- lance, sterilization, disinfection, recall, decomposition, decommis- sioning or decontamination of medical devices and IVDs;’’; (d) by the substitution in subsection (1) for (xxxi) of the following paragraph: ‘‘(xxxi) prescribing the fee to be paid to the [registrar] Authority in respect of an application for the registration, and in respect of the registration of a [medicine, Scheduled substance or medical device] product, medical device or IVD, the fee to be paid annually to the [registrar] Authority in respect of the retention of the certification or the registration of a [medicine, Scheduled sub- stance or medical device] product, medical device or IVD and the date on which such annual fee shall be paid;’’; (e) by the substitution in subsection (1) for paragraph (xxxiii) of the following paragraph: ‘‘(xxxiii) relating to appeals against decisions of the Director-General or the [council] Authority;’’; (f) by the substitution in subsection (1) for paragraph (xxxvii) of the following paragraph: ‘‘(xxxvii) relating to the scientific, pharmaceutical, clinical, technical and other skills required by members of staff of the Authority to evaluate the quality, efficacy and safety of products, medical devices and IVDs;’’; (g) by the insertion after paragraph (xxxix) of the following paragraphs, the existing paragraphs (xl) and (xli) becoming paragraphs (xliv) and (xlv), respectively: ‘‘(xl) (xli) (xlii) (xliii) relating to products, medical devices or IVDs in respect of matters contemplated in paragraphs (i) up to and including paragraph (xi) and paragraphs (xxiii), (xxiv), (xxxii), (xxxiv) and (xxxviii); relating to the control of products, medical devices and IVD in general; relating to the licensing for possessing or using certain products, medical devices or IVDs; relating to time frames for the consideration of applications by the Authority;’’; (h) by the substitution in subsection (3) for paragraph (b) of the following paragraph: ‘‘(b) any regulation in respect of which the Minister is, after consultation with the [council] Authority, of the opinion that the public interest requires it to be made without delay.’’; (i) by the substitution for subsection (5) of the following subsection: ‘‘(5) Regulations made under subsection (1)(xi) may prescribe that any [medicine] product, medical device or IVD or any component thereof shall comply with the requirements set out in any publication which in the opinion of the [council] Authority is generally recognised as authoritative.’’; (j) by the substitution for subsection (6) of the following subsection: ‘‘(6) Regulations may be made under this section in respect of particular products, medical devices or IVDs or classes or categories in respect thereof other than particular classes or categories of products, medical devices or IVDs, and different regulations may be so made in respect of different products, medical devices or IVDs or different classes or categories of products, medical devices or IVDs.’’; and 5 10 15 20 25 30 35 40 45 50 55 60 40 (k) by the substitution for subsection (8) of the following subsection: ‘‘(8) Notwithstanding the provisions of subsection (1), the Minister may, if he or she deems it to be in the public interest, after consultation with the [executive committee appointed under section 9,] Authority, make regulations relating to any matter referred to in subsection (1) or amend or repeal any regulation made in terms of that subsection.’’. 5 Substitution of section 36 of Act 101 of 1965, as amended by section 32 of Act 65 of 1974 - 42 Verify source ↗
The following section is hereby substituted for section 36 of the principal Act:
AI-assisted research summary: The Minister may exclude certain products, medical devices, or IVDs from this Act by Gazette notice, with conditions, and may later amend or withdraw that notice.
42. The following section is hereby substituted for section 36 of the principal Act: ‘‘Exclusion of any product, medical device or IVD from operation of Act 10 36. (1) The Minister may, on the recommendation of the Authority, by notice in the Gazette exclude, subject to such conditions as he or she may determine, any product, medical device or IVD from the operation of any or all of the provisions of this Act, and may in like manner amend or withdraw any such notice. (2) Notwithstanding subsection (1), the exclusion of any product from the operation of section 22G shall be on the recommendation of the Pricing Committee.’’. 15 Substitution of section 37A of Act 101 of 1965, as substituted by section 25 of Act 90 of 1997 20 - 43 Verify source ↗
The following section is hereby substituted for section 37A of the principal Act:
AI-assisted research summary: This section substitutes a new section 37A in the principal Act.
43. The following section is hereby substituted for section 37A of the principal Act: ‘‘Amendment of Schedules - 37A Verify source ↗
Notwithstanding the provisions of section 35(2), the Minister may,
AI-assisted research summary: The Minister may amend schedules by Gazette notice on the Authority’s recommendation, and the Chief Executive Officer must enter registered medicines and medical devices into the register. The Medicines Control Council ceases to exist before commencement, and past Council acts may be treated as Authority acts.
37A. Notwithstanding the provisions of section 35(2), the Minister may, on the recommendation of the [council] Authority, from time to time by notice in the Gazette amend any Schedule prescribed under section 22A(2) by the inclusion therein or the deletion therefrom of any medicine or other substance, or in any other manner.’’. Transitional measures 44. (1) Medicines and medical devices that are registered at the date of commence- ment of this Act shall be deemed to be registered in terms of the principal Act, and the Chief Executive Officer shall enter them in the relevant register. (2) The Medicines Control Council shall cease to exist the day before this Act is brought into operation. 25 30 (3) Anything done by the Council which could have been done by the Authority in 35 terms of this Act shall be deemed to have been done by the Authority. Short title and commencement - 45 Verify source ↗
This Act is called the Medicines and Related Substances Amendment Act, 2008,
AI-assisted research summary: The Act is named the Medicines and Related Substances Amendment Act, 2008, and starts on a date set by the President in the Gazette.
45. This Act is called the Medicines and Related Substances Amendment Act, 2008, and comes into operation on a date fixed by the President by proclamation in the Gazette. 40
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