No. 72 of 2008: Medicines and Related Substances Amendment Act, 2008.
AIDS HELPLINE: 0800-123-22 Prevention is the cure by the insertion after the deï¬nition of ''certiï¬cate of registration'' of the following deï¬nition: '' 'cosmetic' means a cosmetic as deï¬ned in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No.
by the insertion after the deï¬nition of ''export'' of the following deï¬nition: '' 'foodstuff' means a foodstuff as deï¬ned in the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No.
by the deletion of the deï¬nition of ''registrar''.
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.
The South African Health Products Regulatory Authority is hereby established as an organ of state but outside the public service.
subject to the Public Finance Management Act, 1999 (Act No. 1 of 1999); and accountable to and reports to the Minister.
The Authority may exercise the powers and shall perform the functions conferred upon or assigned to it by this Act.
In performing its functions, the Authority shall act without fear, favour or prejudice.''.
Substitution of section 3 of 101 of 1965, as substituted by section 3 of Act 90 of 1997 3.
Executive Officer of the Authority.
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 ï¬ne.
permanent incapacity; or engaging in any activity that is reasonably capable of undermining the integrity of the Authority.
must appoint and supervise staff of the Authority; and must compile business and ï¬nancial plans and reports in terms of the Public Finance Management Act, 1999 (Act No. 1 of 1999).
The Chief Executive Officer shall appoint suitably qualiï¬ed staff and may contract other suitably qualiï¬ed persons to assist the Authority in carrying out its functions.
The Minister shall, after consultation with the Minister for Public Service and Administration, determine the structure and the human resources policy for the Authority.
The human resources policy shall include a code of conduct and provisions on conï¬ict of interests applicable to the Chief Executive Officer and the staff of the Authority.
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).
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).
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.''.
Substitution of section 4 of Act 101 of 1965 4.
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.
The advisory committee contemplated in subsection (1) shall consist of not more than 5 persons who shall be appointed from persons outside the Authority.
The Minister shall appoint a chairperson for the advisory committee from among the members after having consulted the members.
be ï¬t and proper persons; and have appropriate expertise, skills, knowledge or experience and the ability to perform effectively as a member.
The advisory committee shall determine procedures for its meetings.
An advisory committee member who has a personal or ï¬nancial 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.
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.
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.''.
Repeal of sections 5, 6, 7, 8, 9 and 12 of Act 101 of 1965 5. Sections 5, 6, 7, 8, 9 and 12 of the principal Act are hereby repealed.
the registration of products, medical devices or IVDs by the Authority; and such particulars in regard to the products, medical devices or IVDs and the holder of certiï¬cate of registration in respect of such products, medical devices or IVDs as are required by this Act.''.
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.
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.
Any such [resolution] declaration may also relate only to [medicines,] 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.
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.
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).
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 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, 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.''.
where practicable, samples of medical devices or IVDs; and the prescribed registration fee.
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.
is safe and of good quality; and in the case of products, also efficacious, the Authority shall issue the applicant with a certiï¬cate of registration to that effect.
If the Authority is not satisï¬ed as contemplated in paragraph (a),it shall cause the applicant to be notiï¬ed in writing of the reasons why it is not so satisï¬ed and cause the applicant to be informed that he or she may within a period of 30 days after the date of the notiï¬cation furnish the Chief Executive Officer with his or her comments on the Authority's reasons for not being so satisï¬ed.
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 satisï¬ed as aforesaid, it shall not issue the certiï¬cate of registration.
Every product, medical device or IVD shall be registered under such name as the Authority may approve.
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 certiï¬cate of registration issued in respect of such product, medical device or IVD.
may be made subject to such conditions as may be determined by the Authority; and shall in the case of medicines, be valid for a period of ï¬ve years.
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 notiï¬ed by the Chief Executive Officer that the imposition of such condition is contemplated and invited to submit written representations to the Authority in regard to the matter.
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 notiï¬cation 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.
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.
''Amendment of entries in register 15 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 certiï¬cate of registration issued in respect of such product, medical device or IVD be amended by the Chief Executive Officer.
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.
The Chief Executive Officer may, if necessary, cancel the existing registration in respect of such product, medical device or IVD and issue a new certiï¬cate of registration.''.
Substitution of section 15B of Act 101 of 1965 10.
15B. (1) A certiï¬cate of registration may with the approval of the Chief Executive Officer be transferred by the holder thereof to any other person.
An application for approval of the transfer of a certiï¬cate of registration shall be made to the Chief Executive Officer on the prescribed form and shall be accompanied by the certiï¬cate of registration in question and the prescribed application fee.
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 certiï¬cate of registration is transferred, cancel the existing certiï¬cate of registration and issue a new one in the prescribed form to such person.''.
Amendment of section 15C of Act 101 of 1965 11.
''(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 certiï¬cate 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;''.
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.
is of the opinion that a holder of a certiï¬cate 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 certiï¬cate of registration issued in respect of that product, medical device or IVD.
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.
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.
If the person who is the holder of the certiï¬cate 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.''.
Substitution of section 17 of Act 101 of 1965, as substituted by section 5 of Act 20 of 1981 13.
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 certiï¬cate 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.''.
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.
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.
No person shall advertise any [medicine or Scheduled substance] product, medical device or IVD for sale unless such advertisement complies with the prescribed requirements.
The label referred to in subsection (1) shall be approved by the [council] Authority.
The [council] Authority may authorize a deviation from the prescribed format and contents of any label.
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.
18A. (1) No person shall supply any product, medical device or IVD according to a bonus system, rebate system or any other incentive scheme.
Notwithstanding subsection (1), the Minister may prescribe acceptable and prohibited acts in relation to subsection (1).''.
Substitution of section 18B of Act 101 of 1965 16.
18B. (1) No person shall sample any product, medical devices or IVD.
Use of products, medical devices or IVDs for exhibition or appraisal purposes shall be as prescribed.
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 its agent 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.''.
Substitution of section 18C of Act 101 of 1965 17.
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.''.
Substitution of section 19 of Act 101 of 1965, as amended by section 17 of Act 65 of 1974 18.
No person shall sell any [medicine] product, medical device or IVD unless it complies with the prescribed requirements.
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.
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.''.
Substitution of section 20 of Act 101 of 1965, as amended by section 18 of Act 65 of 1974 19.
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.
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].''.
Substitution of section 21 of Act 101 of 1965, as amended section 6 of Act 20 of 1981 20.
The Authority may in writing authorize any person to sell during a speciï¬ed period to any speciï¬ed person or institution a speciï¬ed quantity of any particular product, medical device or IVD which is not registered.
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.
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).''.
Substitution of section 22 of Act 101 of 1965, as amended by section 6 of Act 20 of 1981 21.
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 certiï¬cate of registration issued in respect of such [medicine] product, medical device or IVD to be informed of the cancellation of such registration.
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.
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 22.
''(2) The Minister may, on the recommendation of the [council] Authority, prescribe the Scheduled substances referred to in this section.'
''(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 speciï¬ed 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.
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.
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 ï¬t.''.
Amendment of section 22C of Act 101 of 1965 24.
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 distributor 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.'
''(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.'
''(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.'
''(6) No medical device or IVD establishment, manufacturer, wholesaler 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.
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.
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 speciï¬ed in the notice, which period shall not be less than 20 days as from the date of the notice, why the licence in question should not be suspended or revoked.'
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.''.
Amendment of section 22F of Act 101 of 1965, as amended by section 7 of Act 59 of 2002 27.
''(c) where the product has been declared not substitutable by the [council] Authority.''.
Amendment of section 22H of Act 101 of 1965 28.
''(1) (a) No wholesaler shall purchase [medicines] products from any source other than from the original manufacturer or from the primary importer of the ï¬nished product.
A wholesaler shall sell [medicines] products only into the retail sector.
Notwithstanding paragraphs (a) and (b), a wholesaler may purchase from or sell to, other wholesalers or the public Schedule 0 substances.
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 29.
by notice in writing transmitted by registered post to any person direct that person; or 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.
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.
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.''.
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.
Any person aggrieved by the decision of the Director-General 5 may within the prescribed period and in the prescribed manner make written representations with regard to such decision to the Minister.
Insertion of section 24A to Act 101 of 1965 31.
24A. (1) Any person aggrieved by the decision of the Authority may 15 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.
Upon being notiï¬ed the Chief Executive Officer shall meet with the appellant within 30 days of being so notiï¬ed in the absence of legal 20 representatives to try to resolve the matter, especially if the appeal involves administrative matters.
Minister in writing to convene an appeal committee.
conduct the appeal hearing and make a decision within 30 days from the day when it ï¬rst meets to hear the appeal.
A party aggrieved by the decision of the appeal committee may approach the High Court for a judicial review.''.
Substitution of section 25 of Act 101 of 1965, as substituted by section 10 of Act 59 of 2002 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.
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.
Every inspector shall be furnished with a certiï¬cate signed by the [Director-General] Chief Executive Officer and stating that he or she has been authorized as an inspector under this Act.
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 certiï¬cate referred to in subsection (2).''.
Substitution of section 27 of Act 101 of 1965, as substituted by section 11 of Act 17 of 1979 34.
[The Director-General] Chief Executive Officer may grant such authority to such analysts, pharmacologists, engineers, technicians and pathologists or any other appropriately qualiï¬ed person as he or she may consider necessary for the proper enforcement of this Act.''.
Amendment of section 28 of Act 101 of 1965 35.
''(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.'
then be transmitted to an analyst, pharmacologist, technician or pathologist together with a certiï¬cate in the prescribed [forms] form signed by such inspector[and a].
A copy of the aforesaid certiï¬cate 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.'
''(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.
''(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.
''(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.'
''(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.''.
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 38.
''(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] 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.''.
Substitution of section 33A of Act 101 of 1965 39.
money accruing to the [council] Authority from any other source.
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.
Details of any such donation or bequest shall be speciï¬ed in the relevant annual report of the [council] Authority.
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.
The [council] Authority shall open an account with a bank as deï¬ned 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).
The [council] Authority shall keep full and proper records of all money received or expended, of its assets and liabilities and of its ï¬nancial transactions.
The records and annual ï¬nancial statements referred to in subsection shall be audited by the Auditor-General.
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 ï¬t.
Any money which at the close of the [council's] Authority's ï¬nancial 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 ï¬nancial 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.
''(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.''.
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 41.
''(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.'
''(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.'
''(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.'
''(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.''.
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.
Notwithstanding subsection (1), the exclusion of any product from the operation of section 22G shall be on the recommendation of the Pricing Committee.''.
Substitution of section 37A of Act 101 of 1965, as substituted by section 25 of Act 90 of 1997 43.
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.''.
Medicines and medical devices that are registered at the date of commencement 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.
The Medicines Control Council shall cease to exist the day before this Act is brought into operation.
Anything done by the Council which could have been done by the Authority in terms of this Act shall be deemed to have been done by the Authority.
This Act is called the Medicines and Related Substances Amendment Act, 2008, and comes into operation on a date ï¬xed by the President by proclamation in the Gazette.