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Medicines and Related Substances Amendment Act (Act No. 59 of 2002)

 Medicines and Related Substances Amendment Act No. 59 of 2002

REPUBLIC OF SOUTH AFRICA

Government Gazette

Vol. 451 Cape Town 17 January 2003 No. 24279

THE PRESIDENCY

No. 115 17 January 2003

It is hereby notified that the President has assented to the following Act, which is hereby published for general information:–

No. 59 of 2002: Medicines and Related Substances Amendment Act, 2002.

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2 No. 24219

.Act No. 59, 2002

GOVERr;MENTGAZETT£. 11 JANUARY W03

MEDICINES AND RELATED SUBSTANCES AMENDMENT ACT, 2002

GENERAL EXPLANATORY NOTE:

Words in bold type in square brackets indicate omissions from existing enactments.

Words underl ined with a solid line indicate insertions in existing enactments.

(English lexl signed by the Presiderrl.J (Assented 10 30 December 2002.)

ACT To amend the Medicines and Related Substances ACI, 1965, so as 10 provide for some definitions; to pro\'ide for the appointment ofoneor more Deputy RegistraT5; to provide for a term of office of members of the Pricing Committee; to provide for the delay of the coming into operation of provisions requiring a licence before a person can compound and dispense or manufacture medicines, or act as a wholesaler or distributor; to provide for appeals against the decisions of the Direelor-General and the council; to provide for regulations relating to the marketing of medicines: and to provide for matters connected therewith.

BE IT ENACTED by the Parliament of the Republic of South Africa. asfollows:- Amendment of section 1 of Act 101 of 1965, as amended by section 1 of Act 65 of 1974, section 1 of Act 17 of 1979, s«tion 1 of Act 20 of 1981, section I of Act 94 of 1991 and section I of Act 90 of 1997 5

I, Section 1of the Medicines and Related Substances Act. 1965 (hereinafter referred to as the pri ncipal Act), is amended by-

(oJ the insertion in subsection (1 ) after the definition of " label" of the following defini tion:

"'magistrate' means a magistrate as defined in section I of the 10 Magistrates Act. 1993 (Act No. 90 of 1993). and includes an additional magistrate and an assis tant magistrate:"; and

(b) the substitution in subsection (1) for the defi nition of " practitioner" of the fo llowing defin ition:

" ' practit ioner' means a person registered as such under the (Chiropr3c- 15 tors, Homeopaths and} All ied Health [Servicel Professions Act. 1982 (Act No. 63 of 1982):".

Amendment of s«tion 6 of Act 101 of 1965, as amended by section 5 of Act 6S of 1974, sttlion 3 of Act 17 of 1979, stttion 46 of Act 97 of 1986, section 4 of Act 94 of 1991 and section S of Act 90 of 1997 20

2, Section 6 of the principal Act is amended by- (0) the deletion of paragraph (b) of subsection (2); and (b) the substitution for subsection (3) of the followi ng subsection:

J No. 2J279

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GOVERNME NT GAZETTE. 17 JANUARY 200J

MEDICINES AND RELATED SUBSTANCF..s AME....OMENT ACT. 2002

"(3) If the office of any member of the council becomes \'aeant before the expiration of the period for which ht: or sht: was appointed. tht: Minister may(. subject to the provisions of section 3,J appoinl another JX'rson to hold office for the unexpired pon ion of the period for which his or her predecessor was appointed.". 5

Substitution of s«tion 12 of Act 101 of 1965, as substituted b\' section 10 of Act 65 of 1974 and amended by section 7 of Act 90 of 1997 .

3. The following section is substi tUled for section 12 of the principal Act:

" Appointment of Registrar and Deputy Registrar of Medicines

12. (1 The Minister rna . after consultation with the council. a int a 10 Registrar and one or more Deputy Registrars or revoke such an appointment.

(2) The Registrar shall exercise: the powers and perform the duties assigned to. or imposed upon. him or her in terms of this Act and such other powers and dUlies as may from time to time be assigned 10 or impose:d upon 15 him or her by the counci l. Minister or DireClOr·General.

(3) A DepUEy Registrar shall assist the Registrar in the excrcise: of his or her powers and the performance of his or her duties and may. subject to the approval of the Registrar. exercise any power confe rred upon the Registrar." . 20

Substitution of section 18C of Act 101 of 1965, as inserted by section 12 of Act 90 of 1997

4. The following section is substitUied for section IBe of the principal Act:

" Marketing or medicines

IBC. The Minister shall. after consultation with the pharmaceutical 25 industTV and other stakeholders. make regulations relati n!! to the marketing of medicines. and such regulations shall also provide for an enforceable Code of Practice.·· .

Amendment of section 22A of Act 101 of 1965, liS inserted by section 21 of Act 65 of 1974. amended by section 9 of Act 17 of 1979 1lnd substituted by section 13 of Act 30 90 of 1997

5. Section 22A of the principal Act is amended by- (a} the substi tution for paragraph (p} of subsection (6) of the fo llowing par.tgraph:

"(p) the sale of a specified Schedule 5 or Schedule 6 substance by a manufacturer of or wholesale dealer in phannaceutical products 35 shall be recorded in a register which shall be kept in the prescribed manner. and shall be balanced so as to show clearly the quantity of every specified Schedule 5 or Schedule 6 substance remaining in stock as on the last day of March. June, September and December of each year. and such balancing shall be completed within the 14 days 40 followi ng each of the said dates;";

(b) the substitution for subsection (8) of the following subsection: "(8) Subject to subsection (9). a (Schedule 7J Schedule 8 substance

shall not be acquired by any person other than the Director·General fo r the purpose of providing a medical practitioner therewith. on the 45 pre~ribed conditions. for the treatment of a panicular patient of that medical practitioner upon such conditions as the Dircctor·Gcneral. on the recommendation of the council, may detemline.";

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GOVERNMENTGAZETTF.. 17 JANUARY ~II().~

MEDICINES AND RELATED SUBSTANCES AMENDMEI\'T ACr. 2002

(e' the substilution for subparagraph (i) of paragraph (a) of subsection (9) of the following subparagraph:

"(il acquire. use. possess. manufacture or supply any Schedule 1 2! Schedule 8 substance. or manufacture any specified Schedule 5 or Schedule 6 substanCe unless he or she has been issued with a permit 5 by tilt: Director-General for such acquisition. u~. possession. manufacture. or supply: Provided that the Director.(Jeneral may. subject to such conditions as he or she may detcrminr. acquire or authorise the use of any Schedule 7 or Schedule 8 substance in order to provide a medica) practitioner. analyst. researcher or veterinarian 10 therewith on the prescribed conditions for thr treatment or preventiOfl o f a medical condition in a panicular patient. or for the purposes of education. analysis or research:":

(d) the substitution for paragraph (a) of subsection ( II 1 of the following paragraph: 15

"(a) No person shall impon or expon any specified Schedule 5. Schedule 6 lor). Schedule 1 or Schedule 8 substance or other substance or medicine prescribed for that purpose unless a permit has been i s~ued to him or her by the Director-General in the prescribed manner and subject to (the prescribed) such conditions as mav be determir'ICd bv the 20 Director-General:" :

(ro) the substitution for subparagraph (i) of paragraph (a) of subsection ( 12) of the fol lowi ng subparagraph:

"(i) any specified Schedule 5. Schedule 6 (or ): Schedule 7 or Schedule 8 substance;": 25

(j) tnc substitution for paragraph (b) of subsection 12 of the following paragraph: "(b) The obtaining of import or expon penn its as required in tenns of

subsection (II) shall not apply to any preparation which contains a substance as prescribed which is specifically exempted from all control measures for the obtaining of such impon or expon pennits by the 1961 30 Single Convention on Narcotic Drugs refem:d to in paragraph (a'.":

(g) the substitulion for paragraph (e) of subsection ( 12) of the following paragraph:

"(e) Notwithstanding paragraph (b). no such imponation or expona- tio ll shall take place unless authorised by the Direclor-General.": 35

(II) the substitut ion for paragraph (a) of subsection ( 14) of 1hc following paragraph:

"(a) II pharmacisl's assistant shall not handle any spec ified Schedule:; or Sched ule 6 substance except as contemplated in subsection (5)(a) and (b): and": and 40

m Ihe substitution for paragraph (b) of subsection (16) of Ihe fo llowi ng paragraph:

"(b) any person may possess a Schedule 3. Schedule 4. Schedule 5(,1or Schedule 6 Lor Schedule 7) substance if he or she is in possession of a prescription issued by an authorised prescriber:". 45

Amendment of stCtion 22C of Act 101 of 1965, as inserted by seetion 14 ofAcl 90 of 1997

6. Section 22C of the principa1 Act is amended by- (a) the substitution for paragraph (b) of subsection (I) of the following paragraph:

"(b) tnc council may. on application in the prescribed manner and on 50 payment of the prescribed fee . issue to a manufacturer. wholesaler or distributor of a medicine or medical device a licence to manufacture. impon or expon. act as a wholesaler of or distribute. as the case may be. such medicine or medical device. upon such conditions as to the application of such acceptable quality assurance 55 principles and good manufacturing and distribution practices as the council may delennine.'-:

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MEDICINES AND REl..ATED SUBSTANCES AMENDMENT ACT. 2002

(b ) the substitution for subsection (2) of the fallowing subsection : "(2) A licence referred to in subsection (I)(a) shall not be issued

unless the applicant has successfully completed a supplementary course (prescribed under the Pharmacy Act. 1974 (Act No, 53 of 1974), by the Interim Pharmacy Council of South Africa) detennined by the 5 Soum 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) the substitution for subsection (5) of the following subsection: " (5) No person shall compound or dispense a medicine unless he or 10

she is authori sed thereto in tenns of the Phannacy Act. 1974. is a veterinarian or is the holder of a licence as contemplated in subsection (I )ra).",

(d ) the substitution for subsection (6) of the followi ng subsection : "(6) No manufacturer, wholesaler or di stributor referred 10 in 15

subsection (l)(b) shall manufacture, impon, expon, act as a wholesaler of or distribute, as the case may be, any medicine (or medical de\'ire] unless he or she is the holder of a licence contemplated in the said subsection.": and

(e) the substitution for subsection (7) of the following subsection : 20 "(7) Subsections (5) and (6) shall come into opermion Isix months

after the) twelve months from the date of commencement of this section,"

Amendment orseetion 22F of Act lOt of 1965. as inserted by settion 14 of Act 90 of 1997 25

7. Section 22F is amended by- (a} the substitution in subsection ( I) for the words preceding paragraph (a} of the

following words: " (1 ) Subject to subsections (2). (3) and (4). a phannacist or a person

licensed in terms of section 22C(1)(a) shall- " ; and 30 (b) the substitution for paragraph (a) of subsection (I) of the following paragraph:

"(a) infonn all members of the public who visit Ihis or her) Ihe pharmacy or any other place where dispensing takes place. as !he case may be, with a prescription for dispensing, of the benefits of the substitution for a branded medicine 101') .Q.y an intcrchangeable 35 multi-source medicine. and shall. in the case of a substitution. take reasonable steps 10 inform the person who prescribed the medicine of such substitut ion; and ".

Amendment of section 22G of Act 101 of 1965, as inserted by section 14 of Act 90 of 1997 40

8, Section 22G of the principal Act is amended by- (a) the substitution for subsection ( I) of the following subsection:

"( I) The Minister shall appoint. for a period not exceeding fi ve vears, such persons as he or she may deem fit to be members of a committee to be known as the pricing committee."; 45

(b) the addition in subsection (2) of the following paragraph: "le) on an appropriate fee to be charged by wholesalers or distri butors or

anv other person selling Schedule 0 medicines.": and (e) the substitution for paragraph (b) of subsection (3) of the following paragraph:

"(b) No pharmacist or person licensed in tenns of section 22C( I )(a) or 50 wholesaler or distributor shall sell a medicine at a price (greater I higher than the price contemplated in paragraph (a) ....

Amendment of section 24 of Act 101 of 1965, as substituted by section 11 of Act 94 uf 1991 and section 15 or Act 90 of 1997

9. Section 24 of the principal Act is amended by- (a) the substitution for the existing heading of the following heading:

" Appt!al against decision of council or Director-General ";

55

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Ac1 No, 59, 2002

GOVERNMENT GAZElTE. 17 JANUA RY :tltl.'

MEDICINES AND RELATED SUBSTANCES AMENDMENT ACT. 2002

(b) the substitution for subsection ( I) of the following subsection: "( I ) Any person aggrieved by a deeision of the [Director-General or

the] council[, as the case may be.] may, within the prescribed period, in the prescribed manner and upon payment of the prescribed fee, appeal against such decision to an appeal committee appointed by the Minister 5 for the purposes of the appeal concerned. " ;

(c) the substi tution for paragraph (a) of subsection (2) of the following paragmph: "(a) the chairperson shall be Is person] appoi nted on account of hi s or

her knowledge of the law {\\ith at least 10 years experience thereof1:": 10

(d) the substitution for subsection (3) of the following subsection: "(3) The appeal committee may after hearing the appeal-

(a) confirm. set aside or vary the decision of the [Director-Genera l or] the council: and

(b ) direct the [Director-General or the}counci ll. as the case may be.l 15 to execute the decision of the appeal committee.":

(e) (he substitution for subsection (4) of the following subsection: "(4) The decision of the appeal committee shall be in writing and a

copy thereof shall be furni shed to the appellant as well as 10 the (Director-General or the] councill. as the case may bel,"; 10

if) the substitution for subsection (6) of the following subsection: " (6) An)' 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'-'; and

(g) the addition of the following subsection: 25 "(7) The Minister shall. after considering representations made in

terms of subsection (6), confirm. set aside or vary the decision of the Director-General. ...

Substitution of section 25 of Act 101 of 1965, as substituted by section 32 of Ad 88 of 1996 30

10. The following section is substituted for section 25 of the principal Act:

" Privileges of council and committees

25_ The council or a committee appointed under [subsection (I ) of section 9] section 9( I). 22G( I) or 24( I) or any memhcr of the councilor of any such committee shall nol be liable in respect of anything done in good 35 faith under this Act. .. .

Amendment of section 28 of Act 101 of 1965, as amended by set::tion 26 of Act 65 of 1974, section 12 of Act 17 of 1979 and section 16 of Act 90 of 1997

n . Section 28 of thc principal Act is amended by- (a) the substitution for subsection (1) of the following subsection: 40

" I An ins tor ma • at all reasonable times- (a) enter upon-

(i) any place or premises from which- (aa) a person authorized under this Act to compound or

dispense medicines or scheduled substances: 45 (bb) the holder of a licence as contemplated in section

22C( 1)(b); (cc) the holder of a cert ificate of registration of a medicine. conducts business;

(ii) any place. premises. vessel or aircraft if he or she suspectSon 50 reasonable grounds that an offence in terms of this Act has been or is being committed thereon or therein or that an attempt has been made or is being made to commit such an offence thereon or therein; or

(ii i) any pri,'ate dwelling, wilh the consent of the occupier or under 55 the authori ty of a warrant issued in terms of subsect ion (5) or without a warrant in terms of subsection (6):

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Ad No. S,. 2002 GOVERNMENT GAZElTE. 17 JANUARY 2003

MEDICINES AND REl..ATI!D SUBSTANCES AMENDMENT Acr. 2002

(bJ inspect any medicine or scheduled substance. any book. record or documenls that the inspector believes on reasonable grounds conlains any information relevanllo the adminislralion or enrorce- men! of this ACI;

(c) seize any book. record. documents or medicine or scheduled 5 substance or take so many samples or any such medicine or scheduled substance as he or she may consider necessary ror the purpose or lesting. examinalion or analvsis in leons or this ACI.'·:

(b) the addilion of the following subsections: "(5 Whereona licaliontoama istraleita 3rSlosuchmn iSlrate 10

rrom inronnalion on oath thai Ihere are reasonable grounds 10 believe that- (a) the conditions ror entry described in subsection (I )(0) exist in

relal ion 10 a private dwelling; (b) entry to that pri vate dwelling is necessary ror any purpose relating 15

to the administration or enrorcemenl of Ihis Act: and (c) entry to the private dwelling has been rerused or that entry thereto

will be refused. a magislrate may issue a warrant authorizing the inspeclor named therein 10 enler that privale dwelling subject 10 such condilions as may be 20 specified in the WaJTani.

(6) Jf an inspector believes on reasonable grounds that- (a) a wanant would be issued to him or her under subsection (5) if he or

she applies for such a warranl; and (b) a delay in obtaining such wamlJlI would defeat the object of the 25

enlry. search and seizure. he or she may without a warrant enter and search any premises for any medicines. scheduled substance. book. record or document relevant 10 the adminisuation or enforcement or this Act and seize or take samples as contemplaled in subsection (1)(c). .. . 30

Amendment of section 3S of Act 101 of 1965, as substituted by seclion 31 or Act 65 of 1974. amended by section 3 orAct 19 or 1976, sedion 14 of Act 17 of 1979. seelion 7 of Act 20 of 1981, section 7 of Act 71 or 1991 and section 16 or Act 94 or 1991 a nd substituted by section 23 of Act 90 of 1997

12. Section 35 of the principal Act is amended by- 35 (a) (he substitut ion in subsection (I) for paragraph (xxiv) of the following

paragraph: "(xxiv) as to the imponation. exponation. conveyance. keeping.

storage, processing and packing of medicines and Scheduled substances. and the manner in which medicines and Scheduled 40 subSl.3.nces shall be kept and comrolled in different categories or hospitals:" and

(b) the subsulution in subsection ( I) for paragraph (xxvii) of Ihe fOllowing paragraph:

"(xxvii) authorizing. regulaling. comrolling. restricting or prohibiling 45 the registration. manufacture. modification. imponation. ~ ponation. storage. transponalion. sale or use of any medical device or class of medical devices or medicines in respecl of its sarety. quality and efficacy:".

Substitution or long title or Act 101 of 1965, as suhslituted by section 22 or Act 94 50 of 1991 a nd section 29 of Act 90 of 1997

13. The following long tille is subslilUled for the long title of the principal Act:

"ACT

To rovide for the re istralion of med icines a nd related substances intended for human and for animal use; to p rovide for the esta blish- 55 ment ora Med icines Control Council ; to provide that such council shall be a juristic pel'SOn; to ma ke other provision for the constitution of the

No. 2421'9

Act No.. 59, 2002

GOVER!'IiMENT GAZETTE. 17 JANUARY y(),1

MEDICINES AND RE1..ATED SUBSTANCES AMENDMENT ACT, 200l

cooncil: to provide that a member of the councilor committee sha ll declare his or her commercial inlerest related to the pharmaceutical or heallh care industry: to provide that the appointment of members of the executh'e committee is subj«t to the approval of the Minister; to provide for the control of medicines and scheduled substances and 5 medical duittS: to make further provision for the prohibition on the sale of medicines which are subject to registration and are not rtgislered: 10 provide for procedures that will expedite the registration of essential medicines. and for the re-evaluatJon of all medicines after five years: to provide for measures for the supply of more aWordable 10 medicines in certain cin:umstanus; to provide thai labels be appro\'td by the council; to prohibit sampling and bonusing of medicines; 10 provide for the licensing of certain persons to compound, dispense or manufacture medicines and medical devices and also to act as wholesalers or distributors; to provide for the generic substitution of 15 medicines: to provide for the establishment of a pricing commillee: to regulate the pun:hase and sale or medicines by manufacturers, distributors, wholesalers. pharmacists and persons licensed to dispense medicines: to make new provisions for appeals against decisions of the Dirtttor-General or the council; to provide that the council may 20 acquire and appropriate funds ; to regulate the Minister's power to make regulations; to provide for the rationalitation of ctrtain laws relating to medicines and related substances that hne remained in force in various territories on the national territory of the Republic by virtue or item 2 of Schedule 6 to the Constitution of the Republic or '25 South Africa, J996; and to provide for matters connected therewith,'· .

Repeal of Act 132 of 1998

14. The Soulh Afncan Medicines and Medical Devices Regulatory AUlhority Act. 1998 (Act No. 132 of 1998). is rt'pealed.

Short title and commencement

IS. This Act is called the Medicines and Related Substances Amendment Act, 2002, :lnd shall come into operation on a dale to be delennined by the Presidenl by proclamalion in the Ga:etle,

30