Statnt*rl lnstrlnnent 62 of ?01fi.

ICAn l5:S?

Ilangenlts Dnrgs {Pnrtluction of'{"annahis firr hletlicinal anrtScientilic t rse) Regul;rtious,, 2{}II

ARRAI\ {iHh{ I1N"f {}fr S }:i{ :TIfi}{$

PAK| Il\ur,t rrgt{,{Rt'

5gr'firln

1. 'T'itl*"

:. iute rpratatiern.

:i. r\ pplicaticn.

. F}ARI- IT

I.Ir-Eit$INii or Srt'Fis ,\i{D [tnsoxs

-1. ;\pplicatiun frrr pr*clucers' licence"

5. Authoris*el pf;xlon in charge arrd rcsp$nsible persrln in chilrge .

6. lssuance o{- licences.7 ^ {ircrunds frrr retirsal.14. Iluration of licence,9" Display cf licenq-:es.

I *, Irrrxluction arrd retur:r of licences.I 1" :\pplicatiou fl:r variation or arnenclment of licences.12" Notice to l\{inister on change cf personnel.13. l{otice to h{inister on various clxrnges.14. Applicaticn l*r lenewal q"rl- Iicence.I5. Stateme nt b1' signatory of nctice,1f]" Armual retums.fi. 'femporarv suspensicnl r,rf licences.lS. Reinstatement r:rf suspsncled licences.1?. Llancellatian ol' licencss fallou'ing suspensir-rn.

?0. {;ancellatiolr c}n other gru}unds.

21 . Notice of cessation of nr:tivities.

6I)9

Ilangelou-q I)rugs {Pnxluction *l'Cannabis ftrr hleclicinal artd

Scientitic {.jse) Regulations,, 2t) I tl

}}\ITT III

S'r,r'unlrY lt'{r,'\ st iRh.s

PART A*PIlRIh{tif}lR O}; SIT'fi

5er" tiort22. {-iomptriance lvith securit} fi}easures.

23. tinauthori*ed accsss.

21. \risual monitt-rring of the pt: rimcter ol- site.

25. lntrusion detection s1'ste rn of the pe rimete r of site,

2{t" lr'fonitoring by personncl of the prirneter of site.

t1.\HI' B*'\IT.T1AS WT{ERIr {IAN}.IAI]IIi IS }IA\DI ,};I)

2"7. Restricted acce ss.

?S. Ph1'sical barriers.

29. \'isual monitoring.30, Intrusiott cletection svstern.

31. Fiitration cl'air3?. h{onitorirrg by personnel.

PAR'| IV

G r,l=- tn,q I { ; t-r xDrr I oN s o F Pn t-}Dt icr i o}i

33. {iaod protluction praetices.

3.1." (lultivatiein of cannahis.

35. Soil and fertilisers.36. Irrigatiott.37. Pest control prulucts.

-18. tr.{an esting.

39. Drf ing.-10. h{icrobial ancl chernical contaminants.

-1.1 . Disintegration of capsule.

12. lvlaximunr yield quantitl'*cannabis oil"-+:3. Solvents.M. ,i\.nalytical testing.-15. Premiscs.

16. Fqniprnent.

?00

S.I. 62 of ?0ltt

,5'*r'li oru

-$7. Sanitatiqrn prclgramme.

+8, Standard nperating proceclures.

+!). Re call,50. Recall reparting"5l . tJuaiit)' assrlrance .

52. $arnptre of lot or batch.

I1,\R3'V

I)"\cK-{GIhi{i, { -rRITl.IN{i A hri Sl*t'pixc

53. f'ackaging.5-1" Ae:curac)' of n'eight.

55. Accurac)' of nurutrcr"of plants.

56. Prmluct label lor cennabis oil.5?. Ilroduct latrel iar cannahis seetls,

58. Product lab*l f*r *annatris plarlts.

59. Fresentation cl' infonlratiott tlll lahel"

f:0. Expiry r,late.

fil . I{efurence to Ac:t $r regulatiotrs.{t?. Shipping"6i3. Irnpor{ anrj export.{:4. I}ersons authorised to hanCle cannabis.

PAKT VI

Rriconn KEgrllic

t15. Record keeping by licensed proclucers"

66. lteconl keeping b)'aulhoriserJ pefficns"

6?. L'Ianner ol- ke*ping records.

68. Ilreserr,'ation *f recorcls.

69. Cannahis inventory.?0. Retunrecl sutrstances"

71 ^ Orcler ior expr-rrt.

1?. Sectrritv iilr'cntorl'.

7il11

F

I)angcnlrrs l)nres (Production of ( lanttabis iirr \lcdrctttitl ;rllJScientific [

-se) Re sulatiotrs, ?0I tl

Settion

?-3. l-Jrie d i,:annatris eqtrivalencY lactor.-i'4, Ilatch rerronciliation"?5. Re search itnd dcvelopment.

76. I)e strr.l) ed cannahis.

7i. Disposal ol cannabis"

?8. Aclverse reactions.79. I)e stmctiorr of' cannabis after the change in praductiou areit

80. ;\dvertisen:ent of cannabis.

PART \'II

Gl,n*.49,

81 . Ire es.

82. Penaltics.

83. Appeals.

FtRst Sctlru:lrlt. I;ees,

Srici-lnu Sr:ln::[jl.l]: l';orms.

Ill is herehy notified that the \{inister of Ilealth and Child (lare

Iras, in terms of section 6 nl'the l)ange rotls Dnrgs Act llChapter I 5 :(i2l.nrade the fallorving regulations: _*

H4,'RT I

Ihnutr{I}'iAR}'

'{'itle

1. 'f he sL. regulations may be c.ited as the Dangerous Dnres( Prsluction olCannabis f'or lr'{edicinal and Scientific I Tse) Regulations .

2018.

Interpretstion

2. In these regulations -_-'appropriate fee" mealls the fee prescribed in the First

Schedule:

7A2

S"l. 62 of 20ltt

"cannabis" includes fresh or dried cannahis, cannabis oil,cannabis plants ur r'.annabis seeds;

"cannabis oil" means an oil, in liquid form at r(xlmtemperature of 22 * 2"{-1., that contains callnabis in itsnatural fonn;

"cannabis plant" inclr"rdes the rvhole or anli g-rrtion' lvhcthergreen ortlrS, of any plant of the genus cannabis alstknon'n as "lntliern hemp", bhang, camba, dagga, mbanje*r intsangu, hut excludes * -

ta) an!- fibre extracted from the pl;urt for tne as orin the manttf'acture of cardage, canvas or similarproducts; or

ib) an)' seed lvhich has heen cnrshecl' cornnrimrted orothenr,ise pnrc-e ssed in such a manner as to llrei"eutgerminalion; 0r

(c) the fixed oil r-rlrtained frorn the see:d;

"'cannabis resin" means the separated resin, w'hether cruleor purified;

"deIta-9-tetrah)'drocannabinoI" fireaIIs Aq-tetrahyclrocannabinol ({6aR, lOalf)- 6a,,7,8,I 0a-te trah1'dro*6,6,9 - tri nre th,vl -3 - pe nt3,'l -6FI -di be neo [b,d]p)'ran- I -ol);

"dried cannabis" means harl'ested cannabis that has treensubiecterJ to an)" clrying process, but does not incluclcsee ds;

"fbrm" means the appropriate farm set out in the SecondSclieclule ;

"{.resh cannahis" means freshll' han'ested cannabis buds andleaves, lrut does not include plant nnterial that can beused to propagate cannabis;

"licensed producer" means the holder of a licence issuetltunder Parl II;

"medical practitioner" means a person registerecl as sueh intenns of the llealth Professions Act fckupter 27:]91;

703

F

i)artger(.lus l)rugs {Pnrducticln of llannabis {rlr \ledicinal andSr:ientifie Llse) Regulations.. ?(}l I

"pt{xlucti (x} " fi}eans e: ttltivati*n, drying, t: Ktrar:ti on, pac ka gi n g.

labe,lling, storuIle. and processing of cannahis;.'Secrelary"

means the $ecretary' resFonsihle for health;"slte'- nleans *-

{a) a truilcling r}r a place in ft }ruilding used h1, alicensed pnrd$cer; {}r

{h) an arca *ccnpied exclusivell, by buildines risedb)' a licensed prrxlucer.

Applir:urir"tn

3. 'l'hese regulations shall appl.y t* the proeluction of cannahi.intended frrr medicinal or scientific puq]oses.

PART II

Llcnssmc or Srrrs axn PliRsoxs

Appliration for produrer\ licence

4. ( l)An application furthe issue of a licence in temrs of -<ectrirn2? of the Act shall be made to the N{inister, in duplicate and shall bt,

accompanied by-(a) the appmrpriate fee;

(b) three copies ol'a plan of the site proposed to tre licenscdwhich shall comply with the requirement specitied rnthese regglations;

(c) in the case of an individual, proof of citizenship or prtxrfof beingordinarilyresident inZimbabrve or proof of anexemption by the N{inister;

(d) in the case of a company, proof of citizenship or prurfof being ordinarily resident in Zirnbabrve of the majoritlof directors orproof of anexemption by the N{inister andpruof of inccrporation in Zimbabrve of the compan\:and

(e) a declaration, signed and dated by the proposedauthorised person in charge, stating that the prt'rposedauthorised perscln in charge. the proposed rcsponsible

7r)4

S.l. 62 *l- 201t-l

persclrt iu charg* and, if applic:atrle, the pr*poser.liiltcmate resp$nsible persorl in charge are f amiliar u,itlrthe ;lrcvisious *t the Aet.

i2)"[']re application shall conlain a detailed description <.rf tl.le

metltod that the appiicallt prop)se s to tme fur keeping recorcls,, n'hichstrall permlt-

{a} contpliance with the r"equirements of Part VI,

itti the lUinister t* aur,lit the activities o{ the licerrsedproducer q'ith respect to cannabis; and

{c} the rec*nciliiltion of'*rders f cr cannabis and shipmentsancl inl'entr:ries rlf cennahis"

t3) T'he application shall also conlain the fr:lk:ning--

{a) if applicable, the nmximum quantitp' ex,plessetl as thenet rveighl in granrs of. lrcsh cannabis, clried cannahis.cannahis nil tc he pnrdur;erJ b1' the applicant uncler thelicence and 1|1s praductiern period;

(b) if- applicable,, the marimu{n quantitv expressed as thenet rveight in 6 grarns of fresh cannahis, elried camrabis,cannabis oil ancl carutabis seeds to be so{ti or providedb1,' the applicant under thc licence arrd the pericxl inr,vhich tlrat quarrtity is to be sold or providetl; and

(c) if applicahle, the maximum numtrer cf cannabis plarrtstei he sald ar provirJed hy the applicanl under fhe licenceand th* period in which that quantity is to bre sok! ol'proviclerS.

(4) An application rnacle in terms of subsection ( tr ) shall be

accotltparrietl h)'a securitl,clearunce refeffecl ta in the "fhirtl Schednle.f*r the follow'ing pers*ns *

(a) the authorised 1xnion irr charge;

{b} the respansitrle prenern in charge;

(c) it"applicatrle, the alterna{e re$pCIr}sible pers$n in charre;

(di if a pnrducer's licence is applitd for by an individutl,that indiviclu,al. and

705

Dangelotis tr)rugs (Pruduction ol Cannabis lor \feelic-inal anclScientific Lise) Re gulations, ?018

{e} ii'a prcxiucer's licence is appliecl ftrr hy a compan},, eachaflicer and director of the cnlnpany.

i5) In the case of an application firr a licence tr: seil or prr:r,idefresh carurabis or carutatlis oil under, the applicant shall prot'iele theh'finiste r, before commencing to sell or prcvide tlre suhstance, g,ittrthe clried cannahis equivalency factcr determirred uneler secti1;n T3antl the method that thel' used to deternrine it"

(6) If the applicant intenrls to p$ssess. prr:duce, sell, prol ide..ship., delil'er transporf ar tlestro] caru]ahis at rnr:lre than ()lte site . rr

separate application shall be sutrmittecl for each proposed site .

(7) An applicatiolt made in terms of subsectiorl ( I ) shall-(a) be signed and dated by the lrroposed authorised pers(-)rl

in charge; and

(h) include a statement signed and dated b1' that pers()nindicating that *{i} all of the infi:tmation and clcrcuments submrtted in

snppcrl of the application are correct and completeto the hest cf their knerrvle dge ; and

tiil thel' har,e the authority to bind the applicant.

Autlrorised p€rs{)n in t:h*rge und rcsponsible persop in chrir,qe

5. {1) A licensed producer shall designate-_

(a) {,)t}e authorised person in charge to have o}'erallresponsibility for management of the activitiesconducted hy the licensed praducer nnder their licenceat their site r,vho ma), if apprapriate, tre the licenseclproducer; anrJ

(b) ofle lesponsihle person in charse to wcrk at the licenseclproducer's site and have responsibility for supen'isinsthe activities lvith reslrcct to cannabis conductetl b}the licenserl producer under their licence at tfuat site:and for ensurins that the activities comply rvith the Actand these regulations u'ho nmli, if apprclpriate, be theaufhorised person in charge.

7{h

S.l. 62 of 2018

(2) A licensed producer ma,v de signate one or mrlre altemate:

responsihle pers{}ns in charge {cl rvcrk at the licensecl producer's siteanel have authority ta replace the responsible person in charse rvhen

that person is absent.

{*1) 'Ihe authorised persr}ll in charge ., the resporlsitrle persollin charge and, if applicable, the altemate respansible p$rson in chargei

shall hei familiar lvith the provisions ol'the Act and its re gulations.

f"ssusnre oy lirenre

6. Suhject to section ?, the ltlinister strall, after eramining thcapplication nnder section;l issne to the applicant a proclucer's licencetha.t indicate s -

(a) the licence nnrnher,

(b) the name eif the licencn holder;

(c) the list of authorise d activities;

{d} the address of the site anel, if applicable. of eACh buildingrvithin the site rvhere thr: Iicensed producer ma)'conductthe authorisecl act iv ities ;

(e) in respect of each huilcling" the autlxrrisetl activitiesthat may be conducted at that building and., in respectof each activitl,', the substailces in respect of w'hich theactivity me)' be contluctecl;

{l} the security le','el, determined in acccrdance with thesecurity requirements, of each locaticn lvithin the sitewhere cannabis is stored;

{S) the elfective date of the licence;

(h) lhe expiry clate ol tlre licence;

(i) any conclitions that the licence holclcr shall meet in order{o-*

ti) complv u'ith any international obligations andany other obligations that may be inrp*sed by theIttinister fronr time to tinre;

(ii) provide the security level referred to in paragraph(il;

747

Dangenlus ilrrrgs {}:'rrxlucticn cif {lannabis lcr i\{edicinal antlScientilic tlse) Resulalions, ?f) I [t

{iii) put in place the securitv rneasilft:s referred to inFart IItr; or

{ivi reduce nn}' palential puhlic health. safet3' {}rsecuntl' risk- inclucling the risk of cannabis beingdiverled to an illicit market otr rrs*.

t}round,s flsr re ffusul

?. 'I'he h{inister shall refuse to issue. renew or amend a pnxhrcer'slicence in the f ollorving circumstances-*

{a} the applicant is not eligihle under secticrr 4:

{fr) the requirenrents of sectiurr I I havs nrrt treen me t;

(c) an inspect$r, n'hc has requesteil an inspection, has not

been given the opportunitS' hy the applicant to conducian inspecti*n;

td) thc ii,{inister has reasor}ahle grounds to believe thatfalse or misleading infonnaticn rvas submittetl in. orfalse or ialsilied documents were submitted n'ilh, tlteapplicatiort;

{e) information received from a peace officer, a con}petentauthority ()r the tinitecl Nati*ns raises reasouahlegrounds to he lie ve that the applicant has been irtvolr ed

in the rJiversion of a controlleel substance or precursorto an illieit rnarkct or ilse l

i0 the applicant d*es not have in place the securitrnreasrrres set out in the Part III in respect of an activitl'for rvhich the lieence is sought;

(S) the applicant is in contraventir:rn cf or has contraveuedin the past 10 years -(i) a prcvision of ths ;\ct or these regulations; ol

(ii) a ternr or cr)nrJitir:rr tf anothsr licence or a pernritissned to it under any other Act;

{h} the issuancs. renerval or ail€udment *f the lice nce islikeil'to creat6' a risk to public henlth, saf ety or securitl',including the rish of cannabis heing dir,'e rteel to an illicitmarket or use;

708

b/

S.I. fr2 ol' 301 H

{i) an}' of the fallolving pers(}r}s cloes not lnlkl a securit3'clearance -ii) the authcrrised pers$tl in chargc:

{ii} ths resp*nsihle person in charge;

{iii) if applicable, the alternate responsible person incharge ;

(iv) il"tlit: applicatlt is ap indir,itlual" Ihat inclivitl'al;and

(r') if the applicant is a eCImpan), ail-1, of its of ficersor rlirectors;

ti) the prupcsed mpthnd *t recoril keeping deies ft*t meetthe requirernents of section 65; or

{k} if applicatrle, the iuftirnration required under se ction t 6has not heen provicled or is insutEcient tc prrxess theaPplication.

{}urarion o.f lkenr*

8" A pruJucer's licencer issued by the \,{inister in tcrms ofsectiotr 6 shall he valirJ f rr a pe ri*tl *f live years ancl ffiaJ* tre reneu'edthererafter before its expiry.

ili s pltt.v o.f li c6 yls s

9. ( I t Sufrjcct to suhsectian (2), a holder of'a pruluc*r's lice ncer

shall eltsure that his or her licence is conspir:n*usly clisplaS'ed at alltirrrcs orl the licensed site t* rvhich they relate.

tzj Subsection (1) shall not apply in respect o* anv perit-xlduring w'hich tlie licence is necessarill' r€rnoved fronr the licenseelsitc concefite d f or ttre prrrposes cf doing anything in terms af the ;\ctor fcrr alt)' other law,firl purpose the pruof whercof, in anv $)l{}ceedingsrrgainst anl' person fbr contraventian af,sutrsection { I }, shall lirr *ponthat person,

{}rodur{ion a,nd return of {iceflc€

10. { 1) Wher}sver ttre h{inister*-

ta) cancels ail!' Iicenee; rlr

709

[]angerous Drugs (Praduction ilf {,lannahis ibr \,ledicinal andScientific Lise) Regulatir;ns, 20 I I

{h} v;lries {}r arulendrs the conditions of any licence; or(c) impcses ilel\'conditicxrs on the renerval of an), licence;

the I'tittister shall requesf the holcler of the licenee tc pnxluce suchlicence rvithin such period as he or she may specify and the lxrlderthereof shall procluce such licence rvithin the specilied perirxl.

{?) An} }}erson who tails to cornply r,vith a request in tcmtsot'subsection {1} shall be guiltl'of an offence and liable to a finer notexcer(ling level 6 or to irnprisonrnent ftrr a perirxt not exceerJing olte

)rear or to both such fine and such imprisCInment.

(3) Whettel'er the h'{inister varies, amends or imposes an\nelv conelitions on an) lice,nce, the N{inister shall return such licencccluly entlorseel to the holder thereof.

Applir:ation fo, t,sriation or ttmendwtent of u lkenre

I I. ( 1) A licensed prr:ducer proposing to amend the contentof tris or her licence :;hall pmvide the h{inister r,r,'ith the lollon'ingtlocuments -

(a) ail application in rvriting describing the proposedamendfitetrlt* as $'ell as anv infonnaticu or documentsmentione d in secti*n .l that are relevant to the proposedanrenclment;

{b} if applicahle. a declaration signed and dated by theauthorised person in charge stating that the notices tolccal authorities have been provided and spec:ifyingthe names, titles and acldresses ol'the senior oilicials tcr

rvham they were addressed and the dates on lvhich the 5'triere provided, together with a copl of each notice; and

(c) a copy of tlre original licence .

(2) The application shall-(a) be signed and &ated b5'the authorised penion irr charge;

and

{b} include a statement signed and dated by that persr)r}indicating that all of the inlorrnation and docnments

71*

S.l. 6? of 2018

submitted in suppext of the application are c(-lrrect andccmple te to thc best of his r-rr her kuau'lcdge.

{3) Sut{ect tr: section ?" the h{inister shall, alier erarniningttre iulurunation anrl docunrcnts reqnircd uur{er this l;ectiqrn and- il"applicable, secticn 16, amend the licence ac*ordingly' and ma)'adCanY canditicns that the licence holder shall mcet in order to--

{a} ccrnply u'ith an}' inte rnaticnal obligati*ns;

ibi provirle the securitl' level referred to in secticn {:{f} orthe nen, le vel applicable as a resnlt of the, amendnrentof' the licence:

(c) prit in place the security nreasures rsfcnecl to ilr PartIII; or

{tt} reduce any patential public health, safety or securityrisk, inclnding th* risk r:f cannabis txing diveficrd tcr

an illicit market tlr use"

Nrs{irc to ldirusler on chunge o{ {-,rsrs*nnel

12. {li A licensed;:rudncer shall*_

{a} ftppl,v for ancl ubtain the h'{inistsr's approval befitrernaking a change invoh'ing the replacement or theaddifion cf-{i} the authorised p€rson in charge;

{ii} the resprnsitde peman in charge and, if appliuahle ^

the altemate resglnsible per$oil in charge ;

{iii) if applicilble, an of{icer or director re ferrerJ to inseetion a(2Xd); or

{iv) an individual authorised to place an order I'rlrcannabis on tlehalf r>l- the licensed prr:d$cer;

tb) exccpt in the case referred to in sutrsec{ion {3), nlrtifl'the N,{iuister, nat later than tive da}s after the eveilt,u'hen a person referretl tc in section 5 ceases to c;tn),'ont their rJuties; and

{c) notifi the S,{inister, nct later than five clavs after theevent, when a person referrecl to in sectian 4{lxd}ceases to b* an officer r-rr directr:r.

?il

I)angerous Drugs (Irnrduction erf Cannahis lor h{edicrinal andScientific Llse) Regulations, 20lB

(2) f'he licensed proclucer s]rall, rvith the application for'appr{}\.'al referrecl to in subsectiein { I Xa), provide the i\{irrister n'iththe fbllort'ing infcrrmation and documents rvith respect to tl.re s1:\t'pers()rl *-

{a} in the case nf the replacernent of the senior p*rsorlin charge or the responsible perron in charge or thereplacemerrt or addition of an alternate resp{}nsihleperson in charge -{ii the infarmation stated in Farm DDPCI and ljomr

DDP{12; and

{ii) the declaration specified in secticn 4 ( I Xe);

{b} in the case of the replaee menl or acldition ol'an ofliceror clirector. the inf'crmation specified in Forrn DDPC I

ccncenring that person.

{3};\ licensed 1:roducer shall notif 1,'the \{inister not later than

the next htrsiuess da)' if the responsitrle persL)rl in charge ceases tocarr)'out thcir duties and there is no 1xrrsen designated ffs al) altcruateresXlonsiblc persrln in charge.

Notice to ,\,{irtister on vzrious thunges

13. ;t licensed producer shall, u,ithin fil'e days after the change,ncltify tlre h{inister clf an3, chanee to-*

ta) the rnethod used for keeping records:

(b) tlre telepht-rrte number, mobile numher and, if applir:able .

the en'lail adclress;

{c} their site; and

(di if- applicable, each builcling rvithin the site rvhere theactivities are conducted under the licence; or

(e) tlre secudty of'their site. other than a change that affectsthe securitl' level of an,v location lvithin the site rvherecannahis, other than camabis plants, is stored.

Applicatiorc .for renewttl o.f {icence

tr;*. {1) An application tor the renerval of a producer's licenceshall he rnaile bl' a licensed producer and lodged with the h{inister

7t2

\-,

S, t" 62 *f ?018

hefcrre thc erpiry of such licence ilud shall be accompanieit hy thelirlkln'ins * -

iai the apprr4:riate fee; antl

{b) a c{}pv of the arigirral licence; and

te) a cleclaratian signed and dated hy'the aulhoriserJ personin eharge stating tlrat as of the date q:{'the applicatit:nto the best of that flenson's kn*$'ledge the intormationsh*wlt on the pnxlucer's licence as specitiecl in secti*n6{a} to {i) is r:oruect and cornplet€, ancl if applicable"the requirernents t:l sections 1? and 13 have been nret.

i2) Sutrject tc secli*n 7, the htrinister shall, al'ler exandningthe inf arnration and rlor-,urneuts rcquir*d under strbsection ( I ) and"if applicahle, section 1{r, issue a ren€n/ed licence that cclntains theinionnati*n set *ut in section 6{a} tc {i)

{3) tf a lic:ensed pnxluccr submits an application in fernrs cl's*ction I I or 1? together rvith an application in tenus of sutrsectian(l ), the h'{inister may prux:e ss them t*get}rer"

{-{.} Where an apXllicaticn fi"rr the renewal of'a licence has trcenlodged nith ther hfinister, the validity af the licence shatl', u,lrere thcappticaut has nol been given notice eif ttre ren$tval or ref trsal r:l'theapplicati*tt by th* date of ex.piry cf snch licence, r:ontinne afler thedate ol expiry until the decisii:n ol'the lt'{inister on the a1:trrlication isnotified to the applicant by the h,{inister:

Stuteynent {:V slgn ctory of n*tice

15. An applicatitu cr notification rnacle trnder secticn l2 or l-1,rcspective l1', shall -*

{a) be sienecl and dated by the autharised pcrsou in charse;and

{tr) include a statement signed and claterl by that persotlinclicating that *'(i) all in{ornration ancl, if applic:able , docurnents

sutlmitted in supJrort of the application ormrtifiurtiou arc con'ect and complete t* the best*f th*ir know'ledse: anil

713

Dangerous Dnrgs {Pmduction of"Cannahis fcrr \{edicinal and

Scienti{ic t-ise} Regulations, 20II

(ii) thel' have the authority t* bind the licensed

llrocl tlccr.

Annusl returns

16. t li tr:1,ery licensed praclucer shall strhmit to the \tinistet'. at

every anniver*ot-r; of the lir:ence and ulxln payment of aunual rcrtum

fees specifierJ in the First Scheclule ., records of all transetctions n hit'h

are required to be kept in terms of this Act"

iZ) The \4inister rnay prescribe the manner in n'hich re cords

ma), bc submitted to him or he r.

(3) [ivery licensed pnxlucer rvho tails to submit to the \ Iinister

t5e recorr3s by the p€rio,l specilied in suhsection ( I ) shall be liable to

the daily penalty of LIS$500 u'hich shall stop to accnre afier a penGj

of one nronth.

(-l) T'he tr,Iinister rnav suspend the licence {}f a prrxJucer u'hr-r

has taile,J to submit the records rvithin the one month referrecl to iil

subsection (-l):

Provided that_*

{i) belore suspending the licence, the lltinister shall invite

ttre prodtlcer to make representations;

(ii) the suspension of the licence shall not prevent the

lv{inister from instituting a ctairn for the recol'en/ ofr,rutstanding daily penalties rvhich ma)' trave accnrer,l

in terms of sntrsection (3).

(5) Ugrn consid*ring the evidetrce n'hich he or she may have

receiyecl, the ll,Iirrister mav proceed to act in temtrs of sectiott 18 or

section 19-

(6) The lr{inister may require information from the licensed

prrxllcer at an) tirne anel lvhereupon snr;h prrxlucer shall, withitt selrell

r,iays ()r any shofier clr longer perir-xl as the h'{iniste r ma}' fix' submit

such information.

7l+

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S.tr. 62 of 2tll8

T'ernp*rttry; sus pe nsion rtf li c en{: e

17. (1) The l\.{irrister ma}'in the public interest require thetemprrar,\' suspension of a licence fcrr such period as he or she rna\,'detemrine.

(2) Where the f'{inister suspcnds a licence in terms tlfsubsection {1}, tre or she shall lorthrvith notify thc licensee of thetr,asons therefcr and call upcln the licencee to sho\4' cause lvhl' thelic'ence should not ire suspendecl.

Reinstaternenf af strs p€nded l ir: e nr e

18. 'Ihe h'finister shall, b)' notice to the lir:ensed producer, re instatea licence, in respect af anl, or all actir,ities cr suhstallces aflected h),the susperrsion, if the licensed pruducer clenronstrates to the \{inisterthat -*

{a} the failure that gat'e rise to thc suspension has beenrectifiecl; or

(bi the suspension lvas unf ounded.

Cnncell(ttion o f lir:ent:€ following sus penston

19. ( 1)'f he h,{inister shall cancel a licence if the lice nsed prulucerfails to cornply rvith the decision of,the L.{inisler to suspend the Iicenceunder section l7 or if the failure that gal'e rise ter the suspension isnot rectifiecl.

(2) The lt'{inisler shall give notice thereof in rvriting to thelicensed prr:ducsr of the intended cancellation.

(3) A notice given in terms of suhsection (2) shall-(a) specify the grounds on rvhich the opinion of the h{inister

is based; and

{b) indicate that the person to rvhom it is directetl nra},lvithin seven days after the receipt thereof submit to thelvfinister any comments he rna)' rvish to put f onvard incorulection with the matte r failure of lvhich the h'linistershall proceed r,vith the cancellation.

?15

Dangerolls Drugs {Produetion of Cannatris tor \tedicinal arrdScienti{ic {.;se} Regulations, 2{}1 I

{ancellcttion on oth€r gr{}ten,ds

?0. T' he \'linister shall cancel a prtxlu$er' s l ieence in" the li:llon'ingcircumstances -*

(ai the lt'trinister ltits reas()nahle grounds to believe that thelicence lvilli issuetl on the hilsis ot- firlse (]r mislcadinginfi:nnation sutrmitted in. or f als€ ilr talsified docunreritssuhrnitted rvith,, the application;

{bi the licensecl prcducer has, since the issuance of thelicence. contraveneti ;r pr{}vision cf the' Act or itsrrgtrlations clr a conditir:n of their licen{re or of an irnpcrtor expril permit issued under this Part,

(c) the licenseel prrxlucer is nt: lt:nger eligible unde r secti*n4,

{d} inlormatian receivcd fi'om an inspector, a competentauthoritl' $r the {inited Nations raises reasonahlegrr-runcls to helievc that the licensed prrxlucer has krcen

involved in the diversi*n of a ccntrollcd substance erprecursor to an illicit market or u$e; or

(e ) any of the lrcrsons re lerrecl to in section 7( l Xi] does nothold a security' cleararlc:q).

Notir:e c;f r"r*s ation af *r'til,l/fes

21 " ( 1) i\ licensed producsr rvho intends to cease conductingactivities at their site, u,hether before or on the expiry af their licenceshall submit to the h{inister a r,r'ritten notice ta that effect at least thirtt,rlay's before ceasing those activities.

{?} A n*tice referre d to in suhsection ( I ) shall be signedancl clatecl hy the licensed producer in charge and shall contain thef ol lou,'i ng inf'arrnation -

{a) tl* expected date of the cessatir:rn ol' activi{ies at thesrte;

tb) a description of the nmnner in lvhich an)' cannabisremaining otr the site a$ of the date relrruecl to inparagraph (a) rvill be dealt r.r'ith tr-v thc licensetlprotlucer, iilcluding .*

716

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S. t, f:i? nl' ?0 l8

{i) if some or ell CIf it w,i}l t}e s$lrj {}r pfi}r'icled toanother licensed prclrhrcer lvhc lr,'ill be conductingactir,ities at the sarn* site, lhe nftrnr: of thatpraducer;

tii) if some *r all r-rf ii rvill be sold srr pr{)r,iclerl t*atroth*r licensed prodncer or a liee nsed elcaler, thename of that pnrclucer and the addrs$is of their sitear the niune of that ele ale, r and the nddrcss of theirpr*mises; and

(iii) ii st:mc or all of it x'ill be destru3,ed, the clate anr,vhich and the locati*n rrt l*'hich the tlestnicti*nis to take place.

{c} the addr*ss *l- the location :rt u'hich the iicensedpraclucer's records, books, electronic data and ctherdacuments will be kept atter activities hav$ ceased; ancl

(d) the name., address" tclephone nurnher' rncbile rrurntrerancl. if applicable , the email adclress of a pe rson n'hculthe lttinister may contact firr further inl*nnation ;rfte ractivities have ceased"

i3) After haviug ci,asecl the activitie s. the licensed pr*rolucershall suhmit to the fotinister & eletailecl ulxlate of the inftrrmatiorrreferred to in paragraphs (3Xai to {d), if it differs f rom what r,vas setorfi in the notice subrritted under suhsecticn ( ti and such update shallbe signed and clated tr1. the licensed producrlr in charge.

(4) If the activities cease hefore the expiry of the licence.the liccnsed produeer shall retrirn to the lv{inister the original of thelicence ancl the htinister shall then revoke the licence.

PAR'I" III

Spcrizury MriASr-iRES

Part A*Ferimeter of Site

t-:ompl[*nce u:ith seruritv nw*sur€s

3?" A licensed prexJucsr shall ensrtre that the securit-v rrlfifr$uresset out in ttris Part are carried out.

7fi

f)ange r:tlns Dnrgs {Production of (lannabis tor fufe dlcinal and

Scientific t.ise) Regulations, 2018

U tt tt u t lt o r i s r: d {/{:re.ts

23. r\ licensed producetr's site shall be designed in a manner that

Flrevents unattthorised acce ss"

Visua{ m*nitoring af the perimetcr oJ site

24. { 1} The perimeter of the licensed producer's site shall he

visgall,v monitcred at all tintes by visual recorrling devices to deteet

any attempted ar actual unauthorised atreess.

(2)'fhe devices nef-errecl to in suhsection (1) shall, in the

conditions under rvhich theS,are ussd, be capable of making a visible

recording of any attempted or actual unauthorise,J access.

{ntrusion detectiott systern o.f the perimeter o.f site

?5. The pe rirneter of the licensed producer's site shall be secttrecl

by means of an intrusicnde tection syste mthat operates at all tirnes aird

that allorvs fcrr the cletection *f any attempted or actttal unautlrorised

acce ss to 6r {no!'el}lent in the site or tampering rvith the s1-stenr.

il,forzitoring b-V personnel of the periwteter o.f site

2{t.{ 1) The intrusion detection system shall tre nronitoretl at all

times by perscnnel rq,ho shall determine the appropriate steps to be

taken in response to the detection of an-y {}ccun'ence referred to insection ?4 or 25.

(2t If any such occurrence is detected, the peilsonnel shall

make a recorcl of'-.(a) the date and time of the occurrence; arid

(b) thc measures taken in respoils€ to it and the date antl

time s,hen theS' were taken.

Part B-Areas where Cannabis is handled

Restrir:ted ilccess

n.{ 1},'\ccess to arcas r,l'ithin a site rvhere cannabis is present

shall tre restricted to persons rvhose presence in thase areas is required

b_v the ir rvork resflonsibilities.

?18

\-

S. t. {r? of 201 I

1?; 'I'he respcnsihle person in charge or, if applicahle, thealternate responsible persoil irr charge shall be phl'sicall,v presentrvhile other pers{Jns are in those areas.

(3) A rec*rd shall be made ol= the identit)' of e\,'er\' Irersotlcntering or eriting those areas.

Pltvsiral harriers

38. A holde,r of a prodncer's licence shall include, physicalharricrs that prevent unauthorised access lvithin a site x'he re cannabisis presenl.

Visunl h'Iottitoring

?9. { I ) A holder of a protlucer's licence shall ensure that areasn'ttere cannat:is is present are visually mtrnitored at all tirnes bv visualreccrding devices to detect illicit eonduct.

{2)'fhe clevices referretl to in subsection {1) shall, in theconditions under r,vhich thel' are used, be capable of rnaking a visihlerecorcling of illicit conduct.

Intrusi on de tertioyt sVstent

30. A licensed praclucer shall ensure that areas w'h.ere cannabisis present are secttred by means of an intrusion detection s1'stemthat opemtes at all times and that allorvs for the detection ol'an)'attempted or actual unauthorised acr:ess to or nrovement in thoseareas or tampering rn'ith the system.

F iltrntion of cdr

31. A licensed producer shall ensure that arees lvhere cannahisis present are equipped lvith a system that filters air to prevent theescape of odours and, if prese rtrt, pollen.

d,Io nitrsring b1t pe rs onne I

32. ( 1) 'Ihe intrusioil cletection system referred to in section3t) shall be rnonitared at all tirnEs bv personnel rvho shall deternrinethe appropriate steps to be taken in response to the detection of an_v

occtrffence referecl tr: in section 29 or 30.

719

flalrgerorrs llnrgs {Prudur:tiott of Canrrabis lor h{ediciual artd

Scientilic t,ise) Reg*latiotrs" 20II

t?) If an3, such occurrcnce is cletected., the persomel shall

make a rccortl af"*(ai lhe date anrj tinre ol the occunence; and

{b} the rneasures taken in response to it and the date atrd

time rvhen thev lvers.

PATTT IV

{-if_*'f.,,gl C OXDIT.IO5_ S *t, pRol}t i {:f"ir. )j.\i

{}ood produrti*n prutti ttts

33. {ti A licensed prcrrJucer slrall ensure that standard cperatingprocedures are developed aud implemented tor all *tctivities tluringprrrduction of ca nnatris.

{'2) T.he prccedures referred t* in sutrsection ( I } shall be

in accurdarrce rt'ith the Gocd Agricnltural Practices antl {ioodlr{anufact urins Fractice s.

C ult iv rttir"t n oJ' t: rtnn*bi,Y

3-t. GoadAgricultural Practices shall lrc applied in the cultivalionof cannahis. as rJeterminecl by the lr,linistry responsihle l-oragriculttrre .

.lcrfJ and ferflllsgru

35. { t } Cilnrratris shall be grown on sail not ccrltaminated r+'ith

sluclg*, heariy nretals, lrcsticide residues or nther ctrenricals.

t?) The chenricels and cluantities used far prr:xJuctior shall

be justifierJ.

{3) htonitorirrg of soil contaminaticn shall be prerformed artd

repr:rted on.

(.t) ir'lanttre apptied shall be thcrnughly comFl*sted and shall

devoid of hunran f aecc,s,

{5) Fertiliser$ shall tre used in suctr a rvay that leaching is

reduced to a lr'{inimunn level.

120

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S.l" 6? of 2018

I rri gation

36. { 1} Inigation shall be ccurtrqrlled ta ensure qualitl'cultir,'aticxrtll' the camatris lllant.

tT,j'l"he qualitS' of the irrigaticxl n'ater shall tre c*nlrollerlt* ensure minirnlrrn ccutaminants, including faeces, heilvy metals"herbicide, pesticides and toxieologically hazarrJous snbstances.

(3i All tillage operati*ns shall be ad;rptect ta plant grortth andreqtiirenrents.

P tr s I r-": {t n { r*l p ro duc:f"s

"i7. ( I ,} Frt: sh or dried ca.nnabis rlr camabis plants $tr seedsshall not be treirterJ n'ith a pest contr*l pruluct unless the ptxlur:t isautht-rt'ised or registerecl for tme under the Plant f]ests and l)iseases,tcrt fChapter I S;O.9J ar is othenvise autharised fcr use unrle r that :\ct.

(?) 'fhe u$e of herhicidts ancl pesticides shall he avoicled as

far as pcssihle ,

Fiarve sting

38. {iood han'esting practices rvith epprupriate prccedures.as determinecl bi,' the h{inistry rcsponsihle for agriculture shall betollorved to ensure that the apprtrpriate quality proeluct is erhtainerllor the interrde+J nse"

Drying

3$. { t } A licensed prcxluc$r shall ensure that there is a unilornrdrf ing speerJof the orops and preventitxt of-mould gror'r,th t y applS'iugappropriate illeasurc s.

(2) In c&ries rvhere c-annahis is ctried in open ftir. the cannabisshall lx spread in a thic lay'er' to ensurc Socxl air circulaticn *f theclrying rakes placecl at suf'licient distance from the drying surface.

{3} \\ihere camatris is not dried in opn air optirrral clryingcouelitiotts" i.e. temperature aucl dry,'ing tirne shall be follolved andrecrlrdecl"

771

l)angerous Dnrgs (Prrxluctian of {]annabis {br l,tedicinal andScientific I"ise) Regulations. ?01 S

h'fi t- rrshi*l und. r:hemit fil (e ntumi nu rcts

-fi1. The nricrcbial and chenrical contarninants of f resh or driedcannahis ur cannabis oil shall he rvithin ge nerally accepted tolerallr:slinrits for herbal rnedicines fklr hlrman cLlnsumptir:n.

Di si nt€ grilti on of c apsules

41. A capsule or similar dosage fann of cannabis oil that isintemled to be sw,allorved rvhole or usecl as a supllositorl' shall nreetthe rs:quirenrents of a disintegration terst that is applicahle to thef ormulation of the cnpsule or sirnilar dosage form.

h{rtriwum ltie{d qucntir}- ronnuhis oil

#,. { I } Cannabis oil strall not e xceed a nraximunt yield quantitrof 30 mg of clelta-9-tetrahy'drocannatrinol per millilitrc of the oil inthe immecliate container, taking into account the potential to cortveficle l ta -9-t etra h vdrrx amahi nol ic ac i d i nta dc lta -q- te t ra hvdrrx an na bi no l .

(2) If cannabis qril is in a capsule q:rr sintilar dosage tirnn,each capsule or unit ol-the dosage frrrm shall not erceed a marilnum,vield qu,antitf *f 10 nrg of clelta-9-tetrahydrocarrnabinol, taking intoaccount ttre potential to convert delta-9-tetrahydrocannabinolic acidi nto delta -9-te tra hl'd rocannabi nol.

J

Solvents

43. {lannabis *il shall not contain residues of solvents oiherthan Class 3 solvents listed in the {iuidance Document-Impurities"Guideline fcrr Residual Solvents, ICI{ "Iopic Q3{l(R5), as amencledfrom time to tirnc.

(2) Thoss rcsidues shall not exceecl tlre limils estahlishedunder that document.

Anttllttic{tl testing

*{. Analy'tical testing for the fcrllor,ving shall be conductecl usingvalidated methods-

{a) ttre disintegration referred to in section 41;(b) the resirjues of solr'ents ref-errecl to in section -13; and

722

S.I. 62 of 2018

{c} {he cont*nt nf delta-9-tetrahyelrocannabinol, clelta-9-tetratrr3,'drncannabinolic acid, c;rnnahidiol anclcannahidiolic acid"

Pren$ ses

45. {l) Fresh or drted cannabis, cannabis oil or cannabis plantsor seecls shall lre p.r*duced, packagetl. lakrclled and stored in prernisesthat are dcsigned, constructerJnnrJ maintained ina illannerthat permitsth*se actil'ities to be condttcted uncier sanitarl' c*nditions" ancl inparticular that --

(a) perrnits the premises [o tre kept c'lean antl orderl-v;

(h) permits the effrctive cleaning ol all surfaces in thepremlses;

{c) permits. the substance to he s{orecl r}r pru}cessetlappropdatelr';

(d) preverfs the cantanrjnation of the substan,ce; ancl

{e } pltt'ents the additi*n rrf an extrar}eon$ substance ta thesuhstance.

{?} '['he substar]scs refered to in subseciion { 1) shall be storcd

under cr:nditions that w'iil maintain their quality.

iiquipw?€nt

-16. Fresh or drieti cannahis, cannatris e;il or cannabis plan{s orseeds s hall be prrxluced, packaged. latrelled and stored us ing equipmentthat is designerl, ccnstntctecf

" nxrintainetl. operated ancl arranged in a

manner that-*

{a) permits the eff'ective cleaning of its surfaces;

ih) permits it to functicn in accordance rvith its intenrleduse;

{ci prev$Irts the c*ntamination of the subs{ance; and

(tJ) prevents the addition of ;rn extraneorl! substance to thesubstarlce.

72:3

Ilangcrrous llnrgs {Production of f,lannabis frrr- h{edicinal antlScientific Lise) Regulations, 201 I

S ttni t nti tt n p rd) gr {tftt

g. F;resh or clried cannabis" cannabis oil or cannatris plants orseeds shall be produced, packagecl, labelled and stored in accordanr:elvith a sanitation prograrn that sets out ---

{ai procedure$ Ior effectively cleanine the prendses inrvhich fhose activities are condncled;

(b) procedures f cr effectil'ely cleaning the equiprneint usedin those activities;

(c) procedures for trandling an!' sul,rstance used in thoseactivities, and

(d) all requirements, in respect nf the healtlr, h)'gienichehar,'io$r and clothing of the personnel rvh* areinvolved in those activities, tlrat are necessary'to ensuretlrat those actil'ities atrc contlucted in sanitary canditians"

Stctrcdsrtl o perating pror edure s

-lll. Fresh $r drier$ cannabis, cannabis oil or cannabis plants orseeds shall be produced, packaged, labelled ancl stored in accorclancelvith stanr3ard operating procedures that are designed to ensure thatthose actir,ities are conductecl in accnrdance rvith the requirenrentsof this Part.

Recttll

49. ( 1) A licensed producer shall establish and maintain a systenlof contrrrl that perrnits the rapid and eomplete rccall of evsry klt orbatch of lresh or dried cannabis, cannabis oil ar camabis plants orseeds thnt has been matle available fcrr sell"

{2} The prooedure tor recall shall be in accorrJance lvith theprovisions set out in the Ilourth schedule.

Rer:a{l reporting

50. IJefore coffunencing a rer:all of lresh cir drisd cannabis,cannabis q.ril or cannabis plants or seeds, fl licensed proclucer shallprcvide the h4inister w'ith the fallarving inforrnation in respect of thesuhstarlce to he recalled---

721

S.l. 6? cf-20tti

(a) its hrand nanre;

{b} the numher cf each k:t ar batch to trc recalled,

{c} if kn*w'n tr}'the licensertr prcxlucer. tlre ilame antl addrcssof each licenser,S prclrlucer rvho import*d r.rr 1:roducerl&ny of it;

{d) the rcasons ftir cornmencing the rccall;

{e} the quantity that rvas prcdur-,etl or impor{eel intoZimhahq'e h3' the licensed prodrrcer,

{D the quantitv that tvas scld or provicled in Zimhahrt'e h1,

the licensed pru:clucer;

{S} the quantity rctnaining in ttrle pCIssession a['the lice nsedpxxtrncer;

{h} the nnnrher of pe rsons to rvhom it \\'as s*lcl or ptovidedb1'the licensed prodrnrer; ancl

(i) il +Jescription of' arry r:ther actiqx that tlle licenseclpnxlucer is taking irr respect q"rl'tlle recall.

Quulitv {rs.t}c r{rnce

51. {l),{ licensed produccr shall ernplo,v a qualit,v assufiincepsrson w.ho-*

{a) is respor}sitrle fr:r assuring the quality of the liesh crclried cannabis, cannahis oil or cfinilabis plan{s or seedstreforc they are made ar.ailablel frlr sale, and

(b) ltas the training, experience arnd technical knarvleclgerelating to the activitl, conductecl ancl the reqnirementsof ttris Part; and

(c.} investigates e!'er)' ci:mplaint receivecl in respect ofthe qmlity of those substances and, if necessar3,, takescorrective and pret sntative rneasures"

(?) The substances shall be produced, packagecl, labelledand sfurer3 using rnethorls ancl procedures that, prior to theirimplementation, hat,e been approved tr.v a quality assnrarrce p€rson.

t3) I-iven batch of the substances shall be apploved hv aqrurlity assurance person beft.rre it is made availahle for sell.

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Darige rt)url Drugs {Pnreluction of Cannahis for \,{edicinal andSc'ientific [Ise) Regulations, 2018

{4} Any ol'fresh cr dried cannabis, cannabis oil. or cannabis

ltlant or seecls that are sold or pror,idetl and suhsequenlly returne d tottrc licensed proclnce r shall not be resold or provicled again.

s2 ( r ) s urriecr,,,:fi'j':flff

":::-r*,nisrer

has reascl*ahregtounds to helieve that & lct or batch cf fresh or dried cannahis,cannabis qlil or cannabis plants or seeds macle available for sale orprovision b]' a licensed prcrclucer, ma), h,v reasoil of' the manner inr+'hich the suhstance was pr*duced, packaged, labelled or stored,

frtlse a risk to the health of a person n'ho obtains the substance fbrthcir otvn medical puryrclsesl the lr,{inister ma} require the licensedprulucer to prol'ide the h,'Iinister rvith a sample af that lot or hatch"

t2) A sample referred ta in subser:tion ( I ) shall be of"sufficientquantitl,' to enabler a deteruninatian of w'hethe r the lot or batch mcets

the requirements of sectious ff and ;ll antl, il'applicable. sections,+2,43 and *{,

(-li T'he h{inister shall not tequire a sanlple to be provided ifnrore than one y'ear has elapsed af ter the erpiry date or prof ision of'

any portion of the batch.

pgRl- vPecx..\GL.\rG. L,tBnu-Ii\iG Ahr) Srrpruxc

Puckugirtg

53. ( I ) A lice nsed producer rvlro sells or provieles fresh or driedcannnbis or cannahis CIil shall ensure that -*

{a} the substance is packaged in an immediate container-

{i) that is in direct contact lvith the substance or, in ttrecase of a substance in a capsule or sirnilar dosagefcrrm, that is in clirect contact u'ith the capsules ornnits of that closage form;

(ii) nT, il-J,:-',::jruHrfrffi ::;J;-*iff:-

(iii) that has a sectu'it1' feature that provides reasonable

726

S.l. 6? of 2018

assutance to consumers that the container has ncltbeen opened prior to receipt; and

{ir') that is a child resistant packaee,

ancl

(b) not more than the equivalent of 30g of <Iried cannabisis in the immecliate container.

(2) A licensed p*rhlcer who sells or prof ides cannabis seedsshall eilsurc that the1, are packaged in a container that *.

(a) is in direct contact r,r,'ith the seeds;

(h) keeps them dry and prevents their cantarnination; and

(r.) has a security feature that provides rcasonahle assurallceto consurrcrs that the container has not been openedprior to receipt.

(3) A licensed prrxlucer who sells or provide s cermatris plantsshall ensure that the3' are sold or provided in a package that has asecuritl' feature that provides reasonable assurance tcl consumers thatthe package has not been openetl prior to receipt.

Ar:cur*c1* 0f weight

5+. { I } ;\ licensed pr:ducer who sells or provicles f resh ordried canuabis or cannatris cil shall ensure that the net u'right of thesubstanee in the imrnediate cnntainer is not less than 954c, and notrurore than 105trc of the net rveight specified on the label in accardarlcew'ith section 56.

{2} A licensecl producer rvha sells or provides cannabis ailshall ensure that the rret t'olnme of the oil in the irnmediate containeris ru:t less than 959c and not more than 105% of the net volnmespecilied on the label in accofflance lvith section 56.

{3i;\ license d pr*ducer rvlrcr sells or provide s cannahis eril ine capsule ar similar elasage frlrm shall ensure that number of capsulesor units in the container is the same as the number specified on thelahel in accorclance rvith section 56.

727

Dange rotili llr:lgs {}}roductior-r of {lannahis ft:r h{eclieinal andScientifir, LIse) Regulat iqrns, ?0 I S

{-$} A licensed proelucer w{ro sells trr pr{}vicie s cannahis se*clsshall ens*re ttrat the ilurntrcr <lf seeqls in the immediat* containe r is thesame as the numher specified cn the label in accorctrance rvith sectirxi57.

Accurc{r} twt trut?tber *f plttnts

55. i\ licensed prcrJucer who sells rlr provirJes cannabis plantsshall ensult that the eract number of plants in the package referredto in sectian 5:3{3} is indicateel on the package.

{trr;ri,ttct lnl;e{ for *ann*hl's {}r utnntthis pil

"56. {t} tn this secticn-n'tr['.trv''

mgan$ weight in weight.

{?) A licenserJ producer rvho sells or provieles ftesh ar driedcannabis or camatris oil shell ensurc that a lahel that r:antaius thelbllorving infcru*ution antl the informaliqrn set nut in subsection (3).

{4} or {5), as applicahle- is aflrxerJ to the inrnrediate containcr-

{a) the narne, telephone numtrer, phy'sical and ernail addre ss

of the licensed prulucer;(h) the lvorrls "[::re$h cannahis", "l)ried cannabis" or

"l-arrnabis oil" {or the equivalent term'-{lannahis oil'"},as applieable;

{ci in respect of the substance in the contain€r-

{i) its brand nanre;

{ii} its batc}r nnmher;

{iii} its recommended stcrage canditions;

{iv} its pac:kaging date; antl

{l') either:A" its expiry clate established in acc*rdance rvith

section 60; or

B, a statement that no expiry date has bet:ncleterunined;

{d) the s1,'mtnl {6\ 11' set out in the upper letl quafier eif thelabel in a colour contrasting rvith the rcst r;f the label

728

\-

S.I. 62 *f 2C118

or in t-l'pe not less than hall'the size ofan), other letterstused on the latrel;

(e ) the lvarning'.K.},1IIPO[I Of, RIjACII OF{-:f ilLDR[i]i"'"

(3) tn the case of f resh or tlried cannabis ., the lahel shall alscr

contain the follolving informati*n in respect of the cannabis in thecontainer_--

(a) its net rveight in gmms;

{b} the percrentage of rJelta-9-tetrahydrocannahinol rv,r1tr,,

follon'ed try the u,ord "delta-9-tetnrh3,drocannatrin*1 ";

{c} the percentage of delta-9-tetrah3,'drocannahinol wi}vthat the caruratris coukJ yield, taking into account thepote ntial to conv ert delta -9-tetra hydrocannabi nol ic ac i di nto delta-9-tetrahydrocannabinol ;

({l) the percsntage of r:annabidiol n'ril', f*llolved hy ther.vord "canuabidiol";

{e) the percentage of cannabidiol rvinr that the cannahiscoulcl y'ield, taking into account the potential to convertcannabidiolic acid into cannabidiol; and

{f} in the case of fresh cannabis, the driecl canrratrisequivalency factcr rletermined nnde r section ?3.

{-t) In the case of cannabis oil that is not sold in a capsuleor similar dosage tbrun, the label shall also contain the follor+'inginforrnatian in respect *f the oil in the container--

{a} its net lveight in emms;

{b} its net volume in millilitres;

{ci the quantity of delta-9-tetrah-vdrocannabinol, inmilli grams per millilitre ;

(d) the quantity of delta-9-tetrahydrocannahinol.in milligrams per millilitre, that the oil cauldyield, taking inta accounl the potential to convefidelta-9-tetrah;,-drocannabinolic acid into delta-g-tctrahydrocannabinol ;

(e) the quantity of canuabidial, in milligrams per rnillilitre;

729

Dangerou$ l")rugs (Prtrduction {:f- Cennahis fkrr hrledicinal andSt:ienti{ic t rse) Regulations, 20 I I

{li the quautitp'' of cannabieli*I, in milligrail}s pernrillilitre ,

that the oil c*ulcl viekJ, takitg into acco$n{ the pltentialto convert cannabidiolic acirl into cannatridicl;

{gi the clrierl canrmhis equival*nr:v l'actor cleterminecl undersectir:rn ?3;

{h} the carrier oil rrqed; and

(i) in the case qrf cannakris cil that is intendeq.l for topir:alrne only, the lvarning "F;{)R'['OPI{:AI- LISE ONI}',D{] li(}l" Il\Cit:ST".

{5i In thcr case of'cannabis oil thirt is scld in a capsitle orsimilar dosage fr:r'ill, the lahel shall alsa contain the follou'inginf ormation in respect ol the cil in the ccntainer*

(a) the *umher of capsulss or units of tlrat dosage fonn;

(t)) the net rveight in grafiLs &s well as the net volume inmillilitres of each capsule tlr unit;

(e) rhe quantity of delta-9-tetrahyclrocannabinol, ittnrilligmms, in each capsule or unit;

{d} the quantity of delta-9-tetrahl'rirocannabinqrl,in rnilligraffis,, that each capsule or unit ctluld

.,vielcl, takiug into accourlt the patential to g1'v111'ort

delta-9-tetrahydrocannahinolic acid into de lta -9-

te t ra hyd rot-- a n na hi nol ;

ie) the quantitl' r:f cannabicliol" in milligrams, in eachcapsule or unit,

{f) the quantity of cannabicliol, in nritrligrarns, that each

capsule or unit could vielcl, taking intn acc{}ur}t the

potential t* convefi cannahidiolic acid into cannahidiol;

tS) the dried cannatris equivatrency factor detenninecl utrrJer

sectian ?3;

(h) the carrier oil used; arrd

(ii in the case clf cannabis cil that is intenrJed tor teipicaluse only, the rt'arning "Ft)R T.OPICi\I- t iSH OhiI j!-.

T}O F{UT INfitrST'''.

73t)

S.I. 6? of 2018

Prrtdutt lrtlxl rtrr r:annuhls sesds

57. A licenseel producer r.vho sells or provides cannabis seedsshall ensure that a lahel that contains the fbllow,ing inf*rnlation isaf fired to the immediate container-

(a) the name, teleph$nc numkr, mcrbile numher, physicaland email arldress of the licensed producer:

(tt) the words "{larurahis seeds";

(c) in re spect of the seecls in the container-(i) the nurnher of seeds;

{ii} therir brand name;

{iii) their batch numher;

(iv) their recornrnendecl storage conditions; and

(r') their packaging date;

and

(tl) the inl-otmation requirecl b"v section 56(2Xd) and {e}.

Produrt lahel fo, utnnsbis plartts

58. i\ licensed producer rvho sells or provirJes cannatris plantsshall ensille that each plant hears a label that contains the lollon'iuginformation_*

(a) the name, telephone nunbeq rnohile number, phl,sicalancl e mail address of the licensed producer;

{b} tlre rvords "Cannabis plant";(c) in respect of the plant--

(i) its trrand name;

(ii) its batch number;

(iii) its packaging date; and

(d) the information required by sectiein 56(2Xd) and {e}.

Frese.ntatictn af information on l*bel

59. ( I i All inftrrmation that is required under section 56 ancl asapplicable, tei appear on a lahel shall be*

731

l]augeruLrs l-]nrgs {Producticn ol- fl;rnnahis l'or h'{ecticinal anel

Scientific tise) Regulafi*ns. ?018

{a} in linglish ilncl an]'otlrer langurge tlrat ffffi-v he apprr.-rved

hy' the h{irrister;

(b) clearl-v- ancl pronrinently display'ed ou ttrte label"

{3} A}l inf*rrnation in a docunrent that is required uncler

section 56 shatl be in trnglish and in any other language that rnal' be

afipruvecl hy tlrc Xtinistcr and readitry tliscernilrle under the custorrmr)'c*nditiqlns of use.

Fixpirv dste

60 t 1] A lir:*nsed prr:rJ$eer shall not include an expiry rJate orl

a lahel ie ferred to in section .s unless--

{a} the licensed pn:ducer has suhrnitted clata to the h'Iinisterthat establishes the stability periad cluring lvhich" ;rftertlre lresh or rJried cantnl:is r:r cannabis oil is packagediu acccr*&urce r.vith section 53 and rvhett it is storedunder its reconunenrjed stora se fonditions ref-erred toin section 57(c)(it');

tb) the substance maintains rt*t less than 80% attrl not nrore

than l20c7r; of its delta-9-tetrahydrocannatrirrol conte ntand cannahidiol c*ntent; ancl

{e,} the rnicrq.rhial and che rnical contantinants ol' thesuhstance rrxrain rvithin the limits ref erred ta in seetion4o; atnd

(d) in the \{inister's opinion the rJata sulrnritted by the

licensed producer meets the requirements *f paragn'lph

{a} and the h'tinister has notilied the prarSucer to thatr: ffe ct.

(?) Iior the puq)oses ol- subsection (l) and section S?(cXir').erpiry d;rte means the date, flxpressed at minimurn as a -vear and

month, that is the end of the stabilit;'* period.

Rqferefice to At:t or regulations

61. It is prohitlited t* include a reference, direct cr inrJirect, tr:the Act or atl)' regulatians madc under the Act on a label of or in anaclvertisemenl fi:r fresh clr driecl cannabis, cannabis oil or cannabis

732

,\F-

S.l. 6? of 2018

plants or seerls unless the rel'erence is a spccilic requirement of eithertlf the ;\ct or thuse resulations.

.!/ruppfng

62. (t ) A licensed procl$cer rvho shitrrs fre sh t-rr t{rieel camabisor cannabis uil to any pers$n shall -*

{a} trilnspr:rt thc substanrrr in onll' onc shiprnent per order;

{b) preparc the package in a mflnner that ensures the securit3'r:f its contents, $ur:h tirat*-(i) it lf ill n*t $pen or pernrit the escape rf"iis corrte nts

during handling and transpofiati*n;

tii) it is scaled so that it cannot he *pened w'ithcut theseal being brurken;

(iii) it pre,r,'ents the escape of cannatris *elour; and

{iv} it prevents its cantents fram being identifieclrn'ithcut it being opened;

(r-) tr$ie a tmnsplrting method that ensures the tracking andsafeke eping ol- the, package durinfi transpar{ation. antl

td) ship it anl-r' tr-r tlre f ollorvitrg adclress -*

ii) in the case of' an authorised recipient rir anincjividrml rvho is reslxlnsible tor that" the slrippingattrdress spe'ci fied; and

{ii} in the case ol any other person, the shippingadclress inclicatecl in the order refcmed to in sectir:rr7t;

ancl

(e) in the case of a client {}r ail individual lr&a is responsitrlefor tha{ client, ship the suhstance in a quar:tity that deiesnol etccecl the equivalent of 150g of dded cannahis.

t?i A licensed pr*clucer rvho ships cannabis seeds to arlyperson re{erred shall -

(a) r:omply t'vith thrl requirements of subsection { 1}{a) to(c); and

7_13

flangerlus ilrugs {}'r*duction uf Cannatlis for \'ledicinal and.Scientific t.ise) Regulatians. 20 1I

(h) ship the package only to the f ollowing-(i) the shipping address indicnted in the order refe rred

to in section 7l: arrrJ

{ii} the arldress of t}re site f cr ttre prr-xluction of cratr-

nabis plants or the site lor the storage cf'cantrabis

that is specified in the person's registration w'ith

the h{inister marje ttnder Parl II.

i3) A licensecl pr*ducer rvho ships cannabis plants to attr

pe rrion shall --(a) prepare the package in a maffrer that etlsures the secttritl

of its cantents, stlch that-*-

(i) it lvill nat opeil or permit the escape r-rl its c'txltents

during handling and transportation;

(ii) it is sealecl so that it canneit be opened w'ithout the

seal being broken; and

(iii) it prevents its coiltents from being identitietlwithaut it heing opened;

(bi use a shipping method relerred to in subsection ( 1){c);

and

{c) ship it to the address refcmed to in subsection (zxb).

(+i A licensed pnrducer r,vho ships calmabis to an)' persotl

shall--_(a) use a shipping method referred to in subsection (lXc);

and

(h) ship it onl1 to the shipping address inclicated in the crderrel"erred to in sec:tion ?1.

Import *nd export

63. A licensed prodrlcer u,ho wishes to irnport or exprrt cannabi s

shall, upon pa_yment of tee s specified in the First Scheelule, submit an

application tc the h,{inister in terms of section 4l of the Dangerous

Drues Regulations. 19?5., published in Rhodesia Gol'ernfllent Noticel111of 1975.

734

\-

S.l. 63 of ztll8

f) e r.g * n s uut h o ri s e tl t o h ttrt cll e c s n nttbi s

C+. {1) ,{ny' of'follor+'ing peffions" ilamel},*_(a) a persolt licenseci fo elo so under the il{edicines ancl

Alliett substances Clontrol Act lChupter l5;oj];(b) an)' p*,lical practitioner, rJental practitir:ner rlr

vetennary srlrgeon;

(ci ail)' pharmaceutical chemist licensed in terms of- theh'ledicine s and Allied Substances Control,{cr lChrtpter/S;ojl or pharmaceutical chemist or other person.*

ti) emplo)'ed in a hospital, clinic, dispensar,v orlike institution atlmirristerecl hy ihe state or hya local authoritS', or in auy other hospital, clinic,clispensarli or like institution approvecl hy' theh,{inister resp{}l}sitrle lor health; or

{ii) emplo}'ed in an1' meclical store of the State:

(d) atryr person in charge of a laboratorv used far thepnrposes of research or instruction and attached to*_(i) a university" a recognised university. college or

*ther educational institution; or(ii) an)' hospital referred to in subparagraph (i) of

paragraph (c);

{e) any analyst employed by the State; or(il anY inspector appointed in tenns of the h{etlicines and

Ailied Substances Control Act fCh*pter ]5;0Jl; or

{g} any other person prescribed by the h{inister reslx}nsibletor justice hy notice in & statutarv instmment afterconsultation rvith the ll.{inister;

may, in that capacity and so far as is necessary firr the practice ore rercise of that pemon's prof ession, ftrnction oremployment^ lar+'f'ullvacquire, lx]ssess and supply, cailnabis.

(2) A qualified ilurse-(a) in ctrarge of a ward, theatre or out*patients' depaflment

in any hospital referred to in subsection { r XcXi}; or

735

llangenlllri tlrug-* (Prrxluction rrf (lannnbis far I{edicinal and

Scientific ['Isei Regulatiotls. ?0 I ll

(h) rvho*(i) is emplo.1,-ed in a silpsrrris*r,v capacity over two

or mtlre wards in an}' h*spital referred to insubsection ( lXclti); and

{ii) has heen appoipted b1 tfue medical prac:titiancr

in cfuarge of the hospital t* he rssptltlsibte at ant'

time for the distribution of Part I schseluted drugs

within the hosPitai;

rn&y,, in that capacit3. and so far as is nel:es$ary fi:r ttre practice o{

tSoi nrlrse -s

lrrnf*r*i.rrr, functiein or emplcyrnent., larvfirllS' ncquire.

aclnrinistet possess and supply a Part I scheduled rJrug.

PAKT VI

Rrrcozu> KripPlxq;

fieiir:rC keeping b-l' lkensed pradLtcers

f;5. t l ) I1rcept in ttre case reterrctl to in section ?0, a licetrsed

prnclucsr rvhn receives cannabis shall reeord the follo$'ing

inlormatitlll'**'

ta) the name of the person frcm rvhom it rvas receivecl;

ttl) thr: arlclress of the site at rvhich it lvas received;

{c) the $ate on r,vhich it was received; and

{d} a1 inclication af which substance \qias received, as $'ell

as the fallawing irrfbrmation-

ti) in the case uf fiesh or dried cannabis ar cannabis

uil, the quantity attd, if applicatrle. bmnd tmlne;

Lir

( ii) in the case of cannahis other than cannabis relerred

ta in subparagraph (i), its quarrtity" tlescription,

iltendetl nse and, if applicable, hrand name.

(?) A licenserl pr*clucer who imports cannabis shall retirin

a copy of't1e explfi perrn:it issued by a c$mpetent authority in the

uotttttn of e rPort.

{3} A licen**ed prottilcer rE ho exp:rts {-:annabis shall retatn

?36

$.1. 62 of ?018

a cop-li of ttie import permit i:*sued h), * c${npetent auttroritt' in thecountrv r-rl- final destination.

{l"er:{}rd ke:e ping h:* *.uthorised p€r.:*ons

f,S. An authorised person shall keep reccxds n,hich strall includethe foll*rving inl ormatian -*-

(a) if applicable. tlrc eiven nailre,, surrulme ancl date of"hirthof ttrc autht:dsed recipie nt lar rvhom the order is placed;

ih) the given name and surnnme *f the individual placinsthe clrder;

{c) the qnantitv, brantl ilame arrd lot number of the fresh ordried cannabis camabis oil or cannabis plants cr seeels

sold ()r pr$vitled:

{d} the dats {}n rt'hich the order t\,'as received;

{e } the *late on rn'hich the suhstance was shipped; and

{f) the address t* u'hiclt the substance tvas shipped.

A,{cnner o.{ kee;tinN recor,Js

{:7 . ( I ) A licensed prcrducer shall ensure that the records,documents and inftrrmatiern referredto in this Part are kept in a rnannerthat rvill enable an audi{ r"rf them to he made in a tirneh' manner anelare a\railahle at their site.

(2) A iir:ensed prodrcer shall retain the records, docunrentsand information for the fcllow'ing periods--

{a} in the case rrf a notit:e that the prodncer is required toprov ide or send under this Part, f or a pericxl of tir,e yearsafier the clay on w'hich the notice is provided or sent;

(h) in the tlasc of infonnation that the prodncer is requirer:ltc record uneler sections 65, and sections 66' 69 and70, for a pericd of five vears attr:r the da3 on rvhich theinfolmation is recordecl;

(c) in the case of tlre visual recardings or the recorcls referretlto in Part III, lclr a period of {ive years after the cla,v cnrvhich the y trvere nrade;

1 ^rrytJ /

Ilangerous L)nrgs tPr"oductrcn of tlannabis ibr h.{edicinal and

Scientific tise) Regulatians, 20lfl

(d) in tlie case of the records demqrnstrating that eaeh batch

of fresh or dried cannabis, cannabis cil or callnahis

plants or seeds, for a periocl of live ,vears after the date:

6f the last sale or provision c-rf any ry:rticn tlf the batch

of fresh or dried camatlis. c.an{lahis tlil or canrrabis

plants {}r seerds;

{e) i11 the case af a clocument for the periffl during rvhich

it is current and for an adtlitional perioti of five Ytlala

af ter the day on lvhich it is replaeect b1'' a new version;

(l) in the case of a docurnent cletailing the description tlfthe ryralifications of the qualit,v assulance persoil ftrr thc

periul cluring r,vhich the quality assulance pe rson acts irt

that capacit.,v and fcrr an additional periotl of five \ ears

after the day on lvhich the persor ceases to clo so;

(g) in the {-rase of the recorcls t:f complaint, tor a period o1-

five )€ars after the da)' otl u'hich the complaint \\'as

recr-rrded,

(h) in the case of the records of any te sting conclucte d b1 or

on behalf of the licenscel trrroducer for a periul o1- frve

)iears atler the date of the last sale or provision of attr

portion of the balch, other than a sale or provisiott lordestructiott;

(i) in the case of the records of the information that the

licensed producer is requireel by section 50 to provicle tcr

the h'finister in respect of recall of cannabis, for a peritxl

of ilve l'ears atter the day on n'hich the substailce \tr'as

recalled;

fi) in the case of the information concerulittg the methfflreferre rl to in section 73, for a periorJ of {i ve years after

the day gn which the infolmation is recorded;

(k) in the case af the records and dosuments refered to in

section ?6, tor a period of five yeaffi after the day on

w'hich the cannabis was destroyed;

tl) in the case of a dacument or record of'a request received

f rtrm a licensing authorit,r', for a pericxl of five )iears after-

\-.

738

S.I. 62 of 2018

the rJay on rvhich the inlormaticil $/as pru)r'ided to thelicensins authcritS'.

(3) A lic:ensed producer shall retain the serious adl'*rsereaction case reptttts and the summar)' repofis ref erred to in section50. respectir,'el3', for a periocl of tvvent\,-fi!'e years efter the ciay orlrvhich they were nrade.

Pre. s erv sti o n o,f re c ords

68. Every licensed proctucer shall keep or ca$se tq) be kept arec.crd ol"snch protluction fcrr a period of fiye vears ancl sfuall presen,esuch record on ttrre premises in rvhich the prcxluction takes plar,*'

Provicle cl that rvhere the premises cease to be used or licensedsuch persolt shall make arrangemenls' acceptable to the h,,Iilister, lorthe presen'ation or destructit:n of suctr recortls.

Curcn*bis inventfirv

69. { 1) ;\ licensed prudtrcsr shall keep a record of the net weiglrto[each of thc follow'ing in an inr-enton'at their site at the enel 1rf eachquarler of the calendar vear-_

{a) cannabis seecls, other than cannabis se eds referred tcl inparusraph {h);

{b) han'ested cannabis, other than cannabis rel-errecl to inparagraphs (e) and (f), that is not to be suhiected to adrving pr$cess;

{c} han'ested camabis, other than cannabis refenecl to irrparaeraphs {e) and {g}, in respect of w'hich the drf ingprocess has not hen completed;

{d) harvested cannabis, other than cannahis referred to inparagmphs {e) and (g), in respect of rvhich fhe *lryingploce ss has been cornpleted;

(e) carlnabis that is destined for dcstructicn,(fl) packaged f resh cannatris;

(g) packaged dried cannabis;

{h) packaged camrabis seecls; and

739

l)angerons tr)rugs (Fnrductinn of {lannabis f{lr h'fedicinal and

Scientilic t-ise ) Regulations,, 2{}l tl

(i; cannabis or cannabis oil, rvith an inclication af"the llame

ilnrtr net w'sight cf each of the sutrstances in questiotr.

{?) A licensed prodncer s}rall keep a rceilrd af the number ol

can*atris plants tlestined to tn sold rlr providecl that are in inventofiat their site at the entl of eae h quarler of the calentler \iear.

{:}} A lir:ensed proJucfr shall kee p & record af the net n'eight

of'each *l the foll*rving tleat are in inventor;,* at tlreir sits at the end

r:l'each quarler of the calenctar )'sar-*

{ai c.annabis cil that has not becn packaged, uther than

cannabis cil relerred tc in paragraph {e);

(b) packaged cannabis oil. other than canrultris oil re {e med

to in parasraph (c); anC

(c) cannabis oil that is destinecJ f or destnrction"

{le, t ttr ne d s ub,s'r{i ff {r{r

?0, :\ licensed proeiucer wltcl *sc:siries fresh nr dried cannabis.

cannabis oil orcanrlatis plants r:r sends that are returned shall ret:qrtd

the f ollorvi ng i nfcrnnatiotl *-

(a) the given na$re anrJ srlrnalne of the F *rson r1'ho re ttlrned

the iubstance or on behalf trf whom the substan(re l\':ls

returned;

{h} the address o1- the site at which it was rcceived;

ic) the nanre of the substance, its quanlity anrJ hrand name..

{d) the clate on rvhich it r'ras received; ad{e) reast}n of the retum.

Order Jbr €x{}ort

7t tl) ;\ licensed proclucer rvho iills an ortler for cxp*rt shall

rccqrrd the lollowing intr:rmation *(a) tfue n*rrne of the pcrson to rvhomthe substance lvas sold

or prilvided;

(b] the shiPPing aclclress;

{e } an indication of which substance lvas ordered. as lve llas the foXlowing inltlrmation'*

?40

S.L (r? of 201ti

ti) in the cfise *f {-resh or driecl cannabis or canrrabisoil, ils quantitt'ancl' if applicable ., brancl narne; or

{ii} in the case of camabis other tharr cannabis ref"erredto in suhparagraph {i), its qmntitv, clescription: ifapplicahle, brand name; and

(d) the date on n'hich the sutrstance was shipped;

{e) the number ancl clate of the imprrt c-e rtificate, ancl(f) the authority b3,' rvhom such certificate is issueti"

{?} i{ license,;l pn Jucer wlxt rcfrme s to lill an oreler for exp*r-tshall retain a copy r:f the rvritten notice of ref usal to {ill the ordel:

Serurit"v inven{ory

72. h licensed prcxJucer shall keep-(a) the visual recordings refenecl to in sections 2:t antt 29;(h) the records ref-erred to in sections 26{2't ancl _12{2); and

{c) the recard ref,erred to in section z7(3t.

Ilried r ttnnshis e quivrt lencv far tor73. A licensed producsr shall keep a rec:ord of the inftrlmation

concerning the rnethqld that lhey' have-usetl to determine the dric6callnabis equivalencl' factor.

Balch recontiliation

74" tl ) ,'\ licensed producer shall keep a recorql of the f ollowirrginformatian concenrin$ieach batch of cannabis that they prCIpagate'so\r,, han'est, dry, packaee of clestro,\.,.--

(a) the date on utrich cannabis plants are propagated trryrneans othe r than sowing seecls and the numtrer gf nervplants prollagated in this maruler;

(tl) the clate on lvhich cannahis seeds are solvn anel their.netweight on that date;

(c) thE clate $n lvhich cannabis is han,ested and its netweight on that date;

{d} the date on which the drying process for cannabis iscompleted, if any'' and its net weight on that *late;

14r

[-)angenlr!$ Dnrgs {}}raductiort uf {,lannabis lor fuledicinal ancl

Scientific {"Jse) Regulatittts. ?01 B

{e) the date $u r+,hich cannabis is packaged and its netrveight r:n that date, ancl

(f) the date oil which cannatris is clestro)'ed and ils ltetr,veight on that date. bel#re the: clestntction.

{2} ,q license*l prulucer shall keep a recofi.l of the folkrn'insirrfcrrrnatio* con(rerniug each lot *r hatch nf cannabis oil that therprrxJuce , ;rackage ur dsstrn]* *

ta) the date $r which the *il is pr*dnced and its net lvcightcrr vnlurne on that clate,

{t}} if applicable., the date on rvhich the oil is put intr-r a

capsllle or other similar dosage forrn an.l the nunrherot'capsule s trr units of that dasage f ernn;

ici in respe cl trf the cannabis that rvas rrsed to produce thc

*il, its description, its nel rveight ar volume. its lot orbatch nurnber and the date ()n w'ltich it rvas produccd.

{d} the date oil rvhicir the oil is packaged antl its net n'eight*r voluffre {-}n that date ; anrj

{e} the rJate on rvhich the cil is tlestroyecl anel its net w'eight

CIr volume on that elate, hefkrre the destructiott.

fl.e s *ttrt'h s,nd de v el o 1;nwnt

75. [:r'er] licetrserJ prtrducer shall keep a record af the tollon'irtgini*r'maticln coilcerning cannahis that the,v use irr a research anddevelopnrent activ i ty *

ta) its tlescriptiur, the qu,arrtity lrsed, its lot *r hatch numberand, if applicable, its hrand name;

{tr) the r1ate cn which it was used in that activit.,v;

{c} the purpose and a brief clescriptian of that activitS';

(d) in respect of any pruluct or compound containing thatcannahis that tlrerv have made {rr assemtrled in the courset:f that activit"v *{i) its dcsc:riptitn;

iii) the r3ate ort lvhich it lvas rnade {}r Asserntrled andthe quantity made or assembled;

"i,4,2

S.I. 62 ol'20lfl

{iii) if applicable, the date on which it u'as used frrrtesting and the qu,antit"v used;

{iv} if applic*ble , the slate orr rvhich it n,as placecl ininl'e ntory and the quanlity placecl in inr.entorS';

(e) any *ther details permitling the reconciliatiolr r-rf theeluantit;- of cannabi*q referred to in paragmph (a) andthe quantities of products or compouncls referrecl t1; i11

para$aph (d).

Ilestroyed r:nnnnbis

76.(l);\ licensedprodtrcershall keep, frrreach ilstance in p,hichthey destroy cannabis, a reconl of the f ollorving infannation-

ta) the date on lvhich the cannabis w{rs destro}'ed, the nanreof the substance destrayed and its net w'eight on thatdatc, before the destruction;

(bi the location at which it rvas destroyeil;

{c) a brief descriplion af the rnethcxl ol- clestruction,(d) the tmmes of the witnesses to the destruction anel lhe

basis on rvhich they are quatified to be lvitnesses; ancl

{e) if applicable, the name of the person rvho acconlpapiedthe cannabis to the lwation at which it is to he destrcrl'exl.

t2) A licensetl prrrducer shall keep, for each instance inw'hich th*3'' destroy cannatris, a stalement signed ancl +Jated h3, eachqrf the R'itne sses referred to in subsection ( t Xd) stating that the1,hat'e rvitnessed the destruction and that the cannabis lvas destra!,edin accordance w'ith a methclcl that complies rvith envir*nmentallegislation applicable to the location at n'hich it is to be clestnrlerj.

Ilisposal qf cunnabis

77 . i 1) Where cannabis requires tc be tlestnryed the licenseclpradltcer shall notify the h{inister rvho shall give directions as to theclisposal of the cannahis"

t2) Iror the purposes of subsection (3) therc is herebyestablished a panel comprising of a police of{icer of or abor,,e rank

743

Dangcrous Drugs {Prcduction of Cannabis ftlr \leclicinal andScientific [.rse] Regulations,, ?t] I I

r.rf'a superintendent designated by lhe {lnntmissioner r-if }'olice, a

st: nior custonrs r:fficer"de signated hy the Conutrissit:ner {ieneraI ol-t}re

Zirntrabrve Revenuc: Authority, the llirectcr {ient:ral of the l'ledir:iltcsilclntrol Authr:rity,' of Zimtrabn'e rlr an instrrcr:t*r designatetl br hirn

cr her ancl a senir.rr oflicial of the Nfinistry rcsponsihle lor justicc

,desisnated tl,v the Attorney-di**eral or arly" person apyrirrted br thc

\{inister itr the rlestruction cf an} eannahis"

{3} {}n n date anql time appointed by the t{inister. the

panel ref errecl to in subsectir,rn {?} shall attend tc tlte dcstructiou br

&ppr$priate means al' the cannahis conr:emed in the full vic:\\ and

pre$ience ol each ather anel shall imrnediate 11'thereafter, subscnhe to

ancl sign a joint declaration attesting to the tertal dcstntctiou of sttclt

rrarmahis- rvhieh shall tle forn'arded firrthw'ith to thc \linister

Atlverse rezttions

?8" {1) ln this secticn-'"adverse, reaction" frlsans a noriotw and turintended rcsfx)nsc

to ft:esh or drietl cannahis or tannabis oil;"'case repcfi" nreans a detailed recorcl of all relevant data

nsscciated lr,ith the $se *f fresh or dried camabis orr:annabis oil b}'a perscn,

"s{:rious aclverss reaction" means a nr:xiorm and nnintendedrespollse to f resh or drierd cannahis *r cannabis oil that

requires in-patient hospitalisati*n clr a prolongationuf existing hospitalisation, that causes congenitalmalfr;rmation, that results in persistent or sistrificantdisahilitl' or incapacity, that is life threatening or thatresults in death.

(?) A licensecl producer rvho sells or provides fresh or dried

cannahis or canrahis oil or any peffion ref erred ta in secticn #[ shall

provide the [,{inister u'ith a case report fcr each serions adverse

reactiqxr to the suirstance, r,vithin 15 days afier the day on rvhich the

producer becclmes alvate of" the reaction.

\/

714

S"l. 62 of 2018

{3} A licensed producer r1,'l}o sells or ptol,ides fiesh gr clri*:dcannabis ol' c&nnahis slil shall flrepare annuallS' ancl maintaip asulnmar)' report fhat ccntains fr c$ncise anrJ critical anaiS'sis gf allatlverse reactir:rrs to the suhstance that have occun"ecl dlrring thepret' iaus tr.+'eive nrcnths"

{4) tl - afte r revie lvirlg a case repofi provide$ unc-ler suhsectigrr{ I } ar after revie rving an!' other saf efy clata relating to the fiesh grclried cannahis or canrmtris oil. the lt{inister has rcasonable erounds tahelieve tlraf it nray. tr3'reasrn tlflthe manner in o.11ic:h it r,vas prrxluccd,packagecl" labelled or stored, lxxe a dsk to the health of a person g,hoin accordanc* H'ith these Regulatirrns obtains it fi.lr the ir otryn medi*llpurp$ses' the h{inister ma!' requesl that, u'ithil thirtl' rJal,s after theda)'o:l which {he request is rcceived, the licensed prtNJucsr-*

{a) pr*r'ides the N{inister rn'ith a copy of any sunurmr},relx}fiprepared uncler subsection (2); or

(tt) plepares and provi*Jes the h{irrister rq,ith an interimsummar)' report c*ntaining a concise and c:riticaianall'Sis *l- all adveffie reactians to the sutrstance thathftt'e {}cculretl since the date of the rnost req-rent sufiunaryreport prcpared untler subsection (?).

Destrttc/l'r:ri of tunnabis ufter change in praCut-tion #re{t

79- II'a registraticn is am*ndetl or at the time of the renelr,alto rellect;t change in the prcldtrction area, the pers$n authclriscg tgpnxluce caffIabis shall destrcy--

{a} any caunabis plants uncler pr*duction that arc in excess*f the nraxitnttm nwnher of plants that ma)' he prr.xlue:eclrurlrJer tlre re gistration. as amended; ancl

{bi any canltahis that the3,' are storing that is in e,\cess i:f theequivalent of, the maximilm qrnntit,v-' of clried carumbisthat filsy tre stored under the registration. as amendecl.

Adt,e rti s e me nt of c arrn ahis

80. lto pemcn shall puhlish, distrihute or in apy other marmerlvhatstlrl'er bring to thcr natice af the public or causs trr ;le nnit ta he

7"X5

I

Ilangerr-lus Drugs {Prcrtluctiott of Clatmahis for \{edic'inal andScientific t ise) Regulations. 2018

published or distrihuteel or to be so brought to the natice of the puhlicany advertiscment conceming cannabis r+'ithout the authority. o1'the

h{inister"

.t}\RT VII

(iE.,runu-

F'ees

81. '['he fees payable in terms of these regulations shall trc thcapptopriate fee opposite the appropriate item specified iir the firstcolumn of the First Schedule.

Penriltie.s

82. Any person rvho contravenes the provisions of thcse

regulatinns shall tre guiltl' of an of-f,ence and liable to a fine ttr.rt

erceecting level 12 cr to imprisonrnent fr:r a period not e\ceedrngone year or tcl hoth such fine and such imprisclnmertt^

Appeals

83. {1};\ny person r,vho is dissatis{ied by any decision made

in terms of these regulations ma),, lr.'ithin 30 clays, appeal to the

h finistcr.

{?} tipon receiving the appeal noted in terms of subsection(l)', thE h'[inister rnfl],u within 30 days, confirrno vary r:r set aside the

clecisiolr appealed against.

(;l) Any person rvho is dissatislied b3' the decision of the

lv'Iinister ma)'? rvithin 21 da"vs, appeal to the Administrative Cotrrt.

7#

S.I" 62 af ?018

Frns'l si:irnr;r,i.r,, {,ssr-riorts 2,,(1 IXs}, I4( Iita},6;s rmd gl}

f'L:ESIlt:rn

I . .{irplicatiqx iqrr a Iicence to prcduce cannabis2, .\pplicatiar: fcr a licence to conchict research or] cannahis,3. Applicarion lor renerval of licence to pruluce cannahis-{. Application for lenend of a licr:nce ta cr_rnchrct research on r:annabis5. Application fr:r r.ariation or aillLrndment af :r licence6. Appiication for inrpcrrti export licence7. Inspectian

ll. Annual letum fees

F-ee

Iirs $

5{i tx}{l

5 iXX}

2t) {itxj

2 stxl2 sti{}

5 ff)fl3 500

15 fltlrJ

Srr:oxn Sc-rrunt_:r_r (,!-ecf ion 4( I ))

R]RN,{

DANGEROT-IS DRLiiiS ;\C"f \CHAYT'{!R } S :02};\PPLICAl'lOhj f;{lR ISStj}1 {jF A LICET{{I[1 FOR PI{ODLj{*l'JOi\j Ol;

CA]\JI'JABIS"f his fonn is submittecJ in ternts a[section 511 ) of theDangeraus Dgrgs {l}roductis:na{'Canrrabis f or \{eclicinal anci Scienti{ic tjse) Regulaticns, 20lg:

(.To be suhnitted in duplicate)

PART A {To be completed by individuals and sole tmdenl

717

Dangerous l)rugs iPrrxluctiotr of {lannahis lc>r \lediciual attdScientific t,rse) Regrtlations. 301 I

t)'{RT B t ?b be cCIrnpleted b3; cornpani.esl

'j. If n compliltl)l lrain* nf conrpan)':

tai Phy'sical address. . ". .

thi Re gistcred ()l fice :

(c ) iimail Adclre,ss: ".. "

(d1 State shrreheilders *r distnibution ol' shases. ..".

1{} P,A,ITTICUL,{RS OF I}IRIiCTORFJ:

{a} [';ull nafires:

ib) '\ddre-os: . ..

(c) Citizenslrip:

{il} Dat* of Rirth: ,.

{e} tlt:nder:.....

I'},'lRT il t Tb ttr. completed. by all applicantsl

1l " Namer under u'hich blrsines$ is cotrducted:

I ?. Phvsic;d ailclress cf premises to be licenscd:

1 -i.

1-tr;\.

I5. T}ARTTCUI,ARS OF AUTHORISEil PIIRSON(a,} Iiull rlanlr:

th) Date attcl place of birth: . .. . ..

(t j GenrJer......

I6. PARTTCULARS O}' RIISPONSIIU,E PRRSOI{

{a} full ilffil$:

{t}} Date anil place of hirth:

tc] {iender: .....

17. State the prr:p*se.d activities: ...,

lf{. 'l-he substances in respect ol'rl,hich e"acir activit.v is to be canducted:

19, State the Lruilclingrs within the,site where the profxlsed activities are to h'e:

ccrnrluc teri { f *pp I ir: a,blc.t'

7"18

Ii.1. 62 crf- 20t g% .r%*

i{-t" Ilar''er You Prer'lousi-1: fiei'J;i Iicenr;* [o prcduce cannabisl] ],lis, N( ]+

il. \'ES, give details. . . . ,

: t H; a**\' ooo,,*ui,on *u;; ;; l,,',u ro,. u i,**,,** b-;,; ,*r,,**o ;,c;:ncelled,l l'HSiNO*If YES, gi ve ile.tpjls: . ". .

22. Nanre and acJclress c.,f'*srrest porice sfation:...

13 l\ame anir apprr:ximate distancc *{-nearest resicrence frrim premises to heIicerrse*l: . . "..

?4' ::|,t|,::t,iland :-"

<.ri attl' tracling cr r:rrher' ricence rrerd rr3, rhe apgrricanr

25. Il an inclii,idual *(a) are ljoll a citieen';1f,. nr crdinarily resiclent in zilnbab$,ei) l.l:s.h-t_i*;(b) if \'trjs supply pioaf rhere*f;

{c) l{ar"c yott *'ithin tirc pi'ececling.tel year": of' thi-.r applicati'' hcencottl'icted inside or outsidc': Zirrilrabt* .,r an nfren.L'i*r,or'ing th*rvrongftil de*ling il ar suppl.v- or po*****ion *i ."unnut is, cr nf arrol'fenc e i n v ol v i n g ci i s han esi5,?'y ri s,,hr$la t tu*i, a f.fi davi t I(il If YHS sfate detarls26. If- a cerntpanv;

{a} Are the tJirec:t*rs of the compafi}'or a rnajorit' there*f citizens orcrdi n*ri r y resi den t i n zi nr hab* e i) y Es i n*,flx{bi {f YES supplv pruof therl:t:f ;

{ci If h*{) sug:pl1., pr*nf r:f exenrption b}, the h,finister;til) l-Ias fhe cunlpan)'or ail)r *f the crirectors ol the cornpa'y,wifhin th*precerding ten yearsr:f ttiis. applicatioo rr**nl,rnoi*ted inside ilr cursicieZirr:bal-rwc of ln atfen"" inlllving th* wlrans{uq crealing in or suppl'or F*lssession of cannahis, orof a'Irr*n**liir,.rt'ing dislxrnestyrr \"r_is,j\L{,},r {,{ftach Afficlar,if }. .

iel If YHS statc clefails. ..

* ilelet* the in*pp{ir.sbie

719

l)angerous Dmgs (Prrxluction of []annabis lor \ledicirtal artd

Scientific I ise) Regulatious, 2018

N{}TE:

l. piilns of the prernises, the appropriate fee, prrxtfl of citizenship, resiclcn$

clr an erennption b1, the h'finistei", etc, are reqtrired to Lre attached to tht

applicaticn.

:. l-erpies of original doctrments must he properly certified.

3" If an1..plan cincument or ie.e required to be attached is not attached. tht:

appl ii:aticn cannot tre accepterl.

.+. If insufficielt sp&ce is provided irr the application. attach a sheet of ptpti'u'ith the additional information.

I enclose the praof of pa,vnrertt of the fee of. '.

i cla herebl'cleclare that the facts herein are full,v rvithin tnv ktrou'ledge artcl

to the hest cf my knor,r'lcdge are true and corre:et.

Signature of apPlicant.... l)ate

io,o,u ,,ni lorttirln ;i t:t;to,', r,, ,'i* ,o,lnpo,'.n

DA]{GHROL.jS DRLIGS ;\Cli IC HAPT.ER I 5 :021

I,ICI4NCE F'OR SITE

T}ROT)UCTION O}- CANNAT}IS F'OR M['T}ICINA,[, AND SCIENTTI'' ICUSFJ

Licence lrio. .

Receipt No..

File f'io.,

l. l,icensee:2. In the case of a company;

Nomes' of tlirettCIrs Citirerrship

3. 'l',vp* of site licensed:4. llescriptiorr of licensecl site:

5. I.oc:ation of site:

6" loJame of persorr carrying on business oI] licensecl sitc:

?50

S.I. 62 *[ 2018

"7

I(.)

Name of'husiness:fl<-rnditit>ns rif rerreu'al impased b_v the h,{inister:'l'he site shall, for the purpose-c of'section of the, be under the supervisicnof the f-pllr:lvilipi per-qon {s}:

liame

Date of reneu'ai of licence:t:xpirv date of lircnce:

Ilate:

{Lircrx'e nurnber\

&'tini.rter

T'urRt Sr-:ni-:nrir.r {SerIi,o rt 4{4 )l

S HC:{ rRI'f .\' {-li . frA R{ hiCli: t{. HQLI I It Ir\ {I1l{T S

Upon an applicati<.rn made in tenns of section 4{.4}, an applicant is requiredto provirle the securitv requiretnents for the authorise.ri persons and shail inchidethe intonna{inn set out helcw:

L Date anrl plac* *f birth: .

3. Height:

4. clertifiecl copy of Natianal ldentity Docurnent

5. Acldre ss (I{ome) ...

6" 'f-he address*s of all locations at which each r-.-''f the stated fxrsons residedduring the y.ears preceding the application.

7, An identification of the stnted person(s) activities during the {ive vearspreceding the application, inch-rcling the narnes and addresses of thepersotls' emplcrvers and arlv post-secr:ndary e-.ducational institutionsattended.

8. T'he stated pr:rson$'fingerprints taken by theZimbabx'e Republic Pclice.

9. The full names of the persons or $pauses.

F-ar;niH ScuEnuu: {.fecl ion 1 g( Z )}

RfrflALI-

A process for rvithdrawing or rettlov'ing cannabis or cirnnabis product lr<xp theclistrihution chiain because af delects in the procluct, r:omplaints of seric:us ac{verse

751

I)angcrou$ llrugs (Prcductitrn of {lannahis li:r \ledicinal attdScientilic 1-1se) Regulations. 201 I

rcacticns; tc the pr*iCuct atrd: {-ir {:oncerns that th*; prccluct is Gr mav be ct'runtrrrf cit'['he rexa]l rnigirt tre initiated bv the proclucer or the htiniste.r.

{ 'lassificiiti*n af Recal ls

Iiecalls are classifred accr.rrcling ta the fallorvitrg s,-vst*m.

3.2.1 Class I ret'all

{"}ccr:r u'hcn pnxlr-lct$ are pr:tentiallS,' liie-thre.atnningcr ca*lti cause a se,rious riskto he.alth. I-,xan:ples af Class I .[)efccts- \'ljrong Product {lahel atrcl cotttents are

dilf erelrt products)*L-'crr*cf pro<.luct hut u,ronp, streugtlt, n'ith serilus nre.elical

c$nse(luenc:es--.hlicrErbial ccntamination crf'stcrilc injection or ophthalrrticprmtuct-*llherrnical contaminaticxr with scilous lnedicai consequences--\lirup of sonte prortucts rn'ith xil$r* thatr onc contaitrer lnvtdvt:d*\\irong activeirrgreclient in a multi-compxrnenf product u'ith strir-rus rn*dical ccnsequences-*I "ack *i' e ff*ctiv*ness fclr e ii{e threatirrg conditir:n.

3.2.2 Clnss ltr reeall

{}ccul'rvhcn product dr:,i'ects coulrj caust: illness ot'mistt:eatment, but i}re n{;t

{--lass i. }:,x;lmples ol Cla*qs II L)efects*lr'{islahreling e.g. rvrong or missing te.tt

cr figure$-*I,{issing ar inccrrrect irtfor:naiiort** leaflr}ts or inserts'- l.'licrotrialcontantinati*n of non-injer:table, ncn-*phthaimic sierile procluct u.ith nredical

conse{prences-*-(lhernicalrphy'sicai contamirratiotr {significant impurities, cross

ccntamination, parficulat*s)* i\{i^x upcf prrxJtrr:tsin contaitrers*Non-cornplianccil"ith speci fication {e. g. i}sl{a-\r, stabiiit_r,', fill irveight or di ssr-rlution } -* I n se,cure clos ttrc

*'ith serious medical c*rrscquenues (e.g cytotc,xics, child resistatlt contairlc-rs"

potent Fr{xlucts}*-l-,ack ai efficacvieffectir,eness f-or rnedical condition that is

not life threatcning"

3.2.3 Class III re*;all

{,}ccur n,hr-n product def"ects ma} not pcs* a significant haearcl to healttr i.e. lon'risk to licalth but recall rnay be, initiatccl fcr ather rt:asclrls, due to qualif; safet]' ilrefficac-3, concerns. Exanlples of Class Ill llefects--Faulty packaging e.g. r\:rongur r:rissir"rg batch number or e.xpirv date

{llass I cr {llass II r-ecalls are consicierecl to be urgent safety-related recalls"'l'he3'must tx, repcrted to ther N,f{-lAZ lor further evaluatiort and investigatior:. Ciass lllrc'.call s alc couside,red ta he lninirnurn n sk to putrlic health but should trorve ver stillbe r*ported to the h,{(lAZ. \iote: Eactr recall is a uniqus exercise and there Ina}'

be occasi*ns urherr the scoJn oi'a recall can be narrot\red t* particular c*stofiletgroups" I"h* classification is deterrnined b-v the h4CAZ. Hxpert arlvice might be

scught wrh*re the nature af the hasard ar rts si gnificant is ncrt clear. Ilerisian madt:lly other stririgent regulatary autharities intc.rnati*nall3,' w'ill also be ctnsidereel.

i5?

S"I. 6? of 2018

'l'he Grricielines da nct apply to the recall af a medicine, vaccine rlr meclic:al devicerelated tc reg,ulatorv issues such as carlcellalian cf registratian dut: ta non-pavrlrentof"retention fees. approved change cf appiicant, mannfacturer, labelling, packageinsert or cthet"registered particulars. Regulatorv issues. in rvhich there is lai:k crf

compliance to cGh{P mayleael to a recall andior a cancellation af registratiall.

.i.3 levels of recall As uith classiiicatir-rn, the ler'*l {or clerpth) of a recall is t*lre assigned irt agre.enrent with the h{(lAZ. In determinirrg ttre recall lel't-.l, theprincipal lactors to he ccnsidered ire the significance of the harard {if anv),the chantrels by *,hich the mcdicine, vaccille. or lnedical devii:c pharrnaceuticalprnclucts have treen distributed, and the level tq:r r,r'lrich ciistrihution has takenplace. Agzurr, cxpcrt opinion nlay lxl necessarv to deterrnine ihe significanc* afthe hazard or risk

'fhere. are three levels af recall: rl',holesale, retail ancl consurner.

3.3. 1 \Vhclesale ler'*l

I ncludes all parties involvexJ in rvholesale distribrition and nrav include u,hr-''les;riers

and retail pharrnacies.

3.3"? Itetail leyel Includes. *- All puhlic and private hospital pharmacies; -Retail phranna':ies,-*Clinrcal irn'estigatr:rs and the institutions in n'hich clinicalinvq:stigations are per{'*mred; * ll{edical, dental and cther health care pracl iticners.- N ursing homcs and *ther related insti tutions: *- {Jther retai I or"rtlsts e. g. meclici neshaps, supermarkets and heatrth food stores;

N ll: In the Lrase rvhere consumers that are knorvn to be in pos session qlf the affecteelproducts, a pl;rn shoulc{ be put in place where specitic telephone calls are madc tathese consumer$ or recall letters sent tr,l arrange fclr retunt of the recalled product.3.3.3 {-lonsunrer level. Includes patients zurC other consumers.

'fhe lallon'ing stages shall he follorved u'hen initiating a recall:

I{ecall Stages Ser:tiarr

I. l{otification to the lrtinister

Iteceipt of {lannabis cr {-lannabis Product Prohlem Report IInformation an problem af cannahis or c{innabis prroclucts

2. trnitiation of a Rec;dl 2

Infr:rmation Required far Assessment i-rl Recall

Inforntation ou product, prt:hlem and distributir:n is required

3. Assessmerit af Recall 3

The classification, level and strateg) q:f recall are determined depencling on theptential ltazard of the cietective prcdtrct and theextentct-praduct distrihution.

?53

Dungen'lrs I-)nrgs (Produr:tiotr of {lannatlis lor l{eclicinal arttlScientilic Lrse) Regulations, 2{}18

-1. tr{ecali -X

l,"etters irnd press release-. (il'requiredi arer dispatclted tcl r*levant firms lnrni:tifvillLr, $n the rec:all.

5. Progrcss *f' ltecall ancf. Rep:rt 5

Prr.rg;ress repcrts and final rcport are subrnittc,d ti: the h{inister.

6. [::valuaticn r:t-thr Kecall 6-['lir:

efTer:tiver]ess cf th* rec:rll is rnanitcr*:d brr the \tlinistr,r

?. Rerinstatement cl $uppl-v

S:usyfcment tu the ]linrtwlnvenn Government G#:ette &t{ed tlw 27tlt ApriI,20J8.Printed fu- tke tlovern*wnt I'rixter, Ilsrare.

7*+