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FarI 1 o jI b ~ m~ Is InIended prImarIly as

a pracIIcal guIde Io Ihe legal resIrIcIIons on Ihe sale or supply


o medIcInal producIs and poIsons.
WhIle every possIble care has been Iaken In Ihe compIla-
IIon o IhIs guIde, no responsIbIlIIy can be accepIed or any
errors or or any consequences o such errors. The aIm has
been Io presenI as clear and concIse a summary o Ihe law as
possIble, and Io InIerpreI Ihe varIous orders and regulaIIons so
as Io decIde Ihe caIegorIes InIo whIch IndIvIdual producIs
should be classIIed. On any quesIIon o InIerpreIaIIon, how-
ever, II should be borne In mInd IhaI only Ihe courIs can gIve
a legally bIndIng decIsIon.
FarI 1 Is prImarIly InIended or Ihe guIdance o hospIIal
and communIIy pharmacIsIs who are concerned wIIh Ihe
reIaIl sale or supply o medIcInes and poIsons.
The MedIcInes AcI 1o8, Ihe FoIsons AcI 172 and Ihe
VeIerInary MedIcInes RegulaIIons 200, IogeIher wIIh Ihe
MIsuse o Drugs AcI 171, regulaIe all reIaIl and wholesale
dealIngs In medIcInes and poIsons. CerIaIn non-medIcInal
poIsons and chemIcals are also subjecI Io Ihe labellIng
requIremenIs o chemIcals legIslaIIon IncludIng Ihe
ChemIcals (Hazard InormaIIon and FackagIng or Supply)
RegulaIIons 200, SecIIon 1.o. II Is ImporIanI Io apprecI-
aIe aI Ihe ouIseI IhaI Ihe MedIcInes AcI 1o8 applIes only Io
subsIances when Ihey are used as medIcInal producIs or as
IngredIenIs In medIcInal producIs. Carbon IeIrachlorIde, or
example, when admInIsIered or a medIcInal purpose Is a
prescrIpIIon-only medIcIne under Ihe MedIcInes AcI 1o8,
buI when II Is noI used as a medIcIne II Is noI subjecI Io Ihe
MedIcInes AcI 1o8. II Is also ImporIanI Io grasp IhaI Ihere
Is no sIaIuIory lIsI o pharmacy medIcInes, IhaI Is, medIcInes
whIch may be sold over Ihe counIer only In regIsIered
pharmacIes.
The basIc prIncIple o Ihe MedIcInes AcI 1o8 Is IhaI all
medIcInes may be sold or supplIed by reIaIl rom regIsIered
pharmacIes. AnoIher prIncIpal sIaIuIory lIsI Is Ihe lIsI o pre-
scrIpIIon-only medIcInes whIch can be supplIed rom phar-
macIes, only In accordance wIIh an approprIaIe pracIIIIoner's
prescrIpIIon.
MedIcInes whIch are noI prescrIpIIon-only medIcInes and
whIch are noI Included In Ihe general sale lIsI are pharmacy
medIcInes, IhaI Is, medIcInes whIch may only be sold rom a
regIsIered pharmacy under Ihe supervIsIon o a pharmacIsI.
The MedIcInes AcI 1o8 applIes Io all medIcInes or human
use. The VeIerInary MedIcInes RegulaIIons 200 replaced Ihe
MedIcInes AcI 1o8 as ar as veIerInary legIslaIIon Is con-
cerned. VeIerInary medIcInes are dealI wIIh In SecIIons 1.8
and 1..
SImIlarly, Ihere are subsIances used In medIcInes whIch
also have non-medIcInal uses. Several o Ihese subsIances are
Included (IogeIher wIIh oIher non-medIcInal poIsons) In Ihe
poIsons lIsI made under Ihe FoIsons AcI 172. Non-medIcInal
poIsons are dealI wIIh In SecIIons 1.4 and 1.S.
Keys Io Ihe annoIaIIons used In Ihe lIsI o medIcInes or
human use (SecIIon 1.3) and Ihe lIsI o medIcInes or veIerI-
nary use (SecIIon 1.) appear on Ihe IrsI page o each lIsI.
1.1.1 Definitions
The ollowIng are deInIIIons o Ierms used In Ihe MedIcInes
AcI 1o8 and Ihe MIsuse o Drugs RegulaIIons 2001, as
amended, or are InIerpreIaIIons o Ierms used In Ihese seIs o
legIslaIIon, IhaI are noI explaIned In Ihe maIn IexI o IhIs
guIde:
^~ Is a II, proper and suIIably experI-
enced person appoInIed or nomInaIed by a desIgnaIed body
Io ensure Ihe sae, approprIaIe and eecIIve managemenI and
use o ConIrolled Drugs wIIhIn organIsaIIons subjecI Io IheIr
oversIghI. The role and responsIbIlIIIes o an accounIable oI-
cer are deIned under Ihe HealIh AcI 200o and under Ihe
ConIrolled Drugs (SupervIsIon o ManagemenI and Use)
RegulaIIons 200o and Ihe ConIrolled Drugs (SupervIsIon o
ManagemenI and Use) (Wales) RegulaIIons 2008.
^~ means a person who Is
regIsIered as an opIomeIrIsI, and agaInsI whose name parIIcu-
1.1 Introduction
1: General Legal Requirements
3
O N E
Introduction
lars o Ihe addIIIonal supply specIalIIy have been enIered In
Ihe relevanI regIsIer (p p22).
^~ ~ means:
(a) In Ihe case o a healIh prescrIpIIon, Ihe daIe on whIch II
was sIgned by Ihe approprIaIe pracIIIIoner gIvIng II or a
daIe IndIcaIed by hIm as beIng Ihe daIe beore whIch II
shall noI be dIspensed, and
(b) In every oIher case, Ihe daIe on whIch Ihe prescrIpIIon
was sIgned by Ihe approprIaIe pracIIIIoner gIvIng II, and,
where a healIh prescrIpIIon bears boIh Ihe daIe on whIch
II was sIgned and a daIe IndIcaIed as beIng IhaI beore
whIch II shall noI be dIspensed, Ihe approprIaIe daIe Is Ihe
laIer o Ihose daIes.
^~ J~ ~ means, brIely:
(a) any name, or abbrevIaIIon, or suIIable InversIon o such
name, aI Ihe head o a monograph In a "specIIed publIca-
IIon" ( below), or
(b) where Ihe producI Is noI descrIbed In a monograph, Ihe
BrIIIsh approved name, or
(c) where Ihere Is no monograph name or BrIIIsh approved
name, Ihe InIernaIIonal non-proprIeIary name (INN),
or
(d) where Ihere Is no monograph name, BrIIIsh approved
name or INN, Ihe accepIed scIenIIIc name or any oIher
name descrIpIIve o Ihe Irue naIure o Ihe producI.
^~ ~ p p13, under "FrescrIpIIons or
prescrIpIIon-only medIcInes".
^~ ~~ ~~ means, brIely,
Ihe quanIIIy o each acIIve IngredIenI (or IhaI parI o Ihe
acIIve molecule responsIble or Ihe IherapeuIIc or pharmaco-
logIcal acIIvIIy) IdenIIIed by IIs approprIaIe non-proprIeIary
name and expressed In Ierms o weIghI, volume, capacIIy or,
or cerIaIn producIs, In unIIs o acIIvIIy or as a percenIage.
The quanIIIy Io be shown Is:
(a) Ihe quanIIIy In each dosage unII (or pasIIlle and
lozenges only II can be shown as a percenIage), or
(b) I Ihere Is no dosage unII, Ihe quanIIIy o each acIIve
IngredIenI In Ihe conIaIner, or
(c) I Ihe producI conIaIns any acIIve IngredIenI whIch can-
noI be deInIIIvely characIerIsed, Ihe quanIIIy o Ihe Ingre-
dIenI presenI In Ihe hIghesI proporIIon (dIluenIs, excIpI-
enI, eIc, need noI be sIaIed).
The quanIIIy o anIImIcrobIal preservaIIve added Io a bIo-
logIcal medIcInal producI musI be sIaIed. ThIs applIes Io anII-
gens, IoxIns, anIIIoxIns, sera, anIIsera and vaccInes.
The quanIIIy can be expressed In Ierms o Ihe dIluIIon o
Ihe unII preparaIIon or a homoeopaIhIc producI (Ie, a prod-
ucI prepared In accordance wIIh Ihe meIhods o homoeo-
paIhIc medIcIne or sImIlar sysIem whIch Is sold or supplIed as
a homoeopaIhIc producI and Is so descrIbed by Ihe person
who sells or supplIes II).
`~ In relaIIon Io:
(a) England and Wales has Ihe same meanIng as In Ihe Care
SIandards AcI 2000, and
(b) ScoIland means Ihe accommodaIIon provIded by a care
home servIce.
Care home servIce has Ihe same meanIng as In Ihe
RegulaIIon o Care (ScoIland) AcI 2001.
`~ ~~ ~ means a wrIIIen plan (whIch
may be amended rom IIme Io IIme) relaIIng Io Ihe IreaImenI
o an IndIvIdual paIIenI agreed by:
(a) Ihe paIIenI Io whom Ihe plan relaIes,
(b) Ihe docIor or denIIsI who Is a parIy Io Ihe plan, and
(c) any supplemenIary prescrIber who Is Io prescrIbe, gIve
dIrecIIons or admInIsIraIIon or admInIsIer under Ihe
plan.
` ~ In relaIIon Io a relevanI medIcInal producI
means Ihe InIernaIIonal non-proprIeIary name, or, I one does
noI exIsI, Ihe usual common name.
` ~ means a
person:
(a) who Is a regIsIered nurse or a regIsIered mIdwIe, and
(b) agaInsI whose name Is recorded In Ihe proessIonal regIs-
Ier an annoIaIIon sIgnIyIng IhaI he Is qualIIed Io order
drugs, medIcInes and applIances rom Ihe Nurse
FrescrIbers' Eormulary or CommunIIy FracIIIIoners In Ihe
currenI edIIIon o Ihe _ k~~ c~.
`~ ~ means a person who Is a regIsIered
dIspensIng opIIcIan and agaInsI whose name parIIculars o Ihe
conIacI lens specIalIIy have been enIered In Ihe regIsIer o dIs-
pensIng opIIcIans maInIaIned under secIIon 7(b) o Ihe
OpIIcIans AcI 18.
`~ means, brIely, Ihe Inner recepIacle whIch holds
Ihe medIcInal producI. A package Is every oIher ouIer recep-
Iacle.
` means any subsIance or preparaIIon InIended Io be
applIed Io Ihe varIous suraces o Ihe human body IncludIng
epIdermIs, pIlary sysIem and haIr, naIls, lIps and exIernal gen-
IIal organs, or Ihe IeeIh and buccal mucosa wholly or maInly
or Ihe purpose o perumIng Ihem, cleansIng Ihem, proIecI-
Ing Ihem, carIng or Ihem or keepIng Ihem In condIIIon,
modIyIng IheIr appearance (wheIher or aesIheIIc purposes or
oIherwIse) or combaIIng body odours or normal body perspI-
raIIon.
a~ ~ ~ means Ihe denIal care
proessIonals regIsIer esIablIshed under secIIon 3oB o Ihe
DenIIsIs AcI 14.
a~ means a person whose name Is regIsIered
under Ihe IIIle o denIal hygIenIsI In Ihe denIal care proes-
sIonals regIsIer.
a~ ~ means a person whose name Is regIsIered
under Ihe IIIle o denIal IherapIsI In Ihe denIal care proes-
sIonals regIsIer.
a ~ Includes a medIcInal prod-
ucI prepared or dIspensed by a pracIIIIoner (docIor, denIIsI or
veIerInarIan) or prepared or dIspensed In accordance wIIh a
prescrIpIIon gIven by a pracIIIIoner and a medIcInal producI
prepared or dIspensed In a regIsIered pharmacy by or under
Ihe supervIsIon o a pharmacIsI, eIIher In accordance wIIh a
specIIcaIIon urnIshed by Ihe purchaser (or example, a cus-
Iomer's recIpe) or In accordance wIIh Ihe pharmacIsI's own
judgemenI as Io Ihe IreaImenI requIred or a person presenI In
Ihe pharmacy (Ie, counIer-prescrIbIng).
4 General legal requirements
a~ means:
(a) where a medIcInal producI Is In Ihe orm o a IableI or
capsule or Is an arIIcle In some oIher sImIlar pharmaceuII-
cal orm, IhaI IableI, capsule or oIher arIIcle, or
(b) where a medIcInal producI Is noI In any such orm as
aoresaId, Ihe unII o measuremenI whIch Is used as Ihe
unII by reerence Io whIch Ihe dose o Ihe medIcInal prod-
ucI Is measured.
bb^ ~~ ~ means:
(a) a docIor who Is lawully engaged In medIcal pracIIce In a
relevanI European sIaIe, or
(b) a denIIsI who Is lawully engaged In denIal pracIIce In a
relevanI European sIaIe (IncludIng a person whose ormal
qualIIcaIIons as a docIor are recognIsed or Ihe purposes
o Ihe pursuII o Ihe proessIonal acIIvIIIes o a denIal
pracIIIIoner under ArIIcle 37 o Ihe European DIrecIIve
200S}3o}EC)
where "relevanI European sIaIe" means an EEA sIaIe, oIher
Ihan Ihe UnIIed KIngdom, or SwIIzerland.
b In relaIIon Io a IableI, means conIaInIng noI
less Ihan 7S per cenI, by weIghI o Ihe IableI, o IngredIenIs
Included wholly or maInly or Ihe purpose o releasIng carbon
dIoxIde when Ihe IableI Is dIssolved or dIspersed In waIer.
b ~ means Ihe daIe aIer whIch, or Ihe monIh and
year aIer Ihe end o whIch, Ihe medIcInal producI should noI
be used, or Ihe daIe beore whIch or Ihe monIh and year
beore Ihe begInnIng o whIch, Ihe medIcInal producI should
be used.
b~ means applIcaIIon Io Ihe skIn, haIr, IeeIh,
mucosa o Ihe mouIh, IhroaI, nose, ear, eye, vagIna or anal
canal when a local acIIon only Is InIended and exIensIve sys-
IemIc absorpIIon Is unlIkely Io occur, and reerences Io medIc-
Inal producIs or exIernal use shall be read accordIngly excepI
IhaI such reerences shall noI Include IhroaI sprays, IhroaI
pasIIlle, IhroaI lozenges, IhroaI IableIs, nasal drops, nasal
sprays, nasal InhalaIIons or IeeIhIng preparaIIons.
c Includes beverages, conecIIonery, arIIcles and sub-
sIances used as IngredIenIs In Ihe preparaIIon o ood, and
Includes any manuacIured subsIance Io whIch Ihere has been
added any vIIamIn and whIch Is adverIIsed as avaIlable and
or sale Io Ihe general publIc as a dIeIary supplemenI.
d~ p~ i means a medIcIne or whIch
all acIIve IngredIenIs are lIsIed In Ihe MedIcInes (FroducIs
OIher Than VeIerInary Drugs) (General Sale LIsI) Order 184
or are so classIIed In IheIr markeIIng auIhorIsaIIon.
e~ means a prescrIpIIon Issued by a doc-
Ior, a denIIsI, a supplemenIary prescrIber, a communIIy
pracIIIIoner nurse prescrIber, a nurse IndependenI prescrIber,
an opIomeIrIsI IndependenI prescrIber or a pharmacIsI Inde-
pendenI prescrIber under or by vIrIue o:
(a) In England and Wales, Ihe NaIIonal HealIh ServIce AcI
177,
(b) In ScoIland, Ihe NaIIonal HealIh ServIce (ScoIland) AcI
178, and
(c) In NorIhern Ireland, Ihe HealIh and Fersonal SocIal
ServIces (NorIhern Ireland) Order 172.
fojb ~ means, In relaIIon Io a medIcal expo-
sure, a pracIIIIoner or Ihe purposes o Ihe IonIsIng RadIaIIon
(MedIcal Exposure) RegulaIIons 2000.
j~ ~ EF means Ihe maxImum quanII-
Iy o a subsIance conIaIned In Ihe amounI o a medIcInal
producI whIch II Is recommended should be Iaken or admIn-
IsIered In any perIod o 24 hours.
j~ EF means Ihe maxImum quanIIIy o a
subsIance conIaIned In Ihe amounI o a medIcInal producI
whIch II Is recommended should be Iaken or admInIsIered aI
any one IIme.
j~ EF means eIIher:
(I) Ihe maxImum quanIIIy o a subsIance by weIghI or vol-
ume conIaIned In a dosage unII o a medIcInal producI, or
(II) Ihe maxImum percenIage o a subsIance conIaIned In a
medIcInal producI calculaIed In Ierms o weIghI In weIghI
(w}w), weIghI In volume (w}v), volume In weIghI (v}w) or
volume In volume (v}v) as approprIaIe, and I Ihe maxI-
mum percenIage calculaIed In Ihose ways dIers, Ihe hIgh-
er or hIghesI such percenIage.
j~ means any subsIance or arIIcle (noI
beIng an InsIrumenI, apparaIus or applIance) whIch Is manu-
acIured, sold, supplIed, ImporIed or exporIed or use wholly
or maInly In eIIher or boIh o Ihe ollowIng ways, IhaI Is Io
say:
(a) use by beIng admInIsIered Io one or more human beIngs
or a medIcInal purpose,
(b) use as an IngredIenI In Ihe preparaIIon o a subsIance or
arIIcle whIch Is Io be admInIsIered Io one or more human
beIngs or a medIcInal purpose.
j~ means any one or more o Ihe ollowIng
purposes, IhaI Is Io say:
(a) IreaIIng or prevenIIng dIsease,
(b) dIagnosIng dIsease or ascerIaInIng Ihe exIsIence, degree
or exIenI o a physIologIcal condIIIon,
(c) conIracepIIon,
(d) InducIng anaesIhesIa,
(e) oIherwIse prevenIIng or InIererIng wIIh Ihe normal oper-
aIIon o a physIologIcal uncIIon, wheIher permanenIly or
IemporarIly, and wheIher by way o IermInaIIng, reducIng
or posIponIng, or IncreasIng or acceleraIIng, Ihe operaIIon
o IhaI uncIIon or In any oIher way.
k means a person:
(a) who Is a regIsIered nurse or a regIsIered mIdwIe, and
(b) agaInsI whose name Is recorded In Ihe proessIonal regIs-
Ier an annoIaIIon sIgnIyIng IhaI he Is qualIIed Io order
drugs, medIcInes and applIances as a nurse IndependenI
prescrIber or a nurse IndependenI}supplemenIary pre-
scrIber.
l~ ~ ~ means a person
who Is regIsIered under Ihe HealIh FroessIons Order 2001 as
an operaIIng deparImenI pracIIIIoner.
l means a person:
(a) who Is a regIsIered opIomeIrIsI, and
(b) agaInsI whose name Is recorded In Ihe relevanI regIsIer
an annoIaIIon sIgnIyIng IhaI he Is qualIIed Io order
5 Introduction
o ~~ ~ means a person who
Is regIsIered In FarI o o Ihe regIsIer maInIaIned by Ihe HealIh
FroessIons CouncIl under ArIIcle S o Ihe HealIh FroessIons
Order 2001.
o means a person whose name Is
regIsIered In Ihe regIsIer o opIomeIrIsIs maInIaIned under
SecIIon 7(a) o Ihe OpIIcIans AcI 18, or In Ihe regIsIer o vIs-
IIIng opIomeIrIsIs rom relevanI European SIaIes maInIaIned
under SecIIon 8B(1)(a) o Ihe AcI.
o means a person who Is regIsIered In
FarI 7 o Ihe regIsIer maInIaIned by Ihe HealIh FroessIons
CouncIl under ArIIcle S o Ihe HealIh FroessIons Order 2001.
o ~ means a person
who Is regIsIered In FarI 10 o Ihe regIsIer maInIaIned by Ihe
HealIh FroessIons CouncIl under ArIIcle S o Ihe HealIh
FroessIons Order 2001.
o ~~ means a person who Is regIsIered In
FarI 8 o Ihe regIsIer maInIaIned by Ihe HealIh FroessIons
CouncIl under ArIIcle S o Ihe HealIh FroessIons Order 2001.
o ~~ means premIses or Ihe IIme beIng
enIered In Ihe regIsIer requIred Io be kepI under Ihe
MedIcInes AcI 1o8 by Ihe RegIsIrar o Ihe Royal
FharmaceuIIcal SocIeIy o GreaI BrIIaIn (or o NorIhern
Ireland, as approprIaIe).
o ~ means a person who Is regIs-
Iered In FarI o Ihe regIsIer maInIaIned by Ihe HealIh
FroessIons CouncIl under ArIIcle S o Ihe HealIh FroessIons
Order 2001.
o ~~ means a person who Is regIsIered
In FarI 11 o Ihe regIsIer maInIaIned by Ihe HealIh FroessIons
CouncIl under ArIIcle S o Ihe HealIh FroessIons Order 2001.
o ~ ~~ ~ means a per-
son who Is regIsIered In FarI 12 o Ihe regIsIer maInIaIned by
Ihe HealIh FroessIons CouncIl under ArIIcle S o Ihe HealIh
FroessIons Order 2001.
o~ ~ means, excepI In RegulaIIon
3A and paragraph 1A o Schedule 3 (o Ihe MedIcInes or
Human Use |MarkeIIng AuIhorIsaIIons EIc.| RegulaIIons 14,
as amended) a medIcInal producI or human use Io whIch Ihe
provIsIons o Ihe 2001}83}EC DIrecIIve apply oIher Ihan:
(a) a IradIIIonal herbal medIcInal producI, or (b) a homoeo-
paIhIc medIcInal producI IhaI ulIls Ihe condIIIons laId
down In ArIIcle 14(1) o Ihe 2001 DIrecIIve.
(ThIs deInIIIon Is Iaken rom Ihe MedIcInes or Human Use
(MarkeIIng AuIhorIsaIIons EIc.) RegulaIIons 14, as amended.)
o~~ means a prescrIpIIon whIch con-
IaIns a dIrecIIon IhaI II may be dIspensed more Ihan once.
o~ ~~ means a busIness (noI beIng a
proessIonal pracIIce carrIed on by a pracIIIIoner) whIch con-
sIsIs o or Includes Ihe reIaIl sale o medIcInal producIs oIher
Ihan medIcInal producIs on a general sale lIsI (wheIher medIc-
Inal producIs on such a lIsI are sold In Ihe course o IhaI busI-
ness or noI).
drugs, medIcInes and applIances as an opIomeIrIsI Inde-
pendenI prescrIber.
m~~ ~~ means admInIsIraIIon by
breach o Ihe skIn or mucous membrane.
m~~ means a person:
(a) who Is a pharmacIsI, and
(b) agaInsI whose name Is recorded In Ihe relevanI regIsIer
an annoIaIIon sIgnIyIng IhaI he Is qualIIed Io order
drugs, medIcInes and applIances as a pharmacIsI Inde-
pendenI prescrIber.
m ~ means Ihe number
recorded agaInsI a person's name by Ihe relevanI NaIIonal
HealIh ServIce agency or Ihe purposes o IhaI person's prIvaIe
prescrIbIng.
mJ means a medIcInal producI o
a descrIpIIon or allIng wIIhIn a class specIIed In ArIIcle 3 o
Ihe FrescrIpIIon Only MedIcInes (Human Use) Order 17.
m~ means IssuIng prescrIpIIons oIher Ihan
healIh prescrIpIIons.
m~ means Ihe regIsIer maInIaIned by Ihe
NursIng and MIdwIery CouncIl under ArIIcle S o Ihe NursIng
and MIdwIery Order 2001.
m~ ~ means Ihe number
recorded agaInsI a person's name In Ihe regIsIer o any body
IhaI lIcenses or regulaIes any proessIon o whIch IhaI person
Is a member.
o~~ ~ means a medIcInal prod-
ucI whIch Is, whIch conIaIns or whIch generaIes a radIoacIIve
subsIance and whIch Is, conIaIns or generaIes IhaI subsIance
In order, when admInIsIered, Io uIIlIse Ihe radIaIIon emIIIed
Ihererom.
o~~~~ means a medIcInal producI whIch,
when ready or use, conIaIns one or more radIonuclIdes
Included or a medIcInal purpose.
o means a person who Is regIsIered
In FarI 2 o Ihe regIsIer maInIaIned by Ihe HealIh FroessIons
CouncIl under ArIIcle S o Ihe HealIh FroessIons Order
2001.
o ~ means a person who Is regIsIered In
FarI 4 o Ihe regIsIer maInIaIned by Ihe HealIh FroessIons
CouncIl under ArIIcle S o Ihe HealIh FroessIons Order
2001.
o ~ means a person regIsIered
In Ihe regIsIer o dIspensIng opIIcIans maInIaIned under sec-
IIon 7(b) o Ihe OpIIcIans AcI 18.
o means a person regIsIered In Ihe
MIdwIves' FarI o Ihe proessIonal regIsIer.
o means a person regIsIered In Ihe Nurses'
FarI or SpecIalIsI CommunIIy FublIc HealIh Nurses' FarI o Ihe
proessIonal regIsIer.
6 General legal requirements
p ~ means Ihe European Fharmaco-
poeIa, Ihe BrIIIsh FharmacopoeIa, Ihe BrIIIsh FharmaceuIIcal
Codex, Ihe InIernaIIonal FharmacopoeIa, Ihe CumulaIIve LIsI
o Recommended InIernaIIonal NonproprIeIary Names, Ihe
BrIIIsh NaIIonal Eormulary, Ihe DenIal FracIIIIoners
Eormulary (or oIher oIcIal compendIa whIch may In Ihe
uIure be produced under Ihe MedIcInes AcI 1o8, SecIIon )
and Ihe lIsI o names prepared and publIshed under SecIIon
100 o Ihe MedIcInes AcI 1o8.
p In relaIIon Io a relevanI medIcInal producI means
Ihe conIenI o acIIve IngredIenI In IhaI producI expressed
quanIIIaIIvely per dosage unII, per unII volume or by weIghI,
accordIng Io Ihe dosage orm.
p~ means:
(a) a regIsIered nurse,
(b) a pharmacIsI,
(c) a regIsIered mIdwIe, or
(d) a person whose name Is regIsIered In Ihe parI o Ihe reg-
IsIer maInIaIned by Ihe HealIh FroessIons CouncIl In pur-
suance o ArIIcle S o Ihe HealIh FroessIons Order 2001
relaIIng Io:
(I) chIropodIsIs and podIaIrIsIs,
(II) physIoIherapIsIs,
(III) radIographers: dIagnosIIc or IherapeuIIc, or (e) a regIs-
Iered opIomeIrIsI
agaInsI whose name Is recorded In Ihe relevanI regIsIer an
annoIaIIon or enIry sIgnIyIng IhaI he Is qualIIed Io order
drugs, medIcInes and applIances as a supplemenIary pre-
scrIber or, In Ihe case o a nurse or mIdwIe, as a nurse Inde-
pendenI}supplemenIary prescrIber.
r ~~ means a preparaIIon, IncludIng a moIher
IIncIure, prepared by a process o soluIIon, exIracIIon or IrIIu-
raIIon wIIh a vIew Io beIng dIluIed Ienold or one hundredold,
eIIher once or repeaIedly, In an InerI dIluenI and Ihen used
eIIher In IhIs dIluIed orm or, where applIcable, by ImpregnaI-
Ing IableIs, granules, powders or oIher InerI subsIances.
s~ ~ means:
(a) any subsIance or combInaIIon o subsIances presenIed as
havIng properIIes or IreaIIng or prevenIIng dIsease In anI-
mals, or
(b) any subsIance or combInaIIon o subsIances IhaI may be
used In, or admInIsIered Io, anImals wIIh a vIew eIIher Io
resIorIng, correcIIng or modIyIng physIologIcal uncIIons
by exerIIng a pharmacologIcal, ImmunologIcal or meIabol-
Ic acIIon, or Io makIng a medIcal dIagnosIs.
s~ means a requIsIIIon whIch sIaIes,
In accordance wIIh ArIIcle 14 paragraph (2)(II) o Ihe MIsuse
o Drugs RegulaIIons 2001, as amended, IhaI Ihe recIpIenI Is a
veIerInary surgeon or veIerInary pracIIIIoner.
7
Introduction
8 General legal requirements