This document provides definitions and explanations of key terms used in UK medicines legislation and regulations. It is intended as a practical guide for pharmacists on the legal restrictions regarding the sale and supply of medicines and poisons. While every effort has been made to ensure accuracy, the document can only provide interpretation of the law, and the courts have the final say on legal matters. Key terms defined include accountable officer, additional supply optometrist, appropriate date, appropriate non-proprietary name, appropriate practitioner, appropriate quantitative particulars, care home, clinical management plan, common name, community practitioner nurse prescriber, contact lens specialist, container, cosmetic, and dental care professionals register.
This document provides definitions and explanations of key terms used in UK medicines legislation and regulations. It is intended as a practical guide for pharmacists on the legal restrictions regarding the sale and supply of medicines and poisons. While every effort has been made to ensure accuracy, the document can only provide interpretation of the law, and the courts have the final say on legal matters. Key terms defined include accountable officer, additional supply optometrist, appropriate date, appropriate non-proprietary name, appropriate practitioner, appropriate quantitative particulars, care home, clinical management plan, common name, community practitioner nurse prescriber, contact lens specialist, container, cosmetic, and dental care professionals register.
This document provides definitions and explanations of key terms used in UK medicines legislation and regulations. It is intended as a practical guide for pharmacists on the legal restrictions regarding the sale and supply of medicines and poisons. While every effort has been made to ensure accuracy, the document can only provide interpretation of the law, and the courts have the final say on legal matters. Key terms defined include accountable officer, additional supply optometrist, appropriate date, appropriate non-proprietary name, appropriate practitioner, appropriate quantitative particulars, care home, clinical management plan, common name, community practitioner nurse prescriber, contact lens specialist, container, cosmetic, and dental care professionals register.
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