Pharmacy and

Medicines Law
in Ireland

Edited by
Peter Weedle BPharm, LLM, PhO, MRPharmS, MPSI
Community Pharmacist
Adjunct Professor of Clinical Pharmacy
University College Cork

Leonie Clarke BSc(Pharm), MSc, COipAF, Dip Legal Studies,

Cert EU Law, MPSI
Pharmaceutical Consultant

london • Chicago
(RP)
Pharmaceutical Press
Contents

Foreword xi
Acknowledgements xvii
About the editors xix
Contributors xxi
Abbreviations xxiii
Latin terms xxvii
Citation of legislation and cases xxix

1 Introduction 1
P Weedle and L Clarke

2 Sources of Irish law 5

F Crean and P Weedle
Irish legal history 5
The Constitution 6
Legislation 7
Common law 7
European law 8
Alternative dispute resolution 10

3 Historical development of medicines and pharmacy law 11

P Weedle, F Crean and L Clarke
To ensure the purity of drugs 12
To raise revenue from the sale of drugs 14
To prevent the misuse of drugs 15
To protect the public 16
To regulate the sale and supply of medicines 17
From the 1960s to the present day 19

4 Placing medicines on the market 25

L Clarke and JM Morris
Key definitions and terms 26
vi I Contents

Registration systems for medicines in Europe 27

Requirement for medicinal products to be licensed 29
Summary of product characteristics 34
Labelling and package leaflets 36
Supply classification 40
Obligations of marketing authorisation and certificate holders 42
Pharmacovigilance 43
Particular categories of medicinal products 44
Clinical trials 48
Pharmacopoeias and European Directorate for the Quality of Medicines 50

5 Manufacturing and wholesaling of medicines 53

JM Morris and L Clarke
Manufacture of medicinal products 53
Wholesale supply of medicinal products 61

6 Advertising of medlcines 67
L Clarke
Scope of Advertising Regulations 68
General provisions on advertising 69
Advertising to the general public 70
Advertising to persons entitled to prescribe or supply medicinal products 73
Medical sales representatives 75
Gifts and hospitality 76
Free sam pies of medicinal products 77
Duties of marketing authorisation and certificate holders 77
Self-regulation and enforcement 78

7 Prescriptlon and control of supply of medicines 81

P Gallagher, L Sahm and L Clarke
Key definitions 82
Medicines·cOnt'lhed tosupply on prescription 83
Administration of medicinal products 84
Exemptions from prescription-control 84
Supply classification system 85
Nurse prescribing 88
Prescription writing requirements 89
Dispensing rules
90
Emergency supply of prescription medicines 93
Labelling of dispensed medicines ..
95
Pharmacy records ,-
96
Paracetamol supply
99
Expiry dates
101
 Contents I vii

Mailorder supply 102

Vending machines 102
Exemptions from prescription requirements 103
Appendix 7.1 Substances which when contained in certain
non-prescription medicinal products may only be supplied in the
manufacturer's original container showing the legal classification for supply 106
Appendix 7.2 Substances which are normally SIA but may be
dispensed as SIB medicines in certain circumstances 106
Appendix 7.3 Medicines that cannot be supplied without a
prescription in an emergency at the request of a patient 107
Appendix 7.4 Cautionary and warning notices for dispensed medicinal
products 108
Appendix 7.5 Supply of medicines to pre-hospital emergency care
providers 111

8 Misuse of Drugs Acts and Regulations 119

L Sahm and P Weedle
The Misuse of Drugs Acts 119
The Misuse of Drugs Regulations 121
The schedules 121
General prohibitions 123
Prescription requirements 127
Dispensing requirements 130
Labelling of controlled drugs 131
Requisitions 131
Hospitals 132
Midwives 132
Ships 133
Offshore installations 133
Messengers 134
Export 134
Registers 134
Retention of records 135
Wholesalers and suppliers 135
Retention of invoices 136
Furnishing information 136
Destruction of controlled drugs 136
Cessation of business 137
Role of the 1MB 137
Storage of controlled drugs 138
Methadone 138
Scheduled substances 139
'Legal highs' 140
viii I Contents

Enforcement 141
Appendix 8.1 Controlled drugs classified into five schedules 142

9 Poisons Acts and Regulations 153

5 Byme and L C/arke
Poisons Act 153
Scope of Poisons Regulations 153
Role of the Pharmacy Act 2007 in the control of poisons 155
Poisons Council (Comhairle na Nimheanna) 155
Schedules to Poisons Regulations 156
General restrictions on sale of poisons 156
lieensed seilers 159
Restrictions on sales of eertain poisons 160
Reeords for Sehedule 2 poisons 161
Restrietions on sales to shopkeepers 163
Storage 164
Labelling of poisons 164
Exemptions 165
Enforcement 166
Appendix 9.1 list of substances declared to be poisons 167
Appendix 9.2 Comhairle na Nimheanna/Poisons Couneil 170
Appendix 9.3 Poisons to whieh record-keeping requirements apply 174
Appendix 9.4 General and specific exemptions from requirements
of POisons Regulations 175
Appendix 9.5 Restrietions on licensed seilers 178

10 Veterinary medicines 183

o Gaughan and 5 McCarthy
EU legislation 183
Nationallegislation 184
Terminology 185
Authorisation requirements 185
Authorisation procedures 186
Exceptional authorisation/administration of an animal remedy 188
Issuing of a licence by the Minister 189
The 'caseade' 190
Manufacture, import and export of animal remedies and starting materials 192
Restrietions on sale of animal remedies 193
Wholesale supply of animal remedies 195
Licensed merchants 196
Companion animal medicines seilers 197
Veterinary prescribing 198
Dispensing requirements for veterinary prescriptions 199
 Contents I Ix

Emergency supply of prescription-only animal remedies 200

Labelling of animal remedies 201
Record-keeping and other requirements for veterinary
practitioners and pharmacists 203

I Possession of animal remedies

Administration of animal remedies
Animal Remedies Record
Advertising of animal remedies
Control of animal remedies and their residues
203
204
205
205
205

11 Methylated spirits legislation 207

5 Byme and P Weedle
Definitions 207
Manufacture 208
Retail sales 208

12 The Pharmacy Act 211

o Dowling
The passing of the 2007 Act 218
Overview of how the 2007 Act works 218
Preliminary and general (Part 1) 220
The Pharmaceutical Society of Ireland (Part 2) 222
The Council of the Society (Part 3) 223
Code of Conduct 226
The Society as an educator 226
The pharmaceutical registration system (Part 4) 227
Offences (Part 5) 232
Complaints, inquiries and discipline (Part 6) 235
Improper relationships between pharmacists and doctors 240
! Powers of investigation (Part 7) 241
I Miscellaneous (Part 8) 242
I The Registrar 242
1
f
Conclusion
Appendix 12.1 Pharmaceutical Society of Ireland Code of Conduct for
243
I
$ Pharmacists 244
!
I 13 Pharmacy Act - regulations and rules 255
}
L Clarke, P Weedle and 0 Dowling
J
)$
Regulation of retail pharmacy businesses regulations 256
Pharmaceutical $ociety of Ireland rules 259

14 The pharmacy disciplinary system 263

F Crean and P Weedle
Overview of disciplinary system 264
x I Contents

The Preliminary Proceedings Committee 266

Interim suspension of registration 270
Procedure before a committee of inquiry 272
Categories of complaints 276
Sanctions 295
Selection of sanction 299
Role of the High Court 302
Functions of the Council after the imposition of sanction 305
Cancellation and restoration of registration by the Council 305
Applications regarding conditions on registration 308
Conclusion 308

15 Liability of community pharmacists in negligence and

for defective products 309
F Crean
Negligence 309
Regulation of Retail Pharmacy Business Regulations 2008: additional duties 313
Maintaining patient medical records 315
Checking a patient's medical history before sale or supply
of medicinal products 315
Sale and dispensing of medicinal products in pregnancy and lactation 316
Liability of supervising and superintendent pharmacists and
pharmacy owners 317
The standard of care 319
Apportionment of liability and causation 321
Causation and remoteness of damage - possible ramificatiOns of an error 322
Compensation 322
Defective products 323
Contract law 329
Disclosure of risks and informed consent 333

list of statutes 335

Index 338