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Index

Key

numbers refer to clauses in the Code

si refers to supplementary information to a clause in the Code

¶ followed by number refers to a paragraph in the Constitution and Procedure

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

abbreviated advertisements – 5

ABPI (the Association of the British Pharmaceutical Industry)
  Board of Management – ¶ 1.3, ¶ 3.1, ¶ 11.4, ¶ 12, ¶ 13.4, ¶ 16.1 & ¶ 16.6  examinations – 16.3 to 16.6 & si

absolute risk, reference to – si to 7.2
 
administrative charges
  appeals against number of – ¶ 16.5
  determination of charges
    in cases – ¶ 16.5
    in relation to admissions – ¶ 16.4
    in co-promotion – ¶ 16.3
    levels of – ¶ 16.2
failure to pay – ¶ 16.6
payment of in relation to rulings
  by Appeal Board – ¶ 10.1 & ¶ 10.2
  by Panel – ¶ 7.1 & ¶ 7.2

administrative staff, promotion to – si to 1.1
admissions by pharmaceutical companies – ¶ 5.6 & ¶ 16.4

advance notification of new products – si to 3.1

adverse event reporting mechanisms – 4.10 & si, 5.6 & si

advertising to the public – 1.1 & 22.1 & si

advice on Code – ¶ 18.1

all-embracing claims – 7.10 & si

amendments to Code and Constitution and Procedure – ¶ 19

amount of advertising in journals – 6 & si

animal data, use of – si to 7.2

appeals against Panel rulings
  appeals by complainants – ¶ 7.3 & ¶ 7.4
  appeals by respondent companies – ¶ 7.3 & ¶ 7.5
  appearance before Appeal Board – ¶ 4.6
  withdrawal of appeals – ¶ 15

approval of promotional material – see certification

artwork, illustrations, graphs and tables
  general – 7.8
  abbreviated advertisements – si to 5.4, 5.5, 5.6, 5.7, 5.8 & 5.9
  references to sources when taken from published
    studies – 7.8 & si
see also si to 7.2 on use of statistical information

audio, audio-visual material and interactive data systems etc
  abbreviated advertisements not permitted – 5.2
  certification – si to 14.1
  prescribing information requirements – 4.4 & si, 4.5 & 4.6

audit of company’s procedures – ¶ 10.4, ¶ 11.3 & ¶ 12.2
charges for – ¶ 16.1c

automated calling systems – 9.9

B

benefit/risk profile – si to 7.10

benefits – 18.1 & si & 18.6 & si

black triangle symbol – 4.11 & si and si to 4.1
  in abbreviated advertisements – 5.7 & si

Blue Guide – si to 1.1 & 24.1, 24.4 & 24.5Legislation

bonus stock – see samples – si to 17

brand names, use of other companies’ – si to 7.3

Bribery Act 2010 - Legislation

briefing material for representatives – 15.9 & si

British Medical Association
  case reports – ¶ 13.5
  consultation with on appointment of Appeal Board independent 
    registered medical practitioners – ¶ 3.2
    on Code – ¶ 19.2
  Medical Ethics Today – Legislation
carers, hospitality to – si to 23.2

C

case preparation manager – ¶ 2.1, ¶ 5.1, ¶ 5.2, & ¶ 5.6

case reports – ¶ 13

certification
  general – 14
  audio and audio-visual material etc – si to 14.1
  content of certificate – 14.5
  educational material relating to diseases or medicines – 14.3
  Internet – si to 14.1
  joint working material – 14.3
  meetings held outside UK – 14.2
  non-promotional material relating to the provision of 
    medical and educational goods and services – 14.3
  notification of signatories – 14.4
  patient organisation material – 14.3
  patient support programme material – 14.3
  preservation of certificates – 14.6 & si
  promotional aids – si to 14.1
  promotional material – 14.1
  promotional material at international conferences
    in UK – si to 3
  qualifications and experience of signatories – 14.1 & si

children in advertisements – si to 7.8

clinical assessments – 12.2

clinical and scientific opinion
  current views of authors – 10.4 & si
  disparaging clinical and scientific opinion – 8.2
  emerging opinion – si to 7.2

clinical trials, disclosure of details – 21.3 & si

clinical trial data, use of – si to 7.5

Codes of Practice for Advertising Over-the-Counter Medicines of the PAGB – page 57

Code of Practice Appeal Board
  Constitution and Procedure – ¶ 3 & ¶ 4
  independent members to be in a majority – ¶ 4.2
  membership – ¶ 3.2
  power to publicly reprimand – ¶ 10.5 & ¶ 11.3
  power to require audit – ¶ 10.4 & ¶ 11.3
  power to require a corrective statement – ¶ 10.6 & ¶ 11.3
  power to require pre-vetting – ¶ 10.4 & ¶ 11.3
  power to require recovery of items – ¶ 10.3 & ¶ 11.3
  reports from Code of Practice Panel – ¶ 4.1 & ¶ 8
  reports to ABPI Board – ¶ 12.1
  reports to, consideration of – ¶ 11
  rulings – ¶ 10

Code of Practice levy – ¶ 16.1

Code of Practice Panel
  Constitution and Procedure – ¶ 2
  membership – ¶ 2.1
  power to suspend advertising on complaints from
    Medicines and Healthcare products Regulatory
    Agency – ¶ 9.2
  power to suspend material or activities in certain
    circumstances pending an appeal – ¶ 7.1
  reports to Appeal Board – ¶ 4.1 & ¶ 8
  rulings – ¶ 7

Commission on Human Medicines, references to – 9.5
Committee on Safety of Medicines, references to – 9.5

comparisons
  general – 7.2 & 7.3 & si
  disparaging references, prohibition on – 8.1 & si
  hanging comparisons – si to 7.2
  price/cost comparisons – si to 7.2

competitions & quizzes – si to 18.1

complaints procedure
  complaints from Medicines and Healthcare
    products Regulatory Agency – ¶ 9
  confidentiality of complainants – see introduction to
    Constitution and Procedure – page 40
  dealing with complaints – ¶ 5 to ¶ 13
  making complaints
    general – see introduction to Constitution and
      Procedure – page 40
    by pharmaceutical companies – ¶ 5.3
    withdrawal of complaints – ¶ 15

conciliation between companies – ¶ 18.2

conferences – see meetings

confidence in the industry – 2 & si

consultants
  disclosure of payments to – 20.2 & 20.3 & si
  from patient organisations – 23.8 & si
  use of – 20 & si

continuing professional development meetings and courses – si to 19.1
contracts with institutions etc – 18.7

co-promotion – si to 14.1

corporate advertising, examination of – si to 14.3

cost comparisons – si to 7.2

criticism in media – ¶ 6

current views of authors – 10.4 & si

D

data on file, provision of – 7. 7

date of prescribing information – 4.2

date of promotional material – 4.9

delivery of items by representatives – si to 15.3

discounts – see trade practices

discredit to the industry – 2 & si

disease awareness campaigns – si to 22.2
  Disease Awareness Campaigns Guidelines – si to 22.2 & Legislation

disguised promotion – 12 & si

disparaging references, prohibition on – 8 & si

distribution of promotional material – 11 & si 

doctors, use of names and photographs – 9.3

donations
  in lieu of hospitality – si to 15.3
  to charities – si to 15.3 & 18.1
  to institutions etc – 18.6 & si
  see also prohibition on financial inducements – 18.1

DVDs for health professessionals – si to 18.1
economic evaluation of medicines – si to 7.2

E

educational goods and services, provision of – 18.4 & si

EFPIA Code on the Promotion of Prescription – Only Medicines to, and Interactions with, Healthcare Professionals – see introduction to Code & page 57

EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations – see introduction to Code & Legislation

electronic data communications – 9.9

email, use of – 9.9 & si & si to 15

employee responsible for ensuring compliance with Code – 1.9 & si

employees, current and prospective, information for – si to 22.2

European Directive – see introduction to Code & page 57

exaggerated or all-embracing claims – 7.10 & si

examinations for representatives – 16.3 to 16.6 & si

exhibitions and exhibition panels, prescribing information requirements – si to 4.1

experience programmes – 12.2

extremes of format, size & cost of promotional material – 9.7 & si – see also si to 11.2

F

facsimile, use of – 9.9 & si to 15

films – see audio, audio-visual material and interactive data systems etc

financial inducements, prohibition of – 18.1

free goods – see samples – si to 17

frequency
  of mailings – 11.2 & si
  of mailings for new medicines – si to 11.2
  of calls by representatives – 15.4 & si

G

General Medical Council – si to 15.3, 18.1 & 19.1 & page 57

General Pharmaceutical Council – si to 15.3, 18.1 & 19.1 & Legislation
gifts – 18.1 & si

grants to institutions etc – 18.6 & si

graphs – see artwork, illustrations, graphs and tables

guidelines on company procedures relating to the Code of Practice – Guidelines

H

hanging comparisons – si to 7.2

health professionals, use of names and photographs – 9.3

health professions, criticism of – 8.2

healthy volunteer studies, use of data from – si to 7.2

high standards, maintenance of – 9.1

Human Medicines Regulations 2012 - see introduction to the Code & Legislation 

I

IFPMA Code of Practice – see introduction to Code & Legislation

illustrations
  see artwork, illustrations, graphs and tables

inducements – 18.1

information to the public – 22 & si, 24 & si

inserts in journals
  cannot be abbreviated advertisements – 5.2
  size of – 6.2
  see also si to 6.3

interactive data systems
  see audio, audio-visual material and interactive
  data systems etc

international conferences, symposia and meetings
  see meetings

international journals, advertising in – si to 1.1

Internet
  general – 24
  abbreviated advertisements not permitted – 5.2
  access to promotional material by public – si to 24.1
  certification – si to 14.1
  journals – 24.4
  prescribing information requirements – 4.6

in-vitro data, use of – si to 7.2

items delivered by representatives – si to 15.3

J

joint ventures & co-promotion – si to 14.1
joint working with the NHS – si to 1.1 & 18.5 & si

journal advertising
advertising in international journals – si to 1.1
  specific requirements – 4.7 & 6
  see also abbreviated advertisements in professional
  publications – 5.2 & si

K

‘knocking copy’ – 8.1 & si – see also 7.3

L

labelling
  labelling of medicines – 1.2 under ‘It does not include’
  labelling of samples – 17.5

legislation – page 57
levy
  failure to pay – ¶ 16.6
  level of – ¶ 16.1
licensing authority, references to – 9.5

limitations on journal advertising – 6 & si

loans,long term or permanent – si to 18.1

M

mailings
  frequency and number of – 11.2 & si
  mailed medicines – 17.10
  mailing lists – 11.3

margins – see trade practices

market extension – si to 1.1

market research
  disclosure of payments – 20.1 & si – 20.3 & si
  general – 12.2 & si
  guidelines – The Legal & Ethical Guidelines for
  Healthcare Market Research – si to 12.2 & page 57

market share claims – si to 7

marketing authorization – 3 & si

media
  complaints arising from – ¶ 6
  relations with – 22 & si

medical and educational goods and services, provision of – 18.4 & si

medicines
  distributed in hospitals – 17.8
  handled by representatives – 17.9
  posted – 17.10

Medicines and Healthcare products Regulatory Agency
  case reports – ¶ 13.5
  complaints from – ¶ 9
  consultation with
  on appointment of Appeal Board independent members – ¶ 3.1
  on Code – ¶ 19.2
  Disease Awareness Campaigns Guidelines – si to 22.2 & Legislation
  references to – 9.5
  MHRA Drug Safety Update - si to 9.5
  references to - 9.5
  submission of briefing material - 15.9 
  submission of certificates – 14.6
  submission of names of signatories for promotional material – 14.4
The Blue Guide Advertising and Promotion of Medicines in the UK – si to 1.1, 24.1, 24.4 & 24.5 & page 57

Medicines Commission, Commission on Human Medicines, Committee on Safety of Medicines, Medicines and Healthcare products Regulatory Agency,Medicines Control Agency and licensing authority, references to – 9.5 & si

meetings
  general – 19
  attendance by administrative staff – si to 19.1
  certification of meetings held outside the UK – 14.2
  continuing professional development (CPD) meetings and courses – si to 19.1
  exhibitions and exhibition panels, prescribing information requirements – si to 4.1
  held outside the UK – si to 19.1,
    certification of – 14.2
  hospitality, provision of – 19.1 & si
  involving travel outside the UK – si to 19.1,
    certification of – 14.2
  organised by affiliates – si to 19.1
  payment of room rental – 19.2 & si
  payment of travelling and accommodation expenses– 18.1 & 19 & si
  postgraduate education allowance (PGEA) meetings and courses – si to 19.1  prohibition on inducements and payments for interviews – 15.3 & 18.1 & si
  promotion at international meetings – si to 3 & 19.1, see also si to 1.1
  reports on meetings – si to 19.3, see also 10.3
  sponsorship of attendance at meetings, disclosure of – 19.4 & si
  sponsorship of meetings, disclosure of – 19.3
  subsistence, provision of – 19.1 & si
  venue, suitability of – 19.1 & si

membership
  of Code of Practice Appeal Board – ¶ 3.2
  of Code of Practice Panel – ¶ 2.1

memory sticks for health professionals - si to 18.1

MHRA Drug Safety Update - si to 9.5

N

naked or partially naked people, use of in advertising – si to 9.1 & 9.2

National Health Service, joint working with – si to 1.1 & 18.5 & si

new medicines
  advance notification of new products – si to 3.1
  avoidance of extremes of format, size or cost – si to 9.7
  introduction of a new medicine – 22.4
  limitations on mailings – 11.2 & si
  samples - 17.2 & si
  use of the word ‘new’ – 7.11

non - interventional studies of marketed medicines
  approval and supervision of – 21.2
  disclosure of – 13.2 & si
  general– 13

non-proprietary name, size and position – 4.3 & 5.5

Nursing & Midwifery Council – Standards of conduct, performance and ethics for nurses and midwives – si to 15.3, 18.1, 18.4 & 19.1 & page 57

O

offence, causing – 9.2

official documents, reproduction of – 9.6

outcome agreements – si to 18.1

over-the-counter medicines
  definition of term – 1.5
  scope of the Code – 1.1 & si

P

package deals – si to 18.1

package leaflets – 1.2 under ‘it does not include’
  on the Internet – 24.5
  provision to the public – si to 22.2 & 24.5

patient access schemes – si to 18.1

patient carers, hospitality to – si to 23.2

patient information leaflets
  provision by doctors to patients – si to 22.2
  see also package leaflets

patient organisations
  relationships with –23 & si
  disclosure of support – 23.7 & si
  services provided by – 23.8 & si

patients, items given to – 18.2 & si

patient support items – 18.2 & si

payments for interviews – 15.3 & si & 18.1 & si

pecuniary advantage, offer or provision of – 18.1 & si

pharmacovigilance – personnel’s knowledge of – 16.2

post - authorization studies – 12.2 & 13

postcards, use of – 9.8

posted medicines – 17.10

postgraduate education allowance (PGEA) meetings and courses – si to 19.1

post-marketing surveillance studies – 12.2 & 13

potency per weight claims – si to 7.2

pre-printed private prescription forms – si to 9.1 & 9.2

prescribing information
  general – 4
  date of – 4.2
  exemptions – 4.1 &5.1
  legibility – 4.1 & si
  provision on
    audio, audio-visual etc – 4.4 & si &4.5
    exhibitions and exhibition panels – si to 4.1
    Internet – 4.6
    journal advertisements –4.7
    multi-page advertisements other than journal
      advertisements – 4.8
    requisite information – 4.2
    size of non-proprietary name – 4.3
    typesize – si to4.1

prescription forms
  pre-printed private prescription forms – si to9.1 & 9.2
  reproduction of official documents – 9.6

Prescription Medicines Code of Practice Authority
  annual report – ¶ 20
  material to be supplied to Authority
    authority of Director to require material – ¶ 1.4
    copies of certificates – 14.6
    examination status of representatives – 16.6
   material required for scrutiny – ¶ 17.1
    medical representatives briefing material – 15.9
    names of signatories – 14.4
  scrutiny – ¶ 17
  structure and responsibilities – ¶ 1

press conferences and press announcements – 22.2 & si

pre-vetting
  cost of – ¶ 10.4 & ¶ 11.3
  power of Appeal Board to require – ¶ 10.4 & ¶ 11.3

price comparisons – si to 7.2

price lists – 1.2 under ‘it does not include’

prices – see trade practices

prizes – si to 18.1

private prescription forms, preprinted – si to 9.1 & 9.2

professional publications – 5.2 & si for definition of term

promotional aids – 1.7 & 18.1 & si

public assessment reports (European & UK)
  outside scope of the Code – 1.2 under ‘It does not include’
provision of
  on the Internet –24.5
  to the public – si to 22.2 & 24.5 & si

public health campaigns – si to 22.2

public relations activities – 22 & si to22.2
  responsibility for – 22.5
public, relations with
  advertising to – 1.1 & 22 & si
  disease awareness campaigns – si to 22.2
  enquiries from – 22.3 & si
  exposed mailings – 9.8 & si
  Internet – 24
  provision of information to – 22 & si, 24 & si
  provision of samples to not allowed – 17.11
  public health campaigns – si to 22.2

Q

quizzes – si to 18.1

quotations – 10.2 & si, 10.3 & 10.4 & si see also 7.6

R

referee, independent – ¶ 5.1, 5.2, 5.3, 7.2, 7.4, 7.5 & 7.6

references
  prohibition in abbreviated advertisements – 5.9
  references to published studies – 7.6 & si, 7.8 & si

relative risk, reference to – si to 7.2

reminder advertising
  see abbreviated advertisements

replies to individual enquiries – 1.2 & si

reply paid cards – si to 9.8
  reply paid cards offering items to be delivered by
  representatives – si to 15.3
  see also samples, request forms – 17.3 & si

representatives
  general – 15
  briefing material – 15.9 & si
  contract representatives – si to 15
  definition of term – 1.6
  delivering items – si to 15.3
  examinations – 16.3 to 16.6
  frequency & manner of calls on doctors – 15.4 & si
  hospitality and payments for meetings – si to 15.3
  identifying themselves – 15.5
  items delivered by representatives – si to 15.3
  prohibition on payments for interviews – 15.3 & si
  provision of summary of product characteristics by representatives – 15.8 & si
  training, general – 15.1, 16.1, 16.3 to 16.5 & si

reprints of articles, distribution of – 10.1 & si

reproduction of official documents – 9.6

risk/benefit profile – si to 7.10

risk, relative and absolute – si to 7.2

risk sharing agreements – si to 18.1

room rental, payment – 19.2 & si

Royal College of Nursing
  case reports – ¶ 13.5
  consultation with
    on appointment of Appeal Board independent
    registered nurse prescriber – ¶ 3.2
    on Code – ¶ 19.2

Royal Pharmaceutical Society
  case reports – ¶ 13.5
  consultation with
    on appointment of Appeal Board independent
    registered pharmacist – ¶ 3.2
    on Code – ¶ 19.2

rubber stamps as aids to prescription writing – si to 9.1 & 9.2

rulings
by Appeal Board – ¶ 10
  by Panel – ¶ 7

S

‘safe', use of the word – 7.9 & si

samples
  general – 17
  definition of – si to 17
  distribution
    in hospitals – 17.8
    to the public not allowed – 17.11
  identification samples – si to 17
  labelling – 17.5
  maximum number of – 17.2
  posted – 17.10
  request forms and their retention – 17.3 & si
  size – 17.4
  starter packs – si to 17
  system of control and accountability – 17.9
  titration packs – si to 17
  use as inducement – 17.12
  use for patient treatment – 17.12
  which medicines can be sampled? – 17.2 & si

sanctions
  audit of company’s procedures – ¶ 10.4, ¶ 11.312.2
  case reports – ¶ 13
  corrective statements – ¶ 10.6 & ¶ 11.3
  pre-vetting – ¶ 10.4 & ¶ 11.3
  publication in medical, pharmaceutical and nursing press - ¶ 13.7
  recovery of items – ¶ 10.3 & ¶ 11.3
  reports to Appeal Board and ABPI Board – ¶ 8, ¶ 11 & ¶ 12
  reprimand and publication – ¶ 10.5 & ¶ 11.3
  suspension/expulsion from ABPI – ¶ 12.2
  special provision for non ABPI companies – ¶ 11.4 & ¶ 12.2
  undertakings from companies ruled in breach – ¶ 7.1, 7.3 & ¶ 10.2

scientific service in charge of information
  general – 21.1
  reports on side effects by representatives – 15.6

scientific service in charge of non-interventional studiesof marketed medicines – 21.2

scope of the Code – 1 & si

scrutiny – ¶ 17

sexual imagery, use of – si to9.1 & 9.2

side-effects
  claims about – 7.9
  need to consult SPC – 4.2 & 5.4
  references to in prescribing information – 4.2
  reporting by representatives – 15.6

size of promotional material
  abbreviated advertisements, size of – 5.3
  journal advertisements, size of – 6
  see also extremes of format

sponsorship of material and meetings, disclosure of – 9.10 & 19.3

sponsorship of meeting attendance, disclosure of – 19.4 & si

starter packs – si to 17
  statistical information, use of – si to 7.2
  see also si to 7.8 on artwork, illustrations, graphs and tables

subsistence, provision of – 19.1 & si
substantiation of information, claims and comparisons
7.4 & 7.5
suitability and taste – 9.1 & 9.2 & si

summaries of product characteristics
  outside scope of the Code – 1.2 under ‘It does not include’
  need to consult – 4.2 & 5.4
  provision of
    by representatives – 15.8 & si
    on the Internet – 24.5
    to the public – si to 22.2 & 24.5 & si
    with press releases and press packs – si to 22.2
    with samples – 17.5
  summary in prescribing information – 4.2
superlatives – 7.10 & si

suspension of advertising on complaints from Medicines and Healthcare products Regulatory Agency – ¶ 9.2

suspension of material or activities pending appeal when required by Panel – ¶ 7.1 & ¶ 7.3

switch and therapy review programmes – si to 18.4

symposia – see meetings

T

tables – see artwork, illustrations, graphs and tables

taste in advertising – si to 9.1 & 9.2

‘teaser’ advertising – si to 9.1 & 9.2

telemessages, use of – 9.9 & si to 15

telephone and text messages, use of – 9.9 & si to 15

terms of trade – see trade practices

textbooks, provision of – si to 18.1

text messages, use of – 9.9 & si to 15

‘the’, use of the word – si to 7.10

therapy review programmes – si to 18.4

timing under complaints procedure
  general – ¶ 14
  appeals – ¶ 7.3
  commenting on appeal by complainant – ¶ 7.4
  commenting on appeal by respondent – ¶ 7.5
  extensions – ¶ 7.1, ¶ 7.3 & ¶ 14
  payment of administrative charge – ¶ 7.1, ¶ 7.2, ¶ 10.1 & ¶ 10.2
  providing an undertaking on rulings by
    Appeal Board – ¶ 10.2    Panel – ¶ 7.1 & ¶7.3
  responding to complaint – ¶ 5.4
  suspension pending appeal when required by Panel – ¶ 7.1 & ¶ 7.3

titration pack – see samples – si to 17

trade practices, prices, discounts, margins, etc – si to 18.1

training
  training on Code – 16.1 & si
  training of representatives – 15.1, 16.1, 16.3 to 16.5 & si

travelling expenses – 18.1 & 19 & si

U

unauthorized medicines and unauthorized indications – 3 & si - see also unlicensed medicines

undertakings by companies ruled in breach – ¶ 7.1, ¶ 7.3 & ¶ 10.2

undertakings, breach of – 25

‘unique’, use of the word – si to 7.10

unlicensed medicines, price lists of - 1.2 & si 

V

volume of promotional material – 11.2 & si

voluntary admissions by pharmaceutical companies –¶ 5.6 & 16.4

W

WHO Ethical criteria for medicinal drug promotion – see introduction to Code and page 57

withdrawal of complaints and appeals – ¶ 15

‘wraparounds’ on journals – si to 6.2

 yellow cards - 4.10 & 5.6