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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

ABCDEFGHIJKLMNOPQRSTUVWXYZ

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 & 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 reactions
  claims about – 7.9
  need to consult SPC – 4.2 & 5.4
  references to in prescribing information – 4.2
  reporting mechanisms – 4.10 & si, 5.6 & si
advertising to the public – 1.1 & 26.1 & 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 & si & 4.6

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

automated calling systems – 9.9

B

benefit/risk profile – si to 7.10

benefits – 18.1 & si & 19.1 & 19.2 & si

black triangle symbol – 4.11 & si and si to 4.1
  in abbreviated advertisements –
5.7 & si
  in material intended for patients –
26.3 & si

Blue Guide – si to 1.1 & 28.1, 28.4 & 28.5 & page 60

bonus stock – see samples – si to 17

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

Bribery Act – page 60

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– page
60

C

carers, hospitality to – si to 27.2

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 – 13.1 & si

clinical trial data, use of – si to 7.5

Codes of Practice for Advertising Over-the-Counter Medicines of the PAGB – page 60

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, Medicines and Healthcare Products Regulatory Agency and licensing authority, references to – 9.5 & si

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

Competition and Markets Authority consultation with on Code – ¶ 19.2

complaints procedure
   complaints from Medicines and Healthcare products Regulatory Agency – ¶ 9
   confidentiality of complainants – see introduction to Constitution and
    Procedure – page
42
   dealing with complaints – ¶
5 to ¶ 13
   making complaints
    general – see introduction to Constitution and
    Procedure – page
42
    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 – 23.2 & 23.3 & si
  from patient organisations –
27.8 & si
  use of –
23 & si

continuing professional development meetings and courses – si to 22.1

contracts with institutions etc – 21

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 26.2
Disease Awareness Campaigns Guidelines – si to
26.2 & page 60

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 –
19.1 & 19.2 & si
  see also prohibition on financial inducements –
18.1

DVDs for health professessionals – si to 18.1

dynamic content for websites – si to 14.1

E

economic evaluation of medicines – si to 7.2

educational goods and services, provision of – 19.1 & si

EFPIA Code on the Promotion of Prescription – Only Medicines to, and Interactions with, Healthcare Professionals – see introduction to Code & page 60

EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations – see introduction to Code & page 60

EFPIA Code on Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations – see introduction to Code & page 60

electronic data communications – 9.9

email, use of – 9.9 & si & si to 15

emoticons, use of – si to 9.1 & 9.2

employee responsible for ensuring compliance with Code – 1.12 & si

employees, current and prospective, information for – si to 26.2

Europe – definition of term – si to 24.1

European Directive – see introduction to Code & page 60

exaggerated or all-embracing claims – 7.10 & si

examinations for representatives – 16.3 to 16.4 & 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-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 & 22.1 & page 60

General Pharmaceutical Council – si to 15.3, 18.1 & 22.1 & page 60

gifts – 18.1 & si

grants to institutions etc – 19.1 & 19.2 & si

graphs – see artwork, illustrations, graphs and tables

guidelines on company procedures relating to the Code of Practice – page 53

H

hanging comparisons – si to 7.2

health professionals, use of names and photographs – 9.3

health professions, criticism of – 8.2

healthcare organisation – definition of term – 1.9 & si

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

high standards, maintenance of – 9.1

hospitality – 22
  limit on cost of meal –
22.2 & si

Human Medicines Regulations – see introduction to Code & page 60

I

IFPMA Code of Practice – see introduction to Code & page 60

illustrations
  see artwork, illustrations, graphs and tables

inducements – 18.1

information to the public – 26 & si, 28 & 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 – 28
  abbreviated advertisements not permitted –
5.2
  access to promotional material by public – si to
28.1
  certification – si to
14.1
  journals –
28.4
  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 & 20 & 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 60

levy
  failure to pay – ¶ 16.6
  level of – ¶
16.1

licensing authority, references to – 9.5

limitations on journal advertising – 6 & si

links to prescribing information – 4.4 & 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 – 23.1 & si – 23.3 & si
  general – 12.2 & si
  guidelines – The Legal & Ethical Guidelines for
  Healthcare Market Research – si to 12.2 & page 60

market share claims – si to 7

marketing authorization – 3 & si

meals – limit on cost – 22.2 & si

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

medical and educational goods and services, provision of – 19 & 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 26.2 & page 60 
  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, 28.1, 28.4 & 28.5 & page 60

meetings general – 22
  attendance by administrative staff – si to
22.1
  certification of meetings held outside the UK –
14.2
  continuing professional development (CPD) meetings and courses – si to
22.1
  exhibitions and exhibition panels, prescribing information requirements – si to
4.1
  held outside the UK – si to
22.1,
  certification of –
14.2
  hospitality, provision of –
22.1 & si
  involving travel outside the UK – si to
22.1,
  certification of –
14.2
  organised by affiliates – si to
22.1
  payment of room rental –
22.3 & si
  payment of travelling and accommodation expenses –
22 & si
  prohibition on inducements and payments for interviews –
15.3 & 18.1 & si
  promotion at international meetings – si to
3 & 22.1, see also si to 1.1
  reports on meetings – si to
22.4, see also 10.3
  sponsorship of attendance at meetings, disclosure of –
22.5 & si
  sponsorship of meetings, disclosure of –
22.4
  subsistence, provision of –
22.1 & si
  venue, suitability of –
22.1 & 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 & 20 & 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 –
26.5
  limitations on mailings –
11.2 & si
  use of the word ‘new’ –
7.11

non - interventional studies of marketed medicines
  approval and supervision of – 25.2 
  disclosure of –
13.3 & si
  general –
13.2 to 13.4 & si

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 & 22.1 & page 60

O

offence, causing – 9.2

official documents, reproduction of – 9.6

other relevant decision makers – definition of term – 1.5

outcome agreements – si to 18.1

over-the-counter medicines
  definition of term – 1.6
  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 –
28.5
  provision to the public – si to
26.2 & 28.5

patient access schemes – si to 18.1

patient carers, hospitality to – si to 27.2

patient information leaflets
  provision by doctors to patients – 26.2 & 26.3 & si
  see also package leaflets

patient organisations
  relationships with – 27 & si
  disclosure of support –
27.7 & si
  services provided by –
27.8 & 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

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-visual etc –
4.5 & si
    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 to
4.1

prescription forms
  pre-printed private prescription forms – si to 9.1 & 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 –
16.4
    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 – 26.2 & 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 – 1.8 & 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 –
28.5
    to the public – si to
26.2 & 28.5 & si

public health campaigns – si to 26.2

public relations activities – 26 & si to 26.2
  responsibility for –
26.6

public, relations with
  advertising to – 1.1 & 26 & si
  disease awareness campaigns – si to
26.2
  enquiries from –
26.4 & si
  exposed mailings –
9.8 & si
  Internet –
28
  provision of information to –
26 & si, 28 & si
  provision of samples to not allowed –
17.11
  public health campaigns – si to
26.2

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

remote detailing – si to 9.9

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 –
1.7
  delivering items – si to
15.3
  examinations –
16.3 & si
  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 & 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 – 22.3 & 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

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, ¶ 11.3 & ¶ 12.2
  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 – 25.1
  reports on adverse reactions by representatives –
15.6

scientific service in charge of non-interventional studies of marketed medicines – 25.2

scope of the Code – 1 & si

scrutiny – ¶ 17

Serious Fraud Office
  consultation with on Code – ¶ 19.2

sexual imagery, use of – si to 9.1 & 9.2

side-effects – see adverse reactions

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 & 22.4

sponsorship of meeting attendance, disclosure of – 22.5 & 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 – 22.1 & si 22.2 & 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 –
28.5
    to the public – si to
26.2 & 28.5 & si
    with press releases and press packs – si to
26.2
    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 19.1

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 19.1

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 & si

transfers of value – 24
 
central platform for disclosure – si to 24.1
  definition of term –
1.10 & si

travelling expenses – 22 & 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 – 29

‘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 60

withdrawal of complaints and appeals – ¶ 15

‘wraparounds’ on journals – si to 6.2

Y

yellow cards– 4.10 & 5.6