Index

Choose a letter from the index to search the Code Of Practice

Key

links to Clauses in the Code
links to supplementary information to a Clause in the Code
links to a paragraph in the Constitution and Procedure

artwork, illustrations, graphs and tables
7.8
- abbreviated advertisements
  5.5
  5.6
  5.7
  5.8
  5.4
- see also si to 7.2 on use of statistical information
  7.2
- references to sources when taken from published studies
  7.8
  7.8
administrative charges
- appeals against number of
  16.5
  - determination of charges
    - in cases
      16.5
    - in relation to voluntary admissions
      16.4
    - levels of
      16.2
    - in co-promotion
      16.3
  - payment of in relation to rulings
    - by Appeal Board
      10.1
      10.2
    - by Panel
      7.1
      7.2
  - failure to pay
    16.6
adverse reactions
- 15.6
- claims about
  7.9
- reporting mechanisms
  4.9
  5.6
  5.7
  4.9
  5.7
- need to consult SPC
  4.2
  5.4
- references to in prescribing information
  4.2
amendments to Code and Constitution and Procedure
19.1
audio-visual material and interactive data systems etc
- prescribing information requirements
  4.4
  4.5
  4.6
  4.4
- abbreviated advertisements not permitted
  5.2
- certification
  14.1
ABPI (the Association of the British Pharmaceutical Industry)
- examinations
  16.3
  16.3
- Board
  1.3
  3.1
  11.4
  12.1
  13.4
  16.1
  16.6
advice on personal medical matters
26.4
automated calling systems
9.9
animal data, use of
7.2
appeals against Panel rulings
- withdrawal of appeals
  15.1
- appeals by complainants
  7.3
  7.4
- appearance before Appeal Board
  4.6
- appeals by respondent companies
  7.3
  7.5
Appeal Board - see Code of Practice Appeal Board
annual report
20
all-embracing claims
7.10
7.10
advice on Code
18.1
absolute risk, reference to
7.2
advance notification of new products
3.1
abbreviated advertisements
5.1
approval of promotional material – see certification
audit of company’s procedures
10.4
11.3
12.2
- charges for
  16.1
applicability of codes
1.11
1.11
amount of advertising in journals
6.1
6.1
advertising to the public
1.1
26.1
26.1

British Medical Association
- consultation with regarding:
  - the Code
    19.2
  - independent Appeal Board members
    3.2
- case reports
  13.5
bonus stock – see samples
17
black triangle symbol
4.10
4.1
4.10
- in abbreviated advertisements
  5.7
  5.7
- in material intended for patients
  26.3
  26.3
benefits, personal
18.1
19.1
19.2
18.1
19.2
briefing material for representatives
15.9
15.9
brand names, use of other companies’
7.3
Bribery Act
benefit/risk profile
7.10
Blue Guide
28.1
28.4
28.5
1.1

complaints procedure
- making complaints
  - general - see introduction to Constitution and Procedure
  - by pharmaceutical companies
    5.3
- complaints from Medicines and Healthcare products Regulatory Agency
  6.1
- complaints arising from media criticism
  6.1
- confidentiality of complainants - see introduction to Constitution and Procedure
- withdrawal of complaints
  15.1
- dealing with complaints
  5.1
  6.1
  7.1
  8.1
  9.1
  10.1
  11.1
  12.1
  13.1
Code of Practice Appeal Board
- Constitution and Procedure
  3.1
  4.1
- membership
  3.2
- power to:
  - require audit
    10.4
    11.3
  - require recovery of items
    10.3
    11.3
  - require a corrective statement
    10.6
    11.3
  - publicly reprimand
    10.5
    11.3
  - require pre-vetting
    10.4
    11.3
- co-option to
  4.2
- independent members to be in a majority
  4.2
- rulings
  10.1
- reports to, consideration of
  11.1
- reports to ABPI Board
  12.1
- reports from Code of Practice Panel
  4.1
  8.1
cost of promotional material
9.7
Code of Practice Panel
- power to suspend advertising on complaints from Medicines and Healthcare products Regulatory Agency
  9.2
- membership
  2.1
- Constitution and Procedure
  2.1
- power to suspend material/activities pending an appeal
  7.1
- rulings
  7.1
- reports to Appeal Board
  8.1
case reports
13.1
conferences - see meetings
clinical and scientific opinion
- emerging opinion
  7.2
- current views of authors
  10.4
- disparaging clinical and scientific opinion
  8.2
consultants
- from patient organisations
  27.8
  27.8
- use of
  23
- disclosure of payments to
  23.2
  23.3
  23.3
certification
- presentations by UK speakers at meetings held outside the UK
  14.2
- patient organisation material
  14.3
- joint working material
  14.3
- preservation of certificates
  14.6
  14.6
- promotional material
  14.1
- notification of signatories
  14.4
- promotional material at international conferences in UK
  3.1
- educational material relating to diseases or medicines
  14.3
- meetings held outside UK
  14.2
  14.2
- content of certificate
  14.5
- general
  14.1
- non-promotional material relating to the provision of medical and educational goods and services
  14.3
- patient support programme material
  14.3
- signatories, qualifications and experience of
  14.1
  14.1
- audio and audio-visual material etc
  14.1
- joint ventures and co-promotion
  14.1
- digital material
  14.1
- promotional aids
  14.1
- Internet
  14.1
clinical trial data, use of
7.5
central platform for disclosure of transfers of value
24.1
corporate advertising, examination of
14.3
co-promotion
14.1
clinical assessments
12.2
competitions & quizzes
8.1
comparisons
- general
  7.2
  7.3
  7.3
- hanging comparisons
  7.2
- disparaging references, prohibition on
  8.1
  8.1
- price/cost comparisons
  7.2
Commission on Human Medicines, Medicines and Healthcare products Regulatory Agency and licensing authority, references to
9.5
9.5
carers, hospitality to
27.2
contracts with institutions etc
21
Competition and Markets Authority
- consultation with on Code
  19.2
criticism in media
6.1
confidence in the industry
2
2
13.7
continuing professional development meetings and courses
22.1
cost comparisons
7.2
children in advertisements
7.8
Codes of Practice for Advertising Over-the-Counter Medicines of the PAGB
Code of Practice levy
16.1
clinical trials, disclosure of details
13.1
13.1
case preparation manager
2.1
5.1
5.2
5.6
conciliation between companies
18.2
current views of authors
10.4
10.4

disease awareness campaigns
26.2
- Disease Awareness Campaigns Guidelines
  26.2
donations
- see also prohibition on financial inducements
  18.1
- in lieu of hospitality
  15.3
- to charities
  18.1
  15.3
- to institutions etc
  19.1
  19.2
  19.2
- to individuals
  19.2
DVDs for health professessionals
18.1
dynamic content for websites
14.1
data on file, provision of
7.7
delivery of items by representatives
15.3
devices
4.1
disclosure of transfers of value
1.10
24
1.10
date of promotional material
4.8
distribution of promotional material
11
disguised promotion
12
discredit to the industry
2
2
13.7
date of prescribing information
4.2
4.2
discounts - see trade practices
doctors, use of names and photographs
9.3
disparaging references
8

EFPIA Code on Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations & page 60
exemptions to promotion - 1.2 under 'It does not include'
1.2
educational goods and services
19
educational or informational material
9.7
employees, current and prospective, information for
26.2
employee responsible for ensuring compliance with Code
1.12
1.12
electronic data communications
9.9
exaggerated or all-embracing claims
7.10
7.10
emoticons
9.2
9.1
exhibitions and exhibition panels, prescribing information requirements
4.1
EFPIA Code on the Promotion of Prescription Medicines to, and Interactions with, Healthcare Professionals see introduction to Code & page 60
economic evaluation of medicines
7.2
examinations for representatives
16.3
16.4
Europe - definition
24.1
experience programmes
12.2
email
9.9
9.9
exposed mailings
9.8
examination of material
14.3
envelopes
9.8
European Directive - see introduction to Code
EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations - see introduction to Code & page 60

frequency
- of mailings for new medicines
  11.2
- of calls by representatives
  15.4
  15.4
- of mailings
  11.2
  11.2
financial information
26.2
financial inducements, prohibition of
18.1
facsimile, use of
9.9
format & size of promotional material
9.7
9.7
free goods

General Pharmaceutical Council & page 60
18.1
22.1
15.3
graphs - see artwork, illustrations, graphs and tables
guidelines on company procedures relating to the Code of Practice
grants to institutions etc
19.1
19.2
19.2
General Medical Council page 60
18.1
22.1
15.3
gifts
18.1

health professional
- definition
  1.4
- use of name and photograph
  9.3
high standards, maintenance of
9.1
health professionals’ code of conduct and page 60
18.1
22.1
15.3
health professions, criticism of
8.2
healthcare organisation - definition
1.9
1.9
healthy volunteer studies, use of data from
Human Medicines Regulations - see introduction to Code
hanging comparisons
health technology assessments - 1.2 under 'Its does not include'
26.2
hospitality
22
- excessive
  2
  13.7
- limit on cost of meal
  22.2
  22.2

international journals, advertising in
1.1
in-vitro data
7.2
Internet
- certification
  14.1
- journals
  28.4
- general
  28
- abbreviated advertisements not permitted
  5.2
- prescribing information requirements
  4.6
- access to promotional material by public
  28.1
information to the public
26
28
inserts in journals
- cannot be abbreviated advertisements
  5.2
- size of
  6.3
interactive data systems - see audio-visual material and interactive data systems etc
items delivered by representatives
15.3
inducements
18.1
2
13.7
informational or educational materials
9.7
items for patients
18.2
18.2
illustrations - see artwork, illustrations, graphs and tables
IFPMA Code of Practice - see introduction to Code
international conferences, symposia and meetings see meetings

journal advertising
- specific requirements
  4.7
  6
- number of pages of
  6.1
- see also abbreviated advertisements in professional publications
  5.2
  5.2
- advertising in international journals
  1.1
joint ventures & co-promotion
14.1
joint working with the NHS
20
1.1
20

knocking copy
8.1
7.3
8.1

legislation page 61
levy
- level of
  16.1
- failure to pay
  16.6
labelling of:
- samples
  17.5
- medicines - under 'It does not include'
  1.2
limitations on journal advertising
6
links to prescribing information
4.4
4.4
loose inserts in journals
6.3
licensing authority, references to
9.5
loans, long term or permanent
18.1

meetings
22
- sponsorship of attendance at meetings, disclosure of
  22.5
  22.5
- organised by affiliates
  22.1
- subsistence, provision of
  22.1
  22.1
- prohibition on inducements and payments for interviews
  15.3
  18.1
  18.1
- attendance by administrative staff
  22.1
- payment of travelling and accommodation expenses
  22
- promotion at international meetings
  22.1
- certification of meetings held outside the UK
  14.2
  14.2
- hospitality, provision of
  22.1
  22.1
- sponsorship of meetings, disclosure of
  22.4
  22.4
- payment of room rental
  22.3
  22.3
- held outside the UK
  22.1
- venue, suitability of
  22.1
  22.1
- reports on meetings
  10.3
  22.4
- exhibitions and exhibition panels, prescribing information requirements
  4.1
- continuing professional development (CPD) meetings and courses
  22.1
- involving travel outside the UK
  22.1
  - certification of
    14.2
    14.2
mailings
- mailed medicines
  17.10
- frequency and number of
  11.2
  11.2
- mailing lists
  11.3
Medicines and Healthcare products Regulatory Agency
- consultation with on:
  - appointment of independent Appeal Board members
    3.1
  - Code
    19.2
- references to
  9.5
  9.5
- submission of:
  - names of signatories for promotional material to
    14.4
  - briefing material to
    15.9
  - certificates to
    14.6
- Disease Awareness Campaigns Guidelines & page 60
  26.2
- MHRA Drug Safety Update
  9.5
- yellow card scheme
  4.10
  5.6
- The Blue Guide Advertising and Promotion of Medicines in the UK & page 60
  28.1
  28.4
  28.5
  1.1
- complaints from
  9.1
- case reports
  13.5
medicines
- posted
  17.8
- handled by representatives
  17.7
- distributed in hospitals
  17.7
marketing authorization
3
2
meals - limit on cost
22.2
22.2
medical and educational goods and services
19
MHRA Drug Safety Update
9.5
margins see trade practices
memory sticks for health professionals
18.1
market research
12.2
12.2
- revealing company responsible
  9.10
- guidelines - The Legal & Ethical Guidelines for Healthcare Market Research
  12.2
- disclosure of payments
  23.1
  23.3
  23.1
  23.3
market share claims
media
- complaints arising from
  6.1
- relations with
  26
market extension
1.1
medicine, definition
1.3

notebooks, pens and pencils
18.3
18.3
Nursing & Midwifery Council - performance and ethics for nurses and midwives & page 61
18.1
22.1
15.3
non-proprietary name, size and position
4.3
5.5
naked or partially naked people, use of in advertising
9.2
9.1
non-interventional studies of marketed medicines
13.2
13.3
13.4
13.2
13.3
13.4
- approval and supervision of
  25.2
- disclosure of
  13.3
  13.3
new medicines
- limitations on mailings
  11.2
  11.2
- format, size or cost of promotional material for
  9.7
- advance notification of
  3.1
new, use of the word
7.11

over-the-counter medicines
- scope of the Code
  1.1
  1.1
- definition
  1.6
official documents, reproduction of
9.6
outcome agreements
18.1
offence, causing
9.2
ordinary course sales and purchase of medicines
1.10
other relevant decision makers - definition
1.5

Prescription Medicines Code of Practice Authority
- structure and responsibilities
  1.1
- material to be supplied to Authority
  - medical representatives’ briefing material
    15.9
  - names of signatories
    14.4
  - material required for scrutiny
    17.1
  - authority of Director to require material
    1.4
  - copies of certificates
    14.6
  - examination status of representatives
    16.4
- annual report
  20
- scrutiny
  17.1
pharmacovigilance - personnel's knowledge of
16.2
package leaflets - 1.2 under 'It does not include'
1.2
- on the Internet
  28.5
- provision to the public
  28.5
  26.2
promotional aid
- use of
  18.1
  18.1
- definition
  1.8
public assessment reports (European & UK)
- provision of
  - to the public
    28.5
    26.2
    28.5
  - on the Internet
    28.5
- exempt from the term ‘promotion’ - under 'It does not include'
  1.2
patient support items
18.2
18.2
public, relations with
- disease awareness campaigns
  26.2
- Internet
  28
- provision of information to
  26
  28
- public health campaigns
  26.2
- exposed mailings
  9.8
  9.8
- enquiries from
  26.4
  26.4
- advertising to
  1.1
  26
- provision of samples to
  17.9
prescription forms
- reproduction of official documents
  9.6
- pre-printed private prescription forms
  9.2
  9.1
press conferences and press announcements
26.2
26.2
public relations activities
26
26.2
- responsibility for
  26.5
post-marketing surveillance studies
12.2
13
posted medicines
17.8
prescribing information
- general
  4
- exemptions
  4.1
  5.1
- provision on
  - exhibitions and exhibition panels
    4.1
  - audio-visual etc
    4.5
    4.5
  - Internet
    4.6
  - journal advertisements
    4.7
- typesize
  4.1
- date of
  4.2
  4.2
- legibility
  4.1
  4.1
- size of non-proprietary name
  4.3
- requisite information
  4.2
  4.2
post-authorization studies
12.2
13
provision of medicines and samples control and accountability
17.9
17.9
patient information leaflets
- provision by doctors to patients
  26.2
  26.3
  26.3
prizes
18.1
pre-vetting
- power of Appeal Board to require
  10.4
  11.3
- cost of
  10.4
  11.3
personal benefits
18.1
19.1
19.2
18.1
19.2
price lists - under 'It does not include'
1.2
potency per weight claims
7.2
pre-printed private prescription forms
9.2
9.1
price comparisons
7.2
postcards, use of
9.8
patient organisations
- disclosure of support for
  27.7
  27.7
- relationships with
  27
- services provided by
  27.8
  27.8
patient safety
2
13.7
promotion
- exemptions - under 'It does not include'
  1.2
- definition
  1.2
package deals
18.1
private prescription forms, preprinted
9.2
9.1
payments for interviews
15.3
18.1
15.3
18.1
- unacceptable
  2
  13.7
professional publications
5.2
5.2
PMCPA guidance & Page 61
pecuniary advantage, offer or provision of
18.1
18.1
prices (see trade prices)
Panel - see Code of Practice Panel
patient access schemes
18.1
public health campaigns
26.2

quizzes
18.1
quotations
7.6
10.2
10.3
10.4
10.2
10.4

reply paid cards
9.8
- see also samples, request forms
  17.3
  17.3
- reply paid cards offering items to be delivered by representatives
  15.3
representatives
- frequency & manner of calls on doctors
  15.4
  15.4
- training, general
  15.1
  16.1
  16.3
  16.3
- definition
  1.7
- delivering items
  15.3
- briefing material
  15.9
  15.9
- contract representatives
- examinations
  16.3
  16.3
- reporting adverse reactions
  15.6
- identifying themselves
  15.5
- general
  15
- provision of summary of product characteristics by representatives
  15.8
  15.8
- prohibition on payments for interviews
  15.3
  15.3
- hospitality and payments for meetings
  15.3
- items delivered by representatives
  15.3
remote detailing
9.9
risk sharing agreements
18.1
risk/benefit profile
7.10
Royal Pharmaceutical Society
- consultation with on:
  - Code
    19.2
  - appointment of independent Appeal Board member
    3.2
- case reports
  13.5
references
- references to published studies
  7.6
  7.8
  7.6
  7.8
- prohibition in abbreviated advertisements
  5.9
rulings by:
- Panel
  7.1
- Appeal Board
  10.1
Royal College of Nursing
- consultation with on:
  - Code
    19.2
  - appointment of independent Appeal Board member
    3.2
- case reports
  13.5
room rental, payment
22.3
22.3
replies to individual enquiries - under 'It does not include'
1.2
1.2
risk, relative and absolute
7.2
relative risk, reference to
7.2
referee, independent
5.2
5.3
7.2
7.4
7.5
7.6
5.1
reprints of articles, distribution of
10.1
10.1
reproduction of official documents
9.6

sanctions
- suspension/expulsion from ABPI
  12.2
- advertisments in medical, pharmaceutical and nursing press
  13.7
- case reports
  13.1
- breach of Clause 2
  13.7
- special provision for non ABPI companies
  11.4
  12.2
- audit of company’s procedures
  10.4
  11.3
  12.2
- corrective statements
  10.6
  11.3
  13.7
- reports to Appeal Board and ABPI Board
  8.1
  11.1
  12.1
- reprimand and publication
  10.5
  11.3
  13.7
- pre-vetting
  10.4
  11.3
- recovery of items
  10.3
  11.3
- undertakings from companies ruled in breach
  7.1
  7.3
  10.2
samples
17
- definition
- distribution
  - to the public
    17.9
  - in hospitals
    17.7
- identification samples
- medicines permitted as
  17.2
  17.2
- control and accountability of
  17.7
- use for patient treatment
  17.10
- use as inducement
  17.10
- labelling
  17.5
- medicines not permitted as
  17.6
- titration packs
- request forms and their retention
  17.3
  17.3
- maximum number of
  17.2
- starter packs
- size
  17.4
- posted
  17.8
size of promotional material
- extremes of format
  9.7
  9.7
- abbreviated advertisements
  5.3
summaries of product characteristics
- provision of
  - summary in prescribing information
    4.2
    4.2
  - by representatives
    15.8
    15.8
  - to the public
    28.5
    26.2
    28.5
  - with press releases and press packs
    26.2
  - with samples
    17.5
  - on the Internet
    28.5
- exempt from the term ‘promotion’ - under 'it does not include'
  1.2
Serious Fraud Office
- consultation with on Code
  19.2
scientific services
25
- to compile and collate all information received
  25.1
- to approve and supervise non-interventional studies
  25.2
scope of the Code
1
statistical information, use of
7.2
7.2
- see also si to 7.8 on artwork, illustrations, graphs and tables
  7.8
sponsorship of meeting attendance, disclosure of
22.5
22.5
sexual imagery, use of
9.2
9.1
sponsorship of material and meetings, disclosure of
9.10
22.4
9.10
22.4
superlatives
7.10
7.10
symposia - see meetings
suitability and taste
9.1
9.2
9.2
scrutiny
17.1
substantiation of information, claims and comparisons
7.4
7.5
subsistence, provision of
22.1
22.2
22.1
22.2
suspension of material/activities required by Panel pending appeal
7.1
7.3
safe - use of the word
7.9
7.9
side-effects - see adverse reactions
suspension of advertising on complaints from Medicines and Healthcare products Regulatory Agency
9.2
signatories
14
starter packs
switch and therapy review programmes
19.1

telephone and text messages
9.9
timing under complaints procedure
- general
  14
- commenting on appeal by respondent
  7.5
- suspension of material/activities required by Panel pending appeal
  7.1
  7.3
- providing an undertaking on rulings by
  - Panel
    7.1
    7.3
  - Appeal Board
    10.2
- responding to complaint
  5.4
- commenting on appeal by complainant
  7.4
- appeals
  7.3
- extensions
  7.1
  7.3
  14
- payment of administrative charge
  7.1
  7.2
  10.1
  10.2
training
- of representatives
  15.1
  16.1
  16.3
  16.3
- on Code
  16.1
  16.1
telemessages
9.9
travelling expenses
22
terms of trade - see trade practices
therapy review programmes
transfers of value
24
- definition
  1.10
  1.10
- see disclosure of transfers of value
  1.10
  24
  1.10
- excluded disclosures
  1.10
- central platform for disclosure
  24.1
tables - see artwork, illustrations, graphs and tables
teaser - advertising
9.1
9.2
the - use of the word
7.10
text messages
9.9
trade practices, prices, discounts, margins, etc - under ‘It does not include’
1.2
18.1
textbooks, provision of
18.1
titration packs
17
taste in advertising
9.2
9.1
two page journal advertisements
6.2

unauthorized medicines and unauthorized indications - see also unlicensed medicines
3
3
undertakings, breach of
29
2
13.7
undertakings by companies ruled in breach
7.1
7.3
10.2
unique - use of the word
7.10
unlicensed medicines, price lists of
1.2
1.2

voluntary admissions by pharmaceutical companies
5.6
16.4
volume of promotional material
11.2
11.2

wraparounds - on journals
6.3
WHO Ethical Criteria for Medicinal Drug Promotion - see introduction to Code and page 61
withdrawal of complaints and appeals
15.1
wrappers
9.8

yellow card scheme
4.10
5.6

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