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

abbreviated advertisements
5.1
ABPI (the Association of the British Pharmaceutical Industry)
- Board
  1.3
  3.1
  11.4
  12.1
  13.4
  16.1
  16.6
- examinations
  16.3
  16.3
absolute risk, reference to
7.2
administrative charges
- appeals against number of
  16.5
  - determination of charges
    - in cases
      16.5
    - in relation to voluntary 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
advance notification of new products
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
  4.9
  5.6
  5.7
  4.9
  5.7
- 15.6
advertising to the public
1.1
26.1
26.1
advice on Code
18.1
advice on personal medical matters
26.4
all-embracing claims
7.10
7.10
amendments to Code and Constitution and Procedure
19.1
amount of advertising in journals
6.1
6.1
animal data, use of
7.2
annual report
20
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
  15.1
Appeal Board - see Code of Practice Appeal Board
applicability of codes
1.11
1.11
approval of promotional material – see certification
artwork, illustrations, graphs and tables
7.8
- abbreviated advertisements
  5.5
  5.6
  5.7
  5.8
  5.4
- references to sources when taken from published studies
  7.8
  7.8
- see also si to 7.2 on use of statistical information
  7.2
audio-visual material and interactive data systems etc
- abbreviated advertisements not permitted
  5.2
- certification
  14.1
- prescribing information requirements
  4.4
  4.5
  4.6
  4.4
audit of company’s procedures
10.4
11.3
12.2
- charges for
  16.1
automated calling systems
9.9

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

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

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

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

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

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

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

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

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

knocking copy
8.1
7.3
8.1

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

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

naked or partially naked people, use of in advertising
9.2
9.1
new medicines
- advance notification of
  3.1
- format, size or cost of promotional material for
  9.7
- limitations on mailings
  11.2
  11.2
new, use of the word
7.11
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
non-proprietary name, size and position
4.3
5.5
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

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

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

quizzes
18.1
quotations
7.6
10.2
10.3
10.4
10.2
10.4

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

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

tables - see artwork, illustrations, graphs and tables
taste in advertising
9.2
9.1
teaser - advertising
9.1
9.2
telemessages
9.9
telephone and text messages
9.9
terms of trade - see trade practices
text messages
9.9
textbooks, provision of
18.1
the - use of the word
7.10
therapy review programmes
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 of material/activities required by Panel pending appeal
  7.1
  7.3
titration packs
17
trade practices, prices, discounts, margins, etc - under ‘It does not include’
1.2
18.1
training
- of representatives
  15.1
  16.1
  16.3
  16.3
- on Code
  16.1
  16.1
transfers of value
24
- central platform for disclosure
  24.1
- definition
  1.10
  1.10
- see disclosure of transfers of value
  1.10
  24
  1.10
- excluded disclosures
  1.10
travelling expenses
22
two page journal advertisements
6.2

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

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

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

yellow card scheme
4.10
5.6

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