1 

General: Clause 1 outlines the scope of the Code and defines certain terms

1.1

Clause 1.1 outlines the general scope of the Code

1.2

Clause 1.2 defines the term ‘promotion’ and states certain activities that are not included in this definition.

1.3

Clause 1.3 defines the term ‘medicine’

1.4

Clause 1.4 defines the term ‘health professional’

1.5

Clause 1.5 defines the term ‘other relevant decision makers’

1.6

Clause 1.6 defines the term ‘over the counter medicine’

1.7

Clause 1.7 defines the term ‘representative’

1.8

Clause 1.8 defines the term ‘promotional aid’

1.9

Clause 1.9 defines the term ‘healthcare organisation’

1.10

Clause 1.10 defines the term ‘transfer of value’.

1.11

Clause 1.11 covers the requirement for pharmaceutical companies to comply with all applicable codes, laws and regulations to which they are subject.

1.12

Clause 1.12 requires the appointment of a senior employee to be responsible for ensuring that the company meets the requirements of the Code.

2 

General: Clause 2 requires that activities or materials associated with promotion must never bring discredit upon, or reduce confidence in the pharmaceutical industry. A breach of clause 2 is reserved as a sign of particular censure.

3 

General: Clause 3 covers the Marketing Authorisation

3.1

Clause 3.1 requires that a medicine is not promoted prior to the grant of the marketing authorisation

3.2

Clause 3.2 requires promotion of a medicine to be in accordance with the terms of the marketing authorisation and not inconsistent with the particulars in the SmPC

4 

General: Clause 4 covers prescribing information and other obligatory information for promotional material

4.1

Clause 4.1 requires the presence of prescribing information on promotional material, except abbreviated advertisements.

4.2

Clause 4.2 describes the contents required to be present within the prescribing information

4.3

Clause 4.3 covers the requirement for the non proprietary name to be placed immediately adjacent to the most prominent display of the brand name

4.4

Clause 4.4 covers provision of prescribing information in digital material

4.5

Clause 4.5 covers provision of prescribing information in audio-visual material and interactive data systems

4.6

Clause 4.6 requires a clear prominent statement as to where prescribing information can be found in promotional material on the internet

4.7

Clause 4.7 covers the requirement for a description as to where the prescribing information can be found on printed material

4.8

Clause 4.8 covers the provision of the date of preparation or last revision of promotional material.

4.9

Clause 4.9 covers the requirement for an adverse event reporting statement

4.10

Clause 4.10 covers the requirements for the black triangle

4.11

There is currently no clause 4.11

5 

General: Clause 5 covers requirements for abbreviated advertisements

5.1

Clause 5.1 covers the exemption from prescribing information requirements for abbreviated advertisements

5.2

Clause 5.2 describes where abbreviated advertisements may and may not appear.

5.3

Clause 5.3 covers size restrictions for abbreviated advertisements.

5.4

Clause 5.4 describes the obligatory contents of an abbreviated advertisement

5.5

Clause 5.5 describes requirements for the non proprietary name in abbreviated advertisements

5.6

Clause 5.6 describes requirements for the adverse event reporting statement in abbreviated advertisements

5.7

Clause 5.7 describes requirements for the black triangle in abbreviated advertisements

5.8

Clause 5.8 allows for a concise statement on why the medicine is recommended in abbreviated advertisements

5.9

Clause 5.9 requires that MA numbers and references are not included in abbreviated advertisements

6

General: Clause 6 covers Journal Advertising 

6.1

Clause 6.1 covers page limits in journal advertising

6.2

Clause 6.2 states that no single page or screen in journal or digital advertising should mislead when read in isolation.

6.3

Clause 6.3 covers restrictions on loose inserts.

7 

General: Clause 7 covers information, claims and comparisons. The majority of breaches of the code are breaches of this clause.

7.1

Clause 7.1 covers the requirement to provide accurate and relevant information about marketed products upon request

7.2

Clause 7.2 states a number of requirements for information, claims and comparisons. It is one of the most commonly breached clauses.

7.3

Clause 7.3 states further requirements for information, claims and comparisons to avoid misleading and to protect competitors. It is among the most commonly breached clauses.

7.4

Clause 7.4 covers the requirement for information to be capable of substantiation

7.5

Clause 7.5 covers the requirement to provide substantiation within 10 working days of request.

7.6

Clause 7.6 covers the requirement to give clear references when referring to published studies.

7.7

Clause 7.7 covers provision of data on file upon request.

7.8

Clause 7.8 covers the requirements for artwork, including illustrations, graphs and tables.

7.9

Clause 7.9 covers claims relating to safety and adverse reactions, including use of the word ‘safe’ and derivatives

7.10

Clause 7.10 requires that promotion must encourage the rational use of a medicine, prohibiting exaggeration and all embracing claims.

7.11

Clause 7.11 covers restrictions on use of the word ’new’

8 

General: Clause 8 covers Disparaging References

8.1

Clause 8.1 relates to disparaging the medicines, products and activities of other pharmaceutical companies.

8.2

Clause 8.2 relates to disparaging the health professions or the clinical and scientific opinions of health professionals.

9 

General: In general clause 9 covers format, suitability, causing offence and sponsorship. It also requires high standards to be maintained at all times.

9.1

Clause 9.1 covers the requirement to maintain high standards. As it is broad, a breach of this clause is often ruled in conjunction with other clause breaches.

9.2

Clause 9.2 covers respect for the professional standing and not causing offence

9.3

Clause 9.3 covers the requirement that names or photos of health professionals are not used in a way that is contrary to the conventions of their profession.

9.4

Clause 9.4 covers restrictions on imitating devices, copy, slogans or general layout adopted by other companies

9.5

Clause 9.5 restricts reference to the Commission on Human Medicines, the MHRA or a licensing authority.

9.6

Clause 9.6 forbids the use of reproductions of official documents in promotion without written permission.

9.7

Clause 9.7 covers extremes of format, size or cost of material.

9.8

Clause 9.8 forbids promotion to the public through exposed mailings such as postcards, envelopes or wrappers

9.9

Clause 9.9 covers the requirement for prior permission to use electronic data communications (e.g. telephone, texts, emails) for promotion.

9.10

Clause 9.10 covers the requirements for declarations of sponsorship.

10 

General: Clause 10 covers reprints and quotations

10.1

Clause 10.1 requires reprints of articles given proactively to be peer reviewed.

10.2

Clause 10.2 covers requirements for quotations

10.3

Clause 10.3 covers permissions to use quotations

10.4

Clause 10.4 requires quotations pertaining to views of authors to be current

11 

General: Clause 11 relates to distribution of material

11.1

Clause 11.1 requires that material is only distributed to those whose need for, or interest in it can be reasonably assumed.

11.2

Clause 11.2 covers frequency of distribution and volume of promotional material distributed

11.3

Clause 11.3 requires mailing lists to be kept up to date

12 

General: Clause 12 relates to disguised promotion

12.1

Clause 12.1 states that promotional material and activities must not be disguised.

12.2

Clause 12.2 covers activities which must not constitute disguised promotion including market research

13 

General: Clause 13 covers clinical studies and non interventional studies

13.1

Clause 13.1 covers requirements for clinical trial disclosure

13.2

Clause 13.2 defines non interventional studies

13.3

Clause 13.3 covers the requirement to publish results of non interventional studies

13.4

Clause 13.4 Defines the criteria that must be applied to prospective non interventional studies

14 

General: Clause 14 covers certification and examination

14.1

Clause 14.1 covers the requirement for promotional material to be certified and how this may be achieved and defines the qualifications required for signatories

14.2

Clause 14.2 covers requirements for certification of meetings involving travel outside the UK

14.3

Clause 14.3 defines the types of materials that must be certified before use.

14.4

Clause 14.4 covers the requirements for the MHRA and PMCPA to be notified of the names of nominated signatories

14.5

Clause 14.5 covers the requirements for certificates pertaining to certification

14.6

Clause 14.6 covers requirements relating to preservation of certificates

15 

General: Clause 15 covers representatives

15.1

Clause 15.1 covers the requirements for representatives to be properly trained

15.2

Clause 15.2 requires representatives to maintain a high standard of ethical conduct

15.3

Clause 15.3 forbids use of subterfuge or inducement by representatives to gain an interview

15.4

Clause 15.4 covers the requirements on call frequency and not causing inconvenience

15.5

Clause 15.5 covers the requirement for representatives to be clear from the outset about which company they represent

15.6

Clause 15.6 covers pharmacovigilance reporting requirements for representatives

15.7

Clause 15.7 covers requirements relating to remuneration of representatives

15.8

Clause 15.8 covers the requirement for representatives to provide a copy of the SmPC for each product that they promote

15.9

Clause 15.9 covers requirements for representative briefings

15.10

Clause 15.10 states that companies are responsible for the activities of their representatives

16 

General: Clause 16 covers training

16.1

Clause 16.1 covers the requirement for those working with the Code to be fully conversant with its requirements

16.2

Clause 16.2 requires all personnel to be fully conversant with pharmacovigilance requirements

16.3

Clause 16.3 covers the requirements for taking the representative examination on the Code

16.4

Clause 16.4 requires details of the numbers of representatives who have passed the examination to be provided to the PMCPA on request.

16.5

There is currently no clause 16.5

16.6

There is currently no clause 16.6

17 

General: Clause 17 covers provision of medicines and samples

17.1

Clause 17.1 states that samples may only be provided to health professionals qualified to prescribe that product

17.2

Clause 17.2 covers limits on provision of samples

17.3

Clause 17.3 requires a written request for provision of samples

17.4

Clause 17.4 covers size restrictions on samples

17.5

Clause 17.5 covers wording on sample packs and the requirement to provide the SmPC

17.6

Clause 17.6 forbids provision of certain samples

17.7

Clause 17.7 covers systems for accountability and control of samples

17.8

Clause 17.8 covers requirements for sending samples by post

17.9

Clause 17.9 forbids the selling or supply of medicines to the public for promotional purposes

17.10

Clause 17.10 forbids provision of samples as inducements

17.11

There is currently no clause 17.11

17.12

There is currently no clause 17.12

18

Clause 18 covers inducements, items for patients, and patient access schemes

18.1

Clause 18.1 forbids the giving or offering of inducements to prescribe. It covers package deals, risk sharing agreements, patient access schemes, donations to charities, and promotional aids.

18.2

Clause 18.2 relates to provision of items intended for patients

18.3

Clause 18.3 covers provision of notebooks, pens and pencils at meetings

18.4

There is currently no clause 18.4

18.5

There is currently no clause 18.5

18.6

There is currently no clause 18.6

18.7

There is currently no clause 18.7

19 

General: Clause 19 covers medical and educational goods and services (MEGS)

19.1

Clause 19.1 relates to the provision of MEGS

19.2

Clause 19.2 covers requirements for the provision of MEGS

19.3

There is currently no clause 19.3

19.4

There is currently no clause 19.4

19.5

There is currently no clause 19.5

20 

General: Clause 20 covers requirements for joint working

20.1

There is currently no clause 20.1

20.2

There is currently no clause 20.2

20.3

There is currently no clause 20.3

20.4

There is currently no clause 20.4

21 

General: Clause 21 covers relationships and contracts with certain organisations

21.1

There is currently no clause 21.1

21.2

There is currently no clause 21.2

21.3

There is currently no clause 21.3

21.4

There is currently no clause 21.4

21.5

There is currently no clause 21.5

21.6

There is currently no clause 21.6

21.7

There is currently no clause 21.7

21.8

There is currently no clause 21.8

21.9

There is currently no clause 21.9

21.10

There is currently no clause 21.10

22 

General: Clause 22 covers meetings, hospitality and sponsorship

22.1

Clause 22.1 covers the situations in which provision of hospitality is allowable

22.2

Clause 22.2 covers the allowable costs for a meal provided as subsistence

22.3

Clause 22.3 forbids payments to prescribers for room rental

22.4

Clause 22.4 covers the requirement for a declaration of sponsorship for meetings

22.5

Clause 22.5 covers disclosure requirements for sponsorship of UK health professionals.

23 

General: Clause 23 covers Use of Consultants

23.1

Clause 23.1 covers the requirements for using consultants

23.2

Clause 23.2 covers disclosure of payments to consultants

23.3

Clause 23.3 covers disclosure of payments pertaining to market research

23.4

Clause 23.4 covers disclosure of fees and expenses to consultants

23.5

There is currently no clause 23.5

23.6

There is currently no clause 23.6

23.7

There is currently no clause 23.7

23.8

There is currently no clause 23.8

23.9

There is currently no clause 23.9

24 

General: Clause 24 covers transfers of value

24.1

Clause 24.1 requires public disclosure of transfers of value

24.2

Clause 24.2 defines which transfers of value are covered by clause 24.

24.3

Clause 24.3 excludes transfers of value in relation to patient organisations as these are covered elsewhere in the Code

24.4

Clause 24.4 relates to frequency of disclosure of transfers of value

24.5

Clause 24.5 states that disclosures must remain in the public domain for 3 years.

24.6

Clause 24.6 requires records of transfers of value to be kept for at least 5 years

24.7

Clause 24.7 allows for aggregation of certain transfers of value for disclosure

24.8

Clause 24.8 relates to transfers of value made to a health professional indirectly

24.9

Clause 24.9 covers recipients of transfers of value that cannot be identified

24.10

Clause 24.10 requires methodologies for collecting and reporting transfers of value to be published

25 

General: Clause 25 covers scientific services

25.1

Clause 25.1 covers the requirement for companies to have a scientific service to collate information about marketed products

25.2

Clause 25.2 covers the requirements for a scientific service for approval and supervision of non interventional studies

25.3

There is currently no clause 25.3.

25.4

There is currently no clause 25.4.

25.5

There is currently no clause 25.5.

25.6

There is currently no clause 25.6.

26 

General: Clause 26 covers relations with the public and the media

26.1

Clause 26.1 prohibits the promotion of prescription medicines to the public

26.2

Clause 26.2 states that information provided to the public must not raise unfounded hopes or encourage the public to request a prescription.

26.3

Clause 26.3 covers requirements for adverse event reporting language on material for patients

26.4

Clause 26.4 prohibits the provision of advice on personal medical matters to members of the public

26.5

Clause 26.5 states that companies are responsible for the information provided by their public relations agencies.

26.6

There is currently no clause 26.6

27 

General: Clause 27 covers relationships with patient organisations

27.1

Clause 27.1 allows for interactions with patient organisations whilst respecting their independence

27.2

Clause 27.2 covers some of the requirements for working with patient organisations including declarations of sponsorship and clarity of general arrangements

27.3

Clause 27.3 covers written agreements with patient organisations

27.4

Clause 27.4 prohibits companies from being the sole funder of a patient organisation

27.5

Clause 27.5 requires a written agreement to use a patient organisations logo or proprietary material

27.6

Clause 27.6 forbids companies to seek to influence the text of patient organisation material in a manner favourable to its commercial interests

27.7

Clause 27.7 covers disclosure of transfers of value to patient organisations

27.8

Clause 27.8 covers the requirements for contracts with patient organisations

27.9

Clause 27.9 covers requirements for declarations of sponsorship in relation to patient organisations

28 

General: Clause 28 covers the internet and other digital platforms

28.1

Clause 28.1 states that promotional material on the internet must comply with all relevant requirements of the Code

28.2

Clause 28.2 defines the origin of material on the internet which falls within the scope of the Code

28.3

Clause 28.3 requires material on the internet intended for the public to comply with the Code

28.4

Clause 28.4 allows for advertising of medicines in electronic journals intended for health professionals that can be accessed by the public

28.5

Clause 28.5 allows for provision of certain reference material on the internet for the public

28.6

Clause 28.6 requires it to be made clear when a user is leaving a company site on the internet

29 

General: Clause 29 covers compliance with undertakings