1
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General: Clause 1 outlines the scope of the Code and defines certain terms
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1.1
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Clause 1.1 outlines the general scope of the Code
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1.2
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Clause 1.2 defines the term ‘promotion’ and states certain activities that are not included in this definition.
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1.3
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Clause 1.3 defines the term ‘medicine’
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1.4
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Clause 1.4 defines the term ‘health professional’
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1.5
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Clause 1.5 defines the term ‘other relevant decision makers’
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1.6
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Clause 1.6 defines the term ‘over the counter medicine’
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1.7
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Clause 1.7 defines the term ‘representative’
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1.8
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Clause 1.8 defines the term ‘promotional aid’
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1.9
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Clause 1.9 defines the term ‘healthcare organisation’
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1.10
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Clause 1.10 defines the term ‘transfer of value’.
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1.11
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Clause 1.11 covers the requirement for pharmaceutical companies to comply with all applicable codes, laws and regulations to which they are subject.
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1.12
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Clause 1.12 requires the appointment of a senior employee to be responsible for ensuring that the company meets the requirements of the Code.
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2
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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.
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3
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General: Clause 3 covers the Marketing Authorisation
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3.1
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Clause 3.1 requires that a medicine is not promoted prior to the grant of the marketing authorisation
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3.2
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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
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4
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General: Clause 4 covers prescribing information and other obligatory information for promotional material
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4.1
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Clause 4.1 requires the presence of prescribing information on promotional material, except abbreviated advertisements.
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4.2
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Clause 4.2 describes the contents required to be present within the prescribing information
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4.3
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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
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4.4
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Clause 4.4 covers provision of prescribing information in digital material
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4.5
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Clause 4.5 covers provision of prescribing information in audio-visual material and interactive data systems
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4.6
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Clause 4.6 requires a clear prominent statement as to where prescribing information can be found in promotional material on the internet
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4.7
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Clause 4.7 covers the requirement for a description as to where the prescribing information can be found on printed material
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4.8
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Clause 4.8 covers the provision of the date of preparation or last revision of promotional material.
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4.9
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Clause 4.9 covers the requirement for an adverse event reporting statement
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4.10
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Clause 4.10 covers the requirements for the black triangle
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4.11
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There is currently no clause 4.11
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5
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General: Clause 5 covers requirements for abbreviated advertisements
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5.1
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Clause 5.1 covers the exemption from prescribing information requirements for abbreviated advertisements
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5.2
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Clause 5.2 describes where abbreviated advertisements may and may not appear.
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5.3
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Clause 5.3 covers size restrictions for abbreviated advertisements.
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5.4
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Clause 5.4 describes the obligatory contents of an abbreviated advertisement
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5.5
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Clause 5.5 describes requirements for the non proprietary name in abbreviated advertisements
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5.6
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Clause 5.6 describes requirements for the adverse event reporting statement in abbreviated advertisements
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5.7
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Clause 5.7 describes requirements for the black triangle in abbreviated advertisements
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5.8
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Clause 5.8 allows for a concise statement on why the medicine is recommended in abbreviated advertisements
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5.9
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Clause 5.9 requires that MA numbers and references are not included in abbreviated advertisements
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6
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General: Clause 6 covers Journal Advertising
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6.1
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Clause 6.1 covers page limits in journal advertising
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6.2
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Clause 6.2 states that no single page or screen in journal or digital advertising should mislead when read in isolation.
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6.3
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Clause 6.3 covers restrictions on loose inserts.
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7
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General: Clause 7 covers information, claims and comparisons. The majority of breaches of the code are breaches of this clause.
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7.1
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Clause 7.1 covers the requirement to provide accurate and relevant information about marketed products upon request
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7.2
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Clause 7.2 states a number of requirements for information, claims and comparisons. It is one of the most commonly breached clauses.
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7.3
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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.
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7.4
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Clause 7.4 covers the requirement for information to be capable of substantiation
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7.5
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Clause 7.5 covers the requirement to provide substantiation within 10 working days of request.
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7.6
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Clause 7.6 covers the requirement to give clear references when referring to published studies.
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7.7
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Clause 7.7 covers provision of data on file upon request.
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7.8
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Clause 7.8 covers the requirements for artwork, including illustrations, graphs and tables.
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7.9
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Clause 7.9 covers claims relating to safety and adverse reactions, including use of the word ‘safe’ and derivatives
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7.10
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Clause 7.10 requires that promotion must encourage the rational use of a medicine, prohibiting exaggeration and all embracing claims.
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7.11
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Clause 7.11 covers restrictions on use of the word ’new’
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8
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General: Clause 8 covers Disparaging References
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8.1
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Clause 8.1 relates to disparaging the medicines, products and activities of other pharmaceutical companies.
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8.2
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Clause 8.2 relates to disparaging the health professions or the clinical and scientific opinions of health professionals.
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9
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General: In general clause 9 covers format, suitability, causing offence and sponsorship. It also requires high standards to be maintained at all times.
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9.1
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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.
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9.2
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Clause 9.2 covers respect for the professional standing and not causing offence
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9.3
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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.
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9.4
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Clause 9.4 covers restrictions on imitating devices, copy, slogans or general layout adopted by other companies
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9.5
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Clause 9.5 restricts reference to the Commission on Human Medicines, the MHRA or a licensing authority.
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9.6
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Clause 9.6 forbids the use of reproductions of official documents in promotion without written permission.
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9.7
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Clause 9.7 covers extremes of format, size or cost of material.
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9.8
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Clause 9.8 forbids promotion to the public through exposed mailings such as postcards, envelopes or wrappers
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9.9
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Clause 9.9 covers the requirement for prior permission to use electronic data communications (e.g. telephone, texts, emails) for promotion.
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9.10
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Clause 9.10 covers the requirements for declarations of sponsorship.
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10
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General: Clause 10 covers reprints and quotations
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10.1
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Clause 10.1 requires reprints of articles given proactively to be peer reviewed.
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10.2
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Clause 10.2 covers requirements for quotations
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10.3
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Clause 10.3 covers permissions to use quotations
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10.4
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Clause 10.4 requires quotations pertaining to views of authors to be current
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11
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General: Clause 11 relates to distribution of material
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11.1
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Clause 11.1 requires that material is only distributed to those whose need for, or interest in it can be reasonably assumed.
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11.2
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Clause 11.2 covers frequency of distribution and volume of promotional material distributed
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11.3
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Clause 11.3 requires mailing lists to be kept up to date
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12
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General: Clause 12 relates to disguised promotion
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12.1
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Clause 12.1 states that promotional material and activities must not be disguised.
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12.2
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Clause 12.2 covers activities which must not constitute disguised promotion including market research
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13
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General: Clause 13 covers clinical studies and non interventional studies
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13.1
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Clause 13.1 covers requirements for clinical trial disclosure
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13.2
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Clause 13.2 defines non interventional studies
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13.3
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Clause 13.3 covers the requirement to publish results of non interventional studies
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13.4
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Clause 13.4 Defines the criteria that must be applied to prospective non interventional studies
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14
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General: Clause 14 covers certification and examination
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14.1
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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
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14.2
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Clause 14.2 covers requirements for certification of meetings involving travel outside the UK
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14.3
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Clause 14.3 defines the types of materials that must be certified before use.
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14.4
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Clause 14.4 covers the requirements for the MHRA and PMCPA to be notified of the names of nominated signatories
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14.5
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Clause 14.5 covers the requirements for certificates pertaining to certification
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14.6
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Clause 14.6 covers requirements relating to preservation of certificates
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15
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General: Clause 15 covers representatives
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15.1
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Clause 15.1 covers the requirements for representatives to be properly trained
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15.2
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Clause 15.2 requires representatives to maintain a high standard of ethical conduct
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15.3
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Clause 15.3 forbids use of subterfuge or inducement by representatives to gain an interview
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15.4
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Clause 15.4 covers the requirements on call frequency and not causing inconvenience
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15.5
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Clause 15.5 covers the requirement for representatives to be clear from the outset about which company they represent
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15.6
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Clause 15.6 covers pharmacovigilance reporting requirements for representatives
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15.7
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Clause 15.7 covers requirements relating to remuneration of representatives
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15.8
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Clause 15.8 covers the requirement for representatives to provide a copy of the SmPC for each product that they promote
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15.9
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Clause 15.9 covers requirements for representative briefings
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15.10
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Clause 15.10 states that companies are responsible for the activities of their representatives
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16
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General: Clause 16 covers training
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16.1
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Clause 16.1 covers the requirement for those working with the Code to be fully conversant with its requirements
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16.2
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Clause 16.2 requires all personnel to be fully conversant with pharmacovigilance requirements
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16.3
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Clause 16.3 covers the requirements for taking the representative examination on the Code
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16.4
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Clause 16.4 requires details of the numbers of representatives who have passed the examination to be provided to the PMCPA on request.
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16.5
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There is currently no clause 16.5
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16.6
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There is currently no clause 16.6
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17
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General: Clause 17 covers provision of medicines and samples
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17.1
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Clause 17.1 states that samples may only be provided to health professionals qualified to prescribe that product
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17.2
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Clause 17.2 covers limits on provision of samples
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17.3
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Clause 17.3 requires a written request for provision of samples
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17.4
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Clause 17.4 covers size restrictions on samples
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17.5
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Clause 17.5 covers wording on sample packs and the requirement to provide the SmPC
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17.6
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Clause 17.6 forbids provision of certain samples
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17.7
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Clause 17.7 covers systems for accountability and control of samples
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17.8
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Clause 17.8 covers requirements for sending samples by post
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17.9
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Clause 17.9 forbids the selling or supply of medicines to the public for promotional purposes
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17.10
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Clause 17.10 forbids provision of samples as inducements
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17.11
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There is currently no clause 17.11
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17.12
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There is currently no clause 17.12
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18
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Clause 18 covers inducements, items for patients, and patient access schemes
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18.1
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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.
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18.2
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Clause 18.2 relates to provision of items intended for patients
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18.3
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Clause 18.3 covers provision of notebooks, pens and pencils at meetings
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18.4
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There is currently no clause 18.4
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18.5
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There is currently no clause 18.5
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18.6
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There is currently no clause 18.6
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18.7
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There is currently no clause 18.7
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19
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General: Clause 19 covers medical and educational goods and services (MEGS)
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19.1
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Clause 19.1 relates to the provision of MEGS
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19.2
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Clause 19.2 covers requirements for the provision of MEGS
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19.3
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There is currently no clause 19.3
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19.4
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There is currently no clause 19.4
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19.5
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There is currently no clause 19.5
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20
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General: Clause 20 covers requirements for joint working
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20.1
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There is currently no clause 20.1
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20.2
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There is currently no clause 20.2
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20.3
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There is currently no clause 20.3
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20.4
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There is currently no clause 20.4
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21
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General: Clause 21 covers relationships and contracts with certain organisations
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21.1
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There is currently no clause 21.1
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21.2
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There is currently no clause 21.2
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21.3
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There is currently no clause 21.3
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21.4
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There is currently no clause 21.4
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21.5
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There is currently no clause 21.5
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21.6
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There is currently no clause 21.6
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21.7
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There is currently no clause 21.7
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21.8
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There is currently no clause 21.8
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21.9
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There is currently no clause 21.9
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21.10
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There is currently no clause 21.10
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22
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General: Clause 22 covers meetings, hospitality and sponsorship
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22.1
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Clause 22.1 covers the situations in which provision of hospitality is allowable
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22.2
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Clause 22.2 covers the allowable costs for a meal provided as subsistence
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22.3
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Clause 22.3 forbids payments to prescribers for room rental
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22.4
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Clause 22.4 covers the requirement for a declaration of sponsorship for meetings
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22.5
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Clause 22.5 covers disclosure requirements for sponsorship of UK health professionals.
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23
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General: Clause 23 covers Use of Consultants
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23.1
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Clause 23.1 covers the requirements for using consultants
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23.2
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Clause 23.2 covers disclosure of payments to consultants
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23.3
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Clause 23.3 covers disclosure of payments pertaining to market research
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23.4
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Clause 23.4 covers disclosure of fees and expenses to consultants
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23.5
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There is currently no clause 23.5
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23.6
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There is currently no clause 23.6
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23.7
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There is currently no clause 23.7
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23.8
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There is currently no clause 23.8
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23.9
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There is currently no clause 23.9
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24
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General: Clause 24 covers transfers of value
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24.1
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Clause 24.1 requires public disclosure of transfers of value
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24.2
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Clause 24.2 defines which transfers of value are covered by clause 24.
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24.3
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Clause 24.3 excludes transfers of value in relation to patient organisations as these are covered elsewhere in the Code
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24.4
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Clause 24.4 relates to frequency of disclosure of transfers of value
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24.5
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Clause 24.5 states that disclosures must remain in the public domain for 3 years.
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24.6
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Clause 24.6 requires records of transfers of value to be kept for at least 5 years
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24.7
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Clause 24.7 allows for aggregation of certain transfers of value for disclosure
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24.8
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Clause 24.8 relates to transfers of value made to a health professional indirectly
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24.9
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Clause 24.9 covers recipients of transfers of value that cannot be identified
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24.10
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Clause 24.10 requires methodologies for collecting and reporting transfers of value to be published
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25
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General: Clause 25 covers scientific services
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25.1
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Clause 25.1 covers the requirement for companies to have a scientific service to collate information about marketed products
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25.2
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Clause 25.2 covers the requirements for a scientific service for approval and supervision of non interventional studies
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25.3
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There is currently no clause 25.3.
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25.4
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There is currently no clause 25.4.
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25.5
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There is currently no clause 25.5.
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25.6
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There is currently no clause 25.6.
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26
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General: Clause 26 covers relations with the public and the media
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26.1
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Clause 26.1 prohibits the promotion of prescription medicines to the public
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26.2
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Clause 26.2 states that information provided to the public must not raise unfounded hopes or encourage the public to request a prescription.
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26.3
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Clause 26.3 covers requirements for adverse event reporting language on material for patients
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26.4
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Clause 26.4 prohibits the provision of advice on personal medical matters to members of the public
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26.5
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Clause 26.5 states that companies are responsible for the information provided by their public relations agencies.
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26.6
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There is currently no clause 26.6
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27
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General: Clause 27 covers relationships with patient organisations
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27.1
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Clause 27.1 allows for interactions with patient organisations whilst respecting their independence
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27.2
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Clause 27.2 covers some of the requirements for working with patient organisations including declarations of sponsorship and clarity of general arrangements
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27.3
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Clause 27.3 covers written agreements with patient organisations
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27.4
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Clause 27.4 prohibits companies from being the sole funder of a patient organisation
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27.5
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Clause 27.5 requires a written agreement to use a patient organisations logo or proprietary material
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27.6
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Clause 27.6 forbids companies to seek to influence the text of patient organisation material in a manner favourable to its commercial interests
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27.7
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Clause 27.7 covers disclosure of transfers of value to patient organisations
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27.8
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Clause 27.8 covers the requirements for contracts with patient organisations
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27.9
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Clause 27.9 covers requirements for declarations of sponsorship in relation to patient organisations
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28
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General: Clause 28 covers the internet and other digital platforms
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28.1
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Clause 28.1 states that promotional material on the internet must comply with all relevant requirements of the Code
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28.2
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Clause 28.2 defines the origin of material on the internet which falls within the scope of the Code
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28.3
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Clause 28.3 requires material on the internet intended for the public to comply with the Code
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28.4
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Clause 28.4 allows for advertising of medicines in electronic journals intended for health professionals that can be accessed by the public
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28.5
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Clause 28.5 allows for provision of certain reference material on the internet for the public
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28.6
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Clause 28.6 requires it to be made clear when a user is leaving a company site on the internet
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29
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General: Clause 29 covers compliance with undertakings
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