2024 ABPI Code — Compliance Cheat Sheet

Certification & Approval Cl. 14

All promotional materials must be certified by a nominated signatory before use Cl. 14.1

MI responses to unsolicited queries — examined & recorded, not certified Cl. 14.3

Nominated signatory must be a registered doctor, dentist, pharmacist or nurse Cl. 14.1

Briefing & training materials require certification — no PI required Cl. 14

Rep-created materials (flip charts, email notes) are promotional — must be certified Cl. 17

Prescribing Information Cl. 9

PI must be integral to all promotional materials Cl. 9.1

Printed materials: PI can now be provided via prominent QR code/URL 2024 update

Digital: PI must be directly accessible — one click away Cl. 9.1

Non-proprietary (INN) name must appear immediately adjacent to brand name, at least half the font size Cl. 9.7

Abbreviated ads in journals: minimum 1 page; cannot appear as loose inserts or digitally Cl. 9.8

Claims, Data & Accuracy Cl. 6–8

All claims must be accurate, balanced, not misleading and capable of substantiation Cl. 6.1

No hanging comparatives — "better" or "more effective" requires a named comparator Cl. 6.4

Secondary endpoints must be clearly identified as such — not promoted as primary Cl. 6

Simulated data must be clearly labelled as such Cl. 6

Cost comparisons must be fair, accurate and not misleading Cl. 6.5

Meetings, Hospitality & Congresses Cl. 10–11

Hospitality must be secondary to the main educational purpose — never the primary draw Cl. 10.1

Venue must be appropriate and not extravagant — no luxury/resort venues Cl. 10.3

Delegates cannot be paid to attend or reimbursed travel for local meetings Cl. 10

Advisory boards: must have genuine scientific purpose; documented agenda & output required Cl. 11

Speaker fees must reflect fair market value for expertise — not time alone Cl. 11

'New' label permitted for maximum 12 months after UK launch Cl. 6.6

Gifts, MEGS & Samples Cl. 19–21

No gifts or promotional aids to HCPs or admin staff — no exceptions Cl. 19.1

Patient support items: max £10 excl. VAT; company name ✓, product name ✗ Cl. 19.2

MEGS must benefit patient care — not linked to prescribing targets Cl. 20

Samples: written signed request only; max 4/year; smallest available pack; 2-year limit per HCP Cl. 21

Switching programmes prohibited — therapy reviews must include clinical assessment Cl. 20

Public, Patients & PR Cl. 26–27

POMs cannot be advertised to the general public under any circumstances Cl. 26.1

Disease awareness must not name a product or encourage patients to request a prescription Cl. 26.3

Patient materials must include Yellow Card / MHRA adverse event reporting statement Cl. 26.2

Patient organisation funding must be prominently disclosed on all joint materials Cl. 27

Press releases about unlicensed indications must be reactive only — not proactive Cl. 26

Digital & Social Media Cl. 16

Promotional emails require explicit opt-in — opt-out is not sufficient Cl. 16

HCP websites: promotional content must not be visible behind an access gate Cl. 16

Companies are responsible for employee social media posts relating to the company/products Cl. 16

MI queries via social media must be answered privately — not publicly Cl. 16

AI chatbots are subject to the Code — outputs must be certified 2024 update

Companies are responsible for agency social media activity on their behalf Cl. 16

Sales Representatives Cl. 17

ABPI exam: sit within year 1, pass within year 2 of employment Cl. 17

Max 3 unsolicited calls per prescriber per year — group meetings & requested visits don't count Cl. 17

Remote detailing: permission required in advance or at start of call Cl. 17

MSLs must report via medical — not commercial structure; must not accompany reps Cl. 17

No inducements to gain interview — including charitable donations Cl. 17

Research Cl. 13–15

Clinical trials must be registered within 21 days of first patient enrolment Cl. 13

Negative trial results for licensed medicines must be disclosed Cl. 13

Excess investigators relative to statistical need = seeding study = disguised promotion Cl. 13

NIS protocol must be approved by scientific service — no formal certification needed Cl. 15

Market research: pharmaceutical sponsorship must be declared — company name not required Cl. 14