UCPMP 2024 Clause 3.2: the five items promotional material must carry when its purpose is to inform a prescribing decision
Clause 3.2 applies where the material's purpose is to give prescribers enough information to reach a prescribing decision. Five items must then be given legibly and as an integral part of it. The first two are the drug and the authorisation holder's name and address, and the generic name immediately adjacent to the drug name. The other three are dosage, safety information, and a statement that more information is available on request, with the date.
In short
- The clause is scoped by purpose. A visual aid or a leave-behind carries the list when its purpose is to help a prescriber decide.
- Five items, and the fifth is the easiest to forget.
- 'Legibly' and 'an integral part'. The Code sets no point size.
- The generic name goes immediately adjacent to the most prominent display of the drug name. The Code sets no size rule for promotional material. Labels are different. A label rule under the Drugs and Cosmetics Rules 1945 requires the proper name to be more conspicuous than the trade name.
The condition that decides whether the clause applies
Clause 3.2 turns on 'the purpose of the promotional material'. It applies where that purpose is 'to provide persons qualified to prescribe with sufficient information upon which to reach a decision for prescription or for use'. Where it is, 'the following minimum information must be given legibly and must be an integral part of the promotional material'.
That is a test about purpose. If a piece exists to help a prescriber decide, the clause applies to it whatever it is called internally. If it does not, for instance because the audience is patients, the clause is not the right instrument. Look instead to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the consumer framework. Look also to the Drugs and Cosmetics Rules 1945. Their licence conditions bar any advertisement of Schedule H, H1 and X drugs without the previous sanction of the Central Government. These conditions sit in Rules 74(p) and 78(q) and parallel provisions. Their text sets no audience limit. Separately, Rule 106 says no drug may claim to prevent or cure a disease listed in Schedule J. It sits in the Part of the Rules on labelling and packing, and is commonly read to reach promotional claims.
The Drugs and Magic Remedies Act is not confined to material for patients. Its definition of 'advertisement' includes 'any notice, circular, label, wrapper or other document' (section 2(a)). The saving that matters for doctor material is section 14(c). That saving covers only 'any advertisement relating to any drug sent confidentially in the manner prescribed under section 16 only to a registered medical practitioner'. Its Schedule of diseases includes diabetes and high or low blood pressure, so material for doctors in those areas is not outside the Act by default.
The five items
| Feature | Clause | Basis | What the Code says |
|---|---|---|---|
| Company identification | UCPMP 2024, Clause 3.2(i) | Code (UCPMP 2024) | The relevant drug, the name and address of the holder of authorization for the drug (or the business name and address of the part of the business responsible for placing the drug on the market). Required whether or not the piece is left behind. The manufacturing licence number is a label requirement under the labelling rules of the Drugs and Cosmetics Rules 1945. Clause 3.2 does not require it on promotional material. |
| Generic name | UCPMP 2024, Clause 3.2(ii) | Code (UCPMP 2024) | The name of the drug, along with a list of active ingredients, using the generic name, placed immediately adjacent to the most prominent display of the name of the drug. Adjacency is the requirement. Size is not. The Code sets no relationship between the generic name and the brand name in point size. |
| Dosage and administration | UCPMP 2024, Clause 3.2(iii) | Code (UCPMP 2024) | Recommended dosage, method of use, and where not obvious, its method of administration. |
| Safety information | UCPMP 2024, Clause 3.2(iv) | Code (UCPMP 2024) | Adverse reactions, warnings, precautions for use and relevant contraindications for the use of the product. Read with Clause 1.3, which requires information to be balanced and not misleading. That is where fair balance actually comes from. |
| Availability statement and date | UCPMP 2024, Clause 3.2(v) | Code (UCPMP 2024) | A statement that additional information is available on request, and the date on which the above particulars were generated or last updated. Easy to add and easy to forget. A piece reprinted for years with no date on the particulars does not meet this. |
The item most easily forgotten
Clause 3.2(v) requires a statement that additional information is available on request together with the date on which the particulars were generated or last updated. It is easy to add and easy to forget, and it is the item that quietly fails on artwork reprinted across cycles.
What the clause does not say
It sets no point size. It requires the information to be 'legibly' given and to be 'an integral part' of the material. That is a test about whether a reader can actually read it and whether it travels with the piece. Any numeric minimum a team works to is an internal MLR standard, and worth labelling as such so nobody defends it as law.
Frequently asked questions
When does UCPMP Clause 3.2 apply?
Where the purpose of the promotional material is to provide persons qualified to prescribe with sufficient information upon which to reach a decision for prescription or for use. It is a test about purpose, whatever the piece is called.
Does Clause 3.2 set a minimum font size?
No. It requires the information to be given legibly and to be an integral part of the material. No point size appears anywhere in the Code.
What is the fifth item?
A statement that additional information is available on request, and the date on which the particulars were generated or last updated. It is easy to forget, especially on artwork reprinted across cycles.
Check it before MLR does
Collateral Advisor flags possible gaps against this check in the pages you upload, for your team to review.
Free trial, no card needed. MarketingSense is a pre-MLR advisory assistant. Your medical, legal and regulatory team still makes the final call.