01Date of Preparation or Revision — The Quiet Promise of Recording the Edition

Print the year and month the material was prepared, or the year and month it was revised, in a visible place such as the front or back cover. Among the many items the guidance lists, this single line placed sixteenth is so quiet that, reading the heading alone, you might pass right over it. Yet this item mirrors the character of the whole guidance better than any other.

It is not a showy prohibition. It differs in kind from the assertive rules that say "do not write this" or "do not exaggerate that." All it asks is that you leave one line of history: when this was made, and when it was changed. That is all. But the accumulation of such plain acts is exactly what supports trust in a material from the ground up.

Why a Mere "Year and Month" Carries Such Weight

It makes sense once you return to the spirit of the foreword. The electronic package insert is the original; promotional materials stand in a supplementary role to it. The original gets revised — an indication is added, dosage is reconsidered, occasionally a serious adverse reaction is newly written in. When the original moves, the material that copied from it grows stale too.

At that moment, if the material bears no date of preparation or revision, the reader cannot judge "as of when does the booklet in my hands speak?" Was it updated against the new package insert, or does it still carry the old wording from before the revision? That one line of date is the minimal clue that makes such a judgment possible.

Suppose two explanatory materials for the same product sit forgotten in a clinic drawer. At a glance the contents look much alike. But one predates the addition of a serious adverse reaction, the other follows it. Without a date on the cover, no one can tell which edition is the one currently in force. The date is the key that distinguishes old from new.

Securing Verifiability by Structure

At the root of the guidance lies a stance of avoiding not only falsehood but misunderstanding. Recording the date is the practical expression of that stance. When someone later tries to verify a material — in an audit, a self-inspection, or a recall decision — verification cannot even begin if "which edition" is unknown.

In science, an experimental record without a date can be neither reproduced nor re-tested. Evidence cannot be divorced from "when and under what conditions it was obtained." A material is the same: a sheet lacking the attribute of a date shuts the door on verification by its own hand.

02Putting It Into Practice — The Fine Print and Common Slips

Once the intent sinks in, the next task is to turn it into a working procedure. From here we bring it down to specifics: where to write it, how to write it, and what not to overlook. The reasoning is spent in the first half. What remains is the routine that keeps you from repeating the same omission at every revision.

The Fine Print — Where and How to Write It

The place is defined as "somewhere visible." This is not merely about appearance. When a recall or replacement becomes necessary, it matters that the person holding the material can flip it over and check the date at once. Placing it in a visible spot on the front or back cover serves the intent better than tucking it small at the bottom of a colophon.

Forgetting to update the date after revising is an easy oversight. If only the contents are corrected while the date stays at the old edition, the result is not "passing off old information as current" but a different kind of misunderstanding — "carelessly making current information look old." Both distort the reader's judgment and are equally at fault. Build a step into the end of every revision that aligns the date with the change.

The Relation Between "Date" and "Edition" — What Are We Trying to Distinguish?

SituationWith a dateWithout a date
Cross-checking after an insert revisionYou can instantly judge which original the material is based onThe correspondence to the original is untraceable; stale wording goes undetected
Recalling a material in the fieldThe target edition is pinned down by date and the recall scope can be drawnOld and new are mixed; no line for the recall can be set
Later self-inspection or auditVerification can start from "when was it made"The starting point is missing and accountability cannot be met

Governing the Unwritten by Higher Norms

The guidance does not bind the date format word for word. Calendar style, how finely to record it — such details are left to discretion. But "left to discretion" does not mean "anything goes." As the foreword teaches, even unwritten territory is governed by a higher norm: the purpose of keeping the reader able to judge correctly. When in doubt about how to write the date, choose by one standard — whether that line will withstand later verification.

In closing

Placed sixteenth, "date of preparation or revision" is the plain core of the guidance. It forbids nothing; it keeps, as a structure, the state in which an edition is left on record and can later be verified or recalled. The accumulation of that is what supports trust in the material as a whole.

The date is no ornament but the entrance to verifiability. Update it without fail at every revision, and place it where it can be seen — keeping this small habit is the shortest path to making integrity visible.