Labelling of medicines
The word Labelling
May 2002 (comment added December 2003)
What I understand with the word Labelling is the making of labels (design, print etc), or the process of putting/sticking the labels onto the packages/containers. The print on blister pack sheets and on tablet wheels consequently falls within my definition. Pill imprint is outside the definition, but I choose to include the topic. Package inserts (patient leaflets) may be considered parts of the label, but I choose not to include that topic on these pages.
Directive 2001/83/EC definition: Information on the immediate or outer packaging.
This is the European situation. USA has complicated the situation, as they consider labelling as all the documentation that the manufacturer has submitted to the FDA for a medicinal product. The very wide definition of Labelling serves the purpose of giving FDA more control over the promotional practices of pharmaceutical companies.
In my view the American way to define Labelling is confusing. It is not naturally deductible. It is different from the definition in other parts of the world. And I believe it is also different to the definition of Labelling in other industries in US.
But such is the situation. It is not possible to turn the clock back, and the Americans are to numerous.
In international writing the word Labelling has to be interpreted from the context.
Comment from Leander Fontaine, December 2003:
Just saw your remark about the US definition of labeling.
Firstly, you are right, there is no clear definition that would unambiguously identify all documents that are covered - which has repeatedly lead to situations where companies and FDA disagree about whether or not something is labeling, and labeling standards apply.
Is helpful to differentiate between labeling (in a narrower sense) and "promotional labeling". Labeling in a narrower sense is all information that comes directly with the product (labels, package inserts, information on blister foils etc.) or - if product and information travel separately - information that is supposed to be in the hands of/available to a user (dispensing pharmacist, physician, patient) when using the product or contemplating use. So, it also covers prescribing information that is sent electronically to e.g. a pharmacist, or information posted on a company website.
Promotional labeling is - I would say - all promotional information about the product (e.g. claims, more in depth efficacy information etc.). It is this promotional labeling that causes some problems of definition. Imagine an article written by a non-company physician summarizing the properties of a product. Even if this article has been published in an independent journal before, it may possibly considered labeling if it used by the sales force to promote the product. But it will of course depend on the article itself and how exactly it is used.
This very wide definition of labeling serves the purpose of giving FDA more control over the promotional practices of pharmaceutical companies.