Article 62 permits the inclusion on the label of information which is compatible with the SmPC and which is useful for the patient, provided it is not promotional.
Promotional information cannot be included on medicines packs. The term “promotional information” does not have a firm definition and differences in interpretation between regulatory bodies and the industry have caused problems in the past.
The statements below are examples of promotional phrases which are not permitted on medicines packaging by virtue of Article 62 of Council Directive 2001/83/EC. This list is not exhaustive and others may be deemed unacceptable too. A key indicator that a phrase may be promotional is that it is based on phrases which are subjective, rely on market research or sales evidence and/or the phrase is not supported by the SmPC.
Comparative statements may not be made on packaging – top parity statements must not be used in packaging because a comparison is being made with all the other products in the category. Examples include: “Nothing acts faster”, “nothing works better”, “there is no stronger pain relief.”
Not habit-forming, Non-addictive – while the criteria for non-prescription status includes the factor that the ingredient must have a low potential for dependence, these phrases should not be used without qualification where there is potential for psychological dependency.
Website addresses – website addresses may not be included on the outer packaging of any medicine.
However, in certain limited circumstances, a website address may be permitted to appear at the end of the PIL. Applications will be considered on a case-by-case basis by the PIQU, but will generally be accepted for products where additional support is referenced in the SmPC as being essential for the safe and effective use of the medicine.
Applicants intending to include website addresses in the PIL should ensure that the website is fully compliant with the provisions of Article 62 of Council Directive 2001/83/EC [as amended], contains information useful for the patient, that is consistent with the SmPC and is non-promotional. The URL should be accessible by the PIQU assessment team at the time of application so that the information can be assessed against these provisions.