The Borderline Classification Committee
To protect public health on behalf of the Malta Licensing Authority,
the Medicines Authority (“MA”) regulates medicinal products for
human use in accordance with the European Community Pharmaceutical
Directives and Maltese legislation. Directive 2001/83/EC
(as amended) and Medicines Act, 2003 (Act No. III of 2003) (as amended)
state that:
A
medicinal product means any substance or combination
of substances:
(a)
“Any substance or combination of substances presented as having properties for treating or preventing disease
in human beings;
(b)
"Any substance or combination of substances which may be used in or administered to human beings either with
a view to restoring, correcting
or modifying physiological functions by exerting a pharmacological,
immunological or metabolic action, or to making a medical diagnosis”.
Most human medicines are clearly identifiable
as such and are subject to EU marketing authorisation regulations.
However, there are some products, where it is not so easy to distinguish
a medicinal product from, for example, cosmetics, medical devices
or food supplements. These are known as ‘borderline products’.
The Borderline Classification Committee classifies borderline products
into medicinal or non-medicinal products.
Products for which medicinal
claims are made or which contain substances likely to have pharmacological
or toxicological actions in the body are likely to be considered
as medicines, and will therefore need a marketing authorisation
to be placed on the market.
More information can be found in the
Guideline for
Borderline Products. - 'A Guide to What is a Medicinal
Product'.
Please refer to
Application Form for the classification of a borderline
product and the
Guidelines on how to complete the application form.
List of Products Classified as
Medicinal Products between May 2004 and June 2006
List of Products
Classified as Medicinal Products between July 2006 and December 2007
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