Swissmedic Vigilance News

Information for private individuals, healthcare professionals and the
pharmaceutical industry regarding the reporting of adverse effects and
the competent authority, depending on the suspected product
Ioanna Istampoulouoglou
Safety of Medicines Division, Swissmedic, Bern, Switzerland
The use of therapeutic products, foodstuffs and
cosmetic products may be associated with adverse
effects. Unlike therapeutic products, however, adverse
effects of foodstuffs and cosmetic products
do not have to be reported. It is therefore important
that the person submitting the report correctly
classifies the suspected product used before reporting
an adverse effect.
Therapeutic products include medical devices and
medicinal products. Medicinal products include
not only conventional medicinal products but also
complementary medicines (i.e. homeopathic, anthroposophic
and Asian medicinal products) and
herbal medicines. These are subject to the KPTPO
in the TPA (Complementary and Phytotherapeutic
Products Ordinance, Therapeutic Products Act) and
thus fall under the responsibility of Swissmedic (for
further information see Herbal medicinal product,
swissmedic.ch). Relevant lists of the currently authorised
complementary and herbal medicines are
available under Lists and directories, swissmedic.ch.
If severe and/or previously unknown adverse effects
occur after use of a medicinal product, healthcare
professionals and pharmaceutical companies are
obligated to report these according to Art. 59 TPA.
Under the Swiss TPA, consumers, patients and their
organisations and interested third parties can also
report adverse effects and incidents to Swissmedic.
Both foodstuffs and cosmetic products (cosmetics)
are subject to the Foodstuffs Act and are regulated
in food legislation. These products are therefore
the responsibility of the Federal Food Safety
and Veterinary Office (FSVO). Foodstuffs include,
among others, nutritional supplements and novel
foods (such as cañihua and protein extracts from
insects), etc. Cosmetic products include perfuming
products and products used to cleanse and care for
the skin, hair, teeth and mucous membranes.
There is no duty to report the occurrence of adverse
effects for foodstuffs (including nutritional supplements
and novel foods) or cosmetic products.
In the specific case of a serious and/or previously
unknown adverse effect report in which the suspected
product contains both a medicinal product and
a foodstuff or cosmetic product, this must also be
reported and the report should primarily be made
to Swissmedic.
Products containing cannabidiol (CBD) are not only
available in Switzerland as authorised medicinal
products but also as (currently non-marketable)
foodstuffs (including nutritional supplements) and
cosmetic products (Products containing cannabidiol
(CBD) – Overview, swissmedic.ch). Two medicinal
products containing CBD are currently authorised
by Swissmedic in Switzerland: Epidyolex ® and Sativex
® . If adverse effects occur in connection with products
containing cannabinoids, Swissmedic receives
these reports. The products are classified as necessary
under the relevant legislation by the Delimitation
Specialist Group and – if they are not medicinal
products – fed into the correct channel.
Swissmedic Vigilance News | Edition 31 – November 2023
34