Swissmedic Annual Report 2018

56 Market access | Medicinal products
Quality defects and batch recalls
Swissmedic records reports on quality defects in medicinal
products and takes the necessary actions. The reports are
assessed and prioritised; where a potentially high health
risk is identified, a batch recall is initiated and professionals
and the public are informed. Swissmedic also reviews foreign
reports on quality defects specifically to ascertain
whether products marketed in Switzerland are affected. It
is engaged in a lively international exchange of information
for this purpose. On request, Swissmedic authorises the
distribution of medicinal products produced for other countries
in order to avoid supply shortages in cases where the
market cannot be served with an equivalent product from a
different authorisation holder. The Agency works with the
Federal Office for National Economic Supply (FONES) on
these applications, since authorisation holders report supply
shortages to FONES.
Activities
• A total of 736 reports of quality defects were received
in 2018. This represents a 25 % increase on the previous
year. The number of batches recalled in the Swiss
market also increased.
• Many reports concerned manufacturing incidents, often
caused by inadequate compliance with Good Manufacturing
Practice (GMP). In spring 2018, several batches of
a heparin preparation that is widely used in hospitals
were recalled following machinery problems that
resulted in leaking ampoules, causing a temporary
interruption in supply. Regular supplies of heparins to
Swiss hospitals resumed once the machine in question
had been modified.
• In the second half of 2018, several batches of sartan
antihypertensives had to be recalled after potentially
carcinogenic nitrosamines were found in active substance
sourced from a Chinese manufacturer.
736
32
528
560
19
390
622
Measures against illegal medicinal products
Swissmedic increases public awareness of the dangers associated
with the use of illegal medicinal products. Professionals
and the public are warned of the risks in media releases,
interviews and publications. The Agency consults
regularly with authorities and organisations as part of this
task, and promotes effective national and international networking.
Swissmedic receives reports on illegal products, activities
and distribution, reviews them and initiates corrective action
as necessary or passes them on to the competent office.
The Agency works closely with the customs authorities
to monitor imports of medicinal products and orders the
return or destruction of illegal shipments.
17
2018 2017 2016
Number of reports of quality defects
448
Number of batch recalls (affected medicinal products)
Number of reports relating to Switzerland