to every practising physician and pharmacist in the
country as one mechanism to comply with the
regulation.
Many of the promotional activities of the phar-
maceutical industry are directed at professionals in
the healthcare market (doctors, pharmacists, hospi-
tals, etc.), as advertising POM medications directly
to the patient is prohibited. However, companies are
receiving an increasing number of enquiries directly
from patients about their products. This has neces-
sitated the provision of a regulatory Guidance for
companies onhowtoanswersuchdirectrequestsfor
information from the general public.
Pharmaceutical companies are now permitted to
answergeneral inquiries in anon-promotional way.
However, promotion to the public is specifically
permittedonlyin the case of P or GSL medicinal
products.
Disease awareness campaigns are a recognized
and approved way for pharmaceutical companies
to communicate with the general public. Disease
awareness campaigns may make reference to treat-
ment options, but need to carefully avoid high-
lighting any specific medicinal product, as this
would be viewed as promotional. Any promotion
of a particular medicinal product will bring the
campaign within the scope of the Community
Code (Directive 2001/83), and violate the law.
Promotional aids, gifts, hospitality, supply of
free samples and the conduct and training of med-
ical representatives all fall as squarely within the
regulations as printed and audiovisual promotional
materials.
34.16 Medicines regulation in
SwitzerlandSwitzerland is a federation of cantons. Each canton
governs its own regional issues, while the national
Swiss government is concerned with overarching
matters. Democracy extends to a yet smaller scale
in Switzerland because, even within the cantons,
individual villages or cities retain varying degrees
of independence. The result is a fascinating legal
mosaic: a system of great diversity within the
national borders of a relatively small country.
Switzerland lies outside of both the EU and the
EEA. Nevertheless, the Swiss RA has adopted all
the ICH guidelines and requires MA applications
in the CTD format. Modules II–V can be submitted
in English; while the country-specific Module I has
to be submitted in one of the Swiss languages
(German, French, Italian or Romantsch; however,
informally, the RA discourages the last of these).
The SmPC and PIL must provide information in
German, Italian and French, unless for some pecu-
liar reason, the product will only be distributed in
cantons using just one of these languages. Switzer-
land does not automatically ratify European MA.
However, because of its special relationship and
national status, marketing applications that have
been ratified in Liechtenstein can lead to simpler
application processes at the Swiss RA (named
‘SwissMedic’).
Although SwissMedic functions as an RA for all
of Switzerland, there are nonetheless parts of med-
icinesregulation thataregovernedbycantonal laws,
and not centrally harmonized across the whole
country. For example, the GMP and GCP inspecto-
rate and distribution of medicines is a cantonal, not
national, responsibility, even though the GMP and
GCP guidances are promulgated nationwide by
SwissMedic. It is advisable to talk to the relevant
personnel (e.g. the cantonal pharmacist for GMP
and medicines distribution issues) at the cantonal
administration, when applying for MA.
As in the EU, an inland legal representative is
needed for all non-Swiss applicants. These legal
representatives are as valuable to sponsors for navi-
gating this complicated situation, as to SwissMedic
as a point of contact and communication.34.17 Medical devices and drug/
device combinationsAll medical devices are subject to regulatory
review and MA similar to the medicinal products.
In the United Kingdom the national regulatory
authorities for devices and medicinal products
were merged in 2003. However, note that the
EMEA, CHMP and COMP do not regulate medical
devices, unlike their US equivalents.482 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION