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Handbook for Investors. Business location in Switzerland.

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In the ma<strong>in</strong>, Swiss product liability regulations are comparable<br />

with those <strong>in</strong> the European Union – the manufacturer is liable <strong>for</strong><br />

damage caused by defective goods, irrespective of whether the<br />

manufacturer itself is negligent. In <strong>Switzerland</strong>, liability applies to<br />

all products put <strong>in</strong>to circulation from 1994 onwards. The health<br />

and safety requirements <strong>for</strong> technical equipment are governed<br />

by ord<strong>in</strong>ance. In terms of technical standards, <strong>Switzerland</strong> has<br />

largely adopted European Union regulations, thereby remov<strong>in</strong>g<br />

any major barriers to export<strong>in</strong>g to the EU <strong>in</strong> this area.<br />

The follow<strong>in</strong>g sections give further details on the regulations relat<strong>in</strong>g<br />

to a number of important product categories. Due, however,<br />

to the large number of laws and ord<strong>in</strong>ances <strong>in</strong> existence, it is essential<br />

that detailed <strong>in</strong><strong>for</strong>mation be sought <strong>in</strong> specific cases.<br />

3.4.1 Foodstuffs<br />

The Swiss Foodstuffs Ord<strong>in</strong>ance (Lebensmittelverordnung, LMV)<br />

conta<strong>in</strong>s very strict regulations on the <strong>in</strong><strong>for</strong>mation that must be<br />

declared. All <strong>in</strong>gredients must be named and listed on the packag<strong>in</strong>g<br />

or labels of pre-packed foodstuffs <strong>in</strong> descend<strong>in</strong>g order of<br />

quantity. Foodstuffs not on the federal list must be authorized by<br />

the Federal Office of Public Health (FOPH). Approval is mandatory<br />

<strong>for</strong> products where an <strong>in</strong>gredient conta<strong>in</strong>s more than 1 % of<br />

genetically modified organisms. It is <strong>for</strong>bidden to market foodstuffs<br />

as hav<strong>in</strong>g a therapeutic effect. Products with a therapeutic<br />

effect are medic<strong>in</strong>es and must be authorized by Swissmedic (see<br />

Section 3.4.2).<br />

Federal Office of Public Health (FOPH)<br />

Mutual recognition agreements (MRAs)<br />

www.seco.adm<strong>in</strong>.ch<br />

Languages: German, French<br />

www.bag.adm<strong>in</strong>.ch<br />

Languages: German, English, French, Italian<br />

Permitted foodstuffs<br />

Government approvals<br />

www.e-service.adm<strong>in</strong>.ch/bewilligungen<br />

Languages: German, French<br />

www.adm<strong>in</strong>.ch<br />

Search under: Law on foodstuffs<br />

Languages: German, English, French, Italian<br />

Official test centers – <strong>Switzerland</strong>, EU<br />

www.seco.adm<strong>in</strong>.ch<br />

Search under: SAS (accredited centers)<br />

Languages: German, English, French, Italian<br />

3.4.2 Pharmaceutical products<br />

The manufacture and sale of medic<strong>in</strong>es is subject to mandatory<br />

approval <strong>in</strong> <strong>Switzerland</strong>. It takes on average six months to register<br />

a new pharmaceutical product with Swissmedic, the Swiss Agency<br />

<strong>for</strong> Therapeutic Products, mak<strong>in</strong>g <strong>Switzerland</strong>’s registration process<br />

one of the quickest <strong>in</strong> the world. Normal evaluation of a<br />

license application <strong>for</strong> a human medic<strong>in</strong>e costs a maximum of<br />

CHF 25,000 (CHF 60,000 under the fast track procedure).<br />

Swiss Association <strong>for</strong> Standardization<br />

www.snv.ch<br />

Languages: German, English, French<br />

The registration requirements are largely comparable with those<br />

<strong>in</strong> the EU, which makes it simple to apply <strong>for</strong> registration <strong>in</strong><br />

<strong>Switzerland</strong> and the EU simultaneously. Swiss registration enjoys<br />

high-level <strong>in</strong>ternational stand<strong>in</strong>g, thanks to the country’s exceptional<br />

scientific reputation, its strict criteria and the large number<br />

of renowned cl<strong>in</strong>ical-test<strong>in</strong>g hospitals. The fast track procedure<br />

enables vital medic<strong>in</strong>es (e.g. to treat AIDS or Alzheimer’s) to be<br />

brought to market very quickly (three-four months maximum),<br />

despite rigorous test<strong>in</strong>g.<br />

<strong>Handbook</strong> <strong>for</strong> <strong>Investors</strong> 2010<br />

33

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