国内政策【切换】 国际政策

瑞士医疗产品法

Law on Therapeutic Products


Federal Law
on Medicinal Products and Medical Devices
dated 15 December 2000
The Federal Assembly of the Swiss Confederation,
in accordance with Article 95 Paragraph 1 and Article 118 Paragraph 2, of the
Federal Constitution1,
after consultation of the draft legislation of the Federal Council of 1 March 19992,
decrees:
Chapter 1 General provisions
Section 1 General provisions
Art. 1 Purpose
1 The intention of this law is to protect human and animal health and for this
purpose it shall guarantee that only high quality, safe and effective therapeutic
products are placed on the market.
2 In addition this law is intended to:
a. protect the consumers of therapeutic products against fraud;
b. contribute so that the therapeutic products placed on the market are used in
accordance with their purpose and with moderation;
c. contribute so that a reliable and well-ordered provision of therapeutic
products, including the necessary professional information and advice, is
offered throughout the country.
3 In the execution of this law, in particular in the enactment of the ordinances and in
the application to an individual case, it shall be necessary to ensure that:
a. the efficiency and independence of the Swiss control of therapeutic products
is guaranteed;
b. favourable conditions exist for research and development in the field of
therapeutic products;
1 SR 101
2 BBl 1999 3453 (German), FF 1999 3151 (French), FF 1999 2959 (Italian)
c. all competitors on the market fulfil the same legal requirements of safety and
quality.
Art. 2 Scope
1 This law shall apply to:
a. the handling of therapeutic products (medicinal products and medical
devices), particularly in their manufacture and placement on the market;
b. narcotics in the sense of the Federal Narcotics and Psychotropic Substances
Act of 3 October 19513, in so far as they are used as therapeutic products;
c. therapeutic procedures, such as gene therapy, in so far as they directly relate
to therapeutic products; the Federal Council may enact provisions specific to
this subject.
2 The Federal Council may completely or partially exempt medical devices for the
use on animals or in veterinary diagnostics from the scope of this law.
Art. 3 Duty of diligence
Any person handling therapeutic products has to take all necessary measures
according to the state of science and technology such that human or animal health is
not jeopardized.
Art. 4 Definitions
1 Within the meaning of the law, it is understood by:
a. Medicinal products: products of chemical or biological origin, which have,
or are presented as having, a medicinal effect on the human or animal
organism, in particular in the diagnosis, prevention or treatment of diseases,
injuries and handicaps; blood and blood products are also considered as
medicinal products.
b. Medical devices: products, including instruments, apparatus, in vitro
diagnostics, software and other goods or substances which have, or are
presented as having, a medical use and whose principal action is not
obtained with a medicinal product;
c. Manufacture: all stages of manufacture of a therapeutic product, from the
acquisition of the starting materials through the processing to the packaging,
storage and delivery of the final products as well as the quality controls and
batch release;
d. Placing on the market: the distribution and supply of therapeutic products;
e. Distribution: the transfer or release, either free of charge or against payment,
but not the supply, of a therapeutic product;
3 SR 812.121
f. Supply: the transfer or release, either free of charge or against payment, of a
finished therapeutic product destined for the use by the purchaser, as well as
for the use on a third party or on animals;
g. Pharmacopoeia (Pharmacopoeia Europaea and Pharmacopoeia Helvetica):
a collection of regulations on the quality of medicinal products, excipients
and certain medical devices.
2 The Federal Council may, by decree, delimit from each other the terms used in this
law as well as the terms in Paragraph 1, define them in more detail, and may
designate exceptions based upon new findings in science and technology as well as
on international developments.
Chapter 2 Medicinal products
Section 1 Manufacture
Art. 5 Requirement of an establishment licence
1 An establishment licence from the Swiss Institute of Therapeutic Products
(Institute) shall be required by those who:
a. manufacture medicinal products;
b. add medicinal products into animal feed.
2 The Federal Council may allow special dispensation for the requirement of an
establishment licence. In particular it may:
a. place under the subject of a cantonal establishment licence or mandatory
notification the manufacture of therapeutic products, produced according to
a magistral formula, an officinal formula, or an own formula, conforming to
the Pharmacopoeia or to any other pharmacopoeia or formularies (art. 9,
par. 2, subpar. a, b and c, art. 14, par. 1, subpar. c) recognised by the
Institute;
b. exempt from an establishment licence livestock holders who add medicinal
products to animal feed intended for their own livestock.
Art. 6 Conditions
1 The establishment licence shall be issued if:
a. the necessary professional and operational conditions are fulfilled;
b. an appropriate system of quality assurance exists.
2 The competent authority shall verify by inspection that the conditions are fulfilled.
Art. 7 Requirements of manufacture
1 The manufacture of therapeutic products must conform to the recognised principles
of Good Manufacturing Practice.
2 The Federal Council shall define in more detail the principles of Good
Manufacturing Practice. In doing so, it shall take into account internationally
recognized guidelines and standards.
Section 2 Principle for placing products on the market and
marketing authorization procedure
Art. 8 Principle for placing products on the market
Medicinal products and excipients placed on the market must meet the requirements
of the Pharmacopoeia provided that appropriate regulations are listed therein.
Art. 9 Marketing authorization
1 Finished medicinal products and veterinary medicinal products intended for the
manufacture of medicinal foodstuffs (premixed medicinal products) shall only be
allowed to be placed on the market if authorized by the Institute. International
agreements on the recognition of marketing authorizations shall be reserved.
2 The following shall be exempt from a marketing authorization:
a. medicinal products prepared upon a medical prescription by a public
pharmacy or a hospital pharmacy or under a mandate of these by another
establishment holding an establishment licence for manufacture, and which
are supplied to a given person or group of persons or for a given animal or
livestock (magistral formula);
b. medicinal products prepared in small quantities by a public pharmacy, a
hospital pharmacy, a chemist's shop or by another establishment holding an
establishment licence for manufacture, conforming to a special monograph
of the Pharmacopoeia or another pharmacopoeia or a formula recognised
by the Institute, and which are supplied to their own customers (officinal
formula);
c. medicinal products prepared in small quantities by a public pharmacy, a
hospital pharmacy, a chemist's shop or by another establishment holding an
establishment licence for manufacture, according to an own formula and
within the limits of the right to supply of the person responsible for the
manufacture in accordance with Article 25, and which are destined for
supply to their own customers. The holder of the formula may appoint
another establishment holding an establishment licence for manufacture to
prepare the medicinal products for supply to their own customers;
d. medicinal products intended for clinical trials;
e. medicinal products which cannot be standardized.
3 The Federal Council may make provision for a requirement of a marketing
authorization for the production or manufacturing process of medicinal products
which cannot be standardized.
4 The Institute may authorize, for a limited period, the distribution or supply of
unauthorized medicinal products against life-threatening diseases if such an
authorization is compatible with the protection of health, that a significant
therapeutic benefit is expected from the administration of these medicines, and that
no equivalent medicine exists.
Art. 10 Conditions attached to the marketing authorization
1 Any person requesting a marketing authorization for a medicinal product or
process must:
a. prove that the medicinal product or process is of high quality and is safe and
effective;
b. be a holder of an establishment licence for manufacture, import or wholesale
trade issued by the competent authority;
c. have his registered address or registered office, or have set up a subsidiary,
in Switzerland.
2 The Institute shall verify that the conditions attached to the marketing
authorization are fulfilled. To this effect, it may carry out product-specific
inspections.
Art. 11 Application for a marketing authorization
1 The application for a marketing authorization must contain all of the data and
documents necessary for its assessment, in particular:
a. the name of the medicinal product;
b. the name of the manufacturer and the distribution company;
c. the process of manufacture, the composition, the quality and the stability of
the medicinal product;
d. the attestation of residues and the discontinuation period for medicinal
products intended for animals kept for the production of foodstuffs;
e. the therapeutic effects and undesirable effects;
f. the labelling, the medical information, the method of supply and the method
of administration;
g. the results of physical, chemical, galenic and biological or microbiological
tests as well as of pharmacological and toxicological tests;
h. the results of clinical trials.
2 The Federal Council shall:
a. lay down, taking into account the recognized international guidelines and
standards, the requirements for organisation, carrying out and recording of
the pharmacological and toxicological tests referred to in Paragraph 1 Letter
g, and shall adopt provisions for the control procedure;
b. establish the languages used for the labelling and the information leaflets.
3 The Institute shall define in more detail the data and documents mentioned in
Paragraph 1. It may make provision for further data and documents.
Art. 12 Second Application
1 An application for a marketing authorization for a medicinal product, which is
essentially the same as an already authorized medicinal product (original
preparation) and is intended for the same use, may be based on the results of the
pharmacological, toxicological and clinical tests of the already authorized medicinal
product if:
a. the applicant for the original preparation gives written permission;
b. the protection period of the original preparation has expired.
2 The protection period shall be ten years. The Federal Council may also grant an
appropriate protection period for the test results for the original preparation referred
to in Paragraph 1 for new indications, new modes of administration, new
pharmaceutical forms, or new dosages.
Art. 13 Medicinal products and processes authorized in foreign countries
If a medicinal product or process is already authorized in a country having
equivalent medicinal product control, the results of tests made for this purpose shall
be taken into account.
Art. 14 Simplified procedures for marketing authorization
1 The Institute shall make provision for simplified procedures for the marketing
authorization of certain categories of medicinal products where this is compatible
with the quality, safety and efficacy requirements, and where there is no conflict
with Swiss interests or international commitments. In particular, this shall apply for:
a. medicinal products where the active agents are known;
b. medicinal products of complementary medicine;
c. medicinal products prepared for stocks by a public pharmacy, a chemist's
shop or by another establishment holding an establishment licence for
manufacture, according to an own formula (over the counter medicine),
conforming to the Pharmacopoeia or another pharmacopoeia, or a formula
recognized by the Institute, and which are supplied to their own customers;
d. medicinal products prepared by a hospital pharmacy for the needs of the
hospital;
e. medicinal products prepared by the army and used in the context of a
coordinated health service;
f. important medicinal products for rare diseases;
g. veterinary medicinal products, which are intended exclusively for animals
not kept for the production of foodstuffs.
2 The Institute shall make provision for a simplified procedure of marketing
authorization for an application by another person responsible for the placement on
the market of a medicinal product which is already authorized in Switzerland and
which is imported from a country with an equivalent system of marketing
authorization:
a. if the medicinal product satisfies the same requirements as the medicinal
product already authorized in Switzerland, in particular in regard to the
labelling and the medical information mentioned in Article 11;
b. if the other person responsible for the placement on the market of the
medicinal product can continually guarantee that all of the authorized
medicinal products that he distributes fulfil the same requirements of safety
and quality as the first applicant.
3 A medicinal product may not be authorized within the meaning of Paragraph 2 as
long as the authorized medicinal product of the first applicant (original preparation)
is protected by a patent. The Federal Council shall regulate the procedure for
claiming such a patent protection. The application of the legislation of intellectual
property shall be reserved.
Art. 15 Mandatory notification
Where certain medicinal products or categories of medicinal products fulfil the
conditions for a simplified marketing authorization and where the implementation of
such a procedure is not appropriate, the Institute may enact provisions for a simple
mandatory notification.
Art. 16 Granting of a marketing authorization
1 The Institute shall authorize the placement on the market of a medicinal product if
the conditions are fulfilled. It may attach fees and conditions to the marketing
authorization.
2 The marketing authorization shall be valid for five years. During this period, the
Institute may, either on its own initiative or upon request, adapt the decision to grant
the marketing authorization to changes in circumstances or revoke it.
3 The Institute may, independently of the validity period of the marketing
authorization, re-examine the medicinal products by groups and if necessary adapt
or revoke the granting decision.
4 Upon request, it shall renew the marketing authorization if the conditions are still
fulfilled.
Art. 17 Official batch release
1 If the manufacture of a medicinal product requires particular measures, in
particular for the guarantee of safety, then a request for release must be presented to
the Institute for each batch before distribution. The international agreements on
batch release are reserved.
2 The Institute shall determine the categories of medicinal products for which an
official batch release is required, as well as the procedure and the requirements to be
fulfilled.
3 It shall publish a list of medicinal products which require a batch release for their
distribution.
Section 3 Importation, exportation and foreign trade
Art. 18 Requirement of an establishment licence
1 An establishment licence granted by the Institute shall be required by any person
who in a professional capacity:
a. imports finished medicinal products intended for distribution or supply,;
b. exports finished medicinal products intended for distribution or supply;
c. trades medicinal products in foreign countries from Switzerland, without
them entering Switzerland.
2 The Federal Council may also make provision for a requirement of establishment
licence for the importation or exportation of non-finished medicinal products.
3 It may issue exemptions from the requirement of an establishment licence for:
a. medical professionals who are active across borders;
b. international organizations.
4 Storage in a custom's warehouse shall be considered an importation.
5 The Federal Council may issue special regulations for transit.
6 If another State requests exportation certificates and attestions for the importation
of medicinal products, the Institute may issue such documents to persons having an
establishment licence for exportation.
Art. 19 Conditions for the issue of the establishment licence
1 The establishment licence shall be issued if:
a. the necessary professional and operational conditions are fulfilled;
b. an appropriate system of quality assurance exists.
2 The establishment licence shall also be issued to the applicant who already
possesses an establishment licence for manufacture. Furthermore, the establishment
licence referred to in Article 18 Paragraphs 1b and c, shall be issued to the applicant
already possessing an establishment licence for the importation or wholesale trade of
medicinal products.
3 The competent authority shall verify by inspection that the conditions for an
establishment licence are fulfilled.
Art. 20 Special provisions for importation
1 Medicinal products which are authorized for placement on the market, or which
are not subject to such an authorization, may be imported.
2 The Federal Council may permit the importation of small quantities of nonauthorized
finished medicinal products by:
a. private individuals for their personal use;
b. medical professionals.
3 It may:
a. stipulate that the importation of certain medicinal products requiring a
specific control for the protection of health is granted in particular cases by
the Institute;
b. restrict or prohibit the importation of certain medicinal products if
circumstances suggest that they could be intended for an illegal purpose or
an abusive use.
4 The Institute shall draw up a list of medicinal products for which the importation
shall be restricted or prohibited.
Art. 21 Restrictions on exportation and foreign trade
1 The exportation of medicinal products and their foreign trade from Switzerland
shall be prohibited if:
a. they are prohibited in the destination country;
b. circumstances suggest that they could be intended for an illegal purpose.
2 The Federal Council may stipulate that the exportation of medicinal products for
which the placement on the market is not authorized in Switzerland or in the country
of destination is, in particular cases, prohibited by the Institute or subject to
restrictions.
3 The Institute shall draw up a list of medicinal products for which the exportation
shall be restricted or prohibited.
4 In particular cases, it may grant exemptions from export restrictions or bans, in
particular if the authority of the destination country agrees to the importation.
Art. 22 Duties of diligence at the time of exportation
1 Any person exporting finished medicinal products, prepackaged or not, should
provide the recipient, without being asked, with the appropriate basic medical and
pharmaceutical information.
2 Any person exporting medicinal products intended for use in clinical trials must
provide proof that the principles of Good Clinical Practice were observed.
Section 4 Distribution, prescription and supply
Art. 23 Categories of medicinal products
1 Medicinal products shall be classified in categories according to whether or not
they are subject to prescription.
2 A category of medicinal products on free sale shall be created. Articles 24 to 27
and 30 do not apply to this category.
3 The Federal Council shall lay down the criteria of classification. The Institute shall
categorize each medicinal product for which it has assigned a marketing
authorization.
Art. 24 Supply of medicinal products subject to prescription
1 The following shall be entitled to supply medicinal products subject to
prescription:
a. pharmacists, upon a medical prescription, and in justified exceptional cases,
without a medical prescription;
b. all other medical professionals in accordance with the provisions on
selfdistribution;
c. all duly trained professionals, under the supervision of a person specified in
Paragraphs 1a and b.
2 Medicinal foods for animals which are subject to a prescription may also, with a
prescription from a veterinary surgeon, be supplied by persons licensed to add
medicinal products to animal feed.
3 The cantons may authorize the persons referred to in Article 25 Paragraph 1c, to
handle certain medicinal products subject to prescription.
Art. 25 Supply of medicinal products not subject to prescription
1 The following shall be entitled to supply medicinal products not subject to
prescription:
a. persons entitled to supply medicinal products subject to prescription;
b. chemists holding a federal diploma, within the limits of their right to supply
medicinal products;
c. all other duly trained persons, within the limits of their right to supply
medicinal products;
d. all duly trained professionals, under the supervision of persons referred to in
Paragraphs 1a and b.
2 The Federal Council shall determine the categories of duly trained persons which
are referred to in Paragraph 1c.
3 The Institute shall determine the categories of medicinal products which may be
supplied by the persons referred to in Paragraph 1b and 1c.
4 The cantons may grant to chemists holding a federal diploma the r