Therapeutic Products Act (TPA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Manufacture
Art. 5 Mandatory licence
1 A licence from the Agency shall be required by those who: a. manufacture medicinal products; b. add medicinal products to animal feed. 2 The Federal Council regulates exemptions from the licence requirement. In particular, it may: a. make the manufacture of medicinal products under Article 9 paragraph 2 letters a–cbis subject to a mandatory cantonal licence or reporting requirement; b. exempt from the licence requirement livestock holders who add medicinal products to animal feed intended for their own livestock. 3 It may provide for a licence requirement in accordance with the corresponding internationally recognised requirements for the manufacture of certain categories of pharmaceutical excipients which present an increased risk to patients.
Para. 1 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 2 let. a — Amended by No 1 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 6 Conditions
1 The licence shall be issued if: a. the necessary technical 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 Manufacturing standards
1 The manufacture of medicinal products and pharmaceutical excipients whose manufacture requires a licence must conform to the recognised rules of good manufacturing practice. 2 The Federal Council shall specify the recognised rules of good manufacturing practice. In doing so, it shall take account of internationally recognised guidelines and standards.
Para. 1 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 7a Public pharmacies and hospital pharmacies
Public pharmacies and public hospitals must hold a manufacturing licence that covers the following: a. public pharmacies: a licence authorising at least the manufacture of medicinal products in accordance with Article 9 paragraph 2 letter a; b. hospital pharmacies: a licence authorising at least the manufacture of medicinal products in accordance with Article 9 paragraph 2.
Art. 7a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Section 2 Principle for Placing Products on the Ma
Art. 8 Principle for placing products on the market
Medicinal products and excipients placed on the market must meet the requirements of the Pharmacopoeia or other pharmacopoeias recognised by the Agency provided that such requirements exist.
Art. 8 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 9 Marketing authorisation
1 Ready-to-use medicinal products and veterinary medicinal products intended for the manufacture of medicinal foodstuffs (premixed medicinal products) may be placed on the market only if authorised by the Agency; the foregoing is without prejudice to international agreements on the recognition of marketing authorisations. 2 The following shall be exempt from authorisation: a. medicinal products prepared according to a doctor’s prescription by a public pharmacy or a hospital pharmacy, or under mandate to the latter by another establishment holding a manufacturing licence, and for a given person or group of persons or for a given animal or livestock (magistral formula); on the basis of a prescription, the medicinal product may be manufactured by the public pharmacy or the hospital pharmacy as required or on a small industrial scale but may only be dispensed on a doctor’s prescription; b. medicinal products prepared as required or on a small industrial scale by a public pharmacy, a hospit
Para. 2 let. a — Amended by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 (AS 2008 4873, 2010 4027; BBl 2007 2393). Para. 2 let. b — Amended by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 (AS 2008 4873, 2010 4027; BBl 2007 2393). Para. 2 let. c — Amended by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 (AS 2008 4873, 2010 4027; BBl 2007 2393). Para. 2 let. tab — Inserted by No I of the FA of 13 June 2008, in force since 1 Oct. 2010 (AS 2008 4873, 2010 402
Art. 9a Temporary authorisation
1 The Agency may, in accordance with a simplified procedure under Article 14 paragraph 1, temporarily authorise medicinal products for life-threatening or debilitating diseases if: a. they are compatible with the protection of health; b. their use is expected to have a major therapeutic benefit; and c. no authorised, alternative or equivalent medicinal product is available in Switzerland. 2 The Agency shall determine the evidence to be submitted for the evaluation of an application pursuant to paragraph 1.
Art. 9a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 9b Temporary authorisation for use and limited placing on the market
1 The Agency may temporarily authorise the use of medicinal products referred to in Article 9 paragraph 2 letter d on certain persons or on certain categories of persons outside clinical trials. 2 It may also authorise the temporary or quantitative marketing of a medicinal product to bridge the temporary unavailability of an identical medicinal product authorised in Switzerland, provided that: a. the medicinal product is authorised in another country that has equivalent medicinal product control; and b. no essentially identical medicinal product is authorised and available in Switzerland.
Art. 9b — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 10 Conditions for granting a marketing authorisation
1 Any person applying for a marketing authorisation must: a. prove that the medicinal products with indications or procedures are of high quality and are safe and effective; abis. in the case of complementary medicines without indication, at any time on the basis of documentation: 1. prove that they are of high quality, and 2. credibly demonstrate that the medicinal product in question does not pose a risk to the safety of consumers; b. be a holder of an authorisation to manufacture, import or conduct wholesale trade issued by the competent authority; c. have a registered address, registered office or a branch office in Switzerland. 2 The Agency shall verify that the conditions for granting the marketing authorisation are fulfilled. To this effect, it may carry out product-specific inspections.
Para. 1 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. a — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. abis — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 11 Application for a marketing authorisation
1 The application for a marketing authorisation must contain all of the essential data and documents for its assessment, in particular: a. the name of the medicinal product; b. the name of the manufacturer and the distributor; c. the manufacturing process, the composition, the quality and the stability of the medicinal product. 2 The application for a marketing authorisation for the following medicinal products must include the information and documents listed below: a. Medicinal products with indication: 1. the results of physical, chemical, pharmaceutical and biological or microbiological tests, 2. the results of pharmacological and toxicological tests and clinical trials, including all results from trials in specific population groups, 3. the therapeutic effects and the undesirable effects, 4. the labelling, the information supplied about the medicinal product, and the dispensing method and method of administration, 5. an assessment of the risks and, if necessary, a plan for their s
Art. 11 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 11a Document protection in general
The documents relating to a medicinal product containing at least one new active substance and authorised in accordance with Article 11 shall be protected for a period of ten years.
Art. 11a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 11b Document protection in special cases
1 If a medicinal product is submitted with one or more known active substances, the corresponding documentation on new indications, modes of administration, dosage forms or dosages, or on its application to a new target animal species shall be protected for a period of three years. 2 For a new indication, this period of protection shall be set by the Agency, on request, at 10 years if it is expected to bring a significant clinical benefit in comparison with existing therapies and if it is backed up by extensive clinical trials. 3 On request, the Agency shall grant a ten-year document protection for a medicinal product specifically and exclusively for paediatric use in accordance with the paediatric investigation plan, provided that no document protection exists for another medicinal product authorised by the Agency with the same active substance for the same specific paediatric use. 4 In the case of an important orphan medicinal product, the Agency shall, on request, grant document pro
Art. 11b — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 12 Authorisation of essentially similar medicinal products
1 The application for a marketing authorisation for a medicinal product which is essentially the same as a medicinal product whose documents are protected in accordance with Articles 11a or 11b may be based on the results of the pharmacological, toxicological and clinical tests if: a. the holder of the marketing authorisation for the medicinal product with document protection provides written permission; or b. the protection period for the relevant documents has expired. 2 If the holder of the marketing authorisation does not agree, the granting of a marketing authorisation for an essentially identical medicinal product shall be permissible at the earliest on the first day after expiry of the period of protection for the medicinal product with document protection. A corresponding application for marketing authorisation may be submitted at the earliest two years before the end of the term of protection.
Art. 12 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 13 Medicinal products and procedures authorised in foreign countries
If a medicinal product or procedure is already authorised in a country having equivalent medicinal product control, the results of tests carried out for this purpose shall be taken into account.
Art. 14 Simplified authorisation procedure
1 The Agency shall make provision for simplified procedures for the authorisation 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 agreements. In particular, this applies in the case of: a. medicinal products made with known active substances; abis. medicinal products whose active substances are used in a medicinal product which, when the application was submitted, has been authorised as a medicinal product for at least 10 years in at least one EU or EFTA country and which is comparable in terms of indications, dosage and method of administration; ater. non-prescription medicinal products with indications which, when the application was submitted, have been proven to have been used medically for at least 30 years, and for at least 15 years in EU and EFTA countries; aquater. medicinal products which, when the application was submitted, have been au
Para. 1 let. abis — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. ater — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. aquater — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. b — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2
Art. 14a Application for a marketing authorisation under the simplified authorisation procedure
1 Applications for a marketing authorisation under the simplified authorisation procedure must contain the following data and documents for the following medicinal products: a. Medicinal products referred to in Article 14 paragraph 1 letter abis: 1. the data and documents referred to in Article 11 paragraphs 1 and 2 letter a numbers 1–4; the data referred to in Article 11 paragraph 2 letter a number 2 may be replaced by a compilation of equivalent scientific evidence, 2. proof of the marketing authorisations of the foreign comparator product; b. Medicinal products referred to in Article 14 paragraph 1letter ater: 1. the data and documents referred to in Article 11 paragraphs 1 and 2 letter a numbers 1, 3 and 4, 2. an assessment of the risks, 3. proof of 30 or 15 years of medical use; c. Medicinal products referred to in Article 14 paragraph 1 letter aquater: 1. the data and documents referred to in Article 11 paragraphs 1 and 2 letter a numbers 1, 3 and 4, 2. an assessment of the risks
Art. 14a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 15 Marketing authorisation on the basis of a notification
1 The following may be placed on the market following notification to the Agency: a. complementary medicines without indications, the active substances of which are included in lists for specific therapy approaches; b. other medicinal products or groups of medicinal products for which, due to their low risk potential, a simplified marketing authorisation proves to be disproportionate. 2 The Agency shall draw up the lists referred to in paragraph 1 letter a. It shall determine the medicinal products or groups of medicinal products referred to in paragraph 1 letter b and regulate the notification procedure.
Art. 15 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 16 Authorisation decision and period of the marketing authorisation
1 The Agency shall grant a marketing authorisation if the conditions are fulfilled. It may attach conditions and requirements to the authorisation. 2 The marketing authorisation is issued for the first time for a period of five years. The Agency shall order a shorter period of authorisation if: the authorisations are limited in accordance with Article 9a; or b. this is necessary for the protection of health. 3 The authorisation of medicinal products on the basis of a notification shall be valid for an unlimited period. 4 …
Art. 16 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 2 let. b — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 4 — Repealed by No I of the FA of 18 March 2016, with effect from 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 16a Revocation and transfer of the authorisation
1 The Agency shall revoke the authorisation for a medicinal product if: a. it is not actually placed on the market within three years of the granting of the authorisation; b. it is no longer actually on the market during a period of three successive years after it has been placed on the market. 2 The Federal Council may provide for exceptions from paragraph 1. 3 It may provide that, in the case of medicinal products for severe illnesses, injuries or disabilities or of medicinal products with a paediatric indication or for paediatric use, the authorisation is revoked before the period referred to in paragraph 1 has expired. It decides the duration of such periods and lays down the criteria for revocation. 4 If the holder of the marketing authorisation intends to cease marketing a medicinal product authorised for a paediatric indication or for paediatric use for which they have obtained protection under Article 11b paragraphs 3 and 4 of this Act or under Article 140n or 140t of the Paten
Art. 16a — Inserted by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 (AS 2008 4873, 2010 4027; BBl 2007 2393). Art. 16a — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 4 — SR 232.14 Para. 4 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 201
Art. 16b Renewal of the marketing authorisation
1 A marketing authorisation shall be renewed upon application if the authorisation requirements continue to be met. 2 As a rule, renewed authorisations are valid for an unlimited period. The Agency may, however, limit them, in particular authorisations in accordance with Article 16 paragraph 2 letters a and b.
Art. 16b — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 16c Review of the marketing authorisation
The Agency may review the authorisation at any time; it may adapt or revoke the authorisation in the light of changing circumstances.
Art. 16c — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 17 Official batch release
1 If the manufacture of a medicinal product requires special measures to be taken, in particular to guarantee safety, then a release authorisation must be obtained from the Agency for each batch before distribution; the foregoing is without prejudice to international agreements on batch release recognition. 2 The Agency shall determine the categories of medicinal products for which official batch release is required, as well as 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 Imports, Exports and Foreign Trade
Art. 18 Mandatory licence
1 A licence granted by the Agency is required by any person who professionally: a. imports ready-to-use medicinal products intended for distribution or dispensing; b. exports ready-to-use medicinal products intended for distribution or dispensing; c. trades medicinal products in foreign countries from Switzerland, without their entering Switzerland; d. acts from Switzerland as a broker or agent for medicinal products. 2 The Federal Council shall specify the requirements for activities under paragraph 1. 3 It may issue exemptions from the requirement of licence for: a. medical professionals who work across borders; b. international organisations. 4 Goods stored in a customs warehouse or a bonded warehouse shall be considered to be imported. 5 The Federal Council may issue special regulations for goods in transit. 6 If another State requests export certificates and attestations for the importing of medicinal products, the Agency may issue such documents to persons holding an authorisatio
Para. 1 let. d — Amended by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). Para. 2 — Amended by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135). Para. 4 — Inserted by Annex No 17 of the Customs Act of 18 March 2005, in force since 1 May 2007 (AS 2007 1411; BBl 2004 567).
Art. 19 Licensing conditions
1 The licence shall be issued if: a. the necessary technical and operational conditions are fulfilled; b. an appropriate system of quality assurance exists. 2 The licence shall also be issued to the applicant who already possesses a manufacturing licence for medicinal products. Furthermore, the licence referred to in Article 18 paragraphs 1 letters b and c shall be issued to the applicant already possessing a licence for the import or wholesale trade of medicinal products. 3 The competent authority shall verify by inspection that the conditions are fulfilled.
Art. 20 Special provisions for imports
1 Medicinal products which have been authorised, or which are not subject to authorisation, may be imported. 2 The Federal Council may permit the importing of small quantities of non-authorised ready-to-use medicinal products by: a. private individuals for their personal use; b. medical professionals. 2bis It may allow unauthorised, ready-to-use, non-prescription medicinal products for which no alternative and equivalent medicinal product has been authorised to be imported in small quantities in accordance with Article 25 paragraph 1 letters b and c within the limits of their dispensing authority. 3 It may: a. stipulate that the licence to import certain medicinal products requiring a specific control for the protection of health be granted in particular cases by the Agency; b. restrict or prohibit the importing of certain medicinal products if circumstances suggest that they could be intended for illegal purposes or misuse. 4 The Agency shall draw up a list of medicinal products for w
Para. 2bis — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 21 Restrictions on export and foreign trade
1 The export of medicinal products and their foreign trade from Switzerland shall be prohibited if: a. they are prohibited in the target country; b. circumstances suggest that they are intended for illegal purposes; or c. it is deemed that they are intended for capital punishment. 1bis The Federal Council shall regulate the requirements for the export and foreign trade of medicinal products which could be used for capital punishment. It shall take account of the EU provisions. 2 The Federal Council may stipulate that in particular cases the export of medicinal products which are not authorised in Switzerland or in the target country is prohibited by the Agency or subject to restrictions. 3 The Agency shall draw up a list of medicinal products for which export 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 target country agrees to the import.
Para. 1 let. b — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. c — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1bis — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 22 Duties of diligence at the time of export
1 Any person exporting ready-to-use medicinal products, whether pre-packaged 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 demand proof that the rules of good clinical trial practice are applied.
Section 4 Distribution, Prescription, Dispensing a
Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 23 Categories of medicinal products
1 Medicinal products shall be classified into categories according to whether or not they are subject to prescription. 2 A category of over-the-counter medicinal products shall be created for which neither medical and pharmaceutical nor professional customer advice is required. Articles 24–27 and 30 do not apply to this category. 3 The Federal Council shall lay down the classification criteria.
Para. 2 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 23a Allocation of the medicinal products to the individual categories
1 The Agency shall categorise each medicinal product for which it has granted a marketing authorisation in accordance with the criteria laid down by the Federal Council. It shall take into account the professional competence of the professional groups entitled to dispense medicinal products. 2 It shall review the categorisation of medicinal products periodically or at the request of the holder of the marketing authorisation and adapt it to the state of the art in science and technology.
Art. 23a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 24 Dispensing of medicinal products subject to prescription
1 The following persons shall be entitled to dispense prescription-only medicinal products: a. pharmacists, on presentation of a doctor’s prescription. They may dispense medicinal products without a doctor’s prescription if they have direct contact with the person concerned, if they document the product dispensed, and if: 1. the medicinal products and indications have been designated by the Federal Council, or 2. the case is justified and exceptional; b. all other medical professionals in accordance with the provisions on pro-pharmacy and taking account of Article 1 paragraph 3 letter c; c. all duly trained professionals, under the supervision of a person specified in letters a and b. 1bis The Federal Council shall determine the form and the scope of the documentation obligation pursuant to paragraph 1 letter a. 2 Prescription-only medicated foodstuffs for animals may also, on presentation of a prescription from a veterinary surgeon, be dispensed by persons licensed to add medicinal pr
Para. 1 let. a — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. b — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1bis — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 25 Dispensing of non-prescription medicinal products
1 The following shall be entitled to dispense non-prescription medicinal products: a. persons entitled to dispense prescription medicinal products; b. druggist holding a federal diploma; c. all other duly trained persons, within the limits of their right to dispense medicinal products; d. all duly trained professionals, under the supervision of persons referred to in letters a and b. 2 The Federal Council shall determine the categories of duly trained persons which are referred to in paragraph 1 letter c. 3 The Agency shall determine the medicinal products which may be dispensed by the persons referred to in paragraph 1 letter c. 4 … 5 Subject to the provisions of paragraphs 2 and 3, the cantons may grant to persons holding a qualification recognised by the canton the right to dispense certain groups of medicinal products, such as those pertaining to complementary medicine. The Agency must be informed of this.
Para. 1 let. b — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 4 — Repealed by No I of the FA of 18 March 2016, with effect from 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 26 Principle of prescription, dispensing and application
1 The recognised rules of pharmaceutical and medical sciences must be respected when prescribing, dispensing and using medicinal products, and the principles of the corresponding therapy approach must be respected when prescribing, dispensing and using complementary medicines without indications. The Federal Council may specify these rules in more detail. 2 A medicinal product may only be prescribed if the state of health of the consumer or patient is known. 2bis The following principles and minimum requirements must be observed for the prescription of medicinal products: a. The prescription meets the minimal requirements set by the Federal Council following consultations with the medical professions concerned. b. The prescription shall become the property of the person for whom it was issued. The person should remain free to decide whether to receive the prescribed product or to obtain a second opinion and to determine with which authorised provider they want to redeem the prescriptio
Art. 26 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 2bis let. b — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019, let. a in force since 1 Jan. 2020 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 274
Art. 27 Mail-order trade
1 In principle, mail-order trade in medicinal products is prohibited. 2 A licence may only be issued under the following conditions: a. there is a doctor’s prescription for the medicinal product; b. no safety requirements oppose it; c. appropriate consultation is guaranteed; d. sufficient medical supervision of the effect of the medicinal product is guaranteed. 3 The Federal Council shall regulate the details. 4 The cantons shall issue the authorisation.
Art. 28 Licence for wholesale trade
1 Any person engaged in the wholesale trade of medicinal products must possess a licence issued by the Agency. 2 The licence shall be issued if: a. the necessary technical and operational conditions are fulfilled; b. an appropriate system of quality assurance exists. 3 The licence shall also be issued if the applicant already possesses a manufacturing or import licence for medicinal products. 4 The competent authority shall verify by inspection that the conditions are fulfilled.
Art. 29 Wholesale standards
1 Any person engaged in the wholesale trade of medicinal products must respect the recognised principles of good distribution practice. 2 The Federal Council shall specify the recognised principles of good distribution practice. In doing so, it shall take account of internationally recognised guidelines and standards.
Art. 29 — Amended by Annex No 2 of the FD of 29 Sept. 2017 (Medicrime Convention), in force since 1 Jan. 2019 (AS 2018 4771; BBl 2017 3135).
Art. 30 Dispensing licence
1 Any person dispensing medicinal products must possess a cantonal licence. 2 The licence shall be issued when the required specialist conditions are met and there is a quality assurance system in place which is appropriate for the type and size of the establishment. 3 The cantons may issue further requirements. They regulate the mandatory licensing process and carry out periodical inspections of retail establishments and practices.
Art. 30 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2020 (AS 2017 2745, 2018 3575; BBl 2013 1).
Section 5 Advertising and Price Comparisons
Art. 31 Principle
1 In principle, it shall be permitted to: a. advertise all types of medicinal products if the advertising is directed exclusively at persons who prescribe or dispense them; b. advertise non-prescription medicinal products to the general public. 2 The Federal Council shall lay down the conditions for the publication of price comparisons for prescription medicinal products. 3 It may, in order to protect health and prevent fraud, restrict or prohibit the advertising of certain medicinal products or groups of medicinal products and enact regulations concerning cross-border advertising.
Art. 32 Unlawful advertising
1 Advertising shall be deemed unlawful: a. if it is misleading or contrary to public order and morality; b. if it may incite an excessive, abusive or inappropriate use of medicinal products; c. if it is for medicinal products which may not be placed on the market nationally or cantonally. 2 Advertising directed at the general public shall be deemed unlawful for medicinal products which: a. may only be supplied on a prescription; b. contain narcotic or psychotropic substances as referred to in the Narcotics Act of 3 October 1951; c. may not, on account of their composition and their intended use, be used without the intervention of a doctor for the necessary diagnosis, prescription or treatment; d. are frequently the object of abuse or which lead to an addiction or dependence.
Para. 1 let. c — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 2 let. b — SR 812.121
Art. 33
Repealed by No I of the FA of 18 March 2016, with effect from 1 Jan. 2020 (AS 2017 2745, 2019 1393; BBl 2013 1).
Section 6 Special Provisions on Blood and Blood Pr
Art. 33a Ban on payment for blood donations
1 It is prohibited to offer, grant, claim or accept a financial gain or other advantage in exchange for a human blood donation. 2 The following are not regarded as a financial gain or other advantage: a. compensation for any loss of earnings or expenses directly incurred by the donor; b. damages for any injury sustained by the donor as a result of the blood donation; c. a subsequent symbolic gesture of gratitude.
Art. 33a — Inserted by No I of the FA of 29 Sept. 2023 (Amendments to the Provisions on Blood Donation), in force since 1 Jan. 2025 (AS 2024 534; BBl 2022 2348, 3169).
Art. 34 Operating licence
1 Any person drawing blood from persons for the purpose of transfusion or the manufacture of therapeutic products or for supply to a third party must possess an operating licence issued by the Agency. 2 The licence shall be issued if: a. the necessary technical and operational conditions are fulfilled; b. an appropriate system of quality assurance exists. 3 The Agency shall verify by inspection that the licensing conditions are fulfilled. 4 Establishments such as hospitals which only stock blood or blood products must possess a cantonal operating licence. The cantons shall lay down the conditions and the procedure for granting this licence. They shall carry out periodical inspections.
Art. 35 Licence for individual imports
1 An import licence is required for each individual batch of imported blood and blood products. Storage in a customs warehouse shall be deemed to be importing. 1bis Blood and labile blood products imported for transfusions must meet the requirements of the ban on payment for blood donations specified in Article 33a. 2 The Federal Council may make provision for exemptions from an import licence if all danger to persons is excluded.
Para. 1bis — Inserted by No I of the FA of 29 Sept. 2023 (Amendments to the Provisions on Blood Donation), in force since 1 Jan. 2025 (AS 2024 534; BBl 2022 2348, 3169).
Art. 36 Fitness of the donor to give blood
1 The holder of the licence referred to in Article 34 paragraph 1 must verify that the donor is fit to give blood. 2 Persons excluded from donating blood shall be those: a. whose health could suffer from the extraction of blood; b. whose blood may transmit pathogens. 2bis The exclusion criteria must not discriminate against anyone. Insofar as the criteria are linked to the risk behaviour of persons who are willing to donate, they shall relate to individual behaviour and must be scientifically justified. 3 The Federal Council shall lay down the requirements relating to the donor’s fitness to give blood, the competence to establish this fitness and the data which must be recorded at the time of the blood donation.
Para. 2bis — Inserted by No I of the FA of 29 Sept. 2023 (Amendments to the Provisions on Blood Donation), in force since 1 Jan. 2025 (AS 2024 534; BBl 2022 2348, 3169).
Art. 37 Rules of good manufacturing practice in the handling of blood and blood products
1 Any operations relating to blood and labile blood products, in particular the extraction, manufacture, processing, storage and the placing on the market, must be conducted in accordance with the principles of quality management and the recognised principles of good manufacturing practice in the handling of blood and blood products. 2 Blood and labile blood products as well as associated blood samples must be labelled such that they can be unambiguously identified at any time. 3 The Federal Council shall specify the recognised rules of good manufacturing practice. In doing so, it shall take account of internationally recognised guidelines and standards.
Art. 38 Obligation to test
1 Donated blood must be tested for the presence or signs of pathogens and examinations must be carried out in order to guarantee compatibility. 2 The Federal Council shall specify: a. for which pathogens or which signs of their presence the blood should be tested; b. the procedure to be followed when a test result is positive; c. the examinations to be carried out in order to guarantee compatibility; d. the regulations concerning the execution of tests. 3 It may grant exemptions to the obligation to test in the case of autologous transfusions.
Art. 39 Obligation to record
1 Any person handling blood or blood products must: a. record all of the processes which are important for safety; b. maintain the records in such a manner as to be able to trace the data back to the person who donated or received the blood; 2 For each extraction of blood, the following shall in particular be recorded: a. the surname, first name and the date of birth of the blood donor; b. the date on which the blood was taken; c. the test results and their interpretation. 3 For a person excluded from donating blood, the following shall be recorded: a. the surname, first name and the date of birth; b. the date and the reasons for exclusion. 4 For a person to whom blood or blood products are to be administered, the following shall be recorded: a. the surname, first name and the date of birth; b. the date of administration; c. the labelling and the origin of the blood or blood products. 5 The Federal Council shall regulate the details. In particular, it may grant exemptions from the obli
Art. 40 Obligation to archive
1 The information recorded under Article 39 and all important documents must be archived for 30 years. 2 The Federal Council shall regulate the details. In particular, it may: a. make provision for the transfer to the Agency, or the archiving, of the records referred to in Article 39 and any important documents, should the establishment cease its activity prior to the expiry of the archiving period; b. grant exemptions from the obligation to archive in the case of autologous transfusions.
Para. 1 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 41 Further safety provisions
The Federal Council may prescribe additional safety precautions; in particular it may determine that the procedures for the removal or the inactivation of possible pathogens may only be applied after the Agency has given authorisation.
Art. 41 — Amended by No I of the FA of 29 Sept. 2023 (Amendments to the Provisions on Blood Donation), in force since 1 Jan. 2025 (AS 2024 534; BBl 2022 2348, 3169).
Section 7 Special Provisions on Veterinary Medicin
Art. 42 Prescription and dispensing
1 A medicinal product may only be prescribed or supplied for an animal if the prescriber knows the animal or livestock. 2 If the medicinal product is intended for production animals, the prescriber must also know the state of health of the animal. 3 The Federal Council may prohibit the prescription and dispensing of medicinal products or the application of medicinal products that need no authorisation in accordance with Article 9 paragraph 2 for production animals. It may also restrict the prescription, dispensing or application of these products.
Para. 3 — Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 42a Measures to reduce antimicrobial resistance
1 The Federal Council may provide for measures to reduce antimicrobial resistance, in particular: a. measures to reduce antibiotic consumption and promote animal health; b. requirements for the training and further education of veterinarians and livestock holders. 2 It may also restrict or prohibit the use of certain antibiotic agents in veterinary medicine in accordance with foreign regulations if this appears necessary for the effective treatment of patients.
Art. 42a — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 43 Obligation to keep a record
Any person who imports or exports, distributes or dispenses veterinary medicinal products or administers or allows them to be administered to production animals must keep a record of incomings and outgoings of such medicinal products and archive the supporting documents.
Art. 44 Standardisation and coordination of enforcement
The Federal Council may impose measures for enforcement on the cantons and oblige them to inform the competent federal office of the enforcement measures taken and the test results.