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Art. 14 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Simplified authorisation procedure

TPA; Chapter 2 Medicinal Products
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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. {note: 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).} 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. {note: 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).} 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. {note: 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).} medicinal products which, when the application was submitted, have been authorised as medicinal products for at least 15 years in a canton; b. {note: 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18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} complementary medicines; c. {note: Repealed by No I of the FA of 18 March 2016, with effect from 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} ... cbis. {note: 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).} herbal medicines; d. {note: 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).} medicinal products prepared by a hospital pharmacy or in the hospital’s own radiopharmaceutical unit for the needs of the hospital; e. medicinal products prepared by the army and used in the context of the coordinated army medical corps; f. important medicinal products for rare diseases; g. veterinary medicinal products, which are intended exclusively for animals not kept for the production of foodstuffs. The Agency shall make provision for a simplified authorisation procedure in the case of an application from another person responsible for the placing on the market of a medicinal product which is already authorised in Switzerland and which is imported from a country with an equivalent authorisation system: a. if the medicinal product satisfies the same requirements as the medicinal product already authorised in Switzerland, in particular in regard to the labelling and the medical information mentioned in Article 11; b. if the other person responsible for placing the medicinal product on the market can continue to guarantee that all the authorised medicinal products that he distributes fulfil the same requirements of safety and quality as those of the first applicant. As part of the authorisation procedure for medicinal products that are imported as parallel imports, the Agency shall make provision for simplified rules with regard to labelling and the information supplied about the medicinal product. {note: Amended by Annex No 1 of the FA of 30 Sept. 2022 (Cost Containment Measures – Package 1 b), in force since 1 Jan. 2024 ( AS 2023 630; BBl 2019 6071).}

Art. 14 TPA · Simplified authorisation procedure

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 authorised as medicinal products for at least 15 years in a canton; b. complementary medicines; c. ... cbis. herbal medicines; d. medicinal products prepared by a hospital pharmacy or in the hospital’s own radiopharmaceutical unit for the needs of the hospital; e. medicinal products prepared by the army and used in the context of the coordinated army medical corps; f. important medicinal products for rare diseases; g. veterinary medicinal products, which are intended exclusively for animals not kept for the production of foodstuffs.

The Agency shall make provision for a simplified authorisation procedure in the case of an application from another person responsible for the placing on the market of a medicinal product which is already authorised in Switzerland and which is imported from a country with an equivalent authorisation system: a. if the medicinal product satisfies the same requirements as the medicinal product already authorised in Switzerland, in particular in regard to the labelling and the medical information mentioned in Article 11; b. if the other person responsible for placing the medicinal product on the market can continue to guarantee that all the authorised medicinal products that he distributes fulfil the same requirements of safety and quality as those of the first applicant.

As part of the authorisation procedure for medicinal products that are imported as parallel imports, the Agency shall make provision for simplified rules with regard to labelling and the information supplied about the medicinal product.

← Art. 13 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 14a TPA →

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Court Decisions Applying This Provision (13)

VPB 08-1321-6731 (Art. 14, al. 3, LPTh)
Swiss Approval of Foreign-Approved Products
This article is cited in the context of a proposed abrogation to allow for simplified authorization procedures for importing patented medicines when patent protection is of lesser importance.
C-3334/2020 (Art. 14 Abs. 1 Bst. aquater HMG)
Homeopathic Medicine Simplified Approval Dispute
Cited as the basis for the simplified drug approval procedure, which was the subject of the original application.
A-3621/2014 (Art. 14 al. 1 let. a LPTh)
Pharmaceutical Product Approval Document Access Dispute
Cited in relation to simplified authorization procedures.
C-6960/2013 (Art. 14 Abs. 1 Bst. b HMG)
Regulatory Agency Reclassifies Plant-Derived Drugs
Cited in conjunction with the KPAV to justify the classification of the products and the limitation of economic freedom.
C-4776/2010 (Art. 14 HMG)
E.________-_______ Generic Drug Marketing Authorization Rejection Upheld
Cited as the provision for simplified approval procedures for medicinal products with known active ingredients, which was relevant to the discussion of generic drugs.
RR.2011.299 (Art. 14 Abs. 2 HMG)
Switzerland v. Germany: Cross-Border Evidence Sharing and Data Privacy in Contraceptive Case
Permits the import of a medicinal product into Switzerland, provided it is already authorized in Switzerland and imported from a country with an equivalent authorization system, under certain conditions.
C-7594/2008 (Art. 14 cpv. 1 lett. a LATer)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited again in the context of the simplified approval procedure, subject to quality, safety, and efficacy requirements.
C-7594/2008 (Art. 14 cpv. 1 lett. a LATer)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited as a basis for the possibility of a simplified approval procedure for known active ingredients.
36.2011.49 · ti (Art. 14 cpv. 1 lett. f LATer)
Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication
Cited in the context of evaluating orphan drugs, noting that high therapeutic utility is not explicitly required for authorization under this specific clause.
C-2251/2006 (Art. 14 Abs. 2 HMG)
Patented Formulation Blocks Parallel Import of Medicine
Allows for simplified approval of parallel imports under certain conditions.
C-2251/2006 (Art. 14 Abs. 3 HMG)
Patented Formulation Blocks Parallel Import of Medicine
Prohibits the approval of parallel imports as long as the originator product is patent-protected.
VPB 06-2701-2245 (Art. 14, al. 1, let. d LPTh)
Swiss Drug Shortage Mitigation Act
This article is to be supplemented to allow for simplified authorization of radiopharmaceutical products, recognizing their specific nature and supply challenges in hospitals.
VPB 07-0197-2275 (Art. 14 al. 1 let. d LPTh)
Therapeutic Products Act Amendment: Medication Authorization and Exceptions
Defines simplified authorization procedures for certain drugs, including those manufactured by hospital pharmacies for hospital needs.