812.21 HMGLPTHLATER

CH AI generated

Art. 10 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Conditions for granting a marketing authorisation

TPA; Chapter 2 Medicinal Products

Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

Legislator summary

AI generated

Any person applying for a marketing authorisation must: {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).} a. {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).} prove that the medicinal products with indications or procedures are of high quality and are safe and effective; 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).} 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. The Agency shall verify that the conditions for granting the marketing authorisation are fulfilled. To this effect, it may carry out product-specific inspections.

Art. 10 TPA · Conditions for granting a marketing authorisation

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.

The Agency shall verify that the conditions for granting the marketing authorisation are fulfilled. To this effect, it may carry out product-specific inspections.

← Art. 9b TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 11 TPA →

Court Decisions Applying This Provision (25)

C-1664/2019 (Art. 10 al. 1 let. a LPTh)

Pharmaceutical Company Denied Market Authorization for Acne Gel

Requirement for the applicant to prove the quality, safety, and efficacy of the drug.

C-2645/2014 (Art. 10 Abs. 2 HMG)

Responsible Person's Unauthorized Drug Distribution Leads to Permit Suspension

This provision is cited as the basis for determining the trustworthiness of the responsible technical personnel, which is a prerequisite for maintaining the operating license.

A-3621/2014 (Art. 10 al. 1 let. a LPTh)

Pharmaceutical Product Approval Document Access Dispute

Cited in relation to the requirements for obtaining marketing authorization.

C-568/2013 (Art. 10 Abs. 1 Bst. a HMG)

Fixed-Combination Bronchial Lozenge Application Rejection Upheld

Requires that a medicinal product must be of high quality, safe, and effective to be authorized.

C-2532/2013 (Art. 10 Abs. 1 Bst. a HMG)

Biowaiver Denial Upheld Due to Insufficient Data and Quality Control Deficiencies

This provision states that a drug must be proven to be of high quality, safe, and effective for approval, a key criterion in the decision.

C-4776/2010 (Art. 10 Abs. 1 Bst. a HMG)

E.________-_______ Generic Drug Marketing Authorization Rejection Upheld

Cited as a fundamental requirement for drug approval, stipulating that the product must be of high quality, safe, and effective.

C-4776/2010 (Art. 10 HMG)

E.________-_______ Generic Drug Marketing Authorization Rejection Upheld

Cited as the basis for general admission requirements for medicinal products, setting the framework for the specific rules applied.

C-4687/2010 (art. 10 cpv. 1 lett. a LATer)

Anesthetic Homologation Denied Due to Insufficient Safety Evidence

Cited in the context of the applicant's obligation to demonstrate that the preparation meets legal requirements, particularly regarding safety.

C-7594/2008 (Art. 10 cpv. 1 lett. a e b LATer)

Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic

Cited to outline the requirements for a marketing authorization application, including quality, safety, and efficacy.

C-2790/2010 (Art. 10 Abs. 1 Bst. a HMG)

Pharmaceutical Company v. Regulatory Authority: Marketing Authorization Suspension Upheld

Basis for requiring the applicant to prove the quality, safety, and efficacy of the medicinal product.

C-1922/2009 (art. 10 al. 1 let. a LPTh)

Pharmaceutical Company Denied Market Authorization Due to Insufficient Quality and Safety Data

Cited as a legal requirement for the applicant to prove the quality, safety, and efficacy of the medicinal product.

36.2011.49 · ti (Art. 10 cpv. 1 lett. a LATer)

Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication

Cited concerning the applicant's duty to attest to the quality, safety, and efficacy of the medicine.

C-6050/2008 (Art. 10 HMG)

Seizure of Unapproved Medication for Personal Use Upheld

Stipulates that medicines are approved in Switzerland, not just active substances.

C-2261/2006 (Art. 10 cpv. 1 lett. a LATer)

Swissmedic Denies Local Anesthetic Registration Due to Safety Concerns

The court used this article to establish that the applicant must demonstrate the quality, safety, and efficacy of the medication to obtain marketing authorization.

C-2251/2006 (Art. 10 Abs. 1 Bst. a HMG)

Patented Formulation Blocks Parallel Import of Medicine

Requires applicants to demonstrate that their medicinal product is of high quality, safe, and effective.