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Art. 10 Legge federale del 15 dicembre 2000 sui medicamenti e i dispositivi medici (LATer) - Condizioni per l’omologazione

LATer; Capitolo 2: Medicamenti

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Art. 10 LATer · Condizioni per l’omologazione

Chi chiede l’omologazione deve: a. per ogni medicamento con menzione dell’indicazione o procedimento, attestare che è di elevato valore qualitativo, sicuro ed efficace; abis. per ogni medicamento della medicina complementare senza menzione dell’indicazione, poter in ogni momento produrre la documentazione necessaria per: 1. provarne l’elevato valore qualitativo, e 2. rendere verosimile che non costituisce un pericolo per la sicurezza dei consumatori; b. disporre di un’autorizzazione di fabbricazione, importazione o commercio all’ingrosso rilasciata dall’autorità competente; c. avere il domicilio o la sede sociale in Svizzera o avervi fondato una filiale.

L’Istituto verifica le condizioni per l’omologazione. A tal fine può effettuare ispezioni riferite a singoli prodotti.

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Decisioni giudiziarie che applicano questa disposizione (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.