812.21
HMGLPTHLATER
CH
CH
Art. 16 Bundesgesetz vom 15. Dezember 2000 über Arzneimittel und Medizinprodukte (HMG) - Zulassungsentscheid und Zulassungsdauer
HMG; 2. Kapitel: Arzneimittel
Art. 16 HMG · Zulassungsentscheid und Zulassungsdauer
Das Institut verfügt die Zulassung, wenn die Voraussetzungen erfüllt sind. Es kann die Zulassung mit Auflagen und Bedingungen verknüpfen.
Die Zulassung wird erstmals für fünf Jahre verfügt. Das Institut verfügt eine kürzere Zulassungsdauer, wenn es: a. sich um befristete Zulassungen nach Artikel 9 a handelt; oder b. dies zum Schutz der Gesundheit erforderlich ist.
Die Zulassung von Arzneimitteln aufgrund einer Meldung ist unbefristet gültig.
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Gerichtsentscheide zu dieser Bestimmung (18)
C-2532/2013 (Art. 16 HMG)
Biowaiver Denial Upheld Due to Insufficient Data and Quality Control Deficiencies
This provision concerns the conditions for drug approval by the institute, which was central to the material assessment of the case.
C-5170/2012 (Art. 16 Abs. 2 und 3 HMG)
Efficacy and Safety Data Justify Drug Marketing Authorization Revocation
These provisions form the legal basis for the Swissmedic institute to adapt or revoke an authorization.
C-4776/2010 (Art. 16 Abs. 1 HMG)
E.________-_______ Generic Drug Marketing Authorization Rejection Upheld
Cited as the principle that drug approval is a police permit, for which a right of entitlement exists if legal requirements are met.
RR.2011.299 (Art. 16 HMG)
Switzerland v. Germany: Cross-Border Evidence Sharing and Data Privacy in Contraceptive Case
Specifies the simplified authorization procedure for parallel imports of medicinal products.
C-4687/2010 (art. 16 LATer)
Anesthetic Homologation Denied Due to Insufficient Safety Evidence
Cited as the basis for the Institute's authority to revoke or modify marketing authorizations.
C-4687/2010 (art. 16 cpv. 1 LATer)
Anesthetic Homologation Denied Due to Insufficient Safety Evidence
Cited as the basis for the Institute's decision to grant or deny market authorization.
C-1922/2009 (art. 16 al. 1 LPTh)
Pharmaceutical Company Denied Market Authorization Due to Insufficient Quality and Safety Data
Cited implicitly as the basis for rejecting the application when conditions are not met.
C-1922/2009 (art. 16 al. 4 LPTh)
Pharmaceutical Company Denied Market Authorization Due to Insufficient Quality and Safety Data
Cited to explain that a new authorization cannot be granted if facts preventing its issuance are known, and that transformation of an OICM registration requires conditions to be met.
36.2011.49 · ti (Art. 16 LATer)
Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication
Cited regarding the notification of the outcome of the expert assessment by Swissmedic before sales authorization.
C-2251/2006 (Art. 16 Abs. 1 HMG)
Patented Formulation Blocks Parallel Import of Medicine
States that a person who meets the legal requirements for a license has a right to its issuance.
JAAC 69.21 (Art. 16 Abs. 1 HMG)
Drug Quality Deficiencies Lead to Marketing Authorization Refusal
This provision establishes that drug approvals are time-limited and require renewal, implying the need for re-evaluation of requirements, which is relevant to the conversion process.
JAAC 69.21 (Art. 16 Abs. 4 HMG)
Drug Quality Deficiencies Lead to Marketing Authorization Refusal
This provision states that the renewal of a drug approval requires re-evaluation of the approval criteria, which is directly applicable to the conversion process from an IKS registration to a Swissmedic approval.
JAAC 67.58 (Art. 16 Abs. 2 HMG)
Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld
Forms the legal basis for the authority to adapt a drug approval decision due to changed circumstances, including requiring specific information in the drug information text.
JAAC 67.58 (Art. 16 al. 1 HMG)
Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld
States that labeling and drug information are part of the drug approval.
JAAC 67.58 (Art. 16 al. 3 HMG)
Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld
Allows the authority to review approved drugs by groups and adapt or revoke approvals, relevant to the discussion on group reviews versus individual adjustments.