812.21 HMGLPTHLATER

CH AI generated

Art. 16 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Authorisation decision and period of the marketing authorisation

TPA; Chapter 2 Medicinal Products

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

Legislator summary

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The Agency shall grant a marketing authorisation if the conditions are fulfilled. It may attach conditions and requirements to the authorisation. 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: a. the authorisations are limited in accordance with Article 9 a; or b. this is necessary for the protection of health. {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).} The authorisation of medicinal products on the basis of a notification shall be valid for an unlimited period. {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).} ... {note: Repealed by No I of the FA of 18 March 2016, with effect from 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).}

Art. 16 TPA · Authorisation decision and period of the marketing authorisation

The Agency shall grant a marketing authorisation if the conditions are fulfilled. It may attach conditions and requirements to the authorisation.

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: a. the authorisations are limited in accordance with Article 9 a; or b. this is necessary for the protection of health.

The authorisation of medicinal products on the basis of a notification shall be valid for an unlimited period.

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← Art. 15 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 16a TPA →

Court Decisions Applying This Provision (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.