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812.21 HMGLPTHLATER CH AI generated

Art. 5 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Mandatory licence

TPA; Chapter 2 Medicinal Products
Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

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A licence from the Agency shall be required by those who: {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. manufacture medicinal products; b. add medicinal products to animal feed. The Federal Council regulates exemptions from the licence requirement. In particular, it may: a. {note: Amended by No 1 of the FA of 18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} make the manufacture of medicinal products under Article 9 paragraph 2 letters a–c bis subject to a mandatory cantonal licence or reporting requirement; b. exempt from the licence requirement livestock holders who add medicinal products to animal feed intended for their own livestock. It may provide for a licence requirement in accordance with the corresponding internationally recognised requirements for the manufacture of certain categories of pharmaceutical excipients which present an increased risk to patients. {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).}

Art. 5 TPA · Mandatory licence

A licence from the Agency shall be required by those who: a. manufacture medicinal products; b. add medicinal products to animal feed.

The Federal Council regulates exemptions from the licence requirement. In particular, it may: a. make the manufacture of medicinal products under Article 9 paragraph 2 letters a–c bis subject to a mandatory cantonal licence or reporting requirement; b. exempt from the licence requirement livestock holders who add medicinal products to animal feed intended for their own livestock.

It may provide for a licence requirement in accordance with the corresponding internationally recognised requirements for the manufacture of certain categories of pharmaceutical excipients which present an increased risk to patients.

← Art. 4 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 6 TPA →

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Court Decisions Applying This Provision (7)

JAAC 67.135 (Art. 5 al. 2 LPTh)
Competence for Pharmaceutical Manufacturing Licenses and Limits on Application Scope
Cited in the dispositive as the basis for the annulment of the manufacturing authorization due to lack of federal competence.
2023.12.19.sr.1 · bl (Art. 5 lit. a HMG)
Narcotics Act Case Discontinued Due to Procedural Limitations
Cited in the first instance judgment regarding the conviction for violation of the HMG.
BV.2022.9 (art. 5 LPTh)
Swissmedic Property Seizure Upheld in Unapproved Product Sales Case
Relates to authorization for manufacturing medicinal products, a potential requirement for the activity investigated.
SG.2019.7 · bs (Art. 5 Abs. 1 lit. a HMG)
Aseptic Compounding Fees for Cytostatics vs. Principle of Economy
Cited in the reasoning (point 4.3.1) regarding the requirement for a manufacturing authorization from swissmedic.
SG.2019.7 · bs (Art. 5 Abs. 2 lit. a HMG)
Aseptic Compounding Fees for Cytostatics vs. Principle of Economy
Cited in the reasoning (point 4.3.1) regarding cantonal authorization requirements for manufacturing.
460.20.23 · bl (Art. 5 Abs. 1 lit. a HMG)
Suicide Capacity and Reckless Harm Ruling
Cited in relation to the defendant's conviction for manufacturing a medicinal product without a license.
VPB 07-0197-2275 (Art. 5 al. 2 let. a LPTh)
Therapeutic Products Act Amendment: Medication Authorization and Exceptions
Grants the Federal Council the power to regulate derogations from the authorization regime, including submitting certain fabrications to cantonal authorization or reporting obligations.