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Art. 11 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Application for a marketing authorisation

TPA; Chapter 2 Medicinal Products

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

Art. 11 TPA · Application for a marketing authorisation

The application for a marketing authorisation must contain all of the essential data and documents for its assessment, in particular: a. the name of the medicinal product; b. the name of the manufacturer and the distributor; c. the manufacturing process, the composition, the quality and the stability of the medicinal product.

The application for a marketing authorisation for the following medicinal products must include the information and documents listed below: a. Medicinal products with indication: 1. the results of physical, chemical, pharmaceutical and biological or microbiological tests, 2. the results of pharmacological and toxicological tests and clinical trials, including all results from trials in specific population groups, 3. the therapeutic effects and the undesirable effects, 4. the labelling, the information supplied about the medicinal product, and the dispensing method and method of administration, 5. an assessment of the risks and, if necessary, a plan for their systematic recording, investigation and prevention (pharmacovigilance plan), 6. the paediatric investigation plan referred to in Article 54 a; b. Medicinal products for animals raised for food production: 1. the information and documents referred to in letter a, 2. the detection of residues, 3. the withdrawal periods.

In addition to the information and documents referred to in paragraph 1, the application for the authorisation of the processes indicated in Article 9 paragraph 3 must include those referred to in paragraph 2 letter a.

The Agency shall describe the information and the documents referred to in paragraphs 1–3 in greater detail.

The Federal Council shall stipulate: a. the requirements for organising, carrying out and recording the pharmacological and toxicological tests referred to in paragraph 2 letter a number 2 and the control procedure, taking into account internationally recognised guidelines and standards; b. the languages to be used for labelling and information leaflets.

← Art. 10 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 11a TPA →

Court Decisions Applying This Provision (16)

A-3621/2014 (Art. 11 let. 1 let. g et h LPTh)

Pharmaceutical Product Approval Document Access Dispute

Cited in relation to the documentation required for marketing authorization applications.

C-2532/2013 (Art. 11 Abs. 1 HMG)

Biowaiver Denial Upheld Due to Insufficient Data and Quality Control Deficiencies

This provision, along with AMZV, details the required documentation for drug approval applications.

C-4776/2010 (Art. 11 Abs. 1 HMG)

E.________-_______ Generic Drug Marketing Authorization Rejection Upheld

Cited as the requirement for admission applications to include necessary information and documentation.

C-7594/2008 (Art. 11 LATer)

Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic

Cited to specify that an approval application must contain all necessary data and documents for evaluating the product.

36.2011.49 · ti (Art. 11 LATer)

Health Insurance Reimbursement for Off-Label Psoriatic Arthritis Medication

Cited regarding the data required for a marketing authorization application, specifically therapeutic properties.

BVGE-2011-60 (Art. 11 al. 3 LPTh)

Pharmaceutical Company Publication Mandate Infringes Economic Freedom

Cited as the basis for the institute issuing implementing ordinances (OEMéd), but the specific requirements of Art. 16a OMéd are found to exceed the scope of this delegation.

C-6050/2008 (Art. 11 HMG)

Seizure of Unapproved Medication for Personal Use Upheld

Lists the approval requirements for medicines.

C-2251/2006 (Art. 11 Abs. 1 HMG)

Patented Formulation Blocks Parallel Import of Medicine

Specifies the information and documentation required for the approval of medicinal products.

JAAC 70.19 (Art. 11 Abs. 1 Bst. g HMG)

Pharmaceutical Company v. Suspension of Marketing Authorization for Failure to Provide Updated Quality Documentation

Legal basis for requiring the submission of results from microbiological tests to demonstrate the quality and safety of a medicinal product, including preservation testing.

JAAC 69.21 (Art. 11 Abs. 1 HMG)

Drug Quality Deficiencies Lead to Marketing Authorization Refusal

This provision details the information and documents required for drug approval applications, which relates to the applicant's failure to provide complete quality documentation.

JAAC 68.134 (Art. 11 Abs. 1 HMG)

Drug Marketing Authorization: Repeated Failure to Provide Quality Documentation Justifies Rejection

Requirement for market authorization applications to include all necessary information and documentation for assessing quality, safety, and efficacy.

JAAC 68.31 (Art. 11 Abs. 1 Bst. f HMG)

Preservative-Free Eye Drops: Four-Week Expiry Upheld Amid Safety Concerns

Requirement for marketing authorization applications to include all necessary information and documents, including the product information.

JAAC 67.58 (Art. 11 Abs. 1 Bst. f HMG)

Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld

States that drug information texts are part of the drug approval, implying that modifications require approval.

JAAC 67.58 (Art. 11 Abs. 1 HMG)

Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld

Specifies that drug approval applications must contain all information required for assessing quality, safety, and efficacy, including drug information texts.

JAAC 67.58 (Art. 11 al. 3 HMG)

Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld

Provides the legal basis for the AMZV regulations, which detail drug approval requirements.