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Art. 12 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Authorisation of essentially similar medicinal products

TPA; Chapter 2 Medicinal Products

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Art. 12 TPA · Authorisation of essentially similar medicinal products

The application for a marketing authorisation for a medicinal product which is essentially the same as a medicinal product whose documents are protected in accordance with Articles 11 a or 11 b may be based on the results of the pharmacological, toxicological and clinical tests if: a. the holder of the marketing authorisation for the medicinal product with document protection provides written permission; or b. the protection period for the relevant documents has expired.

If the holder of the marketing authorisation does not agree, the granting of a marketing authorisation for an essentially identical medicinal product shall be permissible at the earliest on the first day after expiry of the period of protection for the medicinal product with document protection. A corresponding application for marketing authorisation may be submitted at the earliest two years before the end of the term of protection.

← Art. 11b TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 13 TPA →

Court Decisions Applying This Provision (11)

A-3621/2014 (Art. 12 al. 1 LPTh)

Pharmaceutical Product Approval Document Access Dispute

Cited in relation to simplified procedures for generic drugs.

A-3621/2014 (Art. 12 al. 2 LPTh)

Pharmaceutical Product Approval Document Access Dispute

Cited in relation to the ten-year protection period for original preparations.

C-4776/2010 (Art. 12 Abs. 1 HMG)

E.________-_______ Generic Drug Marketing Authorization Rejection Upheld

Cited as the legal basis for 'Zweitanmeldung' (second application) and the concept of 'Erstanmelderschutz' (first applicant protection), which was central to the court's reasoning for dismissing the appeal.

C-4776/2010 (Art. 12 Abs. 2 HMG)

E.________-_______ Generic Drug Marketing Authorization Rejection Upheld

Cited regarding the extension of protection periods for specific improvements to original preparations, which was relevant to the 'Erstanmelderschutz' discussion.

C-4776/2010 (Art. 12 HMG)

E.________-_______ Generic Drug Marketing Authorization Rejection Upheld

Cited as the legal basis for the 'Zweitanmeldung' (second application) and the concept of 'Erstanmelderschutz' (first applicant protection), which was central to the court's reasoning for dismissing the appeal.

C-5727/2009 (Art. 12 Abs. 2 HMG)

Generic Drug Marketing Authorization Blocked by First Applicant Protection

The court confirmed that the ten-year period of exclusivity for the original product had not yet expired, thus preventing the review of the second application.

C-6050/2008 (Art. 12 HMG)

Seizure of Unapproved Medication for Personal Use Upheld

Allows an application for approval to rely on earlier approved medicines under certain conditions.

C-7615/2007 (Art. 12 HMG)

Swissmedic v. Pharmaceutical Company Regarding Generic Drug Approval

The court used this article to determine that the drug approval application could not rely on the original drug's documentation before the expiry of the ten-year protection period.

C-2251/2006 (Art. 12 HMG)

Patented Formulation Blocks Parallel Import of Medicine

Regulates the procedure for the approval of medicines that are essentially the same as already approved medicines.

C-8797/2007 (Art. 12 HMG)

Generic Drug Manufacturer's Standing in Marketing Exclusivity Dispute

Cited in relation to the first-time applicant protection, which is relevant to the underlying issue of the proceedings.

C-2263/2006 (Art. 12 Abs. 2 HMG)

Combination Drug Fails to Qualify for Ten-Year Exclusivity

This provision, in conjunction with Art. 17 VAM, was discussed in relation to the duration of the first applicant's protection and the interpretation of 'original product'.