Art. 12 Loi sur la vente des médicaments

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'.