Source: http://www.powellgilbert.com/News-and-insights/publications/April-2015/Briefing-note-Pharmaq-v-Intervet
Timestamp: 2018-01-17 01:26:45
Document Index: 739906537

Matched Legal Cases: ['Art 8', 'Art 3', 'Art 8', 'Art 26', 'Art 3', 'Art 26']

Powell Gilbert - Briefing note: Pharmaq v Intervet
Published By Dr Penny Gilbert
22/04/2015 13:17:40
The EFTA Court rules on the application of Articles 2, 3 & 4 on the SPC Regulation in the content of veterinary vaccine products.
A provisional permission to place a product on the market under Art 8(1) Veterinary Medicines Directive will not amount to an authorisation for the purposes of Art 3(b) and (d) provided that it has been properly granted. Art 8(1) permissions being strictly limited to the use of immunological veterinary medicinal products, without a marketing authorisation, in the event of serious epizootic diseases where there is an absence of suitable medicinal products and after informing the Commission /EFTA surveillance authority of the detailed conditions of use.
However, the grant of a provisional marketing authorisation in exceptional circumstances, under Art 26(3) Veterinary Medicines Directive does constitute an administrative authorisation for the purposes of Art 3(b) and (d) of the SPC Regulation. Art 26(3) permits the grant of an MA, for objective, 3 2041415 justifiable reasons, in exceptional circumstances. Such authorisations are subject to specific procedures, including safety reporting, and also subject to annual assessment.
Likewise, the Oslo District Court must decide whether, in fact, the SPC is invalid on the basis that it extends beyond the scope of the granted MA, which is expressly limited to Intervet’s F93-125 strain. Since the EFTA Court’s decision is not binding on the referring Court (unlike the position with the CJEU) one might also expect the EFTA Court’s assumptions, based on Forsgren, to be reviewed.