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Intervet/Schering Plough Found in Breach of NOAH Code

by 5m Editor
25 September 2009, at 7:01am

UK - The National Office of Animal Health (NOAH) Code of Practice Committee, chaired by Guy Tritton has found Intervet/Schering-Plough Animal Health in breach of four items under complaint, relating to the promotion of Porcilis®.

The Committee considered that the promotional items contained in a Technical Brochure distributed at a symposium in Portugal.

It investigated items that said: “..… and officially registered label claims were granted for ….1 × 2 ml dose scheme”; a Graph entitled “Porcilis PCV once”; “A single dose of Porcilis PCV” and “..… measured after a single vaccination”.

NOAH said they constituted a breach of Code of Practice Clause 4.6 in that “all information must be presented so as to promote the correct use of medicines” and Clause 4.7 in that “promotions must not be inconsistent with the SPC” as:

  • Single dose administration was inconsistent with the product’s Europe-wide SPC and the inclusion of this claim was, therefore, inconsistent with the product’s Marketing Authorisation.
  • The UK Member Company voluntarily invited a significant percentage of UK veterinary consultants in the pig sector to the European launch and they were not advised of this off-label claim at the time. Its own UK launch was some three months later, without the inconsistent claim.

NOAH encourages those interested in finding out more to read the full details of the Committee’s rulings on the NOAH web site. The full report of this particular case will be available shortly.