Provision of Regulatory Affairs Services for Marketing Authorisation of Cattle BCG and DST-F

Tender description

Award of contract for provision of regulatory affairs services whereby the contractor will be responsible for collating all relevant documentation and compiling the Marketing Authorisation (MA) dossiers for both Cattle BCG and DST-F for the Animal and Plant Health Agency (APHA), according to the requirements outlined in Title II of Directive 2009.9.EC and submitting these to the Veterinary Medicines Directorate (VMD) for approval. Lot 1: The Animal and Plant Health Agency (APHA) is appointing a contractor to provide regulatory affairs services whereby the contractor will be responsible for collating all relevant documentation and compiling the Marketing Authorisation (MA) dossiers for both Cattle BCG and DST-F for APHA, according to the requirements outlined in Title II of Directive 2009.9.EC and submitting these to the Veterinary Medicines Directorate (VMD) for approval. This requirement sits within the Cattle BCG vaccine sub-programme funded by Defra and supporting the wider bovine tuberculosis eradication strategy for England. The services to be delivered by the contractor will support APHA’s aim to have Marketing Authorisation Holder approval in the UK for both Cattle BCG and DST-F. The key objectives of the procurement are to: Ensure that the Marketing Authorisation (MA) dossier process is followed, including collation of required study data; Submit the MA application for both Cattle BCG and DST-F; Deliver a successful MA application; Deliver value for money; Support timelines of other related projects in delivery of a deployable Cattle BCG vaccine by delivering the above objectives; Additional information: The contract has been awarded in accordance with the criteria outlined in the tender documents.