Provision of Regulatory Affairs services to support with obtaining Marketing Authorisation from the VMD for Cattle BCG and a companion skin test, DST-F

Descriptions

APHA is seeking a contractor for provision of regulatory services for immunological veterinary medicinal products (IVMPs) to compile two Marketing Authorisation (MA) dossiers and manage the MA submissions CattleBCG and DST-F, a DIVA skin test classified as an IVMP for regulatory purposes. , The contractor will be responsible for collating all relevant documentation and parts of the dossier submission to include summary of the dossier, product quality, safety and efficacy data and bibliographic references. Compiling the dossiers according to the requirements outlined in EurdraLex- Volume 6B & 6C and any additional requirements laid down by the VMD for the content and structure of the dossiers , The dossiers will be produced to a high specification with respect to content, format and ease of access for the assessors it will be submitted by the contractor via the VMD portal. , The contractor will be the point of contact between APHA and VMD throughout the MA application process including managing the responses to questions or issues raised by the VMD during the MA application procedure. The contractor will play a critical role ensuring timelines for responses are met and working closely with the experts at the APHA to ensure complete and full responses to address VMD concerns, questions or points of clarification., APHA estimates that the service is required to commence in January 2022., Note that the contract specification, to be issued as part of the tender documents, will provide comprehensive information on the mandatory standards and requirements for this contract.