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Tender Details
- Country: United Kingdom
- Summary: Provision of Regulatory Affairs Services to Support with Obtaining Marketing Authorisation from the Vmd for Cattle Bcg and a Companion Skin Test, Dst-F
- GBT Ref No: 59665176
- Deadline: 09 Dec 2021
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: -
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: NOV379030
- Purchaser's Detail :
- Description :
- Provision of regulatory affairs services for compilation and submission to the UK Veterinary Medicines Directorate of Marketing Authorisation Dossiers for CattleBCG and DST-F as part of the of the UK Government bovine tuberculosis (bTB) eradication programme.
Title: Provision of Regulatory Affairs services to support with obtaining Marketing Authorisation from the VMD for Cattle BCG and a companion skin test, DST-F
Published by: Defra Network eTendering Portal
Publication Date: 09/11/2021
Deadline Date: 09/12/2021
Deadline Time: 12:00
Notice Type: Contract Notice
Has Documents: No
Has ESPD: No
Abstract: 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 Veterinary Medicines Directorate (VMD) for the content and structure of the dossiersServices are expected to commence from February 2022, please refer to tender document for more information o... - Documents :
Purchaser : DEFRA NETWORK ETENDERING PORTAL
Defra Network eTendering Portal
17 Nobel House
London
SW1P 3JR
UK
Telephone : +44 2072385921
E-mail : colette.newton@defra.gov.uk
NUTS : UK
Internet address(es)
Main address : www.defra.gov.uk
Email :colette.newton@defra.gov.uk
URL :www.defra.gov.uk
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