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

Concepts

• technical services
• provision of regulatory affairs
• uk veterinary medicines directorate of marketing authorisation
• provision of regulatory affairs services
• technical support
• marketing authorisation
• regulatory affairs services
• provision of regulatory services
• structure of the dossiers services
• cattle bcg

Location

United Kingdom:

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.

Total Quantity or Scope

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 dossiers Services are expected to commence from February 2022, please refer to tender document for more information on service commencement date. Additional information: A PIN was issued earlier this year is to alert the market to this opportunity and invited interested parties to download the supplier information pack which has further information on this project. This supplier information pack can be downloaded from Bravo along with the full tender documents.

Renewal Options

Optional 12 month extension. No further renewals expected after this.

CPV Codes

• 71356000 - Technical services
• 71356300 - Technical support services

Indicators

• This is a one-off contract (no recurrence)
• Renewals are available.
• Professional qualifications are sought.

Other Information

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