Marketing Authorisation Support Services

Descriptions

The Secretary of State for Health is presently responsible for the maintenance of two national marketing Authorisations (MAs), Anthrax vaccine and Healthy Start Vitamin Drops. The Department has a legal obligation to meet the requirements for a Qualified Person responsible for pharmacovigiliance in respect of the MAs for which DH acts as MA holder. There is a secondary requirement to ensure that the MAs are maintained in line with EU guidance and current regulatory affairs requirements.The contract will be broken down into two lots as follows:-LOT 1: The provision of Qualified Person for Pharmacovigiliance for Marketing Authorisations held by the Secretary of State for HealthLOT 2 Contract for the provision of Regulatory Affairs Support Services for Marketing Authorisations for Healthy Start Vitamin Drops held by the Secretary of State for HealthThe Department of Health reserves the right to discontinue the tendering process at any time and not award the contract