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Tender description

The requirement for the Marketing Authorisation Holder (MAH) to have a qualified person with responsibility for pharmacovigilance services is described within the pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). A legal obligation is therefore placed on the Department of Health (DH) to meet the requirement for a qualified person (QP) who will be responsible for pharmacovigilance services. DH intends to outsource this function. The DH is therefore responsible for the maintenance of the Market Authorisation (MA) for the Healthy Start children's vitamin drops, held in the name of the Secretary of State for Health. Healthy Start children's drop are a General Sale list licensed medicine and the MA reference is PL01511 / 0003. The Secretary of State has a statutory responsibility to make Healthy Start Vitamins available for people who are entitled to them. The Department of Health (DH) arranges for the procurement of these vitamin products, which are purchased by local authorities and distributed to Healthy Start beneficiaries. Local authorities can claim reimbursement from the DH for the cost of the vitamins. The vitamin product for Healthy Start beneficiaries aged up to 4 — Healthy Start Children's Vitamin drops, are presently a licensed medicine and the Marketing Authorisation (MA) is held by the Secretary of State for Health. The product is a General Sale list licensed medicine and the MA reference is PL01511 / 0003. As the holder of the MA the Secretary of State has legal obligations to ensure compliance with licence requirements set out by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Union (EU). Failure to fulfil these legal obligations could result in the MHRA either suspending or withdrawing the MA for this product. This in turn would mean that the Secretary of State could not meet their responsibilities to make Healthy Start Vitamins available. The requirement for the Marketing Authorisation Holder (MAH) to have a qualified person with responsibility for pharmacovigilance services is described within the pharmacovigilance legislation (Regulation (EU) No 1235 / 2010 and Directive 2010/84/EU of the European Parliament and of the Council). A legal obligation is therefore placed on the DH to meet the requirement for a qualified person (QP) who will be responsible for pharmacovigilance services. DH intends to outsource this function. Bidders are required to refer to the procurement documentation for full details of the requirement. The Contract is expected to be for a period of up to 24 months, with extension options. See attached Procurement documents. DH reserves the right to not proceed to Contract for this requirement.