--- title: "Healthy Start Vitamins - Qualified Person for Pharmacovigilance Services" ocid: "ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97.json" source: "Contracts Finder" current_stage: "Tender" buyer: "DEPARTMENT OF HEALTH" published: "2017-06-23" --- # Healthy Start Vitamins - Qualified Person for Pharmacovigilance Services Buyer: DEPARTMENT OF HEALTH Current stage: Tender OCID: ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97.json) ## Summary The Department of Health is initiating an open procurement process titled "Healthy Start Vitamins - Qualified Person for Pharmacovigilance Services". This procurement falls under the miscellaneous business and business-related services category and is based in England. The tender is currently active and will close on 12 July 2017, with a contract period set to commence on 1 October 2017 and continue for up to 24 months, including extension options. The estimated value of the contract is £110,000. Interested suppliers must register on the BMS system as part of the tender process. This tender presents excellent opportunities for businesses engaged in pharmaceutical services and regulatory compliance, particularly small and medium enterprises (SMEs) that specialise in pharmacovigilance. Companies with expertise in managing the legal obligations related to the distribution of licensed medical products, particularly those suitable for children's health, would be well-positioned to compete for this contract. Bidders are encouraged to consult the procurement documentation for detailed requirements and evaluation criteria. ## Notice This is a notification that the Department is running an OJEU Open Procurement for the services described. - (for which see ITT ref number 60433).Interested suppliers need to register on the BMS system if they have not done so already. Details of registration can be found on the attached instructions document and link provided. The Secretary of State has a statutory responsibility to make Heathy 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 four - 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). 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 as described below. 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. ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Open | | Procurement method details | Open procedure | | Tender suitability | SME | | Awardee scale | Not specified | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 23 Jun 2017 | | Submission deadline | 10 Jul 2017 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 30 Sep 2017 - 30 Sep 2019 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £110,000 | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | DEPARTMENT OF HEALTH | | Locality | LEEDS | | Post town | Leeds | | Postcode | LS2 7UE | | Country | England | | ITL 1 | TLE Yorkshire and The Humber | | ITL 2 | TLE4 West Yorkshire | | ITL 3 | TLE42 Leeds | | Local authority | Leeds | | Electoral ward | Little London & Woodhouse | | Westminster constituency | Leeds Central and Headingley | | Delivery location | Not specified | ## CPV Codes ### Divisions - 79 - Business services: law, marketing, consulting, recruitment, printing and security ### Codes - 79900000 - Miscellaneous business and business-related services ## Release History - 23 Jun 2017 at 13:49 - TenderAmendment - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 - 19 Jun 2017 at 15:09 - TenderAmendment - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 - 19 Jun 2017 at 08:41 - TenderAmendment - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 - 8 Jun 2017 at 09:26 - TenderAmendment - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 - 7 Jun 2017 at 14:41 - TenderAmendment - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 - 7 Jun 2017 at 14:30 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/db8d4608-b38e-4cc0-ac65-841cf908d159 23rd June 2017 - Opportunity notice on Contracts Finder - https://www.contractsfinder.service.gov.uk/Notice/Attachment/a57f4e19-fbad-4bb6-9f3a-fb71af3bb04c ITT - https://www.contractsfinder.service.gov.uk/Notice/Attachment/3551f320-4989-48d4-907c-a42365a972ee Terms of Participation - https://www.contractsfinder.service.gov.uk/Notice/Attachment/bd71e75c-7e56-48a1-9b57-eb62e0e4aa33 Specification - https://www.contractsfinder.service.gov.uk/Notice/Attachment/602dc83f-8a14-4fbd-9556-ddbf48c85f12 Conditions of Contract - https://www.contractsfinder.service.gov.uk/Notice/Attachment/0ca86628-cb52-4efa-ba09-0886c0cc3b3a Evaluation Guidance - https://www.contractsfinder.service.gov.uk/Notice/Attachment/c8d7ae3a-9001-4a11-b940-d0e4e8092e65 Selection Questionnaire - https://www.contractsfinder.service.gov.uk/Notice/Attachment/580ce0f6-0d2e-4bc7-a86c-f5d1acf918d9 Award Questionnaire - https://www.contractsfinder.service.gov.uk/Notice/Attachment/39ee4b8b-016f-4f0a-abdf-c4f1104121b3 Pricing Schedule - https://www.contractsfinder.service.gov.uk/Notice/Attachment/b1b16760-34a6-4fb0-8bf8-0fe4bb4e79a0 Confidentiality Agreement ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-bd2d4af3-7707-4456-8f94-9e37e8cf0c97.json.