Business services: law, marketing, consulting, recruitment, printing and security (№2804808)

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Description

1. Section I
   1. Name and addresses
      Department of Health
      Leeds
      LS2 7UE
      United Kingdom
      E-mail: [email protected]
      
   2. Type of the contracting authority:
      Ministry or any other national or federal authority, including their regional or local subdivisions
      
   3. Main activity:
      Health
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         Healthy Start Vitamins — Qualified Person for Pharmacovigilance Services.

         
         
      2. Main CPV code:
         79000000
         
      3. Type of contract:
         Services
         
      4. Short 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 of the European Parliament and of the Council). 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. DHintends to outsource this function.

         
         
      5. Information about lots:
         This contract is divided into lots: no
      6. Total value of the procurement:
         Value excluding VAT: 143 760.00 GBP
   2. Description
      1. Title:
         
      2. Additional CPV code(s):
         
         
      3. Place of performance:
         
      4. Description of the procurement:
         

         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 fora 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.

         
         
      5. Award criteria:
         Quality criterion - Name: Quality / Weighting: 60
         Price - Weighting: 40
         
      6. Information about options:
         Options: no
      7. Information about European Union funds:
         The procurement is related to a project and/or programme financed by European Union funds: no
      8. Additional information:
         
3. Section IV
   1. Description:
      1. Type of procedure:
         Open procedure
      2. Information about a framework agreement or a dynamic purchasing system:
         
      3. Information about electronic auction:
         
      4. Information about the Government Procurement Agreement (GPA):
         The procurement is covered by the Government Procurement Agreement: yes
   2. Administrative information:
      1. Previous publication concerning this procedure:
         Notice number in the OJ S: 2017/S 109-219526
         
      2. Information about termination of dynamic purchasing system:
         
      3. Information about termination of call for competition in the form of a prior information notice:
         
4. Section V
   1. Contract No: 1
      Lot No: 1
      Title:

      Healthy Start Vitamins — Qualified Person for Pharmacovigilance Services.

      
      
   2. Award of contract
      1. Date of conclusion of the contract: 2017-08-25
         
      2. Information about tenders:
         Number of tenders received: 1
         The contract has been awarded to a group of economic operators: no
      3. Name and address of the contractor:
         PharmaLex UK Services Limited
         Birmingham
         B3 2HB
         United Kingdom
         The contractor is an SME: no
      4. Information on value of the contract/lot (excluding VAT):
         
         Total value of the contract/lot: 143 760.00 GBP
         
      5. Information about subcontracting:
         
         
5. Section VI
   1. Additional information
      
   2. Procedures for review
      1. Review body
         The High Court
         London
         WC2A 2LL
         United Kingdom
         
      2. Body responsible for mediation procedures
         The High Court
         London
         WC2A 2LL
         United Kingdom
         
      3. Service from which information about the review procedure may be obtained
         
         
   3. Date of dispatch of this notice
      2017-09-14