Personnel Requirements

There must be sufficiently competent personnel to carry out all the tasks for which the wholesale dealer is responsible.

3.1 Personnel

  1. There must be sufficiently competent personnel to carry out all the tasks for which the wholesale dealer is responsible. The organisation chart must show the structure of the business with roles and responsibilities. Those in key positions must be set out in written job descriptions, along with any arrangements for deputising.

3.2 The Wholesale Qualified Person (WQP)

  1. Each site must have a designated person as the responsible person, known as the wholesale qualified person (WQP).
  2. The WQP may be a pharmacist, vet or SQP, but if they’re not one of these, they must have at least a year’s experience in either handling, storing and distributing medicines, or in the supplying or obtaining of medicines. They must also have at least a year’s experience in managing the wholesale distribution of medicines on a similar scale with a similar product scope.
  3. If the WQP is not an employee, there must be a written agreement, signed by both parties and this must include the written job description.
  4. The WQP is personally responsible for fulfilling their obligations, as defined by the business management and detailed in the WQP’s job description. The business management must provide the WQP with the resources and the authority needed to fulfil their duties.

  5. The duties and obligations of the WQP include:

    • (i) implementing and maintaining the quality system
    • (ii) managing authorised activities and ensuring the quality and accuracy of the data recorded
    • (iii) developing, implementing and recording a continuous training programme for all staff involved in the wholesale of veterinary medicinal products
    • (iv) co-ordinating and performing any recall operations for veterinary medicinal products in the required time frames
    • (v) ensuring that relevant customer complaints are dealt with effectively
    • (vi) ensuring that validations regularly occur on suppliers and customers to ensure that they are authorised
    • (vii) approve and manage any subcontracted activities which may impact on the wholesale supply of veterinary medicinal products
    • (viii)perform self-inspections at appropriate regular intervals
    • (ix) keep appropriate records of any delegated tasks
    • (x) decide on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products
    • (xi) approve any returns to saleable stock
    • (xii) ensure that the requirements of the Veterinary Medicines Regulations 2013 (as amended) and the associated Good Distribution Practice document are adhered to
    • (xiii) monitor and document deviations against the quality system, conduct CAPAs to correct deviations and avoid their reoccurrence, and monitor the effectiveness of the actions put in place.
  6. The WQP must fulfil their responsibilities personally and must be continuously contactable. If the WQP designated to that site is not available, then the business must appoint a substitute WQP for the necessary time period so that continuity of business is ensured.
  7. The WQP may have a nominated deputy with appropriate reporting and delegating arrangements but must ensure that the necessary controls and checks are in place. The WQP may delegate duties but not responsibilities.
  8. There may be more than one WQP named on a WDA, but each WQP must carry out an annual self-inspection.
  9. The wholesale dealer must take advice from the WQP on matters relating to the WDA but if there is a disagreement that cannot be resolved, the VMD must be consulted, preferably by both parties.
  10. If the WQP is not adequately carrying out the agreed duties, the VMD may consider the suspension of the WDA and/or withdrawal of acceptance of the WQP on that Authorisation and on any other licence.
  11. If the WQP leaves the employment of the wholesale distributor or terminates the agreement (if acting as a contract WQP), it is the responsibility of the WQP to inform the VMD that they are no longer carrying out those functions of the Authorisation.
  12. It is the responsibility of the wholesale dealer to immediately apply for a variation to change the WQP or to cease wholesaling. A wholesale dealer is not allowed to wholesale veterinary medicines without an appropriate WQP in place who is named on the authorisation.

3.3 Other Personnel

  1. There must be sufficient competent personnel involved in all stages of the wholesale process. The numbers required will depend on the volume of veterinary medicinal products and types of activities covered.
  2. An organisational chart showing the business structure, the individuals and their roles and responsibilities must be available. Each staff member must understand their own roles and responsibilities.
  3. The role and responsibilities of employees working in key positions must be set out in written job descriptions, along with any arrangements for deputising.

3.4 Training

  1. All personnel involved in wholesale distribution activities must be trained on the requirements of good distribution practice for veterinary medicinal products. The training must be relevant to their role and part of an agreed training programme.
  2. Staff must receive induction training relevant to their new role and to maintain competency, personnel must also be part of an ongoing programme of training, in accordance with a written training program.
  3. Training must include aspects of product identification to avoid counterfeit product entering the supply chain.
  4. Relevant personnel must receive specific training on the handling and supply for certain products, such as hazardous products, products presenting special risks of abuse including narcotic and psychotropic substances, and temperature-sensitive products.
  5. All training must be recorded and reviewed on a regular basis, at least annually.