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RP/Responsible Person

The MHRA and the European GDP Guideline of 5 November 2013 require that, in order to gain and retain a Wholesale Dealer’s Licence (WDA) licence, wholesale pharmaceutical distributors must designate a Responsible Person (RP) for Good Distribution of Medicinal (GDP) who must be named on the licence.  The responsibilities and liabilities of the RP remain the same whether the Responsible person is employed directly by the licence holder or is an independent contractor. 

According to the MHRA, the RP is responsible for “safeguarding product users against potential hazards arising from poor distribution practices”.  The duties and responsibilities of a RP includeensuring that the provisions of the licence are fulfilled by means of GDP and GMP compliance and best practice within all regulated activities, a compliant quality system is established and maintained and a suitable document control system is in place to ensure that adequate records are maintained.  In addition, the RP will need to oversee the audit of the quality system, carry out independent audits and cooperate with the product licence holder and regulatory authorities with regard to drug returns and product recalls. 

In order to carry out his/her duties, the RP should have knowledge of the products being traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas and records which relate to the licensable activities and regularly review and monitor all such areas.

Skills and Experience required to become an RP

  • Degree in pharmacy (preferable) or Qualified Person status
  • Practical experience in Supply Chain, Production and Quality Assurance relating to the distribution of medicinal products
  • Extensive knowledge of GDP and GMP
  • Experience of hosting MHRA inspections, client audits and self-inspections
  • High level of accuracy 


Bedfordshire is a county in the East of England region to the north of London and within commuting distance.  Major towns and cities in Bedfordshire include Luton, Bedford and Leighton Buzzard.

In earlier centuries Bedfordshire’s economy was based around agriculture, wool and lacemaking.   However, current day Bedfordshire is home to a number of UK and international companies in the aerospace, automotive, logistics, service and high tech industries.  EasyJet, Monarch Airlines and Thomson Airways which are and all based in Luton, close to the airport.

Bedfordshire is steeped in history; it was the birthplace of the Church of England (at The Priory Church of St Peter Dunstable) and during the second World War it provided a safe haven for exiled royalty from Europe as well as airfields from which spy planes departed for sorties behind enemy lines.  Popular tourist attractions in Bedfordshire include Whipsnade Zoo and Woburn Safari Park.

Famous people from Bedfordshire:  Ronnie Barker – comedian and Carola Vorderman – TV presenter