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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
Basel is a city on the Rhine River in northwest Switzerland close to the borders with France and Germany. The official language of Basel is German although, with 35% of the inhabitants being foreign nationals, English is also widely spoken. The University of Basel, founded in 1460, is Switzerland's oldest university and it houses some of Erasmus’s works. Erasmus’s tomb is to be found in the city’s 12th century Romanesque-Gothic cathedral. There are almost 40 museums in Basel as well as many beautiful medieval buildings around the Marktplatz.
Basel is home to large pharmaceutical and chemical industries with companies such as Novartis, Syngenta, Ciba Specialty Chemicals, Hoffmann-La Roche, and Actelion being headquartered in the city. Like other Swiss cities, Basel is also a centre for banking and both the Bank for International Settlements and UBS are located in the city.
Famous people from Basel include: Roger Federer, champion tennis player and Ursula Andress, actress