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The EU GDP Guidelines require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore, the ECA Foundation's GDP Working Group has developed this training course. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
In 2013 the revised 'Guidelines on Good Distribution Practice of Medicinal Products for Human Use' were published. The Guidelines were revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into account the amendments to the Community Code which have been introduced with Directive 2011/62/EU of the European Parliament and of the Council. It is amending Directive 2001/83/EC on the Community code relating to medicinal products for human use with regard to preventing falsified medicinal products to enter the legal supply chain-
In Chapter 2 "Personnel", tasks and responsibilities of the RP are defined. RPs should fulfil their responsibilities personally and should be continuously contactable. The RP may delegate duties but not responsibilities.. General requirements like organisational chart, job descriptions and training requirements are new or outlined in much more detail.
The Training Course is of particular interest to Responsible Persons but also management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in distribution of medicinal products for human use.
All participants receive a Roadmap to Good Distribution Practice containing:
The EU GDP Guidelines