Monday, 30 November 2020 14.00 - 15.30 h
According to Chapter 2, article 2.2 of the EU-GDP Guidelines ("Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)"), "the wholesale distributor must designate a person as responsible person." It further states: "The written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. The wholesale distributor should give the responsible person the defined authority, resources and responsibility needed to fulfil their duties."
Chapter 2, article 2.2 of the EU-GDP Guidelines defines the requirements, responsibilities and duties of the RPs. The RP’s job description should list the responsibilities detailed in the GDP Guidance, plus any other company specific activities assigned to him/her. Thus, the following objectives and responsibilities should be part of the job description:
A copy of the company’s organisation chart should be added to the job description to show where the role fits within the management structure of the wholesale distributor.
The job description should be reviewed and updated whenever the nature of the business, the site authorisation and/or the regulatory
An example of a job description can be found in the Code of Practice for Code of Practice for Responsible Persons (RPs) which has been published by the European GDP Association. You can download the document in the members area. If you are not a member yet, you can apply for free membership.