Are you planning on becoming a Responsible Person for a pharmaceutical wholesaler?
Do you fit the criteria laid out by the National Competent Authority, the MHRA?
The Gold Standard for Responsible Persons has been in laid out for over two years at the date of writing this blog, and when the MHRA carry out a Responsible Person Assessment they will often refer to the Gold Standard.
The Regulator also wishes to know that the applicant can demonstrate;
1) familiarity with the Commission Guidelines for Good Distribution practice of medicinal products for human use (EU GDP 2013/C 343/01);
2) practical experience of handling, storage and distribution of medicinal products for at least 12 months;
3) practical experience in transactions in/selling/procuring medicinal products, for at least 12 months;
4) practical managerial experience in controlling and directing the wholesale distribution of medicinal products on a scale, and of a kind, appropriate to the licence application for at least 12 months;
5) knowledge of Directive 2001/83/EC as amended, of the community code relating to medicinal products for human use;
6) knowledge of the Human Medicines Regulations 2012 (SI2012/1916);
A pharmacy degree can be considered beneficial, as can being a licenced or transitional QP (Qualified Person), but neither are essential;
We cannot help with providing the practical experience, but most pharmacists and those who have worked in a management position in a wholesale business may be suitable to work as a Responsible Person.
Join us on one of our 1 or 2 day GDP Training courses for RPs and Managers, and we can help ensure you have the required knowledge for the role.
If not and you need a Responsible Person, talk to us about our cost effective Contracted Responsible Person options, or remote support packages.
The agenda for our training covers;
- The Competent Authority and their expectations above and beyond EU GDP
- Chapters 1-10 of EU GDP 2013/C 343/01
- “What would you do…?” exercises
- Practical advice and common sense solutions
Whether you have a day, or the full two days, Paradigm can help you on your RP journey.
Welcome to a new Paradigm!