GDP Obligations of the Licence Holder
Avge Pass Rate: 89.5 % | 3 attempts to pass the final assessment.
The GDP Obligations of the Licence Holder course was created as an informative and concise training programme for all those who are designated or are about to be embarking upon the role of Licence Holder (LH) for their licensed premises. It is an excellent first-time course and a reliable refresher course for certification renewals.
In this course you will learn the importance of the requirements of Good Distribution Practice from the Licence Holder’s perspective and your relationship as an LH with your RP, staff and management. Above all, you will know how to implement and maintain quality and compliance with GDP within your company.
As a Licence Holder, your training is still a yearly requirement and the awareness course is a perfect, and convenient, refresher course as online training allows you to learn at your own pace, helping to eliminate stress and expense to you or your company.
See our Course Content list below for more information on the modules included in this course.
The learning objectives of our GDP Obligations of the Licence Holder course are:
- To understand the importance and requirements of GDP, in line with GDP Guidelines 2013/ C 343/01 and MHRA HMR2012.
- To recognise and understand your role as an LH in implementing and maintaining GDP compliance within your company premises day to day.
- To understand the role and function of the Responsible Person (RP), the Quality Management System (QMS), and your own responsibilities as an LH.
You will also learn:
- How to make sure that the products you are licensed to hold are available at all times.
- How to document activities correctly.
- …to familiarise with the HMR2012 and other MHRA and EU Directives, and what the regulations entail for you as Licence Holder.
Click the button below for supporting documentation about GDP if you wish to continue your learning journey.
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Additional Documentation:
- Responsible Person Code of Practice
- EU GDP Directive 2013-C 343-01
- HMR 2012 Part 3 Chapter 2 Section 18 - Wholesale Dealing in Medicinal Products
- HMR 2012 Part 3 Chapter 2 Section 18a - Approved Country for Import
- HMR 2012 Part 3 Chapter 2 Section 42 - Conditions for Wholesale Dealers Licence
- HMR 2012 Part 3 Chapter 2 Section 43 - Obligations of Licence Holder
- HMR 2012 Part 3 Chapter 2 Section 43a - Requirement for Wholesalers to Decommission Unique Identifier
- HMR 2012 Part 3 Chapter 2 Section 44 - Requirement for Wholesalers to deal only with Specified Persons
- HMR 2012 Part 3 Chapter 2 Section 45 - Requirement as to Responsible Persons
- HMR 2012 Part 3 Chapter 2 Section 45aa - Requirement as to responsible persons where licence holder imports from an approved country for import
- HMR 2012 Part 10 Section 167 - Supply to fulfil patient needs
- HMR 2012 Schedule 4 Part 4 - Wholesale Dealers Licence
- Human Medicines Regulations 2012
- MHRA Guidance Note 6 - WDA Application Guidance
- MHRA Guidance Note 8 - What is a medicine
- MHRA Guidance Note 14 - Unlicensed Medicines
- The Windsor Framework - a New Way Forward (CP806)
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