Checklist for Implementation of GDP Principles - Part 10: Specific Provisions for Brokers

Chapter 10 (Specific Provisions for Brokers) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) describes the requirements for brokers to be registered by the local competent authority, to have a QMS in place supported by adequate documentation. Personnel working for brokers should receive adequate training on relevant sections of GDP. There is also a requirement for brokers to follow and apply the principles of Chapter 4, Documentation with all records made available according to national legislation but at least 5 years, the same as for wholesale distributors.

Checklist: Implementation of GDP Principles at Broker

The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 10 of the 2013 guidelines:

• The marketing authorisation holder and the competent authority in the Member State to which the medicinal product is imported of his intention is notified of importation
• The broker is registered
• The broker has a permanent address and contact details in the Union under which they are registered
• The broker notifies the competent authority of any changes thereof without unnecessary delay
• The quality system is defined in writing, approved and kept up to date
• The quality system sets out the responsibilities, processes and risk management
• Personnel involved in brokering activities is trained in the applicable EU and national legislation and in the issues concerning falsified medicinal products
• At least the following procedures and instructions are in place:
  - Procedure for complaints handling
  - Procedure for informing competent authorities and marketing authorisation holders of suspected falsified medicinal products
  - Procedure for supporting recalls
  - Procedure for ensuring that medicinal products brokered have a marketing authorisation
  - Procedure for verifying that their supplying wholesale distributors hold a distribution authorisation, their supplying manufacturers or importers hold a manufacturing authorisation and their customers are authorised to supply medicinal products in the Member State concerned
• Records are kept for any transaction in medicinal products brokered including at least the following information:
  - date
  - name of the medicinal product
  - quantity brokered
  - name and address of the supplier and the customer
  - batch numbers of the medicinal product, where required
• Records are retained for at least 5 years or longer if required by national legislation

Reference

The points listed above are an excerpt from the "ECA Roadmap to Good Distribution Practice (GDP)", which includes checklists to verify the minimum implementation of GDP, based on the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01). The European GDP Association (GDPA) has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. The PDF is available for download free of charge in the GDPA members' area.