Wholesale Distribution Authorisation: Updated Guide for 2020

There has been significant growth in the number of companies seeking a pharmaceutical Wholesale Distribution Authorisation in Ireland (WDA) in recent years.  We have assisted many companies with every step of the process. Our Quality team works with companies from all over the world on issues relating to their WDA’s.

If you want to apply to the HPRA (Health Products Regulatory Authority) for a WDA in Ireland, then Acorn Regulatory can assist with the following aspects:

1. Identify the scope of the pharmaceutical Wholesale Distribution Authorisation
2. Provide a Responsible Person (RP)
3. Prepare & Submit the Wholesale Distribution Application to the HPRA
4. Create a Quality Management System for the management of wholesale distribution activities
5. Provide Quality Support to manage and maintain the Quality System

Identify the scope of the Wholesale Distribution Authorisation (WDA)

Acorn Regulatory can assist the client in identifying the category of the product authorisations that the pharmaceutical Wholesale Distribution Authorisation will contain:

• Products that have a Marketing Authorisation in EEA country(s)
• Products that do not have a Marketing Authorisation in the EEA, but are intended for the EEA market
• Products that do not have a Marketing Authorisation in the EEA, and which are intended for export

Acorn Regulatory will also identify the type of operations required for the Wholesale Distribution Authorisation:

• Procurement – Purchasing or Buying medicinal products from manufacturers or other wholesale distributors
• Holding – Physical Storage of Medicinal Products
• Supply – Providing, selling or donating medicinal products to other wholesalers, pharmacists, or persons authorised to supply medicinal products to the public
• Export – Supplying medicinal products to a country outside of the EU member states or a contracting state of the EEA

Acorn Regulatory will also assist the client in identifying the categories of medicinal products with additional requirements

Provide a Responsible Person (RP)

Acorn Regulatory can provide the client with a Responsible Person (RP) for the Wholesale Distribution Authorisation.

The duties of the RP are:

• To oversee the procurement and supply activities
• Approve Bona Fides of new Suppliers, Customers and Service Providers
• Ensure that the activities of the Wholesale Distribution Authorisation comply with the guidelines outlined by the HPRA, and with the scope of the WDA.

Acorn Regulatory will ensure that the RP is qualified and trained for the role of the RP at the wholesaling premises.

Acorn Regulatory can also provide RP training to the client for a person identified by the client as a suitable RP.

Prepare & Submit the Wholesale Distribution Application to the HPRA

Acorn Regulatory can provide & submit the Wholesale Distribution Application to the HPRA, on behalf of the client, in the form of a submission package.

Create a Quality Management System for the management of wholesale distribution activities

Acorn Regulatory can provide the client with a complete Quality Management System, comprising of SOPs (Standard Operating Procedures), Forms, Logs/ Trackers and any other relevant process which will enable the client to perform and manage the procurement and supply activities of the WDA, whilst maintaining compliance with the requirements of the HPRA Guide to Quality System for General Sale Wholesale Distributors.

Provide Quality Support to manage and maintain the Quality System

Acorn Regulatory can provide the client with a Quality Support representative, for the purpose of managing and maintaining the Quality System associated with the Wholesale Distribution Authorisation. Activities of the Quality Support representative can include but is not limited to:

• Documentation Control
• Process System Control (Change Control, CAPA (Corrective Actions/ Preventive Actions), Risk Assessments)
• Control and Monitoring of Training
• Quality Management Review preparation
• Investigation and Management of Customer Complaints
• Assisting with Bona Fides for Supplier, Customer and Service Provider approvals

The duties of the Quality Support representative also include ensuring that the activities conducted under the Wholesale Distribution Authorisation comply with the guidelines outlined by the HPRA and that the activities conducted are within the scope of the WDA. The Quality Support representative will also act as a supporting function for the Responsible Person and any other member of the Quality Team.

Acorn Regulatory will ensure that the Quality Support representative is qualified and trained for the role of Quality Support for the WDA.

If you would like to talk to us about your WDA requirements, please contact us on 00353 52 61 76 706 or complete the form below and we will get back to you.