With the focus so often being on getting the product certified by a Qualified Person (QP) under a Manufacturers/Importers Authorisation (MIA), what can often be overlooked is what is needed to actually get the product out of the warehouse and in to hands of the patient. Enter the Wholesale Distributors Authorisation (WDA) and the key person within that, the Responsible Person (RP).

There are many similarities between a WDA and a MIA, for example, both require a procedures that cover the basic foundations of a Quality System, eg Deviations, Change Controls, CAPAs, Complaints, Training etc but the key difference is that the WDA will be looking almost exclusively at the product post QP certification.

The WDA (aside from being a regulatory requirement) is just as important as the MIA as it ensures the continuity of GXP from product manufacture through to product distribution.

wda license steps

1. Hiring your RP

The first step in getting your WDA licence is identifying a suitable person to act as your RP. For more information, please read this article on the role of the RP.

As we discuss in the article above, this person will be responsible for overseeing the development, implementation, and maintenance of a quality management system that includes procedures, controls, and documentation to safeguard the quality of medicines.

2. Developing your Pharmaceutical Quality System (PQS)

The next step is to either assess your existing PQS or develop a PQS from scratch that adheres to the EU and UK regulatory guidance with respect to WDAs, depending on where you are planning to establish your WDA. It should be noted that in the UK there is a specific RPi role that must be taken into account.

3. Filing the Application

Once you have your RP in place and your PQS established then you can file your application with the regulatory authority of the country you intend to establish your WDA in. Most regulatory bodies have a specific form or portal to facilitate electronic submission. In this submission you will need to include the names of your key personnel (eg RP), scope of activities performed under the WDA, third party sites and copies of technical agreements in place with those third parties.

4. Preparing for Inspection

Once the application is filed you are on the countdown to the inspection, during this period tasks such as self inspections, bona fide checks can be executed in order to show the inspector a proactive approach has been taken by the team and that you are ready to go live on issuance of the WDA licence.

At MIAS we have a proven track record of assessing clients Quality Systems to help them apply for and maintain their own WDAs. In addition our site in the UK holds a WDA granted by the MHRA, thereby offering an alternative option for our clients to continue the supply of their product to the UK market.

For any questions related to WDA services get in touch with us or fill in the form below.

I agree to receive other communications from MIAS Pharma. *

By clicking submit, you consent to allow us to store and process the personal info submitted above to process your query.