Our WDA E-Book Is Available To Download Now
The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. For many, the issue of Brexit has ‘muddied the water’ somewhat. Anecdotal evidence would suggest that there has been a large increase in the number of companies seeking WDA’s from the HPRA in Ireland. Companies considering a new Wholesale Distribution Authorisation need to be aware of the steps to take in the process. We have created a WDA e-book for companies to better prepare them for the WDA process.
In 2016 we published the first edition of our WDA e-book. It has been downloaded hundreds of times since by sector specialists who are interested in getting an initial understanding of the steps involved in securing a WDA.
We have updated the WDA e-book yet again and it is now available to download.
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. In our updated WDA whitepaper, 5 Steps To Obtaining A Wholesale Distribution Authorisation 2018 edition, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
The document, written by Acorn Regulatory expert staff looks at:
a. Defining the supply chain
b. Implementing a Quality Management System
c. The role of the RP
d. Submitting the Wholesale Distribution Authorisation application
e. The HPRA inspection (or inspection by a similar body such as the MHRA)
To download a copy of the e-book, complete your details below and you will be taken to the download link. You will also receive an email containing a link to the WDA e-book.
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Drug-Device Whitepaper
The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence, and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.
The drug-device whitepaper looks at issues such as:
- the regulatory framework for devices
- what is a drug-device product and how are they defined as such?
- how are they regulated
- how does MDR change the requirements for drug-device products?
- combination products regulated as medical devices
The brief whitepaper also provides a handy drug-device checklist.
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‘Regulatory Intelligence 7’ is now available to download. It is the latest edition in our popular series ‘Regulatory Intelligence’.
This edition covers the following issues:
- Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
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You can download your copy here.
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Get The Latest eCTD Publishing Whitepaper Now
Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing. Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download.
