5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
1 – Define the Supply Chain
By defining the supply chain you are defining the physical and financial flow of the product. This is done by determining both the customers and suppliers of the organisation. The customers must be entitled to receive medicinal product and the suppliers must be possess the appropriate bona-fides to supply the medicinal product. These control measures are some of the tools used to ensure the quality and integrity of the medicinal product is maintained through the supply chain.
The conventional supply of medicines was:
Manufacturer – Wholesaling – Pharmacy – Patient
However now the supply chain can be much more complex
Manufacturer – Wholesaler 1 – Wholesaler 2 – Wholesaler 3 – Wholesaler 4 – Wholesaler 5 – Pharmacy – Patient
Also, many organisation are now engaging in the process of ‘Virtual Wholesaling’ where there is a change from the convention way we might regard wholesaling of:
supply – procurement – storage- export
When these 4 components of wholesaling are not all performed, that is, if the wholesaler is not storing or physically holding the product, then this may be considered as virtual wholesaling. As the financial and physical flows of the product must be controlled it is essential that Quality/Finance/Supply chain to work together to ensure compliance to the GDP guidelines.
2 – Implement a QMS
A Quality Management System (QMS) is used to provide documented evidence that the organisation complies to Good Distribution Practice (GDP) guidelines. The level of complexity of the QMS is directly proportional to the complexity of the organisation. However there are several processes that are a mandatory part of any GDP QMS, irrespective of the complexity such as change control, risk management, recall of medicinal product(s), falsified medicines, complaints and returns.
A process approach can be utilised to implement a QMS, where the organisation is divided into a set of processes. Each process is governed by one or several procedures (SOP’s). Each procedure provides instruction on how the process is performed and a record provides documented evidence that the organisation ‘does what it says it’s doing’. From a quality perspective unless it is recorded then it didn’t happen! Verbal assurances of actions completed are not adequate.
3 – Get an RP
According to Article 79 -EC Directive 2001/83 the organisation must determine a Responsible Person (RP) where the RP will be listed on the application.
Key responsibilities of an RP are:
- Ensure the QMS is implemented & maintained
- Management of authorised activities & accuracy & quality of records
- Ensure initial & continuous training programs are implemented & maintained
- Coordinate & perform any recall operation
- Ensure customer complaints are dealt with effectively
- Ensure suppliers &customers are approved
- Approve any subcontracted activities that impact on GDP
- Ensure self inspection are performed and corrective actions put in place
- Keep appropriate records of any delegated duties
- Decide on final disposition of returned, rejected, recalled or falsified products
- Approve returns to saleable stock
- Ensure adherence to additional requirements imposed on certain products by national law
4 – Submit the WDA Application
A Wholesale Distribution Authorisation form AUT-F0199-15 is submitted to the HPRA. The application will be assessed and if the application is validated an on-site inspection by the HPRA will be scheduled at the wholesaling site detailed on the application form.
Mandatory elements which must be submitted as part of the WDA application include:
- Letter of application
- Certificate of incorporation
- Business document from Companies Registration Office if using a trading style
- Completed application form AUT-F0199-15
- Statement on premises and equipment (may not be applicable for virtual wholesalers)
- Overview of documents and records
- Recall procedure
- Statement on quality system (including a list of procedures)
- Details relating to Responsible Person(s)
- Classification of facility size (not applicable for virtual wholesalers)
- Fee application form
- Relevant fee
- Signed declaration
5 – HPRA Inspection Prior To A Wholesale Distribution Authorisation
Prior to awarding a WDA licence to the organisation the HPRA will inspect the wholesale site for compliance to Good Distribution Practices EU Guidelines 2013/C 343/01. If a WDA is awarded following the initial inspection the organisation is subject to follow-up inspections by the HPRA also.
In the past, the inspection programme consisted of routine inspections performed at a 3 year frequency. Now the HPRA has introduced a risk based approach to scheduling inspections. This can result in the inspection frequency for a wholesaling site decreasing to 5 years but it could increase to an inspection as every 6 months.
The frequency of inspection by the HPRA may be reduced or increased depending on the following factors:
- Good compliance history
- Changes to operations
- Post inspection follow up
In summary, if the organisation can demonstrate a strong compliance to the GDP guidelines this can result in a reduced inspection frequency.
The team at Acorn Regulatory has considerable experience working with clients on WDA projects. If you would like to chat to us about how we can help you then please complete your details below or call us on 00353 52 61 76 706.
Further Reading from Acorn Regulatory
Veterinary Clinical Trials: New EU Law & Global Approaches
Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.
Pharmacovigilance & Social Media in 2020
We have been tracking the role of social media in pharmacovigilance in social media since 2015. We first wrote about it here. 5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.
Download Our Clinical Trials E-Book
Acorn Regulatory is a leading regulatory, pharmacovigilance, and clinical consultancy company headquartered in Ireland. Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market. The team, led by Dr. Danica Cvetkovic, has written extensively on the issue. In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.
A Practical Approach to Risk Management Plans
Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail.