Every day we work with organisations who are seeking to obtain a Wholesale Distribution Authorisation (WDA). A WDA is required in order to conduct wholesale activities of medicinal products. Our team will provide the required support, knowledge, experience and tools to ensure your organisation secures a WDA from the Health Products Regulatory Authority (HPRA).
Does My Organisation Need A Wholesale Distribution Authorisation?
Every organisation intending to procure, hold, supply or export medicinal products within the EEA territories must hold a Wholesale Distribution Authorisation (WDA). If your organisation is planning on conducting any wholesaling activities of medicinal products then you must have a WDA.
The requirements for obtaining a Wholesale Distribution Authorisation include:
- Implementing a Quality Management System (QMS) compliant with the EU GDP Guidelines
- Providing a person responsible for maintaining oversight of the supply chain and compliance to GDP. i.e. Responsible Person (RP)
The Benefits of Working With Acorn Regulatory On Your WDA
We understand that not every small to medium sized companies has the capacity to develop, implement and maintain a QMS. Our team can work with your organisation to put an effective and functioning QMS in place in addition to providing the mandatory services of a Responsible Person (RP). This outsourced option or ‘contract RP’ is a cost effective means of addressing the WDA requirement to have an RP overseeing GDP compliance and supply chain activities.
At Acorn Regulatory, we have the largest team of regulatory experts in Ireland. We are working daily with clients who want to be involved in the wholesaling of medicinal products. We support and guide our clients throughout the full life cycle of the application process including the initial application for an authorisation or to submit a variation to an existing authorisation. Applicants must develop and implement a QMS which complies with Good Distribution Practice (GDP) guidelines for medicines.
Acorn Regulatory has significant experience of developing effective Quality Management Systems which include all the mandatory processes of a QMS such as Change Control, Training, Risk Management, CAPA, Supplier Control and Bona Fides etc. Each SOP is bespoke and developed to address the needs of the organisation.
Acorn Regulatory also provides QMS hosting services. Not only can we develop a bespoke QMS for your organisation we can also host your QMS to ensure data integrity and security.
Advantages of outsourcing GDP Quality Management System and the RP/Deputy RP role to Acorn Regulatory:
- Eliminate HR or employee contractual obligations
- Immediate support
- Flexibility regarding the extent of support required
- Bespoke systems to suit your requirements
- align our resources and response around your specific objectives
- No compliance worries – you can have confidence that your quality system will be effectively maintained and successfully pass GDP Inspections by the HPRA
If you would like to find out more about how Acorn Regulatory can help you in obtaining a Wholesale Distribution Authorisation then get in touch with us today. You can call us on 00353 52 61 76 706, email us: firstname.lastname@example.org or complete your details below.