Wholesale Dealers Licence
A Wholesale Dealers Licence is a legal requirement for anyone wishing to distribute medicines to anyone other than the patient using the medicine.
Prior to 2012, Pharmacies were permitted to trade in small quantities (set at 5% of turnover by value) under Section 10(7) Medicines Act 1968. This exemption was removed by the MHRA as move towards implementing EU Good Distribution Practice guidance.
Wholesale Dealers Licence applications are now only accepted via the MHRA Online Licensing Portal.
Wholesale Dealers Licence Application
Submitting a Wholesale Dealers Licence application is just one part of the process, as the prospective wholesaler will also need to ensure compliance with Good Distribution Practice guidelines.
Once the online application has been successfully made, the MHRA will arrange to inspect all sites (including the administration site) named on the licence within a 90 day period.
The cost of the initial application fee includes the inspection fee and you can expect a follow on inspection 9 to 15 months after your licence has been granted.
Are you ready?
The inspection focuses on aspects of GDP compliance and covers all areas relevant to the categories of products being distributed.
It is important to bear in mind that inspectors are highly intuitive.
The phrase ‘first impressions count’ comes to mind and it is important that the inspection starts off on the right foot.
Some of the things an inspector will look into will include:
- Are the premises structurally suitable, secure and laid out with a logical workflow?
- Is there a Quality Management System in place?
- Are the Standard Operating Procedures (SOP) relevant to the type of products being distributed?
- What is the level of compliance with Good Distribution Practice guidelines?
- Is there any evidence temperature mapping exercises were conducted?
- Is there adequate temperature monitoring in place?
- Is there evidence of staff training and are they competent?
- Does the RP have the experience necessary and is their CPD up to date?
- Is the company only distributing products under the categories listed on their licence?
There are a several hundred other questions which sping to mind.
How Pharma Experts can help
Pharma Experts offers a complete suite of services to help clients meet the regulatory standards and compliance to the latest GDP guidelines.
Our overarching aim is to provide a truly customised solution for each client which may include a combination or all of the following services:
- Initial WDA licence application required for wholesaling medicines.
- Quality Risk Assessment.
- Developing a Quality System (QS) including Standard Operating Procedures (SOPs).
- Temperature Mapping.
- Contract Responsible Person.
- GDP and RP mandatory training (including Driver Training).
- Pre-inspection Audits.
- External Audits.
The above list is not exhaustive.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.