In the United Kingdom (UK), any company or individual intending to start a pharmaceutical wholesale business (defined as selling, supplying or procuring to anyone other than the end-user) within the European Union (EU), must hold a Wholesale Dealer's Licence (WDL).
To obtain the licence for wholesale and distribution of pharmaceutical products, it is necessary to submit a detailed application which includes the following information:
(a) the different classes of product to which the licence will relate, i.e. whether the products are Prescription Only Medicines (POM), Pharmacy medicines (P), General Sales List medicines (GSL) and herbal remedies, or other particular classes of product, such as Medical Devices;
(b) address of each site from which wholesale distribution (i.e. procurement, storage, sale, supply or export of medicinal products) takes place together with an indication of the general range of medicinal products to be stored at each;
(c) a description of the facilities and equipment available at each site for storing the medicinal products and distributing products from or between the sites;
(d) a description of the arrangements at each site for ensuring a satisfactory stock turnover;
(e) the name, address, and qualifications of the Responsible Person;
(f) details of an emergency plan for the recall of defective products and a description of arrangements for keeping records of all products received or dispatched;
Following the submission of the application, the Licensing Authority, whichMedicines and Healthcare products Regulatory Agency (MHRA), will conduct an inspection.
If the Licensing Authority deems any applicant to be unsuitable to hold a Wholesale Dealer's Licence, then it will notify the applicant with the reasons and proposals. The applicant has at least 28 days to respond.
The applicant may either give notice to the MHRA of his desire to be heard or make written representations to the Licensing Authority with respect to its proposals. Upon successful hearing and/or written representation, the Wholesale Dealer's Licence would be granted.
Here's the most easy to follow, step-by-step guide which explains exactly how to obtain your Wholesale Dealer's licence and starting your pharmaceutical wholesale business successfully!
To obtain the licence for wholesale and distribution of pharmaceutical products, it is necessary to submit a detailed application which includes the following information:
(a) the different classes of product to which the licence will relate, i.e. whether the products are Prescription Only Medicines (POM), Pharmacy medicines (P), General Sales List medicines (GSL) and herbal remedies, or other particular classes of product, such as Medical Devices;
(b) address of each site from which wholesale distribution (i.e. procurement, storage, sale, supply or export of medicinal products) takes place together with an indication of the general range of medicinal products to be stored at each;
(c) a description of the facilities and equipment available at each site for storing the medicinal products and distributing products from or between the sites;
(d) a description of the arrangements at each site for ensuring a satisfactory stock turnover;
(e) the name, address, and qualifications of the Responsible Person;
(f) details of an emergency plan for the recall of defective products and a description of arrangements for keeping records of all products received or dispatched;
Following the submission of the application, the Licensing Authority, whichMedicines and Healthcare products Regulatory Agency (MHRA), will conduct an inspection.
A licence is granted when MHRA is satisfied that the Licence Holder will be able to comply
with all it's Good Distribution Practice (GDP) obligations.
If the Licensing Authority deems any applicant to be unsuitable to hold a Wholesale Dealer's Licence, then it will notify the applicant with the reasons and proposals. The applicant has at least 28 days to respond.
The applicant may either give notice to the MHRA of his desire to be heard or make written representations to the Licensing Authority with respect to its proposals. Upon successful hearing and/or written representation, the Wholesale Dealer's Licence would be granted.
Here's the most easy to follow, step-by-step guide which explains exactly how to obtain your Wholesale Dealer's licence and starting your pharmaceutical wholesale business successfully!
- Discover how to prepare for a successful MHRA Inspection
- Reveals the essential procedures that should be in place to ensure total compliance with GDP
- Find out the exact role of The Responsible Person
- What the the Recall categories?
- Click here to discover how to start a successful wholesale pharmaceutical business.
