Wholesale dealing

Question 1

Wholesale dealing definition

Answer 1

Selling, supplying, procuring, holding or exporting medicines to a person who intends to:
- Selling or supplying product
- Administering it or causing it to be administered to one or more human beings

Question 2

What is a wholesaler licence also known as?

Answer 2

Wholesale distribution authorisation (WDA)

Question 3

Wholesale dealing requirements

Answer 3

1. Hold a wholesaler licence
2. Comply with the Good Distribution Practice (GDP) standards, and pass regular GDP inspections
3. Have a suitable ‘Responsible Person’ named on the licence to ensure that medicines are procured, stored and distributed appropriately.

Question 4

Who can you wholesale deal to?

Answer 4

• Other wholesale dealers
• Doctors, dentists: any person lawfully conducting a retail pharmacy business, clinics or independent medical agencies
• doesn’t include non-medical prescribers

Question 5

WDA exemptions

Answer 5

• Pharmacies supplying stock to another pharmacy within the same legal entity
• Registered pharmacies and hospitals supplying small quantities of medicines to HCPs for treatment or onward supply to their pts, or to other community pharmacies or hospitals to meet a patient’s individual needs

Question 6

What is criteria for not needing WDA(H) when community and hospital pharmacies need small quantities of medicines from other pharmacies?

Answer 6

• on occasional basis
• quantity of supply is small
• not for profit
• supply is not onward wholesale distribution

Question 7

If supplies include CDs in Schedules 2 to 5 which license is also needed?

Answer 7

Home Office CD licence
You need to apply directly to home office, there is a fee and licenses are only issues for one year

Question 8

Pharmacy-Pharmacy transaction requirements

Answer 8

• price of med should be recorded, show reasonable price and that it was not for purpose of profit
• additional costs should be stated and explained.
• make sure that pharmacist is satisfied that the supply to another pharmacy is for the individual needs of the patient

Question 9

MHRA and no WDA

Answer 9

• for non holders of WDA, pharmacists need to have received an order/invoice for the supply and record of supply made
• Preferably in POM register and keeping order and invoice