Wholesaling

Question 1

What is required if anyone is trading medicines other than to a patient?

Answer 1

1. Hold a wholesaler license
   - also known as a wholesale distribution
   authorisation (WDA)
2. Comply with good distribution practice (GDP) standards and pass regular GDP inspections
3. Have a suitable experienced responsible person named on the license to ensure that medicines are produced, stored and distributed appropriately

Question 2

What is the WDA specific to?

Answer 2

1. Human medicines WDA(H)
2. Veterinary medicines WDA(V)

Question 3

Who can be supplied with medical products via wholesale?

Answer 3

1. Doctors
2. Dentists
3. Registered pharmacies
4. Hospitals, clinics and independent medical agencies
5. Midwives
6. Podiatrists
7. Optometrists
8. Paramedics
9. Owner or master of ship
10. Orthopists
11. First aid organisations
12. First aid organisations
13. Certified first aiders
14. Working for national lifeboat institution
15. Occupational health schemes
16. Drug treatment services
17. NHS trusts

Question 4

What needs to be done when a POM is supplied from a registered pharmacy to HCPs or organisations?

Answer 4

1. Entry in the POM register - good practice to do this regardless
   Or
2. Signed order/ invoice needs to be retained for 2 years from the date of supply

Question 5

What must the entry into the POM register include?

Answer 5

1. Date POM supplied
2. Name, quantity, strength and formulation of POM
3. Name and address, trade, business or profession of the person to whom the medicine was supplied
4. Purpose for which it was sold or supplied

Question 6

What details are required by legislation on a signed order?

Answer 6

There is no legislation around this - recommend details req in POM register as a minimum - SOPS

Question 7

What are the WDA exemptions?

Answer 7

1. Pharmacies supplying stock to another pharmacy in the same legal entity don’t need a WDA
2. However if a legal entity doesn’t have a WDA - pharmacy supplying the medicines for the purposes of wholesaling must be named on the WDA
3. Registered pharmacies and hospitals supplying small quantities of meds to HCP for treatment or onward supply to their patients or other CPs/hospital don’t need a WDA if:
   - transaction takes place on occasional
   basis
   - small quantity supplied
   - supply is made on not for profit basis
   - supply is not for onward wholesale
   distribution

Question 8

If a WDA(H) is required for supply of CDs in schedules 2-5 what else is needed?

Answer 8

Corresponding HO CD license