The National Pharmacy Association (NPA) is encouraging members to make sure their current practice is permissible within the Human Medicines Regulations 2012, which are expected come into force on 14th August 2012.
The regulations include a repeal of section 10 (7) of the Medicines Act which previously allowed pharmacies to wholesale medicines in some circumstances without a wholesale dealer’s licence (WDL).
Gareth Jones, Public Affairs Manager at the NPA said:
“Pharmacists need to make sure that when these changes come into play, they are operating within the new regulations. The repeal of section 10 (7) means that pharmacies trading commercially will need a wholesaler dealer license – trading without this will risk criminal prosecution. Small scale supplies from one pharmacy to another to meet individual patient needs will still be permitted, as will supplies to other healthcare providers.”
The NPA Pharmacy Services department has produced guidance on how to deal with the repeal of section 10 (7). The resource can be downloaded by visiting www.npa.co.uk. The department will be working in the coming weeks to assess the impact of the new regulations and will produce additional resources as necessary.
The law also includes some new policy changes including:
- Removing statutory warnings for over-the-counter products other than paracetamol
- Updating the process by which independent hospitals, clinics and agencies are able to continue using patient group directions
- Remove the requirement for a pharmacist to contact the prescriber before making changes to a prescription relating to the name of the product or its common name, directions for use of the product, or precautions relating to the product.
The MHRA’s guidance can be found by visiting: www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON152604 -