The regulations came into force on the 14th of August 2012 and still some pharmacies are wholesaling without a WDA(H) and many are still not aware of the removal of some and the addition of other exemptions to supply. We have been told over the past few months of pharmacies and pharmacists who are unaware of some changes. Remember if you wholesale medicines in the UK you should comply with GDP and The current Human Regulations 2012 (S!2012/1916)
The regulations set out a comprehensive regime for the authorisation of medicinal products for human use , for the manufacture, import, distribution, sale and supply of these products, for their labelling, advertising and for pharmacovigilance.
They implement directive 2001/83/EC of the European Parliament and of the council of 6 November 2001. They also provide for the enforcement in the United Kingdom of Regulation (EC) No 726/2004 laying down community procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicine Agency.
They consolidate the UK medicines legislation and replace the Medicines Act of 1968 and over 200 statutory instruments
Policy Changes Introduced by The Legislation
- Removal of statutory warnings for over the counter products except for Paracetamol
- Existing medicines legislation allows health professionals and others to sell, supply and /or administer medicines by way of exemptions from the usual restrictions. Some have been removed, some introduced in order to reflect modern clinical practices.
- PGDs – updating the process by which independent hospitals, clinics, and agencies are able to use these.
- Facilitation of the pharmacist to use their professional judgement to alter a prescription product name, directions for use, precautions in use. This is to allow the changes to be made in a more timely way.
- Repeal of section 10(7) of The Medicines Act 1968 which allowed a pharmacist to wholesale deal medicines to a small extent
In addition the regulations also implement the 2010/84/EU which amends Directive 2010/84.EU which strengthened, clarified and more proportionate regime for pharmacovigilance in the EU market.
Jackie Peck