Quality Assurances and Regulatory Compliance

We appreciate that because our Customer base is outside of the EU the requirement to establish “Bona Fides” could on some occasions be considered unnecessary. However, Masters is unable to supply any product unless its QA department has approved the documentation provided by the Customer. The type of documentation required may include a wholesale licence, pharmacy licence, Pharmacist license or GP registration, in addition to the import licence.  

Documentation across different countries varies considerably but in most cases is always available. The process for obtaining the necessary documents can be time consuming, and sometimes frustrating for the Customer, but Masters are not able to supply any product without evidence of the Customer's entitlement to handle medicines.

 

Licenses held:

  • MHRA Wholesale Dealers Licence WDA(H) 8394
  • MHRA Wholesale Dealers Licence WDA(V) 8394
  • UK Home Office Controlled Drug Licence
  • US State of Florida Drug wholesaler distributor licence
  • US DEA Controlled Drugs Distributor Licence
  • US DEA Controlled Drugs Export Licence

Masters is regulated by the following bodies:

  • MHRA Medicines and Healthcare Products Regulatory Agency (UK)
  • Home Office (UK)
  • US State of Florida (US)
  • New York State Board of Pharmacy (US)
  • ANVISA (Brazil)
  • DNM National Medicines (El Salvador)

We are compliant with the requirements of:

  • Good Distribution Practice (GDP)
  • FDA Food and Drug Administration - (USA)
  • Florida Drug Pedigree Law

 

 

Find out more