EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.
The industry watchdog reminded drug exporters of the new rules this week , explaining that under the Falsified Medicines Directive (FMD) firms storing drugs for export for 36 hours or more need a wholesale distribution authorisation (WDA).
An agency spokesman told in-Pharmatechnologist.com “As a result of the implementation of the Falsified Medicines Directive, UK legislation was amended in August 2013 to require companies that wholesale supply medicines to non-EEA countries, to hold a WDA.
He added that: “Previously export outside the EEA was not covered by legislation.”
European Economic Area
- All EU countries are part of the EEA
- Iceland, Liechtenstein and Norway are also part of the EEA.
- Switzerland is not part of the EEA
The Medicines and Healthcare products Regulatory Agency (MHRA) said the changes mean a number of companies and drug storage sites that did not previously need authorisation must now obtain a WDA to comply with UK law.
Precisely how many is unclear according to the spokesman, who said: “We have no figures of how many companies that do not hold appropriate licences for exporting” adding that the agency continues to receive applications from exporters.
What is clear is what will happen to UK firms found to be exporting drugs outside the European Economic Area (EEA) without a WDA.
The spokesman said: “It is a criminal offence to wholesale medicines without the appropriate WDA. If the MHRA becomes aware of exporter companies not in possession of a licence, the company will be requested to immediately apply.”
According to the MHRA website the cost of applying for a WDA , which was known as a wholesale dealer’s license under previous UK legislation, is £3,739 ($6,219) which includes an inspection fee of £1936 per site.
The agency spokesman said the “MHRA has a statutory duty to process new applications within 90 days.”