Case Summary
Daiichi-Sankyo UK voluntary admitted that due to an administrative error, three of its medical staff had acted as nominated signatories before their names and qualifcations had been notifed to the Medicines and Healthcare products Regulatory Agency (MHRA) and the PMCPA.
As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Daiichi-Sankyo.
The detailed submission by Daiichi-Sankyo is given below.
The Panel noted Daiichi-Sankyo's submission that it had failed to notify the MHRA and PMCPA of three medical nominated signatories which resulted in nearly 300 items being certifed prior to notifcation of their details to the MHRA and PMCPA as required by the Code. Consequently, the materials had not been certifed in accordance with the Code. The Panel ruled breaches of the Code.