Amendment of regulation 12B of the principal Regulations

2.  In regulation 12B of the principal Regulations (requirement to report serious adverse reactions and events), in paragraph (4), for sub-paragraph (c) substitute the following sub-paragraph—

“(c) submits a complete report to the Secretary of State on serious adverse events in any calendar year by no later than 1st April in the following calendar year, using the format set out in Section C of Part 8 of the Schedule.”.