Regulation 19F Fee for testing of samples by the appropriate authorityF1

Where a sample from a batch of a medicinal product is submitted to the appropriate authority in accordance with a batch testing condition imposed under regulation 60A of the Human Medicines Regulations, the fee payable by the holder of the marketing authorisation to which the medicinal product relates is the fee prescribed in Part 6B of Schedule 2 in connection with that submission.

The fee payable by an applicant for a certified copy of a certificate confirming that the appropriate authority is satisfied that the batch is in conformity with the approved specifications is £50.

In this regulation, and in Part 6B of Schedule 2, “appropriate authority” and “batch testing condition” have the same meaning as in regulation 60A of the Human Medicines Regulations.