10.—(1) This regulation shall apply to any establishment which, for the purpose of export or consignment for export to a Member State—
(a)produces or processes any product of animal origin which is covered by Directive 92/118 and which is not already registered or approved under or pursuant to any Community legislation referred to in paragraphs 1 to 11 or 13 to 15 of Schedule 3; under the Animal By-Products Regulations (Northern Ireland) 1993(1) or under Regulation 1274/91 and in respect of which there is not a licence issued under Section 8 of the Medicines Act 1968(2); or
(b)stores any product of animal origin for which Directive 92/118 lays down specific storage requirements.
(2) Any person who has control of an establishment to which this regulation applies shall register that establishment with the Department.
(3) A person who has control of an establishment to which this regulation applies shall give the Department such assurance as to compliance with these Regulations as the Department may require.
(4) The Department shall keep a register of establishments for the purposes of paragraph (2).
(5) The Department may remove an establishment from the register kept under paragraph (4) if it is satisfied that the establishment in question has ceased to comply with the requirements of regulations 9, 10 and 11.