12.—(1) Subject to paragraph (2) below, this regulation shall apply to any establishment which is not already registered or approved in accordance with any Community legislation referred to in paragraphs 1 to 11 or 13 to 15 of Schedule 3, under Directive 90/667 or under Regulation 1274/91 and in respect of which there is no licence issued under section 8 of the Medicines Act 1968 and which—
(a)supplies for export or consignment for export to another member State; or
(b)acts as an intermediate storage facility for,
any product of animal origin covered by Directive 92/118.
(2) This regulation shall not apply if the establishment is registered under regulation 11 in respect of the same products of animal origin.
(3) Any person with control of an establishment to which this regulation applies shall notify the Minister of the name and address of the establishment and details of the product concerned.
(4) If required to do so by a notice served on him by the Minister, an occupier of an establishment to which this regulation applies shall notify the Minister of the name and address of the establishment and shall give to him such undertakings as to compliance with these Regulations as shall be specified in the notice.
(5) The Minister shall keep a register of any notifications received by virtue of paragraph (3) or (4) above.
(6) Any person who has notified the Minister in accordance with paragraph (3) or (4) above shall keep a record of all deliveries of products of animal origin and, where a consignment is divided up or subsequently marketed, of the subsequent destination of the product of animal origin, and shall keep such records for 12 months from the arrival of the consignment.