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PART 6Electronic cigarettes

Vigilance requirements

39.—(1) A producer of electronic cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.

(2) Paragraphs (3) and (4) apply where a producer of electronic cigarettes or refill containers considers or has reason to believe that an electronic cigarette or refill container which is in its possession and is intended to be supplied, or which has been supplied, is not—

(a)safe;

(b)of good quality; or

(c)in conformity with this Part of the Regulations.

(3) The producer must (as appropriate)—

(a)immediately take the corrective action necessary to bring the product into conformity with this Part of the Regulations;

(b)withdraw the product;

(c)recall the product.

(4) The producer must immediately inform the Secretary of State and the competent authority of any other member State in which the product has been supplied or is intended to be supplied, giving details of, in particular—

(a)the risk to human health and safety;

(b)any corrective action taken; and

(c)the results of any corrective action taken.

(5) The Secretary of State or the competent authority of any other member State may request additional information from a producer of electronic cigarettes or refill containers, including information on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.

(6) A producer must comply with a request made of it under paragraph (5) by the date reasonably required by the Secretary of State.