Regulation 8 Insertion of regulation 7A of the Homoeopathic Regulations

After regulation 7 of the Homoeopathic Regulations insert the following regulation—

“Obligations of holders of certificates of registration, and offences by holders of certificates of registration and other persons

7A.

(1)

Every holder of a certificate of registration shall comply with all obligations which relate to him by virtue of the 2001 Directive.

(2)

The holder of a certificate of registration shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any homoeopathic medicinal product to which the certificate relates.

(3)

Schedule 6 shall have effect to create certain criminal offences in connection with the obligations of applicants for, and holders of, certificates of registration and other persons arising under the 2001 Directive.

(4)

Where, by or under any provision of the 2001 Directive or of these Regulations, a person is required to provide any information or furnish any document to the licensing authority and no time is specified in that provision within which that obligation is to be performed, it shall be performed within such time as may be specified in a written notice served on that person by the licensing authority.”.