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The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

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Obligations of holders of marketing authorizations, and offences by holders of marketing authorizations and other persons

7.—(1) Every holder of a United Kingdom marketing authorization for a relevant medicinal product shall comply with all obligations which relate to him by virtue of the relevant Community provisions (apart from Regulation (EEC) No. 2309/93) including, in particular, obligations relating to providing or updating information, to making changes, to applying to vary the authorization, to pharmacovigilance, and to labels and package leaflets.

(2) The holder of a marketing authorization shall maintain a record of reports of which he is aware of suspected adverse reactions in accordance with the relevant Community provisions which shall be open to inspection by a person authorised by the licensing authority, who may take copies of the record and, if the licensing authority so directs, the authorization holder shall furnish the licensing authority with a copy of any such reports of which he has a record or of which he is or subsequently becomes aware.

(3) The holder of a marketing authorization shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any relevant medical product to which the authorization relates.

(4) Schedule 3 shall have effect to create certain criminal offences in connection with the obligations of applicants for, and holders of, marketing authorizations and other persons arising under the relevant Community provisions.

(5) Where, by or under any provision of the relevant Community provisions 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.

(6) The holder of a marketing authorization granted or renewed after the coming into force of these Regulations must be established in the Community.

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