Cap. 458 Art. 28Suspension or revocation of marketing authorisation.

(1) The Licensing Authority shall suspend, revoke, withdraw or vary the marketing authorization for a medicinal product, ensure that the supply of the medicinal product is prohibited and order its withdrawal from the market if:

(a) the medicinal product is harmful; or

(b) it lacks therapeutic efficacy, where such lack of therapeutic efficacy shall be deemed as occurring when it is concluded that therapeutic results cannot be obtained from the medicinal product; or

(c) the risk benefit balance is not favourable; or

(d) its qualitative and quantitative composition is not as declared; or

(e) the controls on the medicinal product and, or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out, or if the requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled:

Provided that the Licensing Authority may limit the prohibition to supply the medicinal product, or its withdrawal from the market, to those batches which are the subject of dispute.

(2) An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in this Act are found to be incorrect or have been amended without authorisation or when the requisite controls required by or under this Act have not been carried out. This provision also applies in cases where the manufacture of the medicinal product is not carried out in compliance with the particulars provided pursuant to the description of the manufacturing method submitted in the application for a marketing authorisation, or where controls employed by the manufacturer are not carried out in compliance with the control methods described in the application for a marketing authorisation.

(3) When the packaging, labelling or the package leaflet of the medicinal product in question do not comply with the requirements as specified by or under this Act, the Licensing Authority may suspend the marketing authorisation by notice served on the holder of the marketing authorisation concerned and the suspension shall continue to have effect until the Licensing Authority is satisfied that the requirements have been fulfilled.

(4) If the Licensing Authority suspends or revokes a marketing authorisation, it shall notify the holder of the marketing authorisation and the Medicines Authority of such decision stating in detail the reasons on which such a decision is based.

(5) The holder of the marketing authorisation may, within fourteen days of such notification, request the Medicines Review Board to examine the circumstances leading to the suspension or the revocation of the marketing authorisation, and the Medicines Review Board shall make its recommendations on the matter to the Licensing Authority: Provided that the request shall not suspend the effects of the decision of the Licensing Authority and that the Licensing Authority shall not be bound by the recommendations made by the Medical Review Board.

(6) The Licensing Authority shall suspend or revoke the marketing authorization for a category of preparations or all preparations where the provisions of Title II are not complied with.

(7) The provisions of this article and of articles 99 to 104, shall apply to homeopathic medicinal products.