S.L. 427.55 Art. 5Exchanges of information and rapid intervention situations.

(1) Where the Director takes measures which restrict the placing on the market of products, or which require their withdrawal or recall, including those provided for in Part III of the

Act, he shall, subject to the provisions of regulation 6 or any specific Community legislation, inform the Director of Market Surveillance of any such measures and of any modification or lifting thereof.

(2) If the Director considers that the effects of the risk do not or cannot go beyond the Maltese territory, he shall inform the Director of Market Surveillance who shall notify such measures to the Commission as long as such information would be relevant with regards to product safety, and in particular, if such measures would have been occasioned by the necessity to respond to a new risk which has not yet been reported in other notifications.

(3) Where the Director adopts or decides to adopt, recommends or agrees with producers and distributors, whether on a compulsory or voluntary basis, measures or actions to prevent, restrict or impose specific conditions on the possible marketing or use, within the Maltese territory, of products by reason of a serious risk, he shall immediately notify the Director of Market Surveillance of such measures or actions and of any modification or lifting thereof.

(4) If the Director considers that the effects of the risk do not, or cannot go beyond, its territory, he shall follow the procedure laid down in subregulations (1) and (2), taking into account the relevant criteria established in regulation 6(7).

(5) In the case of a serious risk, the Director shall notify the Director of Market Surveillance of the voluntary measures laid down in Article 5 of the Directive and in article 6(2) of the Act, as taken by producers and distributors.

(6) Without prejudice to subregulation (1) and (3), before deciding to adopt any measures or take any action, the Director shall pass on any information in his possession regarding the existence of a possible serious risk to the MSA Directorates and to the Director of Market Surveillance.

(7) When the Director, after analysing all technical details including any possible technical advice given by the MSA Directorates and after consultation with the Director of Market Surveillance, decides that there is a serious risk, he shall communicate such decision to the MSA Directorates and to the Director of Market Surveillance who in turn shall communicate such notification to the Commission through the RAPEX system.