S.L. 458.35 Art. 14Public announcements.

(1) A marketing authorisation holder shall inform the

Authority, the Agency and the Commission if it intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product. The marketing authorisation holder shall inform the authorities at the same time or before the public announcement is made. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading.

(2) Unless urgent public announcements are required for the protection of public health, the Authority, the Agency and the Commission shall inform each other not less than twenty-four hours prior to the making of a public announcement relating to information on pharmacovigilance concerns.

(3) For active substances contained in medicinal products authorised in more than one Member State, the Agency shall be responsible for the coordination between national competent authorities of safety announcements and shall provide timetables for the information being made public. Under the coordination of the Agency, the Authority shall make all reasonable efforts to agree on a common message in relation to the safety of the medicinal product concerned and the timetables for their distribution.

(4) When the Agency or the Authority make public information referred to in sub-regulations (2) and (3), any information of a personal or commercially confidential nature shall be deleted unless its public disclosure is necessary for the protection of public health.