1. Without prejudice to the legislation in force in this regard and in cases that require ensuring the public health of individuals, the EDE is committed to educating health professionals, patients and members of society about safety information related to Medical Products, and the following information: a. Serious side effects, serious adverse events or serious adverse reactions, whether expected or not, for Medical Products and appropriate recommendations. b. Professional information on all active ingredients and excipients in the Medical Product provided that publication does not conflict with any confidential interests that deserve protection. c. Correct use of Medical Products for protecting health and combating their misuse. d. Important information about the Medical Products sector, including authorization and revocation decisions and post-marketing surveillance results. 2. The Ministry or the Competent Health Authority may educate and inform its health professionals of safety information related to Medical Products and the information referred to in Clause (1) of this Article, in accordance with good pharmacovigilance practices and any guidelines issued by the EDE related to the Medical Products in question. 3. The Ministry or the Competent Health Authority may educate and inform members of the community about the correct use of Medical Products for protecting health and combating their misuse, in accordance with good pharmacovigilance practices and any guidelines issued by the EDE and related to the Medical Products in question.
Interpretation and application must be checked against the official text and current version.