1. The EDE shall issue a decision to cancel the approval issued by it to advertise the Medical Product during its validity period (the advertisement through all means in which it was published, whether visual, written, audio, or on social media), in any of the following cases: a. If it is proven that obtaining approval from the EDE was a result of submitting forged documents or incorrect information. b. If it is proven that the advertising materials submitted to the EDE do not match the published advertisement. c. If, after publication of the announcement, any new clinical data or new data resulting from post-marketing surveillance activities not previously reported indicate an increase in the number of medical events or serious adverse reactions associated with the medicinal product, which proves that the advertised medicinal product is unsafe. d. The absence of any of the conditions for issuing approval to advertise the Medical Product mentioned in Clause (1) of Article (45) of this Decree-Law, after publishing the advertisement. e. Withdrawal or suspension of the Marketing Approval issued for the imported Medical Product to be advertised in the State of origin, or the State of origin revoking the authorization for international export. f. Any other cases determined by the Executive Regulation of this Decree-Law. 2. The Ownership of the approval to advertise the Medical Product issued by the EDE may not be transferred to another party, and a new application shall be submitted to obtain approval to advertise the Medical Product.
Interpretation and application must be checked against the official text and current version.