1. The approval or permit to import, export or re-export Medical Products, raw materials or pharmaceutical raw materials shall be issued by the EDE in accordance with the following conditions: a. The existence of any type of Marketing Approval or Emergency Use approval valid from the EDE for the Medical Product to be imported or exported. Products exempted from obtaining Marketing Approval in accordance with the provisions of Article (5) of this Decree-Law are exempt from this condition. b. The Applicant shall be a Biobank, Pharmaceutical Laboratory, Non-Clinical and Clinical Research entity, Bioequivalence center, Medical Warehouse, Medical Products factory or contracted Medical Products manufacturing company licensed to carry out the activity specified in accordance with the provisions of this Decree-Law, its Executive Regulations and the decisions issued in implementation thereof. c. Fulfilling the technical and operational conditions and any other conditions, controls or requirements and the validity periods of the approval or import, export or re-export permit in accordance with the type of application submitted, which are determined by the Executive Regulations of this Decree-Law. 2. The EDE shall confirm that the conditions and requirements referred to in Clause (1) of this Article, including shipping conditions, are met by inspecting the shipments. 3. The EDE may restrict or prohibit the import, export or re-export of some Medical Products if their use poses a risk to public health or if circumstances indicate that they may be intended for illegal purposes. A list of Medical Products, raw materials or pharmaceutical raw materials whose import, export or re-export is restricted or prohibited shall be issued by a decision of the BOD. 4. Without prejudice to the laws and provisions in force concerning controlled and semi-controlled substances, narcotic drugs and psychotropic substances, the BOD shall issue a decision to regulate the procedures related to shipments of Medical Products in temporary transit using the State ports or crossing the State territory and not actually passing through it.
Interpretation and application must be checked against the official text and current version.