1. None of the following categories may refuse to provide a Medical Product that has obtained Marketing Approval in accordance with the provisions of this Decree-Law, in an illegal manner or with the intent to monopolize: a. Marketing Rights Holder b. The qualified person appointed by the Marketing Right Holder. c. The licensed Pharmaceutical Establishment designated by the Marketing Right Holder to import and market Medical Products. 2. The categories referred to in Clause (1) of this Article shall be obligated to provide a sufficient stock of the Medical Product in the State, in order to ensure the availability of the Medical Product for use within the State. 3. The categories referred to in Clause (1) of this Article shall inform the EDE, the Ministry and the Competent Health Authority of any potential or actual shortage in the stock of Medical Products, in accordance with the mechanism established by the EDE in coordination with the Ministry and the Competent Health Authorities.
Interpretation and application must be checked against the official text and current version.