1. The Marketing Right Holder shall appoint at least two Pharmaceutical Establishments licensed by the EDE to import Medical Products into the State as importers of the Medical Product for which he has obtained the Marketing Right, and shall appoint one or more Pharmaceutical Establishments licensed in the State to distribute the Medical Product for which he has obtained the Marketing Right, in accordance with the following controls: a. The Marketing Right Holder shall inform the EDE of the designation of one main Pharmaceutical Establishment from the Pharmaceutical Establishments designated by the Marketing Right Holder to undertake all product licensing work, pharmacovigilance activities and management of the entire life cycle of the Medical Product. b. One application shall be submitted by the Pharmaceutical Establishment specified in paragraph (A) of item (1) of this Article, to obtain Marketing Approval of all types for each Medical Product, regardless of the number of designated Pharmaceutical Establishments. c. All designated Pharmaceutical Establishments are required to carry out import operations of Medical Products during the calendar year. 2. The holder of the local Marketing Right for locally manufactured Medical Products shall appoint one or more Pharmaceutical Establishments licensed in the State to store and distribute the Medical Product for which he has obtained the Marketing Right, either by establishing Establishments dedicated to this purpose at the local factory licensed by the EDE or by appointing one or more Pharmaceutical Establishments to carry out these tasks. 3. Any other controls or conditions determined by the Executive Regulation of this Decree-Law. 4. The Cabinet may exempt the Marketing Right Holder from the Application of the provisions of this Article based on the proposal of the President, and in accordance with the controls that it determines.
Interpretation and application must be checked against the official text and current version.