1. The licensed Pharmaceutical Laboratory shall comply with the standards of good laboratory practice approved by the EDE. 2. The person responsible for the Pharmaceutical Laboratory shall approve the certificates of the results of laboratory tests conducted in his Establishment and issue them after they meet the quality standards approved by the EDE. He shall maintain records of data related to the tests in accordance with the systems and procedures specified by the EDE. 3. If the Pharmaceutical Laboratory wishes to import Medical Products, it shall obtain approval from the EDE in accordance with the provisions of Article (32) of this Decree-Law, provided that the purpose of the import is for the laboratory to perform its licensed activity and not for the purposes of trade and circulation.
Interpretation and application must be checked against the official text and current version.