Medical Product Factories and Contracting Companies Manufacture Medical Products may not: 1. Practicing any activity not licensed. 2. Remanufacturing a Medical Product that has a valid Marketing Approval with new technical specifications, except after the Marketing Right Holder obtains a new Marketing Approval to manufacture the product with these specifications from the EDE in accordance with the provisions of Article (15) of this Decree-Law. 3. Manufacture or Circulation in counterfeit or unusable products. 4. Dealing with other unlicensed Pharmaceutical Establishments. 5. The installation of Medical Products shall not commence until after obtaining the certificate referred to in Paragraph (a) of Clause (2) of Article (126) of this Decree-Law. 6. Any other prohibitions specified by the Executive Regulations of this Decree-Law. The Owner of the Medical Product Factories and Contracting Companies Manufacture Medical Products shall be liable for violating the provisions of this Article.
Interpretation and application must be checked against the official text and current version.