Manufacturing of medicines may only be performed by legal persons having a manufacturing authorization issued by the Institute in accordance with the Law on medicines.

Manufacturing of medicines containing drugs may only be performed by legal persons having a manufacturing authorization issued by the Institute in accordance with the Law about preventing drugs abuse.

Legal person that manufactures medicines derived from blood, radiopharmaceuticals and biotechnological medicines shall meet special conditions regarding premises, equipment and personnel. Manufacturer of medicines performing the manufacturing is responsible for the quality, safety and efficacy of the medicine it manufactures.

Manufacturing authorizations for medicines, except for medicines containing drugs and psychotropic substances shall be issued for an indefinite period.

Manufacturing authorizations for medicines containing drugs and psychotropic substances shall be issued for a period of 5 years.

Manufacturing authorization shall be issued for a specific manufacturing site, pharmaceutical form and a specific finished medicine and may relate to the whole process, or parts of the process of a medicine manufacturing.

Legal persons that manufacture medicines shall act in accordance with the manufacturing authorization issued by the Institute, Good manufacturing practice and Good distribution practice.

Institute shall issue a certificate on the application of Good Manufacturing Practice guidelines on the basis of the verification of the fulfillment of conditions, for a period of up to 3 years from the control of fulfillment of conditions and at the request of the Institute.

Manufacture of active substances used as starting materials shall include both total and partial manufacture, import and processes of dividing up, packaging, or presentation prior to its incorporation into a medicinal product. Manufacture of active substances shall be carried out in accordance with Good Manufacturing Practice for active substances.

Legal persons seated in Montenegro performing the activities of manufacture, import and distribution of active substances shall enroll in the Register of manufacturers, importers, or wholesalers of active substances.