Article 8. Licensing of Manufacturing of Medicines and Pharmaceutical Activities

1. Manufacturing of medicines and pharmaceutical activities shall be licensed in compliance with the legislation of the Russian Federation.

2. A license for manufacturing of medicines shall be granted if a list of the dosage forms and (or) types of pharmaceutical substances which the manufacturer of medicines intends to manufacture is provided and necessarily attached to the application of the applicant.

3. If the manufacturing of medicines needs to be expanded by introducing new dosage forms and types of pharmaceutical substances, the manufacturer of medicines shall obtain a new license for manufacturing of medicines.