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Production of medicinal products without permission

  • Forschung und Entwicklung
  • Anlagen, Waren und Stoffe 



    	    

		    
In certain cases, physicians, dentists and non-medical practitioners may manufacture medicinal products without a license, i.e. without having a manufacturing authorization. There are certain regulations for this, and the competent authority must be notified before the activity is commenced.

		    


                					    

						    

							    Competent Department
						    

						    
					    

                        
					    

						    

							    Basic information
						    

						    

							    

								    
Anyone who intends to manufacture medicinal products generally requires a manufacturing license in accordance with Section 13 (1) of the German Medicines Act (AMG). For physicians, dentists and non-medical practitioners, the law describes an exception under certain conditions under § 13 para. 2b or § 20d. 

Anyone wishing to make use of this exemption must notify the competent authority in accordance with Section 67 (1) and (2) AMG.

								    

									    Requirements
You have a license as a (dental) physician or a license as a non-medical practitioner and the production of the medicinal product takes place 


  • under your direct professional responsibility and
  • for the purpose of personal use by you on a specific patient.

The notification to the competent authority must be made before the start of the activity.