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Permission for wholesale trade in medicinal products Issuance

  • Unternehmensstart und Gewerbezulassung 



    		

			

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If you wish to operate a wholesale business in human pharmaceuticals, you must obtain permission from the competent authority before commencing operations.

		    


                					    

						    

							    Competent Department
						    

						    
					    

                        
					    

						    

							    Basic information
						    

						    

							    

								    
If you wish to operate a wholesale business with medicinal products for human use, you need the permission of the competent authority before starting the activity. 

The term "medicinal products" includes not only preparations that are available in pharmacies or administered by doctors, such as tablets, capsules, ointments, creams, cough syrups, drops, vaccines and infusion solutions, but also products that are not recognized as medicinal products at first glance. 

The German Medicines Act also applies, for example, to medical gases, biotechnologically and genetically engineered active ingredients, blood and blood products, radioactive medicines, tissue and tissue preparations such as bones, vessels and corneas. 

You can only be granted a wholesale permit if you meet certain personnel and material requirements. In addition, you must notify a responsible person and attach the documents specified in § 52a AMG to the application. 

Permission is generally granted on a site-by-site basis. In the case of several production sites that are located in the area of responsibility of different supervisory authorities, a separate approval procedure must be carried out for each production site by the respective authority responsible for the production site. 

If you have applied for a corresponding permit, your company or facility will be inspected by the competent authority at regular intervals and on special occasions, for example in the event of a change to the permit or concerns about drug safety. 

The inspection of your company or facility is subject to a fee according to § 64 AMG.

								    

									    Requirements
The requirements result from § 52a AMG. With the application, the applicant must: 


  • specify the particular premises as well as the activities and the medicinal products for which the authorization is to be granted,
  • submit evidence that it has suitable and sufficient premises, equipment and facilities to ensure proper storage and distribution and, where provided, proper decanting, packaging and labeling of medicinal products,
  • designate a responsible person who possesses the expertise required to perform the activity
  • and
  • include a statement in which he or she undertakes in writing to comply with the regulations applicable to the proper operation of a wholesale business.
								    
What documents do I need?
    
    
  • Floor plans of the rooms        
    Submission of floor plans of the rooms in which medicines are stored and distributed. As a rule, the floor plans should be presented on a scale of 1:100 and should include the name of the operating rooms as well as their m². Furthermore, essential furnishings as well as the individual storage areas (quarantine storage, locked storage) should be drawn in.

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