All manufacturers involved in the manufacturing process of biotechnological substances have to submit a manufacturing authorisation. Manufacturers who produce substances of chemical origin do not have to submit such a marketing authorisation.

For each manufacturer of the investigational medicinal product (formulation) a copy of the manufacturing authorisation has to be submitted. Please note that the appendices of the manufacturing authorisation which contain information on manufacturing site and permitted manufacturing activities must be submitted as well. It is not necessary to present plant layouts and cadastral map excerpts.

If the manufacturing authorisations are not in German or English, a translation into one of these languages has to be submitted.

It is not necessary to submit accredited copies.

For manufacturing sites located in a third country the qualified person of the importer has to issue a GMP certificate. In this GMP certificate the qualified person of the importer certifies that each production batch has been manufactured and tested in the stated manufacturing sites in compliance with standards of good manufacturing practice which are at least equivalent to Commission Directive 2003/94/EC.

Please note that the name and the function of the qualified person have to be stated in addition to the name and address of the company.

If an investigational medicinal product is manufactured outside the EU or EEA an importer is necessary. If investigational medicinal products are transported within the EU or the EEA no importer has to be stated. The importer has to have a registered office in the EU. He is the first to receive the investigational medicinal product in the EU and who subsequently forwards them. An importer has to have an authorisation. In some Member States this authorisation is granted together with a manufacturing authorisation. In Germany a separate import authorisation is granted by the respective competent authority of the Land.

In order to simplify assessment by the BfArM, we ask you to list the manufacturers in the IMPD as follows:

First, the name of the manufacturer including the complete address should be given. Then, all manufacturing activities carried out by this manufacturer are to be listed.

The listing of manufacturers involved in the manufacture of the drug substance is done in chapter S2.1, the listing of manufacturers involved in the manufacture of the drug product is provided in chapter P3.1 of the IMPD.

The listing can also take the form of a tabular overview according to the following example for the drug substance and the drug product. Each manufacturer including the complete address should be entered in one cell of the table.

S2.1

P3.1