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Batch release applications (PEI-C Rebuild)

Holder of marketing authorizations for medicinal products are able to submit batch release applications pursuant to section 32 of the German Medicinal Products Act (Arzneimittelgesetz) electronically by using this portal.

The application may include all related documentation. It’s not necessary to submit any documentation via mail in parallel.

A batch release is a certification of a medicinal product or a drug by an authorized person. The batch release must be done before the products are introduced into free trade.

Please notice

The draft problem has been solved. From now on, you can once again create and save templates as normal. For reference batches of the application type "extensions to quantities", isolated problems may occur. For parallel suppliers, the changed procedure continues to be applicable with the reference batch being indicated. The instructions for this were sent to the orgaAdmins in late February.

 

Available for you are the following types of applications:

  • Regular application
  • Parallel testing
  • Packaging and filling batches
  • Parallel import
  • Certificate for plasma pool
  • Testreport for plasma pools
  • Acceptance of an OMCL-Certificate
  • Extensions with regard to quantities
  • Additional releases
  • Certificate of origin of plasma

Entering and submitting an application is subject to the four-eyes principle.

For the sample containers to be sent to the Paul Ehrlich Institute (PEI) there is the possibility to print a delivery slip. With this delivery slip it will be easily possible to assign the sample containers correctly to the unit responsible for testing within PEI.

Access and user authorisation

There is a role-based, central authentication and registration for the access to applications. The roles differentiate between the administrator in the higher federal authorities and the main user(representative) in a company or an authority. Other users are created and administrated by the representative.

In addition to customer data a X.509-certificate is needed for a first registration. This ensures sufficient safety for authentication and authorization.

More information about the certificate, request access authorization and user administration can be found in the user manuals below.

Last modified: 9/3/18

Your position:  Homepage » For Companies » Batch Release