Authority for Justice and Consumer Protection

Apply for permission to import medicinal products, active substances or investigational medicinal products

Prerequisites

• Their company is located in Hamburg.
• Your business has a qualified person in accordance with the Medicines Act.
• They have suitable premises and facilities for the planned import, including testing and storage of the medicinal products.
  Their import activities correspond to the current state of science and technology.
• The product you wish to import is a medicinal product, an active substance of human, animal or microbial origin, an active substance produced by genetic engineering, another substance of human origin intended for use in the manufacture of medicinal products or an investigational medicinal product for clinical trials.
• The medicinal product to be imported is approved in Germany or the EU, or it can be proven that an application for approval has been submitted.
• In the case of investigational medicinal products, the clinical study has been approved or the application for approval has been verifiably submitted.
• The manufacturing facility in the third country has a mutually recognized GMP (Good Manufacturing Practice) certificate. This certificate is not required for investigational medicinal products.

Documents required

• Please provide the following information in your application:
  • exact name of the applicant and information on the legal form
  • Name of the establishment (name, street, place)
  • Information on the activities planned for the import at the facility (note that a foreign inspection of the manufacturer in the third country may be required to issue a Section 72a certificate).
  • If applicable, information on other external warehouses
  • Name, telephone and fax number, e-mail address of a qualified person according to Section 15 of the Medicines Act or
  • a responsible person in the case of imports of medicinal products of human origin for direct use in humans
  • Tabular information on medicinal products intended for import
  • Where applicable, information on the companies commissioned to carry out tests outside the premises
  • Further information can be found on the website of the Department of Pharmacy and Medical Devices.
• Extract from the commercial register
• Proof of availability of the rooms, for example:
  • Copy of the rental agreement or
  • Land register extract
  • Floor plans of the operating buildings and rooms for testing and storage
  • For off-site warehouses: floor plans
• Proof of the required expertise of the competent person (certified copy)
• Curriculum vitae, declaration of commitment and statement on criminal proceedings of the expert person
• Statement on criminal proceedings against the management
• Certificate of good conduct of the management and the competent person (certificate type O)
• Current company description ("Site Master File"), quality assurance manual, list of procedural instructions
• Further information can be found on the website of the Department of Pharmacy and Medical Devices.

Please note

Deadlines

You need permission before you can import the relevant medicines. Apply for permission at least 12 weeks before the planned import, or at least 12 months in the case of foreign inspections.

Procedure

• To clarify details, you can contact the responsible authority before submitting your application.
• Submit an informal application for permission to import medicinal products, active substances of human, animal or microbial origin or produced by genetic engineering, or other substances of human origin intended for the manufacture of medicinal products or investigational medicinal products for clinical trials to the competent authority and submit it with all the necessary documents.
• The responsible authority will examine your application and your documents.
• If necessary, she will request further documents or information from you.
• Once all required documentation has been submitted, the responsible authority will carry out an acceptance inspection.
• The responsible authority will decide on your application.
• You will receive a notification.

Processing time

The processing time depends on the individual case. Once all the required documents are available, it is at least 12 weeks; for foreign inspections, it is at least 12 months.

Fees

Fees apply. These depend on the individual case and are based, among other things, on the time required to process the application, including the acceptance inspection.

Legal remedies

Contradiction

Legal basis

Law on the trade in medicinal products (Medicines Act - AMG) § 72 Import permit