Authority for Justice and Consumer Protection

Permission to import tissue

Prerequisites

• You are a commercial tissue establishment and have a licence to process, preserve, test, store or place tissue or tissue preparations on the market.
• They have the appropriate knowledgeable and reliable staff.
• You have a contract with a third-country institution.
• They have a quality management system for handling imports (SOP's).
• The imported preparations are provided with origin and outer packaging labels.

Documents required

• Permission according to § 20c AMG of the tissue establishment
• Job description of the responsible person and information sheet “Appointment/appointment of a representative or change of the responsible person in accordance with Section 20c Paragraph 2 No. 1 AMG or Section 72b AMG”
• Information on the relevant qualifications and training of the responsible person
• Police clearance certificate of type O
• Copy of the original label, the outer packaging label and the documentation for the outer packaging and the transport container
• List of relevant, current standard operating procedures (SOPs) for the facility’s import activities
• SOP for the application of the Single European Code, the reception and storage of imported tissues and cells in the importing tissue establishment
• Management of serious incidents and serious adverse reactions
• Management of recalls and traceability from donor to recipient

Please note

Please note "Instructions for Pharmacy (Tissue)".

Deadlines

The application should be submitted at least six weeks before the planned import of tissue or tissue preparations.

Procedure

• You submit your written application for an import permit and all necessary documents to the competent authority.
• The responsible authority will examine your application and your documents and, if necessary, request further documents from you.
• The responsible authority will decide on your application.
• You will receive notification of the decision.

Processing time

Processing takes 4 to 6 weeks.

Fees

Fees apply. The amount of the fees depends on the time required for processing. They are calculated based on the state fee schedule.

Legal remedies

Contradiction

Legal basis

§ 72b Medicines Act (AMG)