Application for Authorisation of Tissue Preparations in Accordance with Section 21a (1) AMG
For each product with its individual product name, a separate application must be made. The name of the requested tissue preparation (product name) must be clearly stated in the attached letter and in the documents submitted.
The Paul-Ehrlich-Institut (PEI) also recommends the use of the shortened modules (G-CTD modules 1-5) of the Common Technical Document (CTD) for applications for the approval of tissue preparations in accordance with Section 21 AMG.
Note for requests for Certification of Tissue Preparations according to Section 21 AMG: Due to legal regulations in the AMZulRegAV (Verordnung zur Festlegung von Anforderungen an den Antrag auf Zulassungen, Verlängerungen der Zulassung und Registrierung von Arzneimitteln) (Statutory Regulation governing the Requirements for Applications for Marketing Authorisations, Renewals for Marketing Authorisations, and Regustrations of Medicinal Products), module 1 of the CTD for authorisation applications must also be submitted which is used internationally.
The application format for tissue preparations (G-CTD modules) corresponds to a shortened version of the Common Technical Document (CTD) taking into account German pharmaceutical legislation. The documentation must be prepared in the five G-CTD modules.
Table of contents, application form with annexes, wording for the leaflet and technical information and for the labelling of the container, information on the experts, information for the bibliographic submission
Quality-related global summary consisting of a summary of quality data, non-clinical overview, clinical overview, summary of non-clinical data in tabular form, summary of clinical data in tabular form
Data on development, manufacturing process, quality control, shelf life, composition, dosage form
Presentation of relevant non-clinical data on pharmacology, pharmacokinetics, toxicology, and local tolerance
Presentation of relevant clinical data, results of biopharmaceutical studies, pharmacokinetic and pharmacodynamic analysis reports, post-marketing experience.
The filled out application forms (G-CTD-Module 1 – 5) should be provided electronically as a Word as well as a pdf document. It shall be noted in the cover letter that the Word and the pdf document are identical. An additional hard copy (paper version) is not necessary.
All pages of the application should be provided with a header containing the name of the applied medicinal product and consecutive page numbering.
Email: eSubmission@pei.de
Email: HZG5_Blut_Zellen_Gewebe@pei.de
Updated: 07.03.2025
By way of derogation from Section 21a (1) AMG (German Medicines Act), tissue preparations which may be marketed in a Member State of the European Union or in another Contracting State to the Agreement on the European Economic Area shall, upon their first entry into the area to which this Act applies, require a certificate from the competent federal authority. Before issuing the certificate, the competent senior federal authority shall examine whether the processing of the tissue preparations complies with the requirements for the collection and processing procedures, including the donor selection and laboratory tests, as well as the quantitative and qualitative criteria for the tissue preparations comply with its regulations.
The competent senior federal authority shall issue the certificate if the product in question is equivalent to requirements pursuant to sentence 2 requirements laid down in any other ertificate from the competent authority of the country of origin and the proof of approval has been submitted in the Member State of the European Union or the other Contracting State of the Convention on to the European Economic Area.
The filled out application forms (G-CTD-Module 1 – 5) should be provided electronically as a Word as well as a pdf document. It shall be noted in the cover letter that the Word and the pdf document are identical. An additional hard copy (paper version) is not necessary.
All pages of the application should be provided with a header containing the name of the applied medicinal product and consecutive page numbering.
Please use the following application forms to simplify the procedure.
Email: eSubmission@pei.de
Email: HZG5_Blut_Zellen_Gewebe@pei.de
Updated: 07.03.2025
Donor Screening during Tissue Donation
As part of tissue donation, the donors must be tested for HIV 1 and 2, hepatitis B, hepatitis C and syphilis (according to TPG Tissue Ordinance / TPG GewV, Appendix 3, No. 1a). Tissue donors include living donors as well as dead donors whose blood samples may not be taken later than 24 hours after death (according to TPG GewV, Appendix 3, 2d).
Many serological test systems and nucleic acid amplification (NAT) test systems have not been validated for the use of corpse blood. Therefore, the Paul-Ehrlich-Institut (PEI) provides validation recommendations.
Updated: 21.11.2019
According to the German Medicinal Products Act (Section 21a (7) AMG), applicants and holders of authorisations are obliged to inform the Paul-Ehrlich-Institut (PEI) immediately on changes in information and documents pursuant to Section 21a, paragraphs 2 and 3 AMG (German Medicines Act), and must provide the appropriate documents with the notification..
The holder of the marketing authorisation is also required to inform the competent senior federal authority if there are risks involved with a tissue preparation, if such risks have changed, or if the benefit / risk ratio of the tissue preparation has changed.They are also required to provide any other new information that may influence the assessment of benefit and risks. Additional notification and submission obligations arise from Section 29 (1a), 1d and (2) AMG.
Certain changes may only be implemented if the competent senior federal authority has approved them in writing.
It is assumed that the respective competent Land authority has already granted all the necessary permissions if changes to permits are reported to the PEI. If the PEI is notified of a change, which is associated with a change in the processing and processing permit, a copy of the amended certificate must be presented with the change notification.
E-Mail: eSubmission@pei.de
Updated: 21.11.2019
Changes of the authorisation of tissue preparations pursuant to Sections 21 and 25 AMG (German Medicines Act) are
For approved tissue preparations that are not manufactured using industrial processes, please use the national forms for Changes pursuant to Section 29 AMG. Certain changes may only be implemented if the competent senior federal authority has approved them in writing.
For approved tissue preparations produced by industrial processes, which fall within the scope of Directive 2001/83 / EC, please use the national variation forms subject to the Variation Regulation.
Email: eSubmission@pei.de
Updated: 21.11.2019
