Post-authorisation procedures are regulatory procedures performed after an initial marketing authorisation. In principle, the manner in which a post-authorisation procedure is carried out depends on which legal requirements are applicable. The applicable legal requirements are determined by the procedure used to authorise the medicinal product (e. g. centralised marketing procedure [CP], mutual recognition procedure [MRP], decentralised procedure [DCP] or a strictly national procedure).
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Variation of the marketing authorisation
Variations are subject to authorisation and notification. The variation procedure is either subject to Section 29 AMG (German Medicinal Products Act) or Regulation (EC) No. 1234/2008, known as the variation regulation.
On the PEI's "Electronic Submissions" page, you will find information on submission channels, formats, and formal requirements for submission.
The applicable fees for renewals of and variations to authorisations submitted using the national and MR/DC procedures can be found in the Special Fee Ordinance BMG - BMGBGebV.
Updated: 05.03.2024
A marketing authorisation expires five years after it is issued unless an application for renewal is submitted at least nine months before the expiry date of the marketing authorisation.
A marketing authorisation that has been renewed is valid for an unlimited period unless the competent higher federal authority decides to proceed with one additional five-year renewal.
In the case of purely national marketing authorisations, a distinction must be made between the following procedures:
Marketing authorisations granted via the "mutual recognition procedure" (MRP) or the "decentralised marketing authorisation procedure" (DCP) are renewed in accordance with Art. 24 of Directive 2001/83/EC. Centrally authorised medicinal products are renewed in accordance with Art. 14 of EC Regulation No. 726/2004.
Marketing authorisations subject to renewal pursuant to Section 31 (3) AMG are generally renewed in a "standard renewal" process (corresponding to the former "shortened renewal") in accordance with the CMDh Best Practice Guide - irrespective of the legal basis on which the marketing authorisation was granted. Blood components for transfusion and stem cell preparations from umbilical cord blood undirected allogenic for haematopoietic reconstitution as well as human tissue preparations are exempted from this regulation.
In special cases, an "expanded renewal" is required. The necessary documentation will be requested in such cases.
Documents for medicinal products subject to Directive 2001/83/EC must be submitted electronically.
Submissions of applications for purely nationally authorised medicinal products and medicinal products authorised by means of the MR/DC procedure must follow the requirements of the CMDh "Best Practice Guide on the processing of renewals" and use the electronic application form (eAF) (see below).
A separate form must be used for the renewal of the marketing authorisation of "Blood components for the transfusion of stem cell preparations from umbilical cord blood undirected allogenic for haematopoietic reconstitution" (see below).
For the renewal of the marketing authorisation of "human tissue preparations" the electronic application form (eAF) must be used (see below). The application form including the current summary of product characteristics (SPC), labelling, flow chart on procurement as well as processing and a tabular list of all changes since approval of the medicinal product must be submitted electronically.
A separate form must also be used for an application for renewal of a marketing authorisation of a medicinal product imported in parallel (see below). This application can be made as an informal letter (submitting the required documents pursuant to Section 31 para. 2 German Medicinal Products Act (AMG)).
Updated: 26.04.2023
Variation notifications for marketing authorisations granted in accordance with the centralised procedure or the MR/DC procedure shall be performed on the basis of Regulation (EC) No. 1234/2008 in its applicable version. The Regulation is supplemented by guidelines from the Commission.
As of 4 August 2013, Regulation (EC) No. 1234/2008 must also be used for most of the purely nationally authorised medicinal products in its applicable version.
Nationally authorised medicinal products not subject to Regulation (EC) No. 1234/2008, i.e. the blood components mentioned in Art. No. 6 of Directive 2001/83/EC, tissue preparations authorised pursuant to Section 21 AMG for which no industrial method is used, and medicinal products imported in parallel are exempted from the scope of application of Regulation (EC) No. 1234/2008 (see also tab “National Variations pursuant to Section 29 AMG”).
In addition, not all variations are covered by Regulation (EC) No. 1234/2008, e.g. the change in the marketing authorisation holder or the co-distributor. Such changes must be reported for all national marketing authorisations and marketing authorisations by means of an MR/DC procedure pursuant to Section 29 AMG.
The following distinctions are made in the case of variations for medicinal products for human use subject to Directive 2001/83/EC:
It is also possible to group several variations into one application (grouping), if the conditions are fulfilled pursuant to Annex III of Regulation (EC) No. 1234/2008 and pursuant to EMA or CMDh guidance documents based on this regulation.
Submissions containing the same type IB or type II variation or the same group of variations affecting more than one marketing authorisation of a marketing authorisation holder must be submitted as worksharing.
Notes on the submission and performance of the variation procedure for medicinal products authorised in accordance with the MR/DC procedure can be found in the CMDh guidance documents. Notes on the submission and validation of the variation procedure for purely nationally authorised medicinal products can be found in the 'Joint Announcement by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013'.
As is the case for new marketing procedures, i.e. for medicinal products authorised within the centralised marketing procedure, the coordination of the variation procedures performed at a European level is performed by the competent authority of the reference member state (RMS).
For super-groupings and worksharing with multiple RMS and/or purely national marketing authorisations in more than one member state, the marketing authorisation holder selects the authority of one of the concerned member states to be designated as the reference authority and requests said authority to assume the necessary function. The reference authority thus selected shall confirm the assumption of this function, assigns the worksharing number, and informs the marketing authorisation holder and the CMDh secretariate.
The documents for variations of marketing authorisations subject to Directive 2001/83/EC must be submitted electronically. The electronic application form (eAG) must be used for notifications of variations.
Email: grundsatzfragen@pei.de
Updated: 16.04.2025
For variations concerning the medicinal products mentioned below, Section 29 of the German Medicinal Products Act (AMG) shall be used:
For variations pursuant to Section 29 of the German Medicinal Products Act, slight distinctions are made between:
Change in the marketing authorisation holder, the co-distributor or the local representative as well as editorial changes of the national texts of the summary of product characteristics require notification pursuant to Section 29 for all medicinal products authorised within the national marketing authorisation procedure or within an MR/DC marketing authorisation procedure (see notes on the change in the marketing authorisation holder or notification of a new co-distributor as below). Submission of documentation in English is acceptable.
Application documents are to be submitted electronically.
Please use the appropriate forms published on the Paul-Ehrlich-Institut website.
Submissions for a change of the marketing authorisation holder may also be submitted outside of the eCTD lifecycle (i.e. not in eCTD format).
Email: eSubmission@pei.de
Updated: 19.02.2025
In addition to a notification of variations, marketing authorisation holders of medicines for human use also have certain obligations to inform and notify the senior federal authority.
If there is no electronic portal for these notifications as there is for sunset clause notifications in accordance with Section 29 subsections 1b and 1c AMG or no specific form, the notification can be made informally. The letter should identify the products concerned with the necessary details, as well as the subject of the notification.
Pursuant to Section 31 para 1 sentence 1 No. 2 AMG, the written declaration of renunciation of the marketing authorisation will result in an expiry of the marketing authorisation. The declaration of renunciation can include a date as from which the renunciation shall become effective. If no such date is indicated, the marketing authorisation shall expire at the time of the declaration of renunciation.
If the marketing authorisation expires based on a written renunciation pursuant to Section 31 para. 1 sentence 1 No. 2 AMG, the medicinal product can, based on Section 31, para. 4 AMG, only be marketed for another two years, starting with the 1 January or 1 July following the notification of the expiry pursuant to Section 34 AMG. This does not apply if the competent senior federal authority establishes that a precondition for the withdrawal or the revocation pursuant to Section 30 AMG was available. Section 30 para. 4 AMG shall be applicable.
The renunciation can in principle only be declared by the marketing authorisation holder or a third party authorised by the marketing authorisation holder. Since Section 31 para. 1 sentence 1 No. 2 AMG expressly lays down that a written form is required, the renunciation can only be submitted electronically, i.e. by email or CES if a qualified electronic signature is used pursuant to Art. 25 of Regulation (EU) 910/2014.
In connection with the written renunciation pursrant to Section 31 para 1 sentence 1 No. 2 AMG, extended notification obligations exist pursuant to Section 31 para. 1 sentence 1 No. 2 since 28 October 2013 pursuant to Section 20 para 1g AMG (see also Section “Legal basis” in “Sunset Clause” Rules and Notification Obligations pursuant to Section 29 AMG“).
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
63207 Langen
Email: eSubmission@pei.de
Notification obligations pursuant to Section 29 AMG and Sunset Clause rules
Pharmacovigilance notification forms / online notification (German only)
Updated: 24.03.2025
2nd-step procedures as part of the certification procedure of the plasma master files (PMF)
With Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC, the procedure of centralised PMF certification was introduced. The submission of such a PMF is optional for pharmaceutical companies. It is a documentation, independent from the marketing authorisation dossier, which contains detailed information on human plasma as starting material for the manufacture of medicinal products.
In a first step, of the procedure, the actual certification, the scientific evaluation of the documents submitted takes place at a European level. This is completed with the "EMA Plasma Master File (PMF) certificate of compliance with Community legislation". After this first certification, the PMF should be updated annually, each time at a predetermined "birth date". Each update and variation notification concerning the PMF will result in a re-certification of the PMF, which is also performed at a European level.
In a second step, the effect of the certification or re-certification, as applicable, on the medicines concerned will be taken into account. This part of the procedure will be performed by the competent national authorities of each country in which the concerned medicines are authorised.
Announcement by the Paul-Ehrlich-Institut on the introduction of the plasma master file for sera from human blood and blood preparations, except for fresh frozen plasma and cellular blood components (from 19 September 2001) (German only)
Guideline on Requirements for Plasma Master File (PMF) Certification
Guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1
Updated: 14.04.2021
