Validation of procedures
Instructions on the submission of applications for new authorisation, registration, notifications of variation, and applications for renewal, to the Federal Institute for Drugs and Medical Devices
In order to ensure the speedy processing of all types of authorisation and registration procedures for medicinal products in national or European procedures the following points should be considered:
For all procedures:
In submissions of applications to the BfArM, please indicate, below the address, the ATC Code of the medicinal product(s) concerned.
Exception: The ATC Code may be omitted in collective notifications of variations for various groups of medicinal products (only permitted when the address or the name of the company has been changed).
For phytotherapeutic and traditional medicinal products (new authorisation, registration, variation, renewal) the ATC Code is followed by the appropriate group of medicinal products, i.e. “Phyto”, or “109A”, or “Trad”.
For homoeopathic and anthroposophical medicines (new authorisation, registration, variation, renewal) the ATC Code is always “V60” .
The documentation submitted with the application is to be arranged in such a way that all original documents are contained in one file and/or one cardboard box, and the copies in separate files and/or cardboard boxes. For a series of a medicinal product, e.g. 3 strengths, submit one file and/or one cardboard box with the 3 originals and additionally 1 (n) file(s) and/or cardboard box(es) with the copies (not 3 files and/or cardboard boxes with 1 original each plus 1 (n) copy (copies). Data media like CDs/DVDs should be fully labelled (i.e. ENR, name of medicinal product, processing number, if applicable, module, if applicable) and added to the file/cardboard box containing the original documents. This will save the BfArM time-consuming re-sorting.
Every consignment consisting of more than one parcel should bear a note of the total number of parcels belonging to the consignment, e.g. in a consignment consisting of 5 parcels the parcels should be marked as follows "parcel 1 of 5", "parcel 2 of 5", "parcel 3 of 5" etc. When submitting applications consisting of several cardboard boxes, specify the character of content (e.g. original, copy, cover letter, Module 1, Module 2, etc.) on the outside of each cardboard box.
Every consignment consisting of more than one parcel should be furnished with an accompanying letter stating what the content of the whole consignment is (e.g. renewal application for ENR … in parcel 1, notifications of variations for ENR … with fulfilment of conditions in parcel 2, notifications of variations for ENR … without fulfilment of conditions in parcel 4, supplement for ENR … in parcel 5 etc.). The accompanying letter should always be on the top in parcel 1. The usual cover letters concerning the individual procedures remain unaffected by this.
A parcel should not weigh more than 10 kg! Otherwise you are kindly requested to pack several parcels. This will make internal delivery and handling easier (see also Explanatory Notes on the Submission of Documentation for Applications for Marketing Authorisations and other documents and parcels and formal handling of receipts - available in German only).
The cover letter should include the applicant’s address and the e-mail address of the person in charge.
Any written arrangements with the BfArM regarding the procedure prior to submission should be attached.
In variation and renewal procedures with Germany as RMS, send the lists containing the dispatch details to Dispatch-Lists@bfarm.de
Additional instructions for national notifications of variation in accordance with Section 29 AMG
Documents to be submitted for change to the CTD format