Explanatory remarks for modifying the process

According to Sections 11 sub-section 1a, 11a sub-section 3 AMG, submission of the current version of the product information texts, i.e. Package Leaflet and Summary of Product Information as appropriate, is mandatory and will now be requested in electronic format. These text versions will be used for the purpose of Section 34 AMG.

This change will have no effect on the submission of working documents, e.g. text files for draft versions of SmPC or PL. These files should be submitted either via www.pharmnet.bund.de – online variations or provided in the folder <sequence>workingdocuments together with sequences in eCTD or NeeS format (using CESP or CD/DVD). The file format should be .DOC or .DOCX. Only if these files are sent in accordance with the electronic submission ordinance (AMG-EV) the rules defined elsewhere need to be applied.

Establishing a separate manner for submitting final product information texts after closing a procedure will improve the processing of text files for different purposes: working with draft documents for assessors and publishing final text versions on the internet.

The following rules apply.

Procedure

1. The Marketing Authorisation Holder should submit the current text version in accordance with Sections 11 sub-section 1a, 11a sub-section 3 AMG , i.e. Package Leaflet and Summary of Product Characteristics as appropriate, within 3 weeks following the end of the procedure (initial MAA, variation, renewal DCP, MRP, English text versions) respectively following delivery of the authorisation letter (date of PZU, German text versions).
2. These final versions of product information texts (PL and SmPC as appropriate) have to be submitted under the rules of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products (AMG-EV).
3. Select the set of metadata for “Textfreigabe” per one ENR.
4. You should use the following file naming conventions: spcdeff.pdf, spcenff.pdf; paldeff.pdf; palenff.pdf .
5. The appropriate file format is PDF. You have to eliminate all content from header and footer except for page numbers, all marked changes or comments and all personal details of editing the file and similar items not relevant to the public.
6. All technical settings for PDF should be in accordance with established requirements as of eCTD or NeeS guidance documents.

Notes

By submitting the files you will confirm in your role as MAH that there are no differences between the text version you uploaded and the text version provided with the authorisation letter. BfArM will – as finally responsible for the correctness of the text published according to Section 34 AMG – double-check and use a text verification tool for comparison.

In case of errors identified during text verification you will be informed and a re-submission of corrected documents is required.

In case an appeal is noted the product information texts will not be published. An internal check will provide assurance.

In case of missing submission after 3 weeks, you will be informed that the obligation is not fulfilled.