MRP/DCP

Assistance for submission of high quality national translations after approval of DC- or MR-Procedures

According to the directive 2001/83 article 28 (5) the national marketing authorisation shall be granted after 30 days.  The applicant is supposed to submit national translations in high quality to the CMS/the RMS after 5 days according to Notice to Applicants 2a Chapter 2.

Please find enclosed the work flow of the Austrian Medicines and Medical Devices Agency department Regulatory Affairs - European Procedures and important links to information in order to improve the quality of national translations. Also refer to CMD(h) "Best Practice Guide on the submission of high quality national translations".

1. Submission of national texts by the applicant

• All approved texts from the RMS have to be sent in German translation as Word documents (doc files). The whole labelling has to be combined in one file (outer & inner labelling).
• Please only send documents that contain all text-relevant variations, which have been approved by the time of submission.
• Text passages, which are identical for all strengths and pharmaceutical forms in the RMS texts, should also be translated identically in the national versions.
• The texts must not contain any information in header or footer except page numbers, a version number or a date. Please submit the texts in “clean version”.
• The files have to be named in the following manner:

Summary of product characteristics (Fachinformation):

• Grundzahl_F_FI_YY-MM-DD_Productname.doc

Patient information leaflet (Gebrauchsinformation):

• Grundzahl_F_GI_YY-MM-DD_Productname.doc

Labelling (Kennzeichnung):

• Grundzahl_F_KE_YY-MM-DD_Productname.doc

The so-called „Grundzahl“ is your product’s internal number in AGES PharmMed.

• For the first submission you have to send the national texts to mrp-spcagesat. It is necessary that you fill in the MRP/DCP-number (including in case the correct name of variation e.g. IA/001 or renewal e.g. R/001) and the ATC-code of your product in the subject of your e-mail. In case that your product is a biological (e.g. vaccines, blood derivatives) or a radiopharmaceutical please also indicate this in the subject.
• In case of an advantage for the patient “combined PILs” (several strenghts of one pallet) can be accepted on a case-by-case basis, if all the criteria of „Compilation of QRD decisions on stylistic matters in product information“ are met.
• If the submission is carried out by a consultant he needs to send a  Letter of Authorisation from the applicant (if not sent earlier already).

2. Preliminary Examination

The texts sent to mrp-spcagesat will be subject to a preliminary examination. Submitted texts with the following deficiencies will usually already be rejected after a few working days.

• Submission of national texts in advance of the official approval date of the procedure
• Incomplete submission (missing texts: SPC, PIL, labelling)
• Submitted texts are no Word documents (doc files)
• Non-compliance with the QRD-template
• Non-translated parts of the texts
• Nonsensical translations (e.g. “copy & paste” mistakes)
• Numerous spelling and grammar deficiencies

3. Examination

If there is no deficiency like mentioned in 2) found in the preliminary examination the texts will be forwarded to the responsible person, which will as soon as possible begin with the examination. The following quality criteria will be closely monitored and therefore, also the applicants should check those points before they submit the national translations.

Quality criteria

• The knowledge and the precise implementation of the QRD-template (German version) are essential. On the same website you can find Appendix 2 of the QRD-template, where a German translation of the MedDRA terms concerning frequencies and system organ classes for section “4.8 Undesirable Effects” of the summary of product characteristics is included.
• In the Austrian Patient Information Leaflet any reference to healthcare professionals (German: “medizinisches Fachpersonal”) in terms of medical advice, advice regarding administration of medicinal products or administration of medicinal products is - in accordance with Austrian law – not applicable.
  The Bracketing convention according to the QRD template allows the omittance of any such reference in the Austrian PIL.
• Furthermore, the Austrian Blue-Box Requirements have to be fulfilled.
  Please see Notice to Applicants volume 2a chapter 7.
• Please use the very translations of already specified wordings for the active substance (e.g. Comission decisions, wordings of the Pharmacovigilance Working Party, wordings following Paediatric Worksharings, in case of variations for generic products intending adaptions to the innovator product: the nationally approved texts of the innovator product).
• A German translation of the English standard terms concerning pharmaceutical form, route of administration and containers are offered on the website of the EDQM.
• As far as the German spelling of many active substances and excipients is concerned the European Pharmacopoea (German version) and the Austrian Pharmacopoea (Österreichisches Arzneibuch) can be helpful to you.
• If your medicinal product contains an excipient, which is for example likely to cause allergic reactions and it is necessary that the excipient is mentioned in the texts, you can find a German wording on the website of the EMA. See "Excipients in the label and package leaflet of medicinal products for human use".
• If your product is also available in other EEA member states those countries are often listed at the end of the PIL. The correct German name of  the EEA member states can be found in the EMA document „Names of the EU / EEA countries“.
• The use of a medical dictionary can be helpful in order to translate English medical terms.
• Please use a spell-checking programme before you submit the texts.

Please note: Only use appropriately trained staff for the national translation.

• Excellent knowledge of English
• Excellent knowledge of German
• Specialised knowledge
• Knowledge and active implementation of the above mentioned quality criteria

4. Text discussion with the applicant

After the examination the applicant will be contacted in order to discuss the submitted texts. When everything is clarified and no more corrections are necessary the applicant will be asked to send the final texts in “clean version” to spcagesat.

• The files have to be named in the following manner:

Summary of product characteristics (Fachinformation):

• Grundzahl_F_FI_YY-MM-DD_Productname.doc

Patient information leaflet (Gebrauchsinformation):

• Grundzahl_F_GI_YY-MM-DD_Productname.doc

Labelling (Kennzeichnung):

• Grundzahl_F_KE_YY-MM-DD_Productname.doc