The translations should be submitted by the MA holder, or by a delegated person on behalf of MA holder, in Word format within 7 calendar days after finalisation of the European procedure (EoP letter) to the following address: Stampati.AIC_MR-DC@aifa.gov.it.
Any possible delay should be promptly communicated and adeguately justified.

Statement of compliance of the Italian translation with the final approved texts of the Summary of Product Characteristics, Package Leaflet and Labelling (Product Informations PI). The statement of compliance should be submitted in pdf format in line with the template in Annex 1 and should be dated and signed by the MA holder or by the QPPV or by a qualified personnel responsible for the quality of translations on behalf of MA holder, at the end of the MR/DC procedure. 
The statement should in addition certify that the texts submitted have been written in line with the QRD template and  with the recommendations of CMDh; moreover the statement should also certify  that the translations were reviewed by the company  in order to meet the quality criteria for the authorization procedure, before the submission to AIFA.

The consolidate files in docx format of the Italian translation of the Summary of Product Characteristics (SPC), package leaflet and labelling. The font size of the translations should comply with the provisions of the QRD document EMA/62470/2007 “QRD convention to be followed for the EMA-QRD templates”.

End of procedure approval e-mail from the RMS.

List of variations that impact the annexes (PI), or that concern the MA, possibly approved and submitted after the end of procedure. The template in Annex 1 should be used for the above list. The list should be only provided in the exceptional case of delayed and justified submission of the national translations over7 calendar days after finalisation of the european procedure.

The inclusion in the outer labelling/Blue Box and PL of the name of the Local Representative, where this information has not been present in the cover letter, Module 1 of MA Dossier, could be acceptable upon confirmation of acceptance/delivery of the submission of a notification in accordance with artt.78 e 79 del D.Lgs. N°219/2006 (articles 61(3) and 62 of the Directive 2001/83). The applications shall be sent to: protocollo@pec.aifa.gov.it.

In order to ensure the quality of the italian translations of the Product Information submitted to AIFA the applicant or MA holder should check the following points.

Compliance with the english texts adopted at the end of the procedure
The applicant or MA holder should ensure that the translations submitted to the AIFA is faithful to the entirety of the texts adopted and written clearly, without omission or addition, except for the national requirements to be included in the Blue Box (art. 57 e 62 Directive 2001/83/EC, and amendments) published in guideline CMDh/258/2012 “Blue - Box requirements”. In the event of discrepancies between the approved English text and the proposed italian translation, justification is requested in the statement of compliance (Annex 1) in the section provided for this purpose. In the particular case of withdrawal of patented indications, it is recommended that the applican or MA holder follows the instructions reported on the AIFA website ”Request for deletion of patented indications from Product information - Operational modalities”.

Compliance with QRD template
The translations should be written in compliance with the QRD template, published in the document CMDh/201/2005 “CMDh annotated QRD template for MR/DC procedures”. Moreover, on the EMA website,  are available the Appendix (I-VI) to the Quality Review Documents templates, useful for the translation of some specific sections of the SmPC.

Use of the appropriate scientific terminology
The MA holder, or its representative or a delegated person on behalf of MA holder should ensure that the proposed italian translation is subject to a strict quality control performed by a qualified personnel who has professional knowledge of the field, whose mother tongue is preferibly Italian, and confident in both the terminology used in drafting the SmPC and PL. Moreover, in order to ensure the quality of the translations, it is recommended that the marketing authorization holder (MAH) implements an internal Standard Operating Procedure to ensure the quality control of national translations and also to define the roles and responsibilities of the person delegated to provide the translations.
Please note that a word-to-word translation from one language to another or a translation using translation software will not be accepted.

The Applicants should pay close attention to the following points:

• For the clinical sections of SPC (i.e. Section 4.3, 4.4, 4.8), references should be made to the updated version of the MedDRA (Medical Dictionary for Regulatory Activities) terminology. The Introductory Guide of MedDRA is available, also in Italian version:
  • The informations in section 4.6 of the SPC for Fertility, Pregnancy and Lactation, should be written taking into account the standard statements defined in Appendix I of the QRD template EMA/215345/2023 “Appendix I to the QRD templates for human medicinal products- “Statements for use in Section 4.6 “Fertility, pregnancy and lactation” of SmPC”.
  • The informations in section 4.8 of the SPC for Undesirable effects  should be written taking into account the standard wording defined in Appendix II of the QRD template, EMA/295934/2018 “Appendix II to the QRD templates for human medicinal products- MedDRA terminology to be used in Section 4.8 “Undesirable effects” of SmPC”. List of details of the national reporting systems to communicate adverse reactions (side effects) are reported in the Appendix V of the QRD template, EMA/67830/2013 “Adverse-drug-reaction reporting details”.
  • The informations on excipients with a known effect should be in accordance with the latest Italian version of the guideline EMA/CHMP/302620/2017 Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668).
• For the pharmaceutical sections of SPC it is recommended to pay close attention to the following points:
  • For the informations on the pharmaceutical forms, route of administration and packaging to be mentioned in the dedicated sections of the SPC, package leaflet and labelling, references should be made to the Italian version of the European Pharmacopoeia Standard Terms, available on “Terms List of Standard Terms pharmaceutical dose forms, routes of administration and containers”.
  • For the informations on  the special storage precautions to be mentioned in the appropriate sections of the SPC, package leaflet and labelling, references should be made to the Italian version of Appendix III of the QRD template, EMEA/29277/03 “Appendix III to the QRD templates for human medicinal products”.
• For the informations on Batch number and Expiry date in the labelling, references should be made to the italian version of Appendix IV of the QRD template EMA/286379/2019 “Appendix IV Terms/abbreviations for batch number and expiry date to be used on the labelling of human medicinal products”.
• According to the EMA’s recommendations EMA/25090/2002 “Compilation of QRD decisions on stylistic matters in product information”, abbreviations and acronyms should be avoided, and the term should be written out in full. In cases where this is not possible, at its first occurrence the term should be spelled out in full followed by the acronym/abbreviation in brackets. The acronym/abbreviation can then be used thereafter. See also the most frequently used non-standard abbreviations published on the Agency’s website, EMA/27236/2003 “Table of non-standard abbreviations”.
• User-friendly terms (for PL): It is recommended that the package leaflet should be written in a language understandable by the patient and should reflect the terminology the patient is likely to be familiar with (i.e. headache → mal di testa; hepatic → del fegato; swelling→ gonfiore).
• Consistency of terminology with other medicinal products (innovator, generic or class-similar medicinal products) already approved by the NCA.

In order to comply with the regulatory deadlines for notification of decisions following an application for a marketing authorisation (MA), the MA holder is recommended to follow the present recommendations for the submission of proposed (invented) name:

• According to Directive 2001/83/EC the name of the medicinal product "may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder", irrespective of the legal basis of the MA application.
• For the submission of proposed name, the recommendations of  the guideline EMA/CHMP/287710/2014 - Guideline on the acceptability of names for human medicinal products processed through the centralised procedure available should be taken in account.
• The strenght and pharmaceutical form cannot be included in the product name in Italy, since these data will follow the name in the relevant sections of the texts.
• Normally the name of the active substance in the product name should be reported as free base; however, in the case of established active substances in medicinal products where the strength in Section1 of SPC has traditionally been expressed in the form of a salt or hydrate, the name of the active substance in the product name may be declared in terms of the salt or hydrate also to avoid the risk of dosing errors. 
• The invented name should be used throughout the product information in a consistent format (either upper or lower case) whichever is the choice of the applicant/MAH. However, in order to increase the readability of the product information it would be better that the invented name is written with the first letter in upper case and the rest as lower case letters. In case the name is registered as ‘camel case’ (e.g. InventedName), this would also be acceptable. More informations are available in the document "Compilation of QRD decisions on stylistic matters in product information” 
• The expression of strenght in the name of medicinal product should be reported in line with the guideline EMA/707229/2009 “QRD recommendations on the expression of strength in the name of centrally authorised human medicinal products (as stated in section 1 of SPC, and in the name section of labelling and PL)”.
• For the acceptabiliy of an “umbrella brand” as a name of medicinal product, (that is to say a same brand of an already authorized medicinal product accompanied by a qualifier), the following conditions should be met:
  • The qualifier in the umbrella name should be exclusively related to the pharmacotherapeutic group, or to therapeutic indications or to other informations that uniquely indentifies the product from other medicinal products within this group and that can help the patients to distinguish between others products having the same brand name.
  • The umbrella product name should not be used for other than medicinal products (e.g.  medicinal product/supplement; medicinal product/cosmetic, medicinal product/medical device, medical surgical device).