Marketing authorisation for medicinal products
Translations for all marketing authorisation procedures for medicinal products that reliably comply with the regulations
Professional in all 24 EU languages and 26 EEA languages
The marketing authorisation for medicinal products is strictly regulated in Europe and usually requires extensive technical translations of various medical and pharmaceutical documents. As a specialised language service provider, mpü has developed excellent solutions for all medicinal products that are both tailored to international authorisations and adapted to national regulations.
- All medicinal products
including all special areas such as:- Paediatric medicinal products
- Oncological medicinal products
- Orphan drugs
- Veterinary medicinal products
- etc.
- Generic drugs
- Biosimilars
Over 45 years of translation experience for your reliable
marketing authorisation for medicinal products
Thanks to its many years of experience and expertise, mpü is extremely familiar with the industry-specific challenges of the pharma and biotech industry.
With our extensive interdisciplinary range of services, we have validated processes specially for translations that are part of authorisation procedures that comply with all of the European and national regulations and ensure acceptance by the authorities:
- Time management with short delivery deadlines
- Safety ensured by the constant development of tried and tested procedures
- Consistent quality
- Quality assurance thanks to translation variants according to DIN EN ISO 17100
- Operative excellence for greater levels of efficiency and effectiveness
We speak 150 languages
Regulatory labelling – linguistic expertise in all phases of the life cycle
mpü offers you a full package of solutions and services for the authorisation of medicinal products in strict compliance with all regulations issued by the European Medicines Agency (EMA) and other country-specific authorities.
- Creation of the English product information (SmPC, PIL, labelling), also known as:
Summary of product characteristics (SmPC) | Patient information leaflet (PIL) | Labelling, labels, text on inner and outer packaging - Translation into 26 QC-tested language versions
- Quality assurance
- Readability user test
- Linguistic review
Translations for marketing authorisation procedures: planning ahead – flexible time management
mpü processes assure far-sighted planning of the entire translation process and timely delivery of correct and reviewed documents in the national languages to ensure compliance with the submission deadlines.
Timelines for the translation process for the registration procedures
Centralised procedure (CP): normal procedure
Centralised procedure (CP): normal procedure
The procedure normally takes 180 or 210 days.
| D-10… | Day of eCTD submission The applicant informs mpü about the submission and provides the documents to be translated. This enables reliable planning of the process and resources. |
| D80 | Day 80, Assessment Report (AR) The first version of the Assessment Report (AR) by the rapporteurs/co-rapporteur is available for the applicant. Any requirements to make changes to the summary of product characteristics (SmPC), patient information leaflet (PIL) or labelling should be taken into account at this stage. Translations taking any comments in the assessment report into account can now be started. |
| D120 | Day 120, List of Questions (LoQ), start of CLOCK STOP When submitting the response package the applicant sends the revised documents to mpü. |
| D121 | Day 121, responses to the LoQ to the authorities When submitting the response package the applicant sends the revised documents to mpü. |
| D150 | Day 150, joint AR |
| D180 | Day 180, List of Open Issues (LoOI), start of CLOCK STOP If there have been any requests to make changes to the summary of product characteristics (SmPC), patient information leaflet (PIL) or labelling, the applicant sends these to mpü. |
| D181 | Day 181, responses to the LoOI to the authorities When submitting the answers the applicant sends the revised documents to mpü. |
| D210 | Day 210, positive opinion After the positive opinion, only final corrections should now be made. |
| 5-day period | |
| D215 | Day 215, final corrections to the authorities Delivery of the final corrections to the authorities for linguistic review by the NCAs. |
| D229 | Day 215 to day 229, linguistic review |
| D230 | Day 230, receipt of the result of the linguistic review The applicant sends the necessary changes to mpü. |
| 5-day period | |
| D235 | Day 235, delivery of the final revision to the authorities |
Centralised procedure (CP): accelerated procedure
Centralised procedure (CP): accelerated procedure
The usual procedure takes 90 days plus 30 days for reviewing a response package.
| D-10.. | Day of submission The applicant informs mpü about the submission and provides the documents to be translated. This enables reliable planning of the process and resources. If this is feasible, the translations can be started at this stage. This is advisable due to the accelerated procedure. |
| D60 | Day 60 The first version of the Assessment Report (AR) by the rapporteurs/co-rapporteur is available for the applicant. Any requirements to make changes to the summary of product characteristics (SmPC), patient information leaflet (PIL) or labelling are forwarded to mpü. The translations should be carried out from day 60 at the latest, taking any comments in the assessment report into account. |
| D90 | Day 90, start of CLOCK STOP The applicant receives the list of questions (LoQ). If there have been any requests to make changes to the summary of product characteristics (SmPC), patient information leaflet (PIL) or labelling, the applicant sends these to mpü. When submitting the response package the applicant forwards the revised documents to mpü. |
| D91 | Day 91, responses to the LoQ to the authorities Mit Einreichung des Response Package übermittelt der Antragsteller die geänderten Dokumente an mpü. |
| D120 | Day 120 Forwarding of the positive opinion to the applicant. After the positive opinion, only final corrections should now be made. |
| 5-day period | |
| D125 | Day 125, delivery of the final revision to the authorities |
Decentralised authorisation procedure (DCP)
DCP procedure
The procedure can last 105, 150 or 210 days depending on the consensus building of the national authorities.
| D-10.. | Day of submission The applicant informs mpü about the submission and provides the documents to be translated. This enables reliable planning of the process and resources. |
| D70 | Day 70 The Reference Member State (RMS) distributes the preliminary assessment report (PAR) to the Concerned Member States (CMS) and the applicant. The translations should be carried out from day 70 at the latest, taking any comments in the PAR into account. |
| D105 | Day 105, start of CLOCK STOP The applicant has the deficiency statements from the Member States. If the response package contains any changes to be made to the summary of product characteristics (SmPC), patient information leaflet (PIL) or labelling, the modified documents are forwarded to mpü along with the response package. |
| D150 | Day 150 If consensus has been reached between all MS, the RMS grants the DC approval. Once the DC approval has been granted, only final corrections should now be made. If any points are still not clarified, the RMS informs the applicant. |
| Another phase of discussions follows. | |
| D210 | Day 210 Normally, consensus is reached by day 210 at the latest and the RMS grants the DC approval. Once the DC approval has been granted, only final corrections should now be made. |
Mutual recognition procedure (MRP)
MRP procedure
The procedure takes 90 days.
Requirement: The medicinal product concerned is approved in at least one EU Member State.
Before starting the procedure
The existing application dossier must be checked to ensure it is up to date and, if necessary, updated with any variations for the future reference Member State and, where applicable, other Member States in which the medicinal product concerned is approved.
| D-10.. | Day of submission The applicant informs mpü about the submission of the application for approval and provides the documents to be translated. This enables reliable planning of the process and resources. If this is feasible, the translations can be started at this stage. |
| D50 | From day 50, CLOCK STOP if necessary Comments by the CMS |
| D60 | Day 60 If the response package contains any changes to be made to the summary of product characteristics (SmPC), patient information leaflet (PIL) or labelling, the revised documents should be provided to mpü along with the response package. |
| D90 | Day 90 If consensus has been reached between all MS, the RMS grants the MR approval. Once the MR approval has been granted, only final corrections should now be made. |
Always available for you quickly at all times
Compliance with short registration deadlines
To make sure you do not miss the deadline for submitting all documents in the national languages after receiving a positive opinion (CP) or after the approval (MRP/DCP), we recommend starting the translation process of the source texts or the transfer of the revised parts of the text into the documents in national language as early as possible.
In other words, this process should ideally be started as early as the day of submission of the application for marketing authorisation or variation/the variation notification.
The 5-day period after a positive opinion (CP) or after approval (DCP/MRP) should be reserved for making last-minute changes only.
Weekend work: no problem at mpü.
With the centralised procedure (CP), we will work for you even over the weekend for the 5-day period after the positive opinion so we can finalise all of the language versions promptly.
Adaptations to reflect the current QRD template versions and reviews/proofreading of existing translations can be completed prior to the completion of the application assessment or before receipt of the positive opinion (CP) or approval (DCP/MRP) in preparation for the next step.
Our fast response time ensures your deadline will be met
Translations of all product information
All product information is usually written in English and subsequently translated into all relevant EU languages. It includes:
SmPC, PIL and labelling, also known as
- Summary of product characteristics (SPC or SmPC)
- Patient information leaflet (PIL) or package leaflet (PL)
- Labels (text on inner and outer packaging)
Life cycle management
Procedure
- Centralised authorisation procedure (CP) and accelerated procedure
- Decentralised authorisation procedure (DCP)
- Mutual recognition procedure (MRP)
- National authorisation procedure (NP)
- Variations: type IA, type IB, type II
- Line extensions
- Renewals
- Workshare
- Urgent safety restriction
- Annual re-assessment
- Article 61 (3) notifications (Label/PL/PIL)
- Referral procedure
- PSUR / PSUSAR / PBRER
Regulations
- QRD templates including appendices
- Templates from the national registration authorities
- EDQM Standard Terms
- Excipients Annex
- Annex A, Annex IV, Article 127a
- Table of non-standard abbreviations
- Names of EU/EEA countries
- Excipients Guide
- Compilation of QRD decisions on stylistic matters in product information
- Abbreviation of names of days on calendarised blisters
- QRD convention
- Creation of the PDF files: EMA PDF user guide and checklist
- Country-specific adjustments such as blue box requirements
- Synchronisation/creation of documents for different product strengths and pharmaceutical forms
- Creation of Member State versions
Documents
- CTD/eCTD (modules 1–5)
- GMP
- SOPs
- Correspondence with registration authorities
Correction cycle with country subsidiaries
Review by the customer’s country subsidiaries:
management of the review and implementation of corrections.
Handling of the linguistic review with Member States
- Established contacts with partners in the authorities of all EU Member States
- Handling of all of the communication between authorities and translators
- Content and linguistic processing of feedback from the authorities
- Rapid problem solving based on medical and regulatory expertise in all queries and finalisation of the labelling (QRD Form 2)
We are renowned for producing the highest quality for over 45 years.
Registration dossiers
Preparation and translation of all 5 modules of the common technical document (CTD)
The regulations for regulatory approval of medicinal products are largely harmonised in Europe. The common technical document (CTD or eCTD) serves as the basis for the marketing authorisation of medicinal products on the European market.
In addition to administrative information, it contains detailed information on the pharmaceutical quality and manufacture, efficacy, and safety of the medicinal product (verified by documentation of clinical and non-clinical studies).
Our process includes all steps for a smooth submission both of the entire dossier and the individual documents or modules.
Format preparation and finalisation of your documents
Depending on the format of the source documents that are available (e.g., paper documents, scanned PDFs, PDF files), all templates can be converted into electronically editable Word formats for translation.
The translations will be formatted based on the layout of the source texts, including graphics, tables, etc.
Technical translation into the desired languages
Because the individual modules include different subject areas, all documents are allocated to appropriate native specialist translators/experts (e.g., pharmacists, medical practitioners, molecular medicine experts, biochemists, biologists, chemists, pharmacologists, toxicologists) for translation.
Quality assurance thanks to a revision of the technical translation according to DIN EN ISO 17100
The first quality assurance step is revision by another subject expert. The revision is supplemented using specially developed software tools for quality and consistency checks (completeness, numbers, product names, chemical substances, abbreviations, etc.).
Labelling-specific quality control in Module 1
This step includes checking for compliance with all EMA regulations.
Creation of the dossier in CTD/eCTD format (can be booked without translation too)
We check all documents and create a registration dossier in the CTD/eCTD format valid throughout Europe in compliance with all regulatory requirements for a valid application.
Thanks to many years of experience, mpü in partnership with orangeglobal is able to offer you a comprehensive service package of translations, planning and implementation of marketing authorisations for medicinal products.
We support you throughout the entire process of submitting variations and would be happy to handle the necessary reformatting of old formats, for example from the NTA format to the CTD or eCTD format.
We routinely create a baseline for your dossier to show the current status of the dossier with the European and national authorities.
Discover our language solutions.
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