Certified translations of marketing authorisations for medicinal products

Requirements, processes and significance in the regulatory context

Where patient safety is concerned, every word counts.

The registration of medicinal products is a highly complex and strictly regulated process. Besides scientific data on quality, safety and efficacy, the linguistic and formal accuracy of the documents submitted is of central importance. Certified translations in particular are an indispensable part of international registration procedures for the authorisation of medicinal products and frequently determine the formal validity of an application.

For us at mpü this is not just a work step but a daily responsibility – because, ultimately, it is patient safety that we need to keep in mind with every document we translate.

This guide comprehensively elucidates the role of certified translations in medicinal product authorisations, their legal requirements and practical features in the regulatory environment.

Significance of certified translations in the registration procedure

When registration dossiers are submitted to authorities such as the German Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI) or the European Medicines Agency (EMA), countless documents must be provided in the specific official language required. This is where we support our customers on a daily basis – often under high time pressure and with exceptionally high quality requirements.

Certified translations ensure that:

  • Foreign-language contents are recognised as legally binding
  • The translated content is complete and correct
  • Regulatory requirements are complied with

Without a certified translation an application may be considered incomplete and, in the worst case, rejected.

So we treat every project as if the whole registration process depended on it – because this is often the case.

Regulatory context and documentation requirements

The registration documents are generally submitted in the form of a Common Technical Document (CTD). This comprises five modules including administrative data as well as clinical and non-clinical studies. For our customers this means that an enormous amount of highly sensitive information must be conveyed precisely and consistently.

Typical documents that frequently have to be translated and certified include the following:

Registration certificates and approval documents
GMP certificates (Good Manufacturing Practice): evidence that the manufacturer has operated in accordance with the rules of Good Manufacturing Practice (GMP).
CEP certificates (Certificate of Suitability to the Monographs of the European Pharmacopoeia, Ph.Eur.): Compliance certificate issued by the EDQM which demonstrates the suitability of an active substance based on the monographs of the European Pharmacopoeia.
Clinical trial data (GCP – Good Clinical Practice): evidence that the trials were performed according to the rules of Good Clinical Practice (GCP).
Manufacturing and import permits

The following is particularly relevant

If these documents are not available in German or English, a certified translation by a publicly appointed or certified translator is mandatory according to regulatory requirements.

Who can produce certified translations?

A certified translation must be produced or confirmed by qualified experts only. This is why, at mpü, we work exclusively with experienced, specialised and certified translators who understand both the linguistic and the technical depth of the contents:

  • Generally certified or publicly appointed translators
  • Court-certified interpreters
  • Authorised specialist translators with appropriate certification

The latter provide the translation with:

  • Stamp/seal
  • Signature
  • Certification mark of conformity with the original

These are the only translations that are recognised by the authorities – and it is precisely this assurance that we give our customers in every single project.

Content requirements and quality standards

Certified translations in the pharmaceutical context are subject to particularly high quality requirements – and this is what we specialise in:

  • Completeness – all contents, including seal, stamp and signatures must be translated
  • Terminological precision – specialist terminology must be rendered precisely
  • Regulatory conformity – e. g. compliance with EMA templates (QRD)
  • Liability – translators are legally responsible for errors

The requirements result from the high relevance of the documents for assessment of the safety and efficacy of a medicinal product. For us at mpü this means the greatest of care, multi-level quality assurance and in-depth understanding of regulatory processes.

Language requirements and special features of the procedure

A key aspect is that the registration process involves multiple languages:

Scientific documents are often submitted in English
Patient-relevant information must be available in the relevant national language
National authorities frequently require translations into the official language

In exceptional cases, such as supply shortages, authorities may temporarily do without translations – but this remains the exception. Our task is to steer our customers safely through these requirements and to consistently supply the appropriate language solution.

Certification processes:
Certificates – authentications – apostilles

Certificates

As well as conventional authentication, advanced certifications also play an important role.

Certificates of Translation Accuracy

Formal notarised authentication involving a notary’s seal is frequently unnecessary for the content of the text but a Certificate of Translation Accuracy from the translation supplier is regularly required to ensure regulatory conformity.

mpü delivers a translation certificate for every translation option which contains details of the language and subject experts involved, a precise description of the selected translation process as well as the title of the document and language pairs.

This attests to the fact that a translation has been prepared by a native-speaker translator qualified in the relevant area of expertise to the best of their knowledge – a requirement that is part of our everyday life.

Authentication

Sworn and certified translations

The authentication confirms that the translation corresponds to the source text. It is issued by a translator certified by a District Court (Landgericht).

There are two options:

  • Self-certification by the certified translator – The certified translator confirms that their own translation is complete and accurate.

  • Post-certification – The certified translator confirms that another translator’s translation is complete and accurate. This option is available if the original translator is an expert in a specific subject area (e.g.  medicine, chemistry etc.) but is not certified themselves.

Apostille and legislation

The apostille is a form of authentication used in court transactions involving international documents. It is accepted for legal dealings between signatory states of the multilateral Hague Convention Abolishing the Requirement for Legalization of Foreign Public Documents. The target country is to be stated in the apostille.

The apostille is a legal authentication that is issued in addition to an authentication already provided by a certified translator.

Challenges and best practices at mpü

The creation of certified translations in pharmaceutics involves particular challenges – and these are part of our daily work:

  • Complex specialist terminology
  • Tight regulatory deadlines
  • Different national requirements
  • High liability risks

Best practices

  • Collaboration with specialised technical translators
  • Use of quality assurance processes (e. g. the four-eyes principle)
  • Early planning in the registration process
  • Consideration of country-specific requirements

In brief

Certified translations are far more than a formal requirement – they are an integral part of the marketing authorisation for medicinal products. They ensure the legal binding force and content precision of international documents and make a significant contribution to their successful assessment by the competent authorities.

  • Legal binding force – Certified translations ensure the formal validity of your registration application
  • Highest quality standards – Completeness, terminological precision and regulatory conformity
  • Qualified experts – Certified and publicly appointed translators with specialist expertise
  • Certification processes – Translation certificates, authentications and apostilles from a single source
  • Experience in the regulatory environment – CTD, GMP, GCP, CEP and other types of document
  • mpü as a reliable partner – The greatest of care, multi-level quality assurance and in-depth understanding of regulatory processes

Conclusion

In view of the increasing globalisation of the pharmaceutical industry, the importance of certified translations will continue to grow. Companies are well advised therefore to rely on qualified translation processes at an early stage and to establish them as an integral part of their regulatory strategy.

Our daily aspiration: the highest quality, absolute reliability and the security of knowing that our customers are linguistically well positioned at every step of the registration process.

Frequently asked questions

A certified translation is a translation produced or confirmed by a publicly appointed or certified translator. It is provided with a stamp, seal and signature and is thus legally binding.

Authorities such as the BfArM, PEI or EMA stipulate that all documents are to be provided in the specific official language required. Without a certified translation, an application may be considered incomplete and rejected.

Frequently translated documents include registration certificates, GMP certificates, CEP certificates, clinical trial data (GCP) as well as manufacturing and import permits.

In the case of self-certification, the certified translator confirms that their own translation is complete and accurate. In post-certification, a certified translator endorses another translator’s translation (e.g. that of a subject expert who is not a certified translator).

The apostille is a legal authentication used for documents in an international context. It is issued in addition to the certification by the certified translator and is relevant for states that are members of the Hague Convention.

mpü works exclusively with experienced, specialised and certified translators. We offer multi-level quality assurance, in-depth understanding of regulatory processes and provide every translation with a certificate of translation.

Break new ground with mpü.