turkish pharmaceutical certificate translation

Certificate of Pharmaceutical Product Translation Services

The certificate of pharmaceutical product (abbreviated: CPP or CoPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. It is issued for a single product only, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary.

The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licencing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as prerequisite of registration or importation.

In the presence of such CPP, WHO recommends to national authorities to ensure that analytical methods can be confirmed by the national laboratory, to review and if necessary to adapt product information as per local labeling requirements, and to assess bioequivalence and stability data if necessary.

However, regulatory practices often vary in importing countries. Thus, in addition to CPP, assessment of application dossiers to support drug registrations, with different levels and complexity of requirements are considered necessary to satisfy full assurance on the appropriate quality of drugs.

The content of CPP consists of the following main data:

  • Exporting (certifying country):
  • Importing (requesting country):
  • Name and dosage (pharmaceutical) form of the product (active ingredient(s) and amount(s) per unit dose)
  • Information on registration (licensing) and marketing (presence on the market) status of the product in the market for use in the exporting country
  • Number of product licence (including licence holder details, licence holder’s involvement in manufacturing if any) and date of issue, if applicable.
  • Appended summary of technical basis on which the product has been licensed (if required by the issuing authority)
  • Appended current product information.
  • Details on the applicant for the CPP.
  • If marketing authorization is lacking in the exporting country, information about reasons.

When applicable, information if the manufacturing site is periodically inspected by certifying authority and if the manufacturing site complies with Good Manufacturing Practice (GMP) as recommended by WHO.

Although issuing authorities claim that their CPP conform to WHO format (a statement to confirm whether or not the document is issued in the format recommended by WHO should be included in the certificate), their format and content may vary from an issuing country to another. Also, some authorities do not issue CPP if the respective drug is not licenced in the exporting country.

Pharmaceutical translation requires;

  • knowledge of the subject matter, 
  • knowledge of relevant terminology, 
  • the ability to distinguish contextual meaning and transfer it within the restrictions of target language, i.e., accurately (the meaning has been transferred completely), precisely (all nuances of the language, tone, intent, style have been protected during transfer to the target language), correctly (grammar, syntax, orthography rules have been complied with), completely (no part of the original document was omitted and no additions have been made to the target text), and consistently (specific terms, stylistic elements and language-specific norms have been consistently used throughout the text)

Every translation made by Turkish Translation Services's pharmaceutical translators manifests accuracy, precision, correctness, completeness, consistency, the knowledge of accepted linguistic norms applied to translation, and rigor of methodology.

Similarly, our editors provide preservation of the style and register of the source document.

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