As you might have guessed, we are your one-stop shop for rapid, accurate and above all EMA-compliant translations of
- Summary of Product Characteristics (SmPCs)
- Package Leaflets (PILs)
- Labelling/packaging
All translations strictly comply with EMA’s QRD templates and Appendices I-IV, covering:
- Pregnancy and lactation (Appendix I)
- MedDRA convention and terminology (Appendix II)
- Storage statements (Appendix III)
- Batch number and expiry date conventions (Appendix IV)
We are on-line subscribers to the EDQM, which ensures access to the latest Standard Terms, governing dosage forms, routes of administration and containers. Their use is essential for all submissions of regulatory documentation.
Upon request, we can also update older SmPCs and PILs to comply with the latest templates.
Furthermore, we are fully conversant with other EMA requirements and guidelines that govern product information, including:
- Compilation of QRD decisions on stylistic matters in product information
- Tables of non-standard abbreviations to be used in SPC and labelling
- Compilation of QRD decisions on the use of terms (e.g. active ingredient substance)
- Convention to be followed for EMA-QRD templates (formatting, fonts, etc.)
- List of names of EU-EEA countries
The Linguistic Review Process operates to extremely tight deadlines. So do the translators at Mynnaf Translations. Why jeopardise those deadlines with translations that “miss the mark” in terms of EMA compliance, costing valuable time and money to put right?