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Summary.
- License renewal, national phase management, regulatory affairs, translations.
- On the heels of a Marketing Authorization (MA) renewal procedure, this UK pharmaceutical company entered national phase management and required local support from the Czech Medicines Agency.
- Because the organization updated its product information, the company needed to translate English text to the Czech language for the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labeling and turned to the Arriello team for support.
Challenges.
Ensuring quality translations is an exacting task. And, in this case, circumstances only increased that challenge.
Translations of the approved text in English were due at the CZ agency in five short business days. But the project wasn’t as simple as translating a single SmPC, PIL, and label. For the SmPC and labeling, our client required four separate translations in Czech for the four strengths of the updated products.
On top of this tight deadline, we had to navigate CZ regulatory requirements. If our client wanted the CZ agency to approve its translations and Arriello to act on its behalf, the organization needed to submit a notarized hard copy of its original Power Of Attorney (POA) in person at the agency.
Solution.
To expedite the process, we quickly delivered a draft of the POA to our client to sign and notarize. We then translated the approved text from English to Czech, partnering with a local translator to ensure maximum accuracy and authentic quality translations.
Afterwards, we sent these documents to the Czech agency through a local partner. It’s important to note that this partner had a 20+ year history of working with the CZ agency.
Together, our choice of a local partner and our knowledge of CZ regulations provided better communication, smooth procedures, prepared interactions, and a quicker process for our client.
Faster. Better. Smarter.
Our client’s translations were a success. After reviewing the translations, the CZ agency gave its approval, allowing our client to successfully renew its drug license for five years with all updates on product information in place.
With Arriello, our client enjoyed a fast process thanks to our expertise in translations.
However, we delivered more than speedy results and our client also enjoyed a better experience as our partner had a good working relationship with the agency.
In addition, our in-depth knowledge of regulations and our local partner’s CZ agency experience created a winning combination. We were able to adapt to additional agency requirements and avoid potential obstacles, helping our client take a smarter route to reach its goals.
Arriello provided all deliverables within the time frame, and our client received the faster, better, smarter results it needed for national phase management.
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