The description of the Commission of the Agency College for Evaluation of Medicines (aCBG) is characterized by medical/pharmaceutically oriented translations. A characteristic feature of this field of activity is that the translations must display the content of the source text exactly and be completely unambiguous. In addition, the translations must be a good reflection of medical/pharmaceutical practice. The translations are intended for readers or users from different target groups, such as medical professionals, patients and national government agencies. The work includes checking new or revised Summary of Product Characteristics (SmPCs) translated into Dutch, package leaflet texts, packaging texts and other product information using the English versions of these documents and indicating corrections and recommendations up to improvement. See the Descriptive document.
The description of the Commission of the Agency College for Evaluation of Medicines (aCBG) is characterized by medical/pharmaceutically oriented translations. A characteristic feature of this field of activity is that the translations must display the content of the source text exactly and be completely unambiguous. In addition, the translations must be a good reflection of medical/pharmaceutical practice. The translations are intended for readers or users from different target groups, such as medical professionals, patients and national government agencies. The work includes checking new or revised Summary of Product Characteristics (SmPCs) translated into Dutch, package leaflet texts, packaging texts and other product information using the English versions of these documents and indicating corrections and recommendations up to improvement. In the case of modified texts, only the revised passages are checked and therefore not the entire text. In revised texts, the changes are visibly marked. Comments are formulated by the Contractor in such a way that they may be forwarded unchanged by the Client to the registrar or to the European Medicines Agency (EMA). We reserve the right to take over, modify or delete comments. If the Contractor has any doubts about a translation issue, it will contact our contact person or directly with the relevant employee.
These checks should be carried out in a period of approximately two weeks per month, so that there is no need for comparable Services in the other weeks of the month. During a crisis situation (such as COVID-19), tailor-made agreements apply. Think of a situation where it is important that a medicine comes on the market as soon as possible. This is outside the regular process, often announced shortly in advance and with a very short review time (sometimes less than 24 hours). So it can also happen that it goes outside office hours (evening/weekend) or around national holidays.
The number of translated words over the past four years has been around ten million words. There is an increase in the number of cases, with the complexity of questions also increasing. The expected word count will be twelve million for this agreement.
Regular translation vs. emergency translation, see the Descriptive document.