15. March 2017 · Comments Off on European Medicines Agency · Categories: News · Tags:

Translation and localization projects for the pharmaceutical industry in the EU should be available to all and easy to understand information about medications and language barriers may represent an obstacle here. The most important and comprehensive document on the range and characteristics of a drug is the summary of product characteristics of the medicinal product (summary of product characteristics SmPC). The summary of product characteristics of the medicinal product is the full and official description of a pharmaceutical product, the active ingredients, composition, applications, dosages, dosage forms and known side effects are listed. SmPCs are created for the approval and development of drugs and are the basis of information for medical professionals such as doctors, nurses and pharmacists, as they describe how the medicine is to apply and to prescribe safe and effective. Created and updated the summaries of the features be competent of medicinal of approvals Department of pharmaceutical companies based on their research and product knowledge. SmPCs are checked by national or EU regulatory authorities for medicines and approved. The leaflet is created on the basis of the summary of product characteristics of the medicinal product. She will be attached to the packaging and contains information about the safe and correct use of the medicinal product.

In the leaflet, same information as in the summary of product characteristics of the medicinal product contained essentially, but this must be written in a language understandable for laymen. The texts on pharmaceutical packaging and internal and external labels are shortened versions of the leaflet. SmPCs created by the pharmaceutical companies and package inserts must meet the requirements of the competent authorities in the country or countries in which the medicine is sold. In EU countries must also have the requirements in addition to the requirements of the national competent authorities European Medicines Agency (EMEA) are met. The EMEA and the different national regulatory authorities require that the summary of product characteristics (SmPC), leaflet, as well as the packaging and labelling texts exist in the official languages of the Member States where the medicinal product on the market is brought.

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