Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 73

In the EU, all marketed drugs (OTC or Rx) have a Marketing Authorization (MA). Thus, all OTC drug products have the PV requirements for prescription requirements (expedited reporting, PSURs, signaling, etc.) Local requirements should be checked for products, such as neutraceutical and herbal preparations, etc. Agencies collect AEs on OTC products (e.g., the Medicines and Healthcare Products Regulatory Agency, MHRA, collects them under its Yellow Card Scheme). In other words, PV requirements for an OTC drug in the EU are the same as for Rx drugs.

If a product is sold in both the US and the EU, in practice, the product is handled as a drug with expedited reporting, PSURs, and so forth, for global use, although some documents (e.g., aggregate reports) would not be submitted to FDA if not required.