DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medicinal Products – Quality, Safety and Efficacy
ثبت نشده
چکیده
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.
منابع مشابه
Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework.
Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and a...
متن کاملThe growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety
The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use ar...
متن کاملHygienic Quality of Meat Products in Qazvin Province during (2011-2014), Iran
Background & Aims of the Study: One way to increasing shelf life of meat is the production of sausages along with additives. One of these additives contains nitrite that in an acceptance limit is not a threat for human health but if it's amount is higher than standard, it will react in the body with secondary amine and the result is the formation of...
متن کاملBotanical health products, positioning and requirements for effective and safe use.
Within the group of botanical products there is a large range of variation with regard to their properties. Some products are identical to foods while others come close to or are medicines. Botanical products are regulated differently within the different member states of the European Union (EU) and globally. They are regulated either as food or as medicinal products, and in the latter case oft...
متن کاملListeria monocytogenes Contamination in Unpasteurized Traditional Cheese Products in Qazvin, Iran
Background and purpose: Listeria monocytogenes is a foodborne pathogen and a pothential risk to public health. Listeriosis is one of the most serious infectious diseases in most developed countries. Consumption of raw milk and unpasteurized traditional dairy products such as cheese can be a major reason for listeriosis in humans. This reaserch aimed at investigating Listeria monocytogenes conta...
متن کامل