What is an EMA incident?
Abstract. Economically motivated adulteration (EMA) of food, also known as food fraud, is the intentional adulteration of food for financial advantage.
What is pharmacovigilance EMA?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
What countries fall EMA?
The EMA serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein. The EMA practices pharmacovigilance to ensure the safety and efficacy of medicines.
What is economically motivated adulteration?
Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value.
What is PSMF in pharmacovigilance?
A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal products.
Who approves drug in Europe?
A single marketing authorization allows the sponsor to market the medicine and make it available to patients and healthcare professionals throughout Europe in the “Centralized procedure” and is granted by the European Commission following the scientific assessment of the application by the European Medicines Agency.
Is Sweden in EMA?
4. The Swedish Medical Products Agency: an asset for EU27. Since its start in 1995, the Swedish Medical Products Agency (MPA) has been one of the EMA’s most active partners, with broad in-house expertise in all therapeutic areas. It is a valuable asset that will allow for the continuity of the EMA’s work.
What is a misbranded food?
Food may deemed to be misbranded: If the label, brand, tag or notice under which it is sold is false or misleading in any particular as to the kind, grade or quality or composition; If it is sold as the product of one manufacturer when in reality it is the product of another manufacturer; or.