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Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in ...
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
Only two countries as of 2008 allow direct to consumer advertising (DTCA): the United States and New Zealand. [21] [22] [2] Since the late 1970s, DTCA of prescription drugs has become important in the United States.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
A special type of approval is the paediatric-use marketing authorisation (PUMA), which can be granted for medical products intended exclusively for paediatric use. [ 16 ] The CHMP is obliged by the regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further ...
The European Union and World Health Organization (WHO) have both specified that the advertising of tobacco should not be allowed. The WHO Framework Convention on Tobacco Control, which came into effect on 27 February 2005, requires that all of the 168 countries that agreed to the treaty ban tobacco advertising unless their constitution forbade ...
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The European Union has no major administrative or legal responsibility in the field of healthcare. The European Commission's Directorate-General for Health and Consumers however seeks to align national laws on the safety of food and other products, on consumers' rights, and on the protection of people's health, to formulate new EU wide laws and thus strengthen its internal markets.