New Symbol on Medical Product Packaging

As a result of an initiative to reduce the number of traffic accidents, pharmaceutical companies will be bound as of 2011 to include a symbol in the packaging of those medicinal products that may affect the consumer's driving capacity.  The symbol resembles a traffic sign and shows a red triangle framing the black silhouette of a car.

In order to determine whether the packaging of a product needs this labelling or not, those medicinal products most likely to be affected by the new requirement are being reviewed by the Spanish Agency of Medicinal Products and Medical Devices. About one third of these products has been examined so far, and 60% of them will require the incorporation of the new symbol on its packaging.

This initiative is the consequence of estimates that 5 to 10% of the traffic accidents recorded in the European Union may be due to driving under the influence of medicinal products that cause dizziness, somnolence or a reduced capacity of reaction.  In addition to Spain, the following ten other European countries have developed and are carrying out the project: Austria; Denmark, Norway, Poland; Slovenia, Latvia, Italy, Romania, Estonia, Iceland and France.

 

This article is one of several that appear in Europe Pharmaceutical & Healthcare Newsletter, July 2009.