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News about GMP/cGMP

2015-11-24

Label pictogram for EU-sourced medicinal products?

The government of France has proposed a new labelling claim to the European Commission – a pictogram – indicating that the manufacturing operations of excipients, the manufacturing of the active substance, its production or packaging were carried out within the territory of the European Union or Member States of the European Free Trade Association (EFTA).

 

The EFPIA (European Federation of Pharmaceutical Industries and Associations) however, is not really fond of the idea. The association expressed concerns that implying a link between a medicine’s country of origin and level of quality is “very misguiding”. “ … EFPIA believes that the legislation in place, which ensures that all medicines marketed within the European Union comply with the same EU standards, should already guarantee safe and good quality medicines in EU, … ” a spokesman said.

The pictogram would be shaped a rectangle divided in four equal parts which correspond to the four categories active ingredient, excipients, production and packaging. If a component was e.g. produced in the EU or a member state of the EFTA, the category would bear the word “Europe” in white letters on a blue background. Ingredients made outside Europe would simply carry a black cross.

According to the French Ministry of Economy, Industry and Finance, the aim of the pictogram is to increase the confidence of the public in the quality of their medicinal products. The French proposal seems understandable considering all the negative reports on cGMP violations or quality compliance issues outside the EU, lately (we reported). “ … Now, many of our fellow citizens do not place the same trust in the competent authorities of third countries as they do in the competent authorities of the European Union. This gives rise to a lack of faith in the quality of medicinal products, and generic medicinal products in particular … ”, so the French decree states.

A feedback at the European level is pending, so far.

Source:

EC: Notification detail

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