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The EU’s adoption of its Falsified Medicines Directive follows approval of the new regulation by the European Parliament in February. EU countries now have 18 months to implement the regulation into their own national regulations. The directive is designed to protect EU consumers from falsified medicines. It introduces specific obligations for manufacturers of medicines, including the requirement that importers, manufacturers and distributors of API must be registered as ‘brokers of medicinal products.’ The directive also requires EU member states to implement “strengthened requirements for control and inspections of plants manufacturing active pharmaceutical ingredients; strengthened record-keeping requirements for wholesale distributors; and strengthened rules on inspections.” Companies marketing the medicines will be responsible for verifying that the APIs are made under Good Manufacturing Practice and Good Distribution Practice conditions. Manufacturers must inform authorities about false medicines. Under the directive, prescription medicines must be verifiable as being authentic right down to the level of individual packs of medicines. Greater oversight of internet sales of medicines also is required. EU member states also must introduce more stringent sanctions against individuals and companies that manufacture, distribute, import or export falsified medicines, according to the directive. The Council says the new directive will act "against the alarming increase of falsified medicines detected in the EU and the public health risk which that poses." Industry groups the The Active Pharma Ingredients Committee (APIC; Brussels) and the European Fine Chemicals Group (EFCG; Brussels) have been pressing the EU to toughen up laws on the distribution of falsified medicines for the past several years and more. “We consider it to be a major step forward in the fight against falsified active pharmaceutical ingredients (APIs), and excipients in European medicines,” says Chris Oldenhof, APIC president and a board member of EFCG, in a recent statement on the directive. “However, as we do have some reservations about how it will work out exactly, we will be closely following the implementation by the Member States.” As the EU has been toughening its regulations on falsified – or fake - medicines, Chinese authorities have been cracking down on those manufacturing and selling such medicines, according to Xinhua, China’s state news agency. Xinhua reports that 263 people were arrested in raids that took place May 25. Authorities seized fake drugs with a street value of about Y20 million ($3 million). If found guilty, those arrested face a maximum of three years in jail. Xinhua says the raid is part of a coordinated plan of action to tackle producers and sellers of fake medicines. The production and trade of falsified medicines has become a growing worldwide illegal business. According to the statistics of EU Customs, the number of medicines seized at the outer border of the EU - excluding patent issues - has tripled between 2006 and 2009 to reach approximately 7.5 million items. The e-commerce company in China offers quality products such as Family Resorts Water Slides Manufacturer , China Aquasplash Water Park, and more. For more , please visit Water Playground Equipment today!
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