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A day after Germany imposed a ban on Ranbaxy Laboratories' injectable antibiotic being manufactured at its cephalosporin injectable unit at Dewas in Madhya Pradesh, the European Union, too, followed suit after the German authorities issued a statement of non-compliance.

In an email response to dna, European Medicines Agency (EMA) spokesperson said, "The German supervisory authorities issued a statement of non-compliance with good manufacturing practices (GMP) relating to certain products manufactured at Ranbaxy's Dewas site. This statement of non-compliance entered by the German supervisory authority means that certain aseptically prepared sterile products produced at Block C of the Ranbaxy's Dewas site are not GMP-compliant and can therefore not be imported into the EU."

The company has confirmed that the European, Australian and Canadian authorities have not approved the manufacturing practices at the unit which they inspected in June this year.

In a filing on BSE, it said that the development pertains to only the cephalosporin injectable unit at Dewas in Madhya Pradesh. "The European authorities along with those from Australia and Canada carried out an inspection in June 2014 of all the facilities in Dewas. Well before that time, the company had decided, to stop producing cephalosporin injectables at Dewas".

However, there is no clarity on whether Australia and Canada, too, would follow suit.The company further said that since then, the agencies have approved all its facilities for manufacturing dosage forms and APIs (active pharmaceutical ingredients) at Dewas including that for oral cephalosporins with the only exception of the cephalosporin injectable unit. "We wish to clarify that the current approvals cover all other facilities (dosage forms and APIs) at Dewas, including those producing penem API & injections and oral cephalosporins," it said, adding that Ranbaxy's decision to discontinue manufacture of Cephalosporin injectables would not have a significant impact on the business.

In an exchange of information between National Competent Authorities (NCAs) of the European Economic Area (EEA) following the discovery of serious GMP non-compliance, the EudraGMDP website pointed out that the latest inspection was carried on June 27, 2014.

According to the website, from the knowledge gained during inspection it is considered that the injectable unit does not comply with the GMP requirements. EudraGMDP is hosted by EMA on behalf of the EU member states.

The nature of non-compliance as given on the website indicated unsatisfactory investigations into media trials failures with deficiencies concerning design and operation of the cleanrooms, controls for preparation (including sterilization) of components and equipment, and controls concerning aseptic filling.

The EMA spokesperson also said, "Products already manufactured in this block have been assessed and no recall was needed. The remaining blocks of the Dewas facility, including those manufacturing other aseptically prepared sterile products have been found to be in compliance with GMP and GMP certificates have been entered into the EudraGMDP database by EU authorities."

According to analysts, there could be some marginal impact if the ban is applicable to the entire European Union. "Germany is a regulated market with majority of business done by tenders. Ranbaxy's cephalosporin sales in Germany is around 2%. But if the ban is for the entire union or if other European countries impose similar import ban on the injectable unit at Dewas, the impact would be much higher," said a pharma analyst.

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Ban on Ranbaxy's injectable antibiotic now covers European Union

German chancellor Angela Merkel and Chinas then vice-president Xi Jinping during a meeting at the Great Hall of the People in Beijing in 2012. As the worlds largest trading bloc, the EU is an important strategic partner for China. Photograph: Diego Azubel/Reuters

The emergence of China as a major global player over the last two decades has forced the international community to forge a response to the rising power.

But while much of the attention has focused on the deepening ties between the US and China as part of President Barack Obamas pivot to Asia, the European Union has also been stepping-up its engagement with China.

As the worlds largest economic bloc, the EU is an important strategic partner for China. It is Chinas largest trading partner, while China is the EUs second-largest trading partner after the US. Trade between the two regions equates to more than 1 billion a day, with China the main source of imports for the EU, mainly comprising Chinese industrial and consumer goods.

Last spring President Xi Jinping visited Brussels, the first official visit of a Chinese leader to the EU institutions. To many, it was an important sign of the Chinese leaderships prioritisation of Europe.

At an official level, Chinese-EU trade relations stretch back to 1985 when the first EU-China trade and co-operation agreement was signed.

Over the next decade or so, trade between the two blocs increased dramatically, with the relationship structured around regular bilateral summits and within the forum of the EU-Asean meetings, which celebrated its 20th anniversary this year.

On the European side, the aim is to gain better access to Chinese markets for EU investors. As EU trade negotiators have pointed out, despite the strong trade in goods, trade in services between the two blocs remains low, with China accounting for just 2 to 3 per cent of overall European investments abroad.

Among the EUs main concerns are the high level of government involvement in enterprise, protection rights for intellectual property and a lack of transparency, though recent indications from Beijing that it is to open up the market to foreign direct investment have been warmly welcomed by Brussels.

Despite the willingness on both sides to consolidate trade ties, the EU-Sino relationship faces significant challenges.

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European Union seeks comprehensive investment agreement with China

MEU Vienna 2015: Message from MEP Eugen Freund
MEP and frontrunner of the Austrian Social Democrats for the European Elections 2014, Eugen Freund has a message for all potential MEU participants.

By: Model European Union Vienna

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MEU Vienna 2015: Message from MEP Eugen Freund - Video

Putin Says Russia Will Drop South Stream If EU Does not Approve it
Russian President Vladimir Putin said on Monday Russia could not carry on with the South Stream gas pipeline project if the European Union was opposed to it. Speaking at a joint press conference...

By: WochitBusiness

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One of the political tides over here in the European Union is against the very idea of tax competition. That is, against the idea that different states, different nations, should have different tax rules and rates and that people can thus move around either themselves or their activities so as to pick and choose where and how much they pay in tax. This campaign against tax competition is a pernicious one but it looks like its going to be quite powerful. Its worth therefore laying out what is the point of having tax competition in the first place. We dont have to go all the way to the near paranoia of Mancur Olsen, who described government merely as being stationary bandits out to fleece the populace, either. We can be a lot more moderate than that and still justify tax competition.

Theres mainstream opposition to tax competition as this shows:

Our citizens and our companies expect us to cope with tax avoidance and aggressive tax planning. It is our common duty to meet their expectation by ensuring that everyone pays its fair share of tax to the state where profits are generated, Germanys Wolfgang Schuble, Frances Michel Sapin and Italys Pier Carlo Padoan wrote in a joint letter seen by The Wall Street Journal.

Since certain tax practices of countries and taxpayers have become public recently, the limits of permissible tax competition between member states have shifted. This development is irreversible.

And theres this new campaign from rather further over in left field, from the European Greens:

The aggressive tax competition between EU member states makes it possible for multinational corporations and wealthy individuals to avoid their tax responsibilities. The only winners of this are the wealthiest, whether individuals or corporations, and the losers are the vast majority of European citizens and smaller businesses. We want the EU and European governments to finally take action and we want your support to put pressure on them so they do.

Their declared end goal is that tax rates across the different nations of Europe must be harmonised: expressly with the aim of making tax competition impossible.

Now it is possible just to don our Mancur Olsen blinkers and view this as those bandits, predators upon the population, making sure that none of the sheep to be shorn manage to escape. But we dont have to go quite that far (despite my often agreeing with that view of government).

Think through what we like about competition in the first place. That Exxon, Total Total and Statoil Statoil all compete to provide us with oil is something we rather like. Not, of course, because it benefits Exxon, Statoil and Total. Rather, because it hampers them, hinders them, in their activities. If there was only one monopoly oil supplier in the world then we would be at their mercy. They could charge us as they wished for that gasoline to drive our cars, oil to heat homes and so on. Indeed, weve a large area of economics looking at what monopolies tend to do and we conclude that theyre destructive to the interests of us consumers. That competition between different suppliers acts as a brake on what they can do to us consumers. Thats exactly why we like competition. Because it protects us, the consumers, against them, the producers.

Government, governance, is no different. We here, as the citizenry, are the consumers of governance. And just like we pay for oil when we want it then we also pay for governance in the form of taxes (sadly, whether we want that governance or not). Government is the oil company, the provider of that governance funded by our taxes. And in exactly the same manner we think that competition here is a good thing. For competition limits what they may do to us.

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The Terrible European Union Campaign Against Tax Competition