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BRUSSELS: The European Union is taking a big step toward giving EU member states the power to ban the cultivation of genetically modified crops even if they have been approved by the food safety authority of the 28-nation bloc.

The European Parliament and member states agreed Thursday that national governments can have the final say in the matter, a move that goes counter to many EU initiatives, which traditionally seek a common stance on EU policies.

EU Food Safety Commissioner Vytenis Andriukaitis said member states "can take into account their national context and, above all, the views of their citizens."

The measure still needs final approval from the parliament and member states over the coming weeks but EU officials said that no longer poses a substantial problem after Thursday's agreement.

"Citizens, farmers and industry finally get legal certainty," said Peter Liese, a parliamentarian from the EPP Christian democrat group.

Under the broad agreement, member states will have to get a special opt-out for every GM crop they seek to ban. Other member states must make sure that pollen or seeds do not inadvertently drift into nations that ban them.

The EU has tried to come up with a unified rulebook for the past four years but the issue has proved so divisive it was impossible to find a breakthrough until now.

Environmental groups still consider the proposed text less than watertight and fear that agribusiness multinationals will be able to challenge a national ban in court.

The EU has strict guidelines on authorizing and informing consumers about foods containing GMOs, a policy that has caused problems for producers of genetically modified seeds such as the U.S.-based Monsanto Co., which are used to less stringent rules around the world.

Only one GM crop is planted in the EU so far, predominantly in Spain.

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European Union makes move to let member states block genetically modified crops

In an another quality-related setback, Ranbaxy Laboratories has received an import ban in the European Union on its injectable antibiotic manufactured at its cephalosporin injectable unit at Dewas in Madhya Pradesh, 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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Germany bans Ranbaxy's injectable antibiotic in European Union

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