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欧盟对API提出了新要求已有15人参与
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欧盟规定，至2013年起出口至欧盟的API，必须有本国政府出具证明该API是由符合欧盟GMP工厂生产的。 GMP News 03/05/2012 Import of APIs from Third Countries into the European Union: Template for the written Confirmation of GMP Compliance published for Comments From 2013 on, APIs from Third Countries will be allowed for importation into the European Union when - in addition to the GMP certificate - an enclosed document from the regulatory authority in the exporting countries confirms that: The GMP standards in the exporting country are equivalent to those in the EU The manufacturing plant is regularly and rigorously controlled. These controls should be unannounced. Measures should be taken in case of GMP deviations. The EU must be immediately notified about GMP deviations (by the members states' authorities). This will enforce the Anti-Counterfeiting Directive 2011/62/EU (see also our News from 14 December 2011). On 16 April 2012, the EU Commission aligned on the WHO's model GMP certificate and created a template for comment. The deadline for comment is 1 June 2012. Please also see the Commission consultation paper incl. the template. Note: You will get first hand information about the newest developments regarding manufacture, distribution, and safety of APIs at the "15th APIC/CEFIC European Conference on Acitve Pharmaceutical Ingredients" in Budapest, Hungary, from 7-9 November 2012 |
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