Regulatory Focus™ > News Articles > Brazil Establishes Contingency Process for Dealing With EU API Export Rules

Brazil Establishes Contingency Process for Dealing With EU API Export Rules

Posted 25 April 2013 | By Louise Zornoza 

Under a new plan announced by Brazil's regulatory agency, Anvisa, even if Brazil fails to obtain EU recognition for its active pharmaceutical ingredient (API) good manufacturing practice (GMP) standards by the mandatory date of 2 July 2013, regulators will still provide Brazilian companies with a document indicating GMP compliance so facilitate exports of their APIs.

The Falsified Medicines Directive (Directive 2011/62/EU) was adopted in May 2011 to safeguard public health in the EU by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introduced new rules to more rigorously regulate the supply chain.

According to the Directive, written confirmation of GMP compliance for exports of API to the EU will be required as of 2 July 2013 from countries that are not listed as having equivalent GMPs. Anvisa submitted a formal request to the EU in October 2012 to be part of that list and the European Commission is still assessing that request. 

Brazilian companies that have valid GMP certificates will need to submit a petition to Anvisa using "CERTIFICATE-7239," the regulator said.

 

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