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Denmark asks API users to register; EU sets out GMP assessment criteria

By Gareth Macdonald , 29-Jan-2013
Last updated the 29-Jan-2013 at 14:43 GMT

Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).

The DKMA issued the order this week citing the Falsified Mediciens Directive (FMD) – which is designed to ensure only active pharmaceutical ingredients (API) made in compliance with EU good manufacturing practices are available in Europe -  as the primary motivation.

The Agency – which also wants drug product brokers to register – asked manufacturers to provide specific details of the APIs they use at each site and called on importers to identify the country of origin of any actives shipped to Denmark .

Mette Elstrom from the DKMA told in-Pharmatechnologist.com that: "It has been estimated that we in Denmark would count approximately 15 API manufactures and 15 API distributors. But this is only a guess,"

Elstrom added that to date "we have registered 1 API manufacture, 3 API importers, 4 API distributors and 2 brokers of medicinal products."

Firms registering the agency are liable to inspection by the DKMA within 60 days of receipt of filing their documents and are not permitted to begin using APIs until they are given the go-ahead by the agency.

Denmark is one of a number of European Union countries to start asking drug and API makers for more information as a result of the new import laws, the most recent of which was the UK’s MHRA which quizzed pharmaceutical firms with its jurisdiction about suppliers earlier this month.

Similar efforts have also started outside the Europe Union. Last week the SFDA asked API makers in China for details of their European customers as part of a review prompted by the new legislation.

Assessment criteria

In other API-related news, details of the framework used to see if a country’s good manufacturing practices (GMP) regulations are equivalent to those in Europe were published in the official journal of the European Union earlier this week.

Countries deemed to have comparable rules will not be required to provide local manufacturers with written confirmation of quality for each API batch shipped to Europe. To date only Switzerland has been granted such exemption, although the US, Israel, Australia, Singapore and Japan have asked for such status.

According to the one page document the Commission will base its GMP equivalence assessment on a country’s guidelines on manufacturing, inspection resources, its alert and crisis management systems and ability to communicate information to the EU.

Tony Scott, adviser to the European Fine Chemicals Group (EFCG), told in-Pharmatechnologist.com that: “The commission must have already started making these assessments.

“They granted Switzerland equivalence status (see OJ L 325, 23.11.12) and are not yet prepared to accept Israel’s requestOther countries, including the USA, are presently subject to equivalence assessment.”

He added that the document published on January 23 just “puts the assessment into law.”

He also reiterated the EFCG’s concerns about the overall approach to monitoring API quality detailed in the FMD, arguing that even if manufacturers in 3rd countries have registered GMP-compliant facilities, “the real problem is when registered facilities outsource production to unregistered third party chemical manufacturers and ship under the name of the registered company”, Scott said, suggesting that “such practices could allow such APIs to reach the EU without the correct regulatory oversight.”  

Scott also rejected the idea the EFCG’s criticism is motivated by a desire to minimize competition in the European Union market, commenting that “Our concerns are not about protectionism at all. They are about leveling the playing field and ensuring that API suppliers into the EU have to meet the same quality requirements regardless of where they are based.”

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