Updated on Implementation of the Counterfeit Directive 2011/62 in the EU Countries

All EU countries are obliged to transpose the requirements of the so-called Counterfeit Directive 2011/62EU in their national legislation. The EU Commission monitors the implementation and takes action against EU countries who wouldn't adapt/ extend their legislation on time.

Now, a list has been published with the national regulations of each single EU country. For example, tn the case of Germany, it is referred to the legal act "Zweites Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“ adopted by the Federal Government. It is striking that many countries haven't either implemented the Directive yet or haven't communicated the respective information to the EU.

However, it should be noted that, even if a country has finalized the implementation, this doesn't mean in any case that the Member State law complies with all the requirements according to the EU regulations. The EU Commission will continue to closely monitor the implementation in the different EU countries.

On 15 March 2013, the EU Commission published a document which provides an overview over the measures to be taken for the implementation of Directive 2011/62/EU. The document lists the current status of so-called Delegated Acts (i.e.. GMP for APIs), Implementation Acts and Guidelines (i.e. GDP for APIs).