Kirin Amgen applied for an ABC for Aranesp in Lithuania based on its EU Marketing Authorisation (MA) (granted according to Reg. 2309/93) while it did not have a national MA in Lithuania. Article 19a(e) of Regulation 1768/92 stipulates that applications for ABCs relating to national MAs existing in Lithuania before its entrance to the EU may be filed within 6 months after the date of entrance. AG Bot concludes that this provision should be interpreted strictly since it is the result of elaborate negotiations and have been drafted in view of the entering state's health care system. The EU-MA can therefore not be regarded as an earlier national MA in the sense of article 19a(e).
Another line of argument was that from the moment of entrance to the EU, the EU-MA became in force in Lithuania. This should therefore be regarded as the date of the grant of the MA in the sense of article 3(b) of Reg. 1768/92. This suggested exception is also rejected by the AG since it is not in line with the wording and system of the regulation. According to Bot, this would lead to an unharmonised calculation of terms for the ABCs throughout the EU.
Read the opinion (available in various languages) here.
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