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European Medicines Agency (EMA)
Article 84

Article 84

1.
Without prejudice to the ►M8 Protocol on the Privileges and Immunities of the European Union, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the regulations adopted pursuant to it and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive.

Member States shall inform the Commission of these provisions no later than 31 December 2004. They shall notify any subsequent alterations as soon as possible.

2.
Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
▼M8 ————— ▼M8