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European Medicines Agency (EMA)
Article 58

Article 58

1.
The Agency may give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the ►M8 Union. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply.
2.
The said Committee shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice.