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Regulation (EC) No 726/2004 (EMA)
European Medicines Agency (EMA)
Article 12

Article 12

1.
The marketing authorisation shall be refused if, after verification of the particulars and documents submitted in accordance with Article 6, it appears that the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product.

Authorisation shall likewise be refused if particulars or documents provided by the applicant in accordance with Article 6 are incorrect or if the labelling and package leaflet proposed by the applicant are not in accordance with Title V of Directive 2001/83/EC.

2.
The refusal of a ►M8 Union◄ marketing authorisation shall constitute a prohibition on the placing on the market of the medicinal product concerned throughout the ►M8 Union◄.
3.
Information about all refusals and the reasons for them shall be made publicly accessible.