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European Medicines Agency (EMA)
Article 3

Article 3

1.
No medicinal product appearing in the Annex may be placed on the market within the ►M8 Union unless a marketing authorisation has been granted by the ►M8 Union in accordance with the provisions of this Regulation.
▼M8
2.

Any medicinal product not appearing in Annex I may be granted a marketing authorisation by the Union in accordance with this Regulation, if:

(a)

the medicinal product contains an active substance which, on 20 May 2004, was not authorised in the Union; or

(b)

the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interest of patients' health at Union level.

▼B
3.

►M8 A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC under the following conditions:

(a)

the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC;

(b)

the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the ►M8 Union except for those parts of the summary of product characteristics referring to indications or dosage forms which were still covered by patent law at the time when the generic medicine was marketed; and

(c)

the generic medicinal product is authorised under the same name in all the Member States where the application has been made. For the purposes of this provision, all the linguistic versions of the INN (international non-proprietary name) shall be considered to be the same name.

▼M8 ————— ▼B