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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
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Version Superseded: 02/07/2012
Point in time view as at 30/12/2008.
There are currently no known outstanding effects for the Regulation (EC) No 726/2004 of the European Parliament and of the Council, Article 82.
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1.Only one authorisation may be granted to an applicant for a specific medicinal product.
However, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.
2.As regards medicinal products for human use, Article 98(3) of Directive 2001/83/EC shall apply to medicinal products authorised under this Regulation.
3.Without prejudice to the unique, Community nature of the content of the documents referred to in Article 9(4)(a), (b), (c) and (d) and in Article 34(4)(a) to (e), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product covered by a single authorisation.
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