Regulation 2000/847 - Provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority' - Main contents

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Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority'

Official Journal L 103 , 28/04/2000 P. 0005 - 0008

Commission Regulation (EC) No 847/2000

of 27 April 2000

laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts "similar medicinal product" and "clinical superiority"

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products(1), and in particular Articles 3 and 8 thereof,

Whereas:

• (1) 

  Regulation (EC) No 141/2000 calls on the Commission to adopt provisions necessary for the implementation of Article 3 and to adopt definitions of "similar medicinal product" and "clinical superiority".

• (2) 

  In order to implement Article 3 of Regulation (EC) No 141/2000, additional details on the factors that should be considered when establishing prevalence, likely return on investment and the satisfactory nature of alternative methods of diagnosis, prevention and treatment may be helpful for sponsors and the Committee for Orphan Medicinal Products.

• (3) 

  This information should be presented in accordance with the guidance drawn up by the Commission pursuant to Article 5(3) of Regulation (EC) No 141/2000.

• (4) 

  Given the nature of the medicinal products concerned, and the probability that the conditions to be treated are rare, it is not appropriate to lay down overly prescriptive requirements to establish that the criteria are met.

• (5) 

  The assessment of the criteria referred to in Article 3 should be on the basis of information that is as objective as possible.

• (6) 

  Other Community measures in the field of rare diseases should be taken into account.

• (7) 

  In order to ensure appropriate respect of the market exclusivity provisions laid down in Article 8 of Regulation (EC) No 141/2000, it is necessary to lay down definitions of the concepts of "similar medicinal product" and "clinical superiority"; these definitions should take into account the work and experience of the Committee for Proprietary Medicinal Products in evaluating existing medicinal products, and the relevant opinions of the Scientific Committee on Medicinal Products and Medical Devices.

• (8) 

  The definitions should be further supported by the guidelines foreseen by Article 8(5) of Regulation (EC) No 141/2000.

• (9) 

  These provisions should be updated regularly in the light of scientific and technical knowledge and experience with the designation and regulation of orphan medicinal products.

• (10) 

  The measures provided for in this Regulation are in conformity with the opinion of the Standing Committee on Medicinal Products for Human Use,

HAS ADOPTED THIS REGULATION:

Article 1

Purpose

This Regulation lays down factors to be considered when implementing Article 3 of Regulation (EC) No 141/2000 on orphan medicinal products and establishes definitions of "similar medicinal product" and "clinical superiority" for the purposes of implementing Article 8 of the abovementioned Regulation. It is intended to assist potential sponsors, the Committee for Orphan Medicinal Products, and competent authorities in the interpretation of Regulation (EC) No 141/2000.

Article 2

Criteria for designation

• 1. 

  Prevalence of a condition in the Community

For the purpose of establishing, pursuant to the first subparagraph of Article 3(1)(a) of Regulation (EC) No 141/2000, that a...

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