LegalizeCommission Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’ (Text with EEA relevance. )
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
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 Article 8(4) thereof,
Whereas:
(1) Regulation (EC) No 141/2000 was adopted to promote research in the field of rare diseases. It offers undertakings that develop orphan medicinal products the prospect of obtaining market exclusivity for a certain number of years.
(2) Commission Regulation (EC) No 847/2000 (2) provides a definition of the concept ‘similar medicinal product’, which includes specific cases defining what kind of products are to be regarded as similar for the purposes of the application of Article 8 of Regulation (EC) No 141/2000. That definition should be updated in the light of new scientific and technical knowledge, in particular, due to major developments in the field of biological medicines, and especially advanced therapy medicinal products, and in the light of experience gained with regard to the designation and regulation of orphan medicinal products.
(3) In addition, there is a need for a clear definition of the concept ‘principal molecular structural features’, which is used within the definition of the concept ‘similar active substance’, which is in turn used within the definition of the concept ‘similar medicinal product’. As regards the biological medicinal products, the definition of ‘principal molecular structural features’ shall capture certain molecular modifications significantly contributing to the functional characteristics of the active substance that would impact whether or not the products are considered as similar. However, for advanced therapy medicinal products the principal molecular structural features cannot be fully identified. Therefore, in the case of advanced therapy medicinal products the similarity between two active substances should be assessed on the basis of the biological and functional characteristics.
(4) The definition of ‘active substance’ should be deleted as Article 8(4) of Regulation (EC) No 141/2000 does not empower the Commission to define the term ‘active substance’. The term ‘active substance’ is legally defined in Article 1(3)(a) of Directive 2001/83/EC of the European Parliament and of the Council (3) and the scope and purpose of Article 3(3) of Regulation (EC) No 847/2000 are related to the definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’.
(5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS REGULATION:
Article 1
In Article 3(3) of Regulation (EC) No 847/2000, the introductory sentence and points (a), (b) and (c) are replaced by the following:
‘For the purposes of the application of Article 8 of Regulation (EC) No 141/2000 on orphan medicinal products, the following definitions shall apply:
(a) deleted;
(b) “similar medicinal product” means a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication;
Article 2
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 May 2018.
For the Commission The President Jean-Claude JUNCKER
(2) 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’ (OJ L 103, 28.4.2000, p. 5).
(3) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).