1. This Regulation shall apply to SMEs within the meaning of Recommendation 2003/361/EC in the version of 6 May 2003 which are established in the Community.
2. Unless otherwise specified, this Regulation shall apply both to applications concerning medicinal products for human use and to applications concerning veterinary medicinal products, within the meaning of Directives 2001/83/EC ( 5 ) and 2001/82/EC ( 6 ) of the European Parliament and of the Council respectively.
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04
CitationArticle 2 of Commission Regulation (EC) No 2049/2005 (LawPlayer, data as of 2026-07-04)