Header graphic for print
Focus on Regulation

Tag Archives: medicinal products for non-EU countries

EMA updates guidance concerning medicinal products intended exclusively for non-EU countries

The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several questions which applicants requesting a scientific opinion as provided in Article 58 of Regulation (EC) No 726/2004 (“Article 58”, the “EMA Regulation”) may have. Article 58