Article 16 of the proposal refers to two possible procedures which may be used to enable importing countries to control the quality of the pharmaceuticals exported: a marketing authorisation for the European market (under Article 6 of Directive 2001/83/EC) or the scientific opinion procedure (under Article 58 of Regulation (EC) No 726/2004).
Article 16 of the proposal refers to two possible procedures which may be used to enable importing countries to control the quality of the pharmaceuticals exported: a marketing authorisation for the European market (under Article 6 of Directive 2001/83/EC) or the scientific opinion procedure (under Article 58 of Regulation (EC) No 726/2004).