TITLE II

SCOPE
Article 2
1
This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
2
In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a
‘
medicinal product
’
and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.
3
Notwithstanding paragraph 1 and Article 3(4), Title IV of this Directive shall apply to medicinal products intended only for export and to intermediate products.
Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.