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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.
[F23. Notwithstanding paragraph 1 of this Article and Article 3(4), Title IV of this Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, active substances and excipients.
4. Paragraph 1 shall be without prejudice to Articles 52b and 85a.] ]
Textual Amendments
F1 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.
F2 Substituted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).