1. The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that those penalties are implemented. The penalties must be effective, proportionate and dissuasive.
Those penalties shall not be inferior to those applicable to infringements of national law of similar nature and importance.
2. The rules referred to in paragraph 1 shall address, inter alia, the following:
(a) the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well as the sale of falsified medicinal products at a distance to the public by means of information society services;
(b) non-compliance with the provisions laid down in this Directive on manufacturing, distribution, import and export of active substances;
(c) non-compliance with the provisions laid down in this Directive on the use of excipients.
Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.
3. The Member States shall notify the national provisions adopted pursuant to this Article to the Commission by 2 January 2013 and shall notify any subsequent amendment of those provisions without delay.
By 2 January 2018 , the Commission shall submit a report to the European Parliament and to the Council giving an overview of the transposition measures of Member States as regards this Article, together with an evaluation of the effectiveness of those measures.]
Textual Amendments
F1 Inserted 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).