Corrigendum of the EU Counterfeit Directive

In the Official Journal of the European Union from 9 August 2014, two corrigenda to the Directive 2011/62/EU of the European Parliament and of the Council were published to correcting 2001/83/EG on the Community code relating to medicinal products for human use with regard to the prevention of the entry into the legal supply chain of medicinal products which are falsified.

Corrigendum 1:
On page 78, Article 1 (5) (new point) read: "to inform the competent authority and the marketing authorisation holder immediately" for: "the competent authority and the holder of the manufacturing authorisation".

Corrigendum 2:
On page 80, Article 1 (2), new Article 54a paragraph 1 subparagraph 2, read: "Medicinal products not subject to prescription shall not bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification" (German wording "müssen nicht" = do not have to).

for:  "Medicinal products not subject to prescription shall not have to bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification" (German wording "dürfen nicht" = are not permitted to).

With this second corrigendum it has been made clear that voluntary labelling of medicinal products not subject to prescription is not permitted.

You can find the corrigenda in the Official Journal of the European Union.

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