EMA and EU-Commission – Topical News
Directive 2011/62/EU on Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products has been published in the Official Journal – Part II
RAin Dr. Brigitte Friese
Rechtsanwaltskanzlei Friese, Betzdorf/Sieg (Germany)
In the previous issue of this journal, in points I. – V. the structure and systematic approach of the new Directive on Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products including the amendments to Title IV of the Directive 2001/83/EC (Human Code) – Manufacture and Importation – has been dealt with. In this second part of the publication the amendments to the safety features, new provisions on wholesale distribution and brokering of medicinal products, the new provisions on “Sale at a Distance to the Public” and the provisions on supervision and sanctions will be highlighted.
pharmind 2011, Nr. 9, Seite 1620