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EMA and EU Commission – Topical News
Manufacture of Active Substances in the Light of Prevention of Entry into the Legal Supply Chain of Falisified Medicinal Products: Commission published two Concept Papers for Public Consultation in Relation to the Assessment of the Regulatory Framework of third Countries and the Application of Good Manufacturing Practice
europharm
I. Concept Paper on the Requirements for the Assessment of the Regulatory Framework applicable to the manufacture of active substances of human medicinal productsII. Concept Paper on a Delegated Act on the Principles and Guidelines of GMP for Active Substances for Human Medicinal Products
RAin Dr. Brigitte Röhrig-Friese · Rechtsanwaltskanzlei Röhrig-Friese, Betzdorf/Sieg (Germany)
 | RAin Dr. Brigitte Röhrig-Friese, Rechtsanwaltskanzlei Röhrig-Friese, Sebastian-Kneipp-Straße 19, 57518 Betzdorf/Sieg (Germany), Fax: + 49 (0) 700-72 37 43 73, e-mail: office@kanzlei-roehrig.de |
Directive 2011/62/EU on Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal products which was published in the Official Journal on July 1, 20111) had been the result of an assessment made in the course of the initiative of “Better Regulation Strategy” which had identified one of the important aims to minimize risks emanating from the entry into
