Why has Mutual Recognition never become common practice for Homeopathic Medicinal Products?

Rubrik: Originale

(Treffer aus pharmind, Nr. 02, Seite 262 (2019))

Klein G | Sprenger A

Why has Mutual Recognition never become common practice for Homeopathic Medicinal Products? / The two pioneer cases of Mutual Recognition/Decentralised Procedures with homeopathic medicinal products in the simplified registration – Part 2*Part 1 see Pharm. Ind. 2019;81(1):104–112. · Klein G, Sprenger A · ¹Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und Weleda AG, Schwäbisch Gmünd
Directive 2001/83/EC as amended in 2004 lays down the mutual recognition procedure for homeopathic medicinal poducts (HOMPs) subject to the simplified registration: Any simplified registration according to Art. 14 in a member state can be a reference for a MRP in another member state. But practice shows that it remains unclear, in which cases a simplified registration of a homeopathic medicinal product in certain member states can be considered to be “the same medicinal product” and therefore is suitable to trigger a MRP. The existing general definition of “same medicinal product” given by Chapter 2 of Notice to Applicants Volume 2A ( “any ...

Why has Mutual Recognition never become common practice for Homeopathic Medicinal Products?

Rubrik: Originale

(Treffer aus pharmind, Nr. 01, Seite 104 (2019))

Klein G | Sprenger A

Why has Mutual Recognition never become common practice for Homeopathic Medicinal Products? / The two pioneer cases of Mutual Recognition/Decentralised Procedures with homeopathic medicinal products in the simplified registration – Part 1 · Klein G, Sprenger A · ¹Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und Weleda AG, Schwäbisch Gmünd
Mutual Recognition Procedure Decentralised Procedure Homeopathic Medicinal Product Simplified Registration Deregulation This publication presents the experiences of the first 2 European multi-state registration procedures according to Chapter 4 of Directive 2001/83/EC executed with homeopathic medicinal products (HOMPs). Obtaining registrations for this category of medicinal products presents particular challenges related to their characteristics and market situation ( fig. 1 ). This is considered in the European law by definition of special registration procedures for HOMPs ( fig. 2 ). According to the legal definition, homeopathic medicinal products (HOMPs) are prepared according to homeopathic manufacturing procedures laid down in the European Pharmacopoeia or in an official ...