Evaluation of Bioequivalence of Drug Products / Position Statement of the International Association for Pharmaceutical Technology (APF e. V) on the Draft Guideline on the Investigation of Bioequivalence by the Committee for Medicinal Products for Human Use (CHMP)

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 258 (2009))

International Association for Pharmaceutical Technology (APV e. V.)

Evaluation of Bioequivalence of Drug Products / Position Statement of the International Association for Pharmaceutical Technology (APF e. V) on the Draft Guideline on the Investigation of Bioequivalence by the Committee for Medicinal Products for Human Use (CHMP) / International Association for Pharmaceutical Technology (APV e. V.)
Evaluation of Bioequivalence of Drug Products Position Statement of the International Association for Pharmaceutical Technology (APV e. V.) on the Draft Guideline on the Investigation of Bioequivalence by the Committee for Medicinal Products for Human Use (CHMP) In July 2008 the Committee for Medicinal Products for Human Use (CHMP) has issued a Draft “Guideline on the Investigation of Bioequivalence” which has been adopted by CHMP for release for consultation on July 24, 2008. This guideline will replace the “Note for guidance on the investigation of bioavailability and bioequivalence” (CPMP/EWP/QWP/1401/98) and the related questions in the Q&A document (EMEA/CHMP/EWP/40326/2006). The new guideline also includes recommendations on biowaivers based on the Biopharmaceutic Classification System (BCS). The APV Expert Panel unanimously came to the conclusion that this new guideline represents a significant step forward in the evaluation of bioequivalence of drug products taking into consideration well accepted principles and recent scientific findings in this regulatory document. It was also appreciated that the document focuses solely on bioequivalence and separates these from a general discussion of bioavailability as in the previous Note for Guidance. © ECV- Editio Cantor Verlag (Germany) 2009  

EMEA and EU Commission – Topical News / European Commission: Proposal for a Directive and Regulation amending provisions regarding information to the general public on medicinal products subject to medical prescription

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 264 (2009))

Friese B

EMEA and EU Commission – Topical News / European Commission: Proposal for a Directive and Regulation amending provisions regarding information to the general public on medicinal products subject to medical prescription / Friese B
EMEA and EU-Commission – Topical News European Commission: Proposal for a Directive and Regulation amending provisions regarding information to the general public on medicinal products subject to medical prescription Dr. Brigitte Friese Rechtsanwältin, Wyk-Wrixum auf Föhr, Germany The drafts of the Directive and Regulation amending provisions regarding information to the general public on medicinal products subject to medical prescription intend to improve the ability of the general public to receive information on medicinal products subject to medical prescription. This objective shall be achieved by providing for a detailed definition of “Information” in demarcation to promotion/advertising. The material provisions are contained in the draft Directive; the draft Regulation mainly refers to these provisions and declares them to be applicable to centrally authorised medicinal products. A set of information shall be allowed to be made available for the general public, such as information contained in SPC, labelling, package leaflets, information about environmental impact of the medieinal products, prices, and factual information such as about pack changes or adverse reaction warnings, and information about noninterventional scientifie studies. A comparison between medicinal products may not be contained in this information. This information has to comply with defined quality criteria and may only be disseminated via specified communication channels, health-related publications and internet and after prior approval by competent authorities or self-regulatory or co-regulatory bodies. TV and radio are not allowed as dissemination channels. Furthermore, the prohibition to actively disseminate unsolicited material to the general public is upheld. The websites used for providing information have to be registered and shall be subject to close monitoring of the competent Member States. Furthermore, a monitoring system shall be set up by Member States, ensuring prior control as well as control after dissemination of the information. © ECV- Editio Cantor Verlag (Germany) 2009  

Aktivitäten des CHMP 02/2009

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 268 (2009))

Throm S

Aktivitäten des CHMP 02/2009 / Throm S

Aktivitäten des COMP 02/2009

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 282 (2009))

Throm S

Aktivitäten des COMP 02/2009 / Throm S

Aktivitäten des PDCO 02/2009

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 289 (2009))

Throm S

Aktivitäten des PDCO 02/2009 / Throm S

Zur Frage der Preisbindung einzelimportierter Arzneimittel

Rubrik: Gesetz und Recht

(Treffer aus pharmind, Nr. 02, Seite 291 (2009))

Stallberg C

Zur Frage der Preisbindung einzelimportierter Arzneimittel / Stallberg C
Zur Frage der Preisbindung einzelimportierter Arzneimittel Dr. Christian Stallberg, LL.M. (Cambridge) Clifford Chance, Düsseldorf In dem nachfolgenden Beitrag wird untersucht, ob Importeure bei der Abgabe von Arzneimitteln, die im Wege des Einzelimports nach Deutschland eingeführt werden, der Arzneimittelpreisbindung unterliegen. Wäre dies der Fall, müssten bei der Preisgestaltung die gesetzlich vorgeschriebenen Großhandelshöchstzuschläge sowie Apothekenfestzuschläge beachtet werden. Trotz der praktischen Bedeutung dieser Frage besteht bislang Unsicherheit darüber, ob die Arzneimittelpreisbindung eingreift. Der Artikel zeigt auf, warum beim Vertriebsmodell des Einzelimports letztlich keine Preisbindung Anwendung finden kann. © ECV- Editio Cantor Verlag (Germany) 2009  

Weimer Pharma GmbH

Rubrik: Unternehmensprofile

(Treffer aus pharmind, Nr. 02, Seite 295 (2009))

Weimer Pharma GmbH /

Bericht von der Börse 02/2009

Rubrik: Wirtschaft

(Treffer aus pharmind, Nr. 02, Seite 299 (2009))

Batschari A

Bericht von der Börse 02/2009 / Batschari A

Bericht aus Großbritannien 02/2009

Rubrik: Ausland

(Treffer aus pharmind, Nr. 02, Seite 301 (2009))

Woodhouse R

Bericht aus Großbritannien 02/2009 / Woodhouse R

Bericht aus USA 02/2009

Rubrik: Ausland

(Treffer aus pharmind, Nr. 02, Seite 306 (2009))

Richter M

Bericht aus USA 02/2009 / Richter M