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FDA: Office of Nonprescription Products

28.02.2009
FDA:
Office of Nonprescription Products, Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References and other Regulatory Information. ...

European Commission: Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

16.02.2009
European Commission:
Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. This document is intended to provide recommendations on ...

HMA: Cover letter for Variation Applications in the Mutual Recognition Procedure January 2009

16.02.2009
HMA:
Cover letter for Variation Applications Dossier for Type IA/Type IB/Type II in the Mutual Recognition Procedure January 2009 ...

HMA: Procedural Advice on Repeat Use (MRP/DCP)

16.02.2009
HMA:
Procedural Advice on Repeat Use (MRP/DCP). This procedure can be used in the following situations: either by application to new Concerned Member States (CMS) not involved in the first ...

HMA: Request for Marketing Authorisation Holders for medicinal products presented as pressurised metered dose inhalers

16.02.2009
HMA:
Request for Marketing Authorisation Holders for medicinal products presented as pressurised metered dose inhalers. The aim of that document is to ensure that studies have been ...

EMEA: Adopted Community Herbal Monograph on Boldi folium Peumus boldus Molina

16.02.2009
EMEA:
Adopted Community Herbal Monograph on Boldi folium Peumus boldus Molina (Boldo leaf). (14 January 2009) ...

EMEA: Adopted Community herbal Monograph on Salicis cortex Salix purpurea L.

16.02.2009
EMEA:
Adopted Community herbal Monograph on Salicis cortex Salix purpurea L.; Salix daphnoides Vill.; Salix fragilis L., cortex. (14 January 2009) ...

EMEA: Overview of comments on the draft guideline: Quality aspects of single-dose veterinary spot-on products

16.02.2009
EMEA:
Overview of comments on received on draft guideline: Quality aspects of single-dose veterinary spot-on products. (11 February 2009) ...

EMEA: Draft reflection paper on level of purification of extracts to be considered as herbal preparations

16.02.2009
EMEA:
Draft reflection paper on level of purification of extracts to be considered as herbal preparations. he key issue is whether it is possible to establish criteria to distinguish ...

EMEA: Recommended format for \'List of references supporting an HMPC assessment report\'

16.02.2009
EMEA:
Recommended format for \'List of references supporting an HMPC assessment report\'. (06 November 2008) ...