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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) ...

EMEA: Revised Assessment report template for the development of community monographs and for inclusion of herbal substance(s), preparation(s) or combinations thereof in the list

16.02.2009
EMEA:
Revised Assessment report template for the development of community monographs and for inclusion of herbal substance(s), preparation(s) or combinations thereof in the list - Word ...

EMEA: Guideline on the quality aspects of single-dose veterinary spot-on products

16.02.2009
EMEA:
Guideline on the quality aspects of single-dose veterinary spot-on products. The guideline applies to pharmaceutical veterinary medicinal products presented as single-dose liquids, ...

EMEA: Community herbal monograph Juniperi psuedo-fructus Juniperus communis L

16.02.2009
EMEA:
Community herbal monograph Juniperi psuedo-fructus Juniperus communis L., psuedo fructus (juniper berry). List of references. (14 January 2009) ...