EN PL

News

EMEA: Guideline on the readability of the labelling and package leaflet of medicinal product for human use

30.01.2009
EMEA:
Guideline on the readability of the labelling and package leaflet of medicinal product for human use, Rev 1, 12 January 2009

The main purpose of this document is to ...

EMEA: Adopted guideline, time allowed for Applicants to respond to Questions and Issues raised during the assessment of new Marketing Authorisation Applications in the Centralised Procedure

30.01.2009
EMEA:
Adopted guideline, time allowed for Applicants to respond to Questions and Issues raised during the assessment of new Marketing Authorisation Applications in the Centralised ...

EMEA: Dossier requirements for Post-authorisation submissions in the centralised procedure

30.01.2009
EMEA:
Dossier requirements for Post-authorisation submissions in the centralised procedure from 01 January 2009. Dossier requirements for (Co-) Rapporteur and CHMP members. ...

MHRA: Updated guidance on changes to labelling and patient information leaflets for self certification

30.01.2009
MHRA:
Updated guidance on changes to labelling and patient information leaflets for self certification. This document sets out the circumstances under which changes to the labeling and ...

EMEA: Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

30.01.2009
EMEA:
Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD). This Guideline is intended to assist applicants ...

EMEA: Guideline on the development of New Products for the Treatment of Nicotine Dependence

30.01.2009
EMEA:
Guideline on the development of New Products for the Treatment of Nicotine Dependence. The present document is to provide guidance in the definition of treatment goals, study design, ...

EMEA: Draft guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

30.01.2009
EMEA:
Draft guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension. The main focus of this guideline is pulmonary arterial ...

EMEA: Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods

30.01.2009
EMEA:
Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods. The new guideline will provide recommendations for the validation of a ...

EMEA: Guideline on development, production, characterization and specifications for monoclonal antibodies and related products

30.01.2009
EMEA:
Guideline on development, production, characterization and specifications for monoclonal antibodies and related products. This guideline addresses quality issues for the marketing ...

EDQM: Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium

30.01.2009
EDQM:
Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium
The purpose of this document is to provide to all users of the European Pharmacopoeia ...