EN PL

News

European Commision: Recommendation on “Pharmacovigilance Urgent Measures” procedure under Article 107 of Directive 2001/83/EC

16.02.2009
European Commision:
Recommendation on “Pharmacovigilance Urgent Measures”
procedure under Article 107 of Directive 2001/83/EC. Where, as a result of the evaluation of ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions

16.02.2009
FDA:
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions
...

FDA: Nonclinical Evaluation for Anticancer Pharmaceuticals

16.02.2009
FDA:
Nonclinical Evaluation for Anticancer Pharmaceuticals
This guideline provides information for pharmaceuticals that are only intended to treat cancer in 69 patients with late ...

The Polish Office for Registration: The statement of the President of the Office for Registration relating to the publication of the new version (VIII) of Polish Pharmacopoeia

30.01.2009
The Polish Office for Registration:
The statement of the President of the Office for Registration from 05 January 2009 relating to the publication of the new version (VIII) of Polish ...

Ministry of Health: Regulation project relating to veterinary medicinal product

30.01.2009
Ministry of Health:
Regulation project relating to the presentation of the registration documentation of veterinary medicinal product ...

Ministry of Health: Regulation project relating to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

30.01.2009
Ministry of Health:
Regulation project relating to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products including new rights and obligations of the ...

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 ...