News
EMEA: Guideline on clinical evaluation of diagnostic agents
01.02.2010
Overview of comments on draft guideline on clinical evaluation of diagnostic agents. ...
CMD(h)Recommendations on submission dates for Applicants of the DCP
22.01.2010
This document was produced by the CMD(h) in order to facilitate planning of submission dates of new applications going trough the decentralised procedure ...
CMD(h): Flow chart of the Decentralised Procedure
22.01.2010
The Heads of Medicines Agencies together with MRFG and VMRFG have agreed a flow chart for the DCP ...
EMEA: QRD recommendations on the expression of strength in the name of centrally authorised human medicinal products.
22.01.2010
Directive 2001/83/EC requires a medicinal product labeled as invented name – strength-pharmaceutical form. The strength in the name of the product is the quantity of the active substance which
...
MoH: Regulation of Polish Ministry of Health from 24 December 2009 (Dz. U. Nr 233, poz. 1792) changing the Regulation regarding the methods of setting and paying fees related to the obtaining the Marketing Authorization
07.01.2010
In particular mentioned Regulation changed the “basic amount” which determines fees in all registration procedures. ...
EMEA: Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice
04.01.2010
This procedural advice addresses a number of questions which applicants may have before submitting an application. The information provided - under the form of Questions and Answers - will be
...
MHRA: Advanced therapy medicinal products
04.01.2010
The updated section provides advice and guidance on the regulatory arrangements that apply to advanced therapy medicinal products (ATMPs). ...
New MHRA guidance for the naming of medicinal products
04.01.2010
MHRA has issued new naming policy guidance for product names with respect to invented names and qualifiers, umbrella segments, generic nomenclature and Braille requirements. ...