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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 ...

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. ...

MHRA: New Variations Regulation - Latest guidelines and application form published

04.01.2010
Final versions of the European Commission (EC) procedural and classification guidelines, together with the new variation application form are now published ready for implementation of the new ...

CDMh: Guidance Document For Marketing Authorisation Holders on Submissions of Psurs Under The Eu Psur Work Sharing Scheme

18.12.2009
This document sets out the responsibilities of the Marketing Authorisation Holders with respect to the submission of PSURs under the work sharing scheme. The responsibilities of the National ...