EMEA: Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice

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

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

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

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

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 ...

CMDh: Phvwp and Cmd(H) Best Practice Guide for Work Sharing Concerning The Assessment Of Psurs of Products for Which an EU Harmonised Virtual Birth Date and Related Harmonised Data Lock Point Have Been Agreed

This document sets outs the responsibilities of the P-RMS and P-CMS with respect to work sharing in the assessment of PSURs. The responsibilities of the MAHs are set out in a separate guidance ...

EMEA: Substances considered as not falling within the scope of Regulation (EC) No 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

Regulation (EC) 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The Regulation ...

EMEA: Explanatory note on fees payable to the European Medicines Agency

Following the publication of the Rules for the implementation of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures1 as last adopted by the Agency’s ...

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