Source: Regulatory and procedural guidelines (human and veterinary) Category: Regulatory and procedural guidelinesBy Ralphc25th May 2018 Author: Ralphc Post navigationNextNext post:Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP)Related postsRegulatory and procedural guideline: EudraVigilance registration manual26th July 2018Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted19th July 2018Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 201819th July 2018Regulatory and procedural guideline: IRIS quick guide to the portal for orphan industry users4th July 2018Regulatory and procedural guideline: Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry, draft: consultation open29th June 2018Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product27th June 2018
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Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 201819th July 2018
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Regulatory and procedural guideline: Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry, draft: consultation open29th June 2018
Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product27th June 2018