Of medicinal products
Found 10 free book(s)
ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF …
www.ich.org3 ICH HARMONISED GUIDELINE ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1) ICH Consensus Guideline Released for Adoption on 18 August 2017, at Step 4 of the ICH
Guidance on the homeopathic medicinal products dossier
www.hma.euhomeopathic medicinal product working group (hmpwg) guidance on module 3 of the homeopathic medicinal products dossier discussion in the hmpwg 2003- 2005 release for consultation december 2005 deadline for comments february 2006 discussion in the hmpwg june/november2006 adoption by the hmpwg november 2006 adoption by the hma november 2007 1
Regulatory Q&A on herbal medicinal products
www.ema.europa.euTraditional herbal medicinal products exclusively contain as active ingredients herbal substances and/or herbal preparations. Vitamins and minerals with ancillary action may be present.
Recommendations for the evaluation of animal cell cultures ...
www.who.intENGLISH ONLY FINAL Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the ...
Quick Response (QR) codes in the labelling and/or package ...
www.salute.gov.itQuick Response (QR) codes in the labelling and/or package leaflet of centrally authorised veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised
GUIDE TO GOOD MANUFACTURING PRACTICE FOR …
www.medsafe.govt.nzTable of contents PE 009-8 (Annexes) -i-15 January 2009 ANNEXES Annex 1 Manufacture of sterile medicinal products.....1
DIRECTIVE FOR IMPORTATION AND RELEASE OF …
www.who.intdraft template document [name of national regulatory authority] directive for importation and release of investigational medicinal products for clinical trials to be conducted in (name of the country)
European Medicines Agency Inspections
ec.europa.euguideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
Commission Regulation (EU) No 712/2012 of 3 August 2012 ...
ec.europa.euCOMMISSION REGULATION (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of
Harmonised Technical Guidance for Non-eCTD electronic ...
esubmission.ema.europa.euThis Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities in the EEA (hereafter referred to as NCAs).
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