Make a submission – medicines for human use

Certificate of a pharmaceutical product (English) DOCX : 190 KB | 16/03/2019 Application for a variation to a parallel import licence DOCX : 37 KB | 04/02/2017 Certificate of a pharmaceutical product (French) DOCX : 30 KB | 06/10/2016 Certificate of a pharmaceutical product (Spanish) DOCX : 32 KB | 06/10/2016 Application for registration of broker of finished medicinal products for human use DOCX : 114 KB | 29/07/2016 Application for waiver from written confirmation requirement DOCX : 62 KB | 30/06/2016 Manufacturing summary sheet form DOCX : 105 KB | 13/10/2015 Submissions of risk minimisation and educational materials for MAH DOCX : 60 KB | 17/06/2014 Application for Renewal of a Parallel Import Licence DOCX : 68 KB | 07/12/2013 Application for GDP certificate DOCX : 61 KB | 01/05/2013 Braille declaration form (h) DOCX : 60 KB | 21/02/2011 Application for a registration certificate for a Homeopathic Medicinal Product DOCX : 76 KB | 29/11/2010 Application for a variation to a registration certificate for a Homeopathic Medicinal Product DOCX : 62 KB | 29/11/2010 Application for a drug-device consultation DOCX : 90 KB | 02/06/2008