Make a submission – medicines for human use

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

Submissions of risk minimisation and educational materials for MAH

DOCX : 60 KB | 17/06/2014

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