Administrative regulations

Administrative regulations

(unofficial translations)

4/2019 Applying for and maintaining a marketing authorisation for a medicinal product 

3/2019 Labelling and package leaflets for medicinal products

2/2019 Reporting of product defects and suspected falsifications

1/2019 Good distribution practice of medicinal products 

2/2018 Applying for and maintaining a marketing authorisation and registration for a medicinal product

2/2017 Applying for and maintaining a marketing authorisation and registration for a medicinal product (updated version published on December 21st, 2017)

5/2014 Preparation of advanced therapy medicinal products (ATMP) for the treatment of individual patients (hospital exemption)

5/2013 Good distribution practice of medicinal products

4/2014 Parallel import of medicinal products

4/2013 Pharmacovigilance

3/2013 Labelling and package leaflets for medicinal products

2/2012 Clinical trials on medicinal products

1/2012 Veterinary pharmacovigilance

3/2010 Clinical trials on medicinal products for veterinary use

4/2009 Product defects