Administrative regulations and guidelines

Unofficial translations

Administrative regulations

6/2022 Good manufacturing practice for medicinal products and the requirements for the manufacturing of investigational medicinal products (pdf)

4/2019 Applying for and maintaining a marketing authorisation and registration for a medicinal product (pdf)

3/2019 Labelling and package leaflets for medicinal products (pdf)

2/2019 Reporting of product defects and suspected falsifications (pdf)

1/2019 Good distribution practice of medicinal products (pdf)

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

5/2013 Good distribution practice of medicinal products (pdf)

4/2014 Parallel import of medicinal products (pdf)

4/2013 Pharmacovigilance (pdf)

1/2012 Veterinary pharmacovigilance (pdf)

3/2010 Clinical trials on medicinal products for veterinary use (pdf)

Normative guidelines

1/2019 Labelling and package leaflets for medicinal products (pdf)

1/2017 Reporting of adverse reactions (pdf)

Other guidelines

Fimea's Circular to pharmacies on the conditions for prescription of medicinal products for ADHD and Sic notations (17.2.2021, pdf)