Fimea’s administrative regulation on good manufacturing practices of medicines and the manufacture of medicines used in clinical trials

Updated 3.8.2022

The Finnish Medicines Agency Fimea has updated its regulation on good manufacturing practices of medicines and the manufacture of medicines used in clinical trials. The regulation went through a consultation round between 18 February and 31 March 2022.

The regulation updates the good manufacturing practices followed in the manufacture of medicines and lays down the language requirements for the labelling of investigational medicinal products and the requirements concerning the manufacture of investigational medicinal products in hospital pharmacies and dispensaries. The regulation repeals Fimea’s regulations 5/2019 on good manufacturing practices of medicines and 8/2019 on clinical trials. During transition period, the repealed regulation 8/2019 will however be applied for the clinical trials submitted and ongoing under directive 2001/20/EU (Updated 3.8.2022).

The regulation implemented EU Directives (EU) 2017/1572 and 91/412/EEC on good manufacturing practice for medicinal products and lists the EU regulations on good manufacturing practice that are directly applicable.

The regulation contains requirements regarding the duties of a qualified person who fulfils the criteria for pharmaceutical manufacturers and the good manufacturing practices of excipients used in the industrial manufacture of medicinal products for human use.

Regarding clinical trials, the regulation complies with Regulation (EU) 536/2014 on clinical trials, which entered into force on 31 January 2022. The regulation describes the language requirements (Finnish, Swedish and English) for the labelling of investigational medicinal products and auxiliary medicinal products.

The requirements on the manufacture of investigational medicinal products in hospital pharmacies and dispensaries concern the advance notifications submitted to Fimea, the pharmacist responsible for investigational medicinal products and the manufacturing documentation of investigational medicinal products and their release for use in clinical trials.

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Administrative Regulation 6/2022 (PDF)