In application of Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 and Commission Delegated Regulation (EU) 2016/1443) and (EU)2018/729, operators shall hold a licence/registration when:
- engaged in import, export or intermediary activities, possession and/or placement on the market of substances category 1.
- in possession of substance Category 2A and /or placement on the market of scheduled substances listed in Category 2 in the EU.
- engaged in the import or export or intermediary activities involving of scheduled substances listed in Category 2 or engaged in the export or intermediary activities involving of scheduled substances listed in Category 3.
The licence /registration can only be made using this application form : new application
The licence/registration is valid for 3 years and can be renewed.
Three months before expiry of the licence/registration, a renewal application must be submitted to the FAMHP / Drug Precursors Unit using this application form: renewal.
When applying for a licence /registration or a renewal, a fee of €287.69 is payable to the FAMHP . This fee will be indexed each year.
New application for licence / registration
Please note that the payment will be invoiced after issuing of the licence/registration or renewal.
The duly signed and completed form and any supporting documents must be sent by post to:
Federal Agency for Medicines and Health Products
DG Inspection – Drug Precursors Unit
EUROSTATION Bloc II
Place Victor Horta 40 /40