Licensing - Registration

New application

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 when in possession and/or placement on the market of substances category 1.

- a licence when engaged in import, export or intermediary activities involving scheduled substances listed in Category 1.

- a registration when in possession of substance Category 2A  and /or placement on the market of scheduled substances listed in Category 2 in the EU.

- a registration when 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

Fees

When applying for a licence /registration, a fee of  €135.10 is payable to the FAMHP and will be indexed each year.  The licence/registration is valid for 3 years and can be renewed.

Please note that the payment will be invoiced after issuing of the licence /registration.

 Renewal

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.

This operation is free of charge.

Last updated on 12/04/2019