Since 2 May 2006, a new system for the request and delivery of import/export authorisations is in place. Pursuant to Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 , (EU) 2016/1443) and Commission Delegated Regulation (EU)2018/729, the previous forms (KB 26/10/1993) for import/exports have been replaced with new models which better meet the requirements in the Regulations.
The authorisations are delivered by the Drug Precursors Unit to the interested parties.
Requests for authorisation must be made using the following forms:
- Request for export authorisation
- Request for import authorisation
Applications forms must be signed by the person responsible.
The duly signed and completed forms and any supporting documents must be sent by post or e-mail to:
Federal Agency for Medicines and Health Products
DG Inspection - Authorisations Division - Drug Precursors Unit
Avenue Galilée 5/03
Tel. + 32-2-528 43 12 or +32-2-528 4242
Only correctly signed and filled in forms will be accepted.
Should a request be sent by e-mail, the original request and any supporting documents must be made available to officials at the Customs, Public Health and Federal Police officers.
For import or export authorisation issued, a fee is due to the FAMHP.
Request for import authorisation related to scheduled substances pursuant to the Council Regulation (EC) n° 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, article 20, pursuant the article 1 “ Drugs Act”
Request for export authorisation related to scheduled substances pursuant to the Council Regulation (EC) n° 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, article 12, pursuant the article 1 “ Drugs Act”
These fees are indexed each year.
Please note that these fees no longer need to be paid up-front but will be invoiced once the authorisation has been issued.