Basic principles
Article 7 of the royal decree of 06.09.2017 regulating narcotics and/or psychotropic substances stipulates that, in deviation from the activity licence, an end user licence may be requested for the possession, procurement, import and - if justified - transport, handing over or export of limited quantities of narcotics or psychotropic substances (hereafter: products) that are essential for, or that could be present within the framework of, professional activities.
In practice this means that the end user licence is for instance applicable to the following legal entities or (natural) persons:
- police inspectors or customs officials who may have drugs cases with them (for training detector dogs/training purposes);
- laboratories that possess or want to procure reference standards that are certified substances.
Laboratories analysing medicines or wishing to use products other than reference standards (e.g. APIs) must apply for an activity licence. When in doubt, please contact narcotics@fagg.be in advance.
You will find more information regarding this end user licence and the resulting obligations in the relevant royal decree.
Application for an end user licence
The application form for this type of licence differs depending on the applicant.
- Application form for police/customs/health (keeping of a drugs case);
- Application form for laboratories.
The legal throughput time can be consulted in article 12 of the relevant royal decree.
Information about those responsible
For laboratories, it is recommended to indicate at least one person with main responsibility, and a second person who will take responsibility in his or her temporary absence. These responsible will be indicated taking into account their professional competence and they will be deemed to have a thorough knowledge of the applicable legislation regarding narcotics and psychotropic substances.
If required, a maximum of four persons responsible can be indicated per end user licence.
An extract must be included from the judicial record model I of these individuals at the time of indication, no older than three months.
Only one of those responsible can act as a contact person for the FAMHP.
Information about the organisation procedure
As mentioned on the application form for laboratories, an organisation procedure must be added as stipulated in art. 11 §2 of the aforementioned royal decree.
For an end user, this means a simplified organisation procedure, containing the following elements:
- a description of the secure storage space of the substances;
- a list of the individuals who have access to this storage space;
- a description of how the in/out register is maintained and how often the stocks are counted;
If applicable: a list of the individuals who were indicated for monitoring the administration (such as applications for import licences), and a brief description of how this administration will be carried out.
The individuals must have followed appropriate training.
When indicating these individuals, the licence holder will take into account the details from the extract from the judicial record (template as per art. 596.1 of the Belgian Code of Criminal Procedure) of these persons that is no older than three months at the time of indication. This indication must be re-evaluated by the licence holder each year, on the basis of a new extract.
Renewal of the end user licence
The end user licence is valid for three years and can be renewed no later than three months before the expiry date. This can be done using the same application form as for a new end user licence.
Change of the end user licence
Any changes in the details mentioned on the end user licence must be notified to the FAMHP within fifteen days.
The application form for this change of licence differs again depending on the applicant.
- Application form for change of licence police/customs (keeping of a drugs case)
- Application form for change of licence for laboratories.
If it is found that the end user licence contains errors because some changes were not submitted to the FAMHP, the licence can be revoked or suspended.
Fees
A fee is payable for the first application, renewal and any amendment of an end user authorisation.
These fees are indexed each year and can be find under Fees.
The various fees will be invoiced by the FAMHP and do not have to be paid in advance.
.Contact