Article 6 of the royal decree of 06.09.2017 regulating narcotics and psychotropic substances states that an activity licence is required in advance for all parties who import, export, transport, manufacture, produce, sell, offer for sale, supply, deliver or procure narcotics or psychotropic substances, for the site where the activities with these substances are carried out.
In practice, this means that any and all parties who want to legally perform activities with narcotics or psychotropic substances must be licensed to do so by the FAMHP. These parties are for example:
- manufacturers and distributors of products such as medicines, Investigational Medicinal Products (IMPs) and Active Pharmaceutical Ingredients (APIs);
- laboratories that analyse medicines.
For further information on the legislation on these activity licences, we recommend thorough examination of the relevant parts of the royal decree.
Depending on the substances and the activity type, the granting of an activity licence is subject to some legal obligations. Before you apply, please familiarise yourself with the legislation and examine whether you can in fact meet these obligations.
An activity licence can only be granted in the name of a firm with an official establishment unit (according to the CBE) in Belgium!
The activity licence is granted for a single specific activity site.
This licence cannot be granted until the necessary licences for Good Distribution Practices (GDPs), Good Manufacturing Practices (GMPs), IMPs and distribution of ingredients have been obtained (where applicable).
Article 7 of the royal decree specifies an alternative to the activities licence, which is the end user licence, applicable for parties such as toxicology laboratories and police and customs services. For further information, please see the FAMHP website.
Article 8 of the royal decree also specifies some exemptions from the activity licence, such as for pharmacists and depositary veterinarians.
Application for a new activity licence
The application may only be submitted using this application form. Please complete the application form in full, apply the necessary signatures and enclose the necessary appendices. Otherwise, the application may be deemed inadmissible.
Please see article 12 of the relevant royal decree for the statutory processing time.
Articles 9 and 10 of the royal decree state that the licence applicant shall designate no more than four responsible persons who:
- are selected taking into account their professional competencies (the royal decree does not stipulate any diploma requirements);
- have proper knowledge of the law on the narcotics and psychotropic substances;
- are able to be present at the activity site within a reasonable period of time when their presence is required;
- are tasked with monitoring for compliance with the obligations set out in this royal decree;
- are responsible for the necessary reporting to the FAMHP as stated in the royal decree;
- must inform the FAMHP immediately of any suspension of activities.
If the registered office is not also the activity site, the intention is to appoint a primary responsible person for each of these locations, and a second responsible person who may act on the former’s behalf in cases of temporary absence.
One of these persons is designated by the applicant as a point of contact for the FAMHP for the licence. This person will also receive correspondence from the Narcotics Team at the FAMHP.
As indicated in the application form, an organisation procedure must be enclosed as detailed in article 11(§2) of the aforementioned royal decree.
This organisation procedure must feature at least the following items.
- Description of the secure storage site for the substances, including photos and a floorplan.
- Indication of the persons (given name, surname and, if applicable, job title) who have access to this storage site.
- Description of the method of inventory management of the substances. How often is the inventory checked? By whom? At what times and in what manner? The intention is for this inventory to be inspected regularly to ensure prompt detection of any theft/loss.
- Description of record-keeping method for the substances. How is the record-keeping organised and, where applicable, how is the forwarding of these records to the FAMHP organised (such as in/out records, sales records and manufacturing records)? How does the organisation handle applications for import or export licences, validation of these licences, etc.?
- Reporting of the persons (given name, surname and, if applicable, job title) designated to oversee administration (such as applications for import/export licences, narcotics order forms). The persons must have completed suitable training for this. After the activity licence is granted, the person may be asked to provide a signed confirmation of completion of this training.
- A detailed indication of the planned activities and the various substances, so the precise details of what the activity entails for each substance are clear to the FAMHP. For instance, some substances are only permitted for use in the laboratory of the licensee, while others are distributed/manufactured as medicines.
When designating these persons indicated in the organisation procedure, the licensee must take into account the information from the certificate of good conduct (template as per Article 596.1 of the Belgian Code of Criminal Procedure) for these persons, which is no more than three months old at the time of designation. Moreover, the licensee must also re-evaluate this designation annually based on a new certificate.
If cases of changes to the organisation procedure, the responsible person is asked to report the updated procedure to the FAMHP at firstname.lastname@example.org. This may be relevant when assigning or cancelling login accounts for the NDS-web system because the FAMHP uses the information in the organisation procedure for this.
Renewal of the activity licence
The activity licence is valid for 3 years starting from the issue date and may be renewed by no later than 3 months before the expiry date.
The application may only be submitted using this application form.
Remember to submit your renewal on time. The statutory maximum processing time is three months. It is vital to ensure that you have a valid licence at all times so you do not have to temporarily suspend your activities with these substances.
Complete your application correctly and in full to ensure faster processing.
Changes to an activity licence
Any changes in the details indicated on the activity licence must be reported to the FAMHP within fifteen days.
If it appears that the activity licence contains incorrect information due to failure to report changes to the FAMHP, the licence may be revoked or temporarily suspended.
The application for change may only be submitted using this application form. Please complete the application form in full and enclose the necessary signatures and appendices. Otherwise, it may be deemed inadmissible.
Please see Article 15 of the relevant royal decree for the statutory processing time.
Because the activity licence is granted for a single specific activity site, a change of activity site cannot be regarded as simply a change to a licence. This will always result in preparation of a new licence with a different licence number, possibly involving a site inspection. Consequently, changes of this kind will require submission of a new application (see below). Naturally, the same also applies to changes of legal entity (change of company number).
A change to the organisation procedure (e.g. new persons with access to the secured room, new persons who may apply for import or export licences, etc.) is not regarded as a change to the activity licence. The responsible person must however report the new procedure to the FAMHP at email@example.com. This may be relevant when assigning or cancelling login accounts for the NDS web system because the FAMHP uses the information in the organisation procedure for this.
With inspection and in the case of a manufacturer
With inspection and when the applicant is not a manufacturer
Subsequently, an annual fee will be invoiced until expiry or termination of the authorisation.
Again, this fee varies according to the authorisation holder's activities.
Other (Without transmission of sales, stocks and manufacturing register to the FAMHP)
Three months before expiry of the authorisation of activities, a renewal application must be submitted to the FAMHP Narcotics team using the form provided.
No separate fee is necessary, as this is covered by the annual fee.
A fee of €153,73 is payable in respect of any amendment to the data on the authorisation for activities (other than the operational premises or legal entity).
All of these fees will be indexed each year.
The various fees will be invoiced by the FAMHP and to not have to be paid in advance.