Article 1§1 of the R.D. dated 12 April 1974 states that an authorisation is required for the import, export, transport, manufacture, selling, offering for sale, possession and acquirement (both for payment and free of charge) of substances with the following effects:
The royal decree lists substances, in pure or mixed form, on the basis of their action. In consequence, there is no indicative, exhaustive list of such substances that can be consulted.
When in doubt, please send an e-mail with the name of the substance and the CAS number to substances_HAA@fagg-afmps.be.
Art. 1§3 2° of the royal decree provides for a simplified authorisation for laboratories where the substances are used exclusively for scientific and/or analytical purposes.
Article 1§2 and also article 7 of the royal decree also specify some exemptions from the activity licence, such as for :
- pharmacists and depositary veterinarians;
- activities with medicines, medicated feeds or medicated premixes that contain these substances, if these activities are already allowed by the concerned legislations .
The royal decree does, however, target activities with, for instance, Active Pharmaceutical Ingredients (APIs), pharmaceutical raw materials and substances used by laboratories like reference standards.
In practice, this means that anyone who wants to legally pursue activities with these substances must be authorized for this by the FAMHP. For example:
- manufacturers of medicines and Investigational Medicinal Products (IMPs) (purchase and possession of the API);
- manufacturers/distributors of Active Pharmaceutical Ingredients (APIs) and pharmaceutical raw materials;
- laboratories and distributors of substances used in laboratories.
An authorisation can only be granted in the name of a company/institution with an official establishment unit (according to the CBE) on Belgian territory.
One licence can be granted for multiple places of activities and is valid for 5 years .
This authorisation cannot be granted before the necessary authorisations for, for example, good manufacturing practices or GMP and distribution of raw materials have been obtained (when applicable).
Application for a new licence or for a renewal
Dependent on the situation, one of the following applications form can be introduced:
- Application form for other than analytical/scientific purposes
- Application form for solely scientific/analytical purposes
If for instance a API manufacturer also has a laboratory that works with such substances, a different application form must be completed for the laboratory.
In the exceptional case the applicant is a natural (private?) person, the following application form can be introduced:
- Application form for a natural person
Please complete the application form in full and apply the necessary signatures.
Modification of the licence
Any modification to the information listed on the licence such as adding substances, change of address or change of responsible person) must be reported to the FAMHP with 15 days, by a responsible person listed on the licence.
The request to modify the permit can be submitted via this form.
A CAS number is a unique identification number for chemical substances. It has the following structure: 0000000-00-0.
To look up CAS numbers, you can query the Merck index or the Martindale, among others.
Article 2 of the royal decree imposes a notification of every import or export, within 15 days. You can do this by sending an e-mail to substances_HAA@fagg-afmps.be, mentioning:
- your identity and licence number,
- the name of the substances;
- the quantity;
- the identity of the foreign client or supplier.
Article 3 obliges a register ‘in-out’ for distributors and manufacturers. Dit register moet kunnen worden voorgelegd op vraag van het FAGG.
A fee is owed to the FAMHP for the application for a new licence, a modification, or a renewal.
These fees are indexed annually.
These fees will be invoiced when the license is delivered. This is the reason that we ask you to fill in the invoicing address on the application form.