Scope of application
For the destruction of:
- products held by holders of an end user licence (reference standards),
- medicinal products that were sold in a retail pharmacy and which, for various reasons, have been returned to the dispensary by the patient,
- products mentioned in Annex III of the Royal Decree of 6 September 2017,
- preparations mentioned in Annex Ic and IVc of the Royal Decree of 6 September 2017,
- substances mentioned in Annex V of the Royal Decree of 6 September 2017.
no particular requirement has been set.
Article 44 stipulates only that these products must be destroyed in accordance with the applicable legislation on waste.
Concerning point 3, mentioned above, the number of these products destroyed must be communicated annually to the FAMHP, together with the end-of-year stock levels.
Destruction of the products mentioned in Annexes I (except preparations mentioned in Annex Ic), II and IV (except preparations mentioned in Annex IVc) of the Royal Decree of 6 September 2017 originating from retail pharmacies or holders of an activity licence for activities is regulated under Articles 45 to 48 of the Royal Decree of 6 September 2017 regulating narcotic and psychotropic substances and is summarised below.
Basic principle
The products must be destroyed by an authorised company (see table below).
In order to do this, once it is confirmed that the destruction can take place in the running year, the pharmacist or the licence holder must contact a competent official of the FAMHP Narcotics team.
This competent official will seal the packages and write up a destruction statement once they have performed an on-site inspection (verification that the list corresponds to the products to be destroyed). This statement will be issued in three copies:
- one copy for the authorisation holder or pharmacy requesting the destruction;
- one copy for the company responsible for the removal, which will then hand it over to the company responsible for the destruction (if different);
- one copy for the FAMHP.
Once the products are sealed:
- the sealed package cannot be removed anymore;
- the package must be transported to the destruction company via direct transport.
One exception is the temporary holding by a holder of an activity licence that is authorised for the centralisation of these sealed packages (see table below);
- the destructions must take place before the end of the year.
The transport to the destruction company can be done by:
- the destruction company
and if the date of transport is agreed with the destruction company, by :
- a carefully selected transporter who acts for a holder of an activity licence or the pharmacy
- the pharmacy or the holder of the activity licence (authorised for the activity ‘transport’) themselves.
If the products have been destroyed, a scan of the destruction certificate must be sent to narcotics@fagg-afmps.be (examples 1 and 2 of such a certificate).
Other documents are not accepted.
Centralised collection
In order to reduce the costs associated with this destruction, pharmacists have the possibility of centralisation, in accordance with Article 46 of the Royal Decree of 6 September 2017. The details are indicated in this Article 46.
Certain companies responsible for the removal of products hold an authorisation for the temporary storage of these products, pending their destruction. These companies too may temporarily accumulate a certain number of sealed packages in order to transfer them together to the firm responsible for the effective destruction.
Instructions for companies authorised to acquire products with a view to their destruction
Article 47 of the Royal Decree of 6 September 2017 stipulates that this authorisation holder must:
- check, when receiving products, that the seals are intact and that the number of receptacles corresponds to the figure stated in the destruction statement;
- settle the definitive destruction, whether or not preceded by temporary storage, before 31 December of the year in which the statement was issued;
- provide a certificate of destruction mentioning the destruction date and the statement number.
The following companies are currently authorised:
Renewi nv |
Berkebossenlaan 7 |
2400 Mol |
SGS EWACS nv |
Keetberglaan 4 |
9120 Melsele |
Sarpi EcoServices BE nv |
Steenbakkersdam 43-44 |
2340 Beerse |
Sarpi EcoServices BE nv |
Zoning de Jumet - 3ème rue |
6040 Jumet |
Vanheede Environmental Service bvba |
Moorseelsesteenweg 32 | 8800 Roeselare |
Indaver nv |
Poldervlietweg 5, haven 550 |
2030 Antwerpen |
Ipalle sc | Hameau de Ribonfosse 9 | 7971 Thumaide |
All of these operations are intended to guarantee that these products never leave the legal circuit and are traceable, from their manufacture to their destruction (or their consumption).