Scope of application
For the destruction of:
- products held by holders of an end user authorisation (reference standards),
- medicinal products that were sold in a 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,
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, II and IV of the Royal Decree of 6 September 2017 originating from dispensaries or holders of an activity licence is regulated under Articles 45 to 48 of the Royal Decree of 6 September 2017 regulating narcotic and psychotropic substances and is summarised below.
The products must be removed for destruction by an authorised company. In order to do this, once the removal date is known, the dispensary or the authorisation holder must meet with 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.
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 remove products or to acquire them 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:
- for removal and temporary holding: SGS EWACS nv, Suez R&B BE North nv, Suez R&B BE Wallonie sa
- for effective destruction: Indaver nv.
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).