The FAMHP has once again renewed a number of measures in a new decision by the Chief Executive Officer of the FAMHP. This decision has once again been taken to avoid medicine shortages in the context of the coronavirus pandemic (COVID-19).
In the original decision, published on the FAMHP website, the Chief Executive Officer drew up a list of medicines and raw materials for which urgent measures came into force from 1st April 2020. The list of medicines and raw materials and the measures have been adapted and refined several times during the pandemic. This decision could be extended until 31 March 2021. Based on the new Royal Decree of 8 April 2021, the possibility of taking these measures has been extended.
Although the situation in hospitals is not critical for now, vigilance is still required for the coming months and the risk of a fourth wave should not be overlooked. That is why the Chief Executive Officer's decision has once again been taken and published. Pending the corona law, only the strictly necessary provisions will be renewed.
Mandatory quotas for wholesalers
In order to avoid excessive orders and poor distribution of stocks, wholesalers are limiting sale quantities of the medicines and raw materials on the list to the quantities corresponding to the previous year's sales over the same period, increased by a maximum of 50 %. If this does not jeopardise the supply of other wholesalers or pharmacists, larger quantities may be delivered. In such cases, notification must be made by e-mail to coronashortages@fagg-afmps.be stating "Quota exemption - [Name of medicine]" in the subject line and specifying the recipient and the quantity.
The FAMHP can establish other distribution keys or instructions, should it be necessary.
These measures are valid from 8 June 2021 (read: date of publication in the Belgian Official Gazette) until 30 June 2021.
Listed medicines containing a single active ingredient
• Atracurium besilate (for intravenous administration)
• Cisatracurium besilate (for intravenous administration)
• Clarithromycin lactobionate (for intravenous administration)
• Clonidine hydrochloride (for intravenous administration)
• Dexamethasone sodium phosphate (for intravenous administration)
• Dexmedetomidine hydrochloride (for intravenous administration)
• Diazepam (for intravenous administration)
• Ceftriaxone disodium (for intravenous administration)
• Dobutamine hydrochloride (for intravenous administration)
• Epinephrine
• Epinephrine bitartrate
• Epinephrine hydrochloride
• Esketamine hydrochloride (for intravenous administration)
• Fentanyl citrate (for intravenous administration)
• Ketamine hydrochloride (for intravenous administration)
• Lorazepam (for intravenous administration)
• Midazolam (for intravenous administration)
• Midazolam hydrochloride (for intravenous administration)
• Mivacurium chloride (for intravenous administration)
• Morphine hydrochloride (for intravenous administration)
• Moxifloxacin hydrochloride (for intravenous administration)
• Paracetamol (for intravenous administration)
• Propofol (for intravenous administration)
• Remifentanil hydrochloride (for intravenous administration)
• Rocuronium bromide (for intravenous administration)
• Sufentanil citrate (for intravenous administration)
Listed medicines containing several active ingredients
• Amoxicillin sodium - Clavulanic acid (for intravenous administration)
• Amoxicillin sodium - Clavulanate potassium (for intravenous administration)
• Ceftriaxone disodium - Lidocaine hydrochloride (for intravenous administration)
• Lopinavir - Ritonavir
• Piperacillin sodium - Tazobactam sodium (for intravenous administration)
Listed raw materials
• Amoxicillin
• Amoxycillin sodium
• Amoxycillin trihydrate
• Atracurium besilate
• Cisatracurium besilate
• Clarithromycin
• Clarithromycin citrate
• Clarithromycin lactobionate
• Clavulanic acid
• Clonidine hydrochloride
• Dexamethasone
• Dexamethasone acetate
• Dexamethasone sodium phosphate
• Dexmedetomidine hydrochloride
• Diazepam
• Ceftriaxone disodium
• Dobutamine hydrochloride
• Epinephrine
• Epinephrine bitartrate
• Epinephrine hydrochloride
• Esketamine
• Esketamine hydrochloride
• Fentanyl
• Fentanyl citrate
• Clavulanate potassium
• Ketamine hydrochloride
• Lopinavir
• Lorazepam
• Midazolam
• Midazolam hydrochloride
• Mivacurium chloride
• Morphine
• Morphine hydrochloride
• Moxifloxacin
• Moxifloxacin hydrochloride
• Paracetamol
• Piperacillin
• Piperacillin sodium
• Propofol
• Remifentanil hydrochloride
• Ritonavir
• Rocuronium bromide
• Sufentanil citrate
• Tazobactam
• Tazobactam sodium