The FAMHP has once again put in place a number of measures to avoid shortages of drugs during the coronavirus pandemic (COVID-19).
In a decision, published on the FAMHP’s website, the CEO of the FAMHP established a list of drugs and raw materials for which the following urgent measures came into force from 1st April 2020 for a renewable period of one month. It concerns medicines used in the treatment of COVID-19.
Export ban outside the European Economic Area (EEA)
The delivery of medicines and raw materials from the list established by the FAMHP is authorized only for wholesalers, pharmacies and hospitals established in Belgium. Deliveries to other recipients are prohibited, with the exception of deliveries for the Belgium FPS Health Service in order to build up strategic stocks.
Exports within the EEA are authorized but must be reported in advance to the FAMHP by e-mail to coronashortages@afmps.be, and drugs and raw materials must be intended for marketing within the EEA. The email should therefore have the following subject: "EEA export notification - [Name of Marketing Authorization Holder] - [Drug Name]". The target Member State and the quantities exported must be specified.
An exception to the ban on exports outside the EEA can be requested from the CEO of the FAMHP, by e-mail to coronashortages@afmps.be, with the following subject: "Request for export outside the EEA - [Name of Marketing Authorization Holder] - [Drug Name]". The target country and the quantities exported must be specified.
Mandatory quotas for wholesalers
To avoid excessive orders and poor distribution of stocks, wholesalers are limiting sale quantities of the drugs and raw materials on the list to the quantities corresponding to last year's sales for the same period, increased by a maximum of 50%. Exceptions may be requested by email to coronashortages@afmps.be, with the following subject “Quota Exception- [Name of drug]”. The recipient and the quantity must be specified.
The agency may establish other distribution priorities if necessary.
Reporting large volumes of stock for redistribution
Hospitals, hospital pharmacies and pharmacies open to the public which hold stocks of the listed drugs in excess of 50% above one month’s sales volume for the pharmacy or hospital must report this stock surplus to the FAMHP for possible redistribution. This sales volume is calculated based on last year's sales for the same period, increased by a maximum of 50%. It must be reported now and whenever the stock is exceeded. Reports may be sent by email to coronashortages@afmps.be, with the following subject “Pharmacy stock - [Name of drug]”.
These measures shall be effective from 1st April 2020 to 1st May 2020. The general administrator of the FAMHP may renew these measures for one month at a time if necessary, depending on the evolution of the COVID-19 pandemic.
Listed medications containing a single active ingredient
- Atracurium besilate
- Atropine sulphate
- Azithromycin dihydrate
- Azithromycin monohydrate
- Azithromycin hemiethanolate monohydrate
- Chloroquine
- Cisatracurium besilate
- Clarithromycin lactobionate
- Clonidine hydrochloride
- Dexmedetomidine hydrochloride
- Diazepam (intravenous drugs only)
- Ceftriaxone disodium
- Dobutamine hydrochloride
- Enoxaparin sodium
- Epinephrine
- Epinephrine bitartrate
- Epinephrine hydrochloride
- Etomidate
- Fentanyl
- Fentanyl citrate
- Phenylephrine hydrochloride (intravenous drugs only)
- Hydroxychloroquine sulphate
- Itraconazole
- Ketamine hydrochloride
- Lorazepam (intravenous drugs only)
- Methylprednisolone
- Methylprednisolone acetate
- Midazolam
- Midazolam hydrochloride
- Mivacurium chloride
- Morphine hydrochloride (intravenous drugs only)
- Moxifloxacin hydrochloride
- Norepinephrine bitartrate
- Pantoprazole sodium sesquihydrate (intravenous drugs only)
- Propofol
- Remifentanil hydrochloride
- Rocuronium bromide
- Sarilumab
- Sufentanil citrate
- Suxamethonium chloride hydrate
- Tocilizumab
- Tramadol hydrochloride (intravenous drugs only)
Listed medications containing several active ingredients
- Amoxycillin sodium - Clavulanic acid
- Amoxycillin sodium - Potassium clavulanate
- Amoxycillin trihydrate - Clavulanic acid
- Amoxycillin trihydrate - Potassium clavulanate
- Ceftriaxone disodium - Lidocaine hydrochloride
- Lidocaine hydrochloride - Methylprednisolone
- Lopinavir - Ritonavir
Listed raw materials
- Amoxycillin
- Amoxycillin sodium
- Amoxycillin trihydrate
- Atracurium besilate
- Atropine sulphate
- Azithromycin dihydrate
- Azithromycin monohydrate
- Azithromycin hemiethanolate monohydrate
- Chloroquine
- Cisatracurium besilate
- Clarithromycin
- Clarithromycin citrate
- Clarithromycin lactobionate
- Clavulanic acid
- Clonidine hydrochloride
- Dexmedetomidine hydrochloride
- Diazepam
- Ceftriaxone disodium
- Dobutamine hydrochloride
- Enoxaparin sodium
- Epinephrine
- Epinephrine bitartrate
- Etomidate
- Fentanyl
- Fentanyl citrate
- Phenylephrine hydrochloride
- Hydroxychloroquine sulphate
- Itraconazole
- Potassium clavulanate
- Ketamine hydrochloride
- Lopinavir
- Lorazepam
- Methylprednisolone
- Methylprednisolone aceponate
- Methylprednisolone acetate
- Midazolam
- Midazolam hydrochloride
- Mivacurium chloride
- Morphine hydrochloride
- Morphine sulphate
- Moxifloxacin
- Moxifloxacin hydrochloride
- Norepinephrine bitartrate
- Pantoprazole sodium sesquihydrate
- Propofol
- Remifentanil hydrochloride
- Ritonavir
- Rocuronium bromide
- Sarilumab
- Sufentanil citrate
- Suxamethonium chloride hydrate
- Tocilizumab
- Tramadol hydrochloride
The following drugs are not affected by urgent measures:
- Drugs with tramadol hydrochloride as the sole active ingredient, other than intravenously;
- Drugs with diazepam as the sole active ingredient, other than intravenously;
- Drugs with phenylephrine hydrochloride as the sole active ingredient, other than intravenously;
- Drugs with lorazepam as the sole active ingredient, other than intravenously;
- Drugs with pantoprazole sodium sesquihydrate as the sole active ingredient, other than intravenously;
- Drugs with moxifloxacin hydrochloride as the sole active ingredient, other than intravenously.