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Drug Registration Process in Belgium

Drug Registration Process in Belgium

MoH: Health food Chain Safety environment

MoH website:

Regulatory Authority: The Federal Agency for Medicines and Health Products (FAMHP)  

Link for Regulatory Authority:

Drug Registration procedure: Under construction.

Dossier format: Common Technical Documents (CTD)


  • Foreign makers of medical devices or pharmaceuticals should require an authorized representative from anywhere in the European Union (EU) to access the Belgium region.
  • To gain access to the market, manufacturers must inform the Federal Agency for Medicines and Health Products (FAMHP), the local regulatory agency. Belgium, which lies in the centre of the EU, provides great market potential for international producers and may serve as a distribution touchpoint.
  • Aside from the mandatory CE marking, however, navigating the regulatory framework of the area in the face of pressing registration and approval processes is a difficulty for overseas producers.

Pharmacovigilance Data collection, evaluation and measures:

Pharmacovigilance Data collection

Regarding medication side effects, the Belgian Centre for Pharmacovigilance for Medicines for Human Use (BCPH) accepts both individual reports and compilations of data. Collaboration between medical practitioners, those in possession of marketing authorization, and research facilities carrying out drug-related clinical trials is necessary for this.

Healthcare providers (dentists, physicians, and pharmacists) can report to the BCPH via the “yellow card” any concerns they may have regarding the side effects of medications they see daily.


It is nevertheless particularly important to report  Serious  adverse effects, Unexpected  adverse effects, Suspected  adverse effects and adverse consequences that arise in the specific circumstances listed below:

  1. Populations that are at risk (children, women who are pregnant or nursing, the elderly, patients suffering from hepatic or renal failure, etc.).
  2. vaccination delivery.
  3. Change specializations while receiving treatment, regardless of whether you’re switching from one “original” medication to another, from one “generic” medication to another, or between two “original” medications.
  4. The use of a medication that is “off-label” or inappropriate.

Reporting side effects related to the so-called “Black triangle drugs” is especially crucial. These comprise the novel biological medications as well as those with novel active ingredients. The sign ▼ in the “Répertoire Commenté des Medicaments” denotes them. For the first three years following the medication’s promotion, the ▼ sign is present.

As soon as these medications are put on the market, it is critical that they be thoroughly monitored. As a matter of fact, little is known about a medicine’s side effects before it is approved. The primary goal of the clinical trials carried out for the marketing authorization is to demonstrate the medication’s effectiveness; they are not designed to identify side effects:

  1. Studies typically involve far fewer patients than necessary to identify uncommon side effects.
  2. The trials’ length is insufficient to identify unfavourable effects that manifest later.
  3. Patients who have a high risk of side effects—such as those who are young or old, have significant comorbidities or Poly medication, or have liver and renal failure—are often excluded from trials.

Even in cases where there is some uncertainty regarding the causative relationship, the BCPH asks medical practitioners to report any suspicions they may have of side events, both major and non-serious, with these medications.

The list of these ▼ medicines (in French) is updated monthly.

When marketing authorization holders (MAH) learn of a major adverse impact, they have 15 days to notify the BCPH. This reporting deadline applies to information received from healthcare providers, clinical trial investigators, and scientific publications. 

Pharmacovigilance Data evaluation

Two components make up the assessment of the pharmacovigilance data that is currently accessible.

In addition to assessing the individual adverse effect reports (SUSARs and spontaneous reports), the BCPH also assesses the summary reports:

  1. recurring safety reports pertaining to a medication.
  2. yearly safety reports about a clinical study (if the product already has a discontinued marketing authorization).
  3. safety reports.

The BCPH is supported in these activities by a group of both internal and external specialists.

Regular evaluations of the individual reports are conducted by a designated working group. A second dedicated working group receives the evaluation reports about the periodic safety reports and the dossiers for the renewal of marketing authorization.

The Commission for Medicines for Human Use renders the final decision about the feasibility of implementing the recommendations made by the two working groups when it comes to medications for which the evaluation is within national jurisdiction.

The BCPH makes the required decisions based on the findings of these assessments conducted at the national and European levels.

Taking Measures

Following the review of a dossier, the BCPH may, if necessary, take the following actions:

  • Request that the holder of the marketing authorization amend the information in the SPC (Summary of Product Characteristics) and patient leaflet under the headings “unwanted effects,” “special warnings and precautions for use,” and “contraindications.”
  • Restricting a drug’s indications and, in extremely rare circumstances, removing or suspending a drug’s marketing authorization in accordance with the Ministry of Public Health’s ruling.
  • In an emergency, educating medical professionals via a press release or circular about a particular pharmacovigilance issue.

To alert the concerned healthcare professionals about the pharmacovigilance issue, the authorization holder may also be asked to send a “Direct Healthcare Professionals Communication.”

Additionally, the Belgian Centre for Pharmacotherapeutic Information (link is external) (in French), with whom the BCPH actively interacts, publishes a “Communication from the Pharmacovigilance Center” for medical professionals once a month. This covers conversations on negative effects that have been reported to the BCPH or fresh information found in specialist literature.