How to recognise an authorised medicinal product ?

In Belgium an authorised medicinal product is a medicine that:

• is sold by a pharmacist (only they are allowed to do so);

• has a marketing authorisation (MA) or registration number (a medicine cannot be sold without registration or marketing authorisation).

 

- What exactly is a marketing authorisation or registration number?
- Where to find the marketing authorisation or registration number?
- And what about medicines directly prepared by the pharmacist (magistral and officinal preparations)?
- How can I check if I am buying authorised medicines?
- What tools does the FAMHP make available to me to recognize an authorised medicinal product?

 

What exactly is a marketing authorisation or registration number?

The sale of medicines is very strictly regulated and controlled by the competent authorities (in Belgium, the Federal Agency for Medicines and Health Products - FAMHP).

Before it is sold in licensed pharmacies, the competent authorities assess the quality, safety and efficacy of each medicine.

In order to make this assessment the experts of the competent authorities base their evaluation on scientific data such as:

  • The results of toxicological, pharmacological and clinical tests carried out with the medicine;
  • The scientific literature;
  • The quality data;
  • Any other relevant scientific data.

When the quality, safety and efficacy of a medicine are considered satisfactory, it is allowed to be sold in licensed pharmacies.

The authorisation or registration is granted:

  • either by the Minister responsible for public health after receiving the opinion of the relevant scientific committee in the AFMPS 
  • or by the European Commission after consultation, as appropriate, with the Committee for Medicinal Products for Human Use (CHMP) or with the Committee for Medicinal products for Veterinary Use (CVMP), established within the European Medicines Agency (EMA).

All authorised or registered medicinal products receive a marketing authorisation (MA) or registration number.

The term "registration" is more specifically used for certain homeopathic medicines or herbal products traditionally used as medicines (where the safety has been demonstrated by the length of use and experience). These are registered based on a simplified scientific dossier.

 


Where to find the marketing authorisation or registration number?

To find a marketing authorisation or registration number you should consult the packaging of the medicine.

The number can be in different formats:

(x : figure and Y : letter)

- xxxx YY xxxx F xxx

- BExxxxxx (new numbering from 2008)

- BE-Vxxxxxx (new numbering from 2008 for medicinal products for veterinary use)

- EU/1/xx/xxx/xxx (medicinal product authorised by the European Commission)

For an homeopathic medicine

- xxxx CH xxxx F xx or xxxx UH xxxx F xx (notification)

- HO-BExxxxxx (MA)

- HO-BE-CHxxxxxx or HO-BE-UHxxxxxx (registration)

For a herbal medicinal product

- BE-TUxxxxxx (registration)

- xxxx YY xxxx F xxx, BExxxxxx or EU/1/xx/xxx/xxx  (MA)


 

And what about medicines directly prepared by the pharmacist
(magistral and officinal preparations)?

Some drugs are prepared in a pharmacy under the responsibility of the pharmacist. These are called preparations. Two kinds of preparations are made in pharmacies. These are:

  • Magistral preparations: medicines specifically prescribed by a physician for a specific patient;
  • Officinal preparations: medicines that are not specific to only one patient. These medicines are prepared according to the recommendations of reference books relating to the preparation of medicines as a pharmacopoeia (book that teaches how to prepare medicines) or the “Formulaire thérapeutique magistral” (published in Belgium by the FAMHP for the preparation of medicines in pharmacies).

These preparations are made in accordance with specific rules or "best officinal practices» described in the regulations. All materials used must meet strict quality criteria.

These drugs prepared in pharmacies have a number assigned by the pharmacist. It's not a marketing authorisation or registration number as described above.

 

 
How can I check if I am buying authorised medicines?

Buy your medicines ONLY through legal distribution channels:

  • In a licensed pharmacy
  • In case of medicinal products for human use and not subject to medical prescription, possibly via the website of a licensed pharmacy notified to the FAMHP and the Order of Pharmacists (list of notified sites).

By buying drugs outside the legal distribution channels you may receive counterfeit or falsified medicines and / or you may use them improperly.

Their quality, safety, efficiency cannot be guaranteed as these medicines sold outside the legal channels evade the control of the competent authorities (see the "Medicines by internet! Do not surf with your health!” campaign).

 

What tools does the FAMHP make available to me to recognize an authorised medicinal product?

The FAMHP offers three sources of information.

The database of authorised medicinal products which allows you to see if the medicine you are looking for is indeed authorised or registered.

Click here to view
- The database of authorised or registered medicinal products for human use
- The database of authorised medicinal products for veterinary use

The patient information leaflet (which is in the packaging) and the summary of product characteristics or SPC (especially intended for health professionals) of each medicine were approved at the time of the marketing authorisation or registration and constitute the information and the reference for its appropriate and safe prescription, delivery and use.

These documents are available via the following links

- Patient information leaflets and SPC of authorised and marketed medicines for human use
- Leaflets for the public and SPC of authorised and marketed medicines for veterinary

 

 

 

Last updated on 18/07/2017