ACCESS REQUEST VERIFICATION BY BeMVO – CONTRACTUAL part

LEGITIMACY CHECK

The first action performed by BeMVO on reception of the Access Request form for an End User Location is the Legitimacy Check. This step is critical to be compliant with article 37(b) of the Delegated Regulation.
The acceptance of an End User to get access to the Verification System is based on the definition of the End User categories (see ‘Who are the End Users’) and the underlying official sources.

Public Pharmacies Belgium

To receive access, the Public pharmacy must be listed in the official list of pharmacies available on the FAGG/AFMPS website :

https://www.fagg.be/nl/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/distributie_aflevering/officina
https://www.afmps.be/fr/humain/medicaments/medicaments/distribution/pharmacies_ouvertes_au_public

Any pharmacy requiring access to the Verification System must make sure that his information in this FAGG/AFMPS file is correct (if not, access will be refused).

The legally responsible person that needs to provide the access request and agree on the NMVS Access Policy is the person representing the ‘Exploitant/Uitbater’ in this file.
It is therefor extremely important that End Users requesting access first verifies if the information in the FAGG/AFMPS file is correct.

The legitimacy of the companies with an authorisation of preparation (bereidingsvergunning / authorisation de préparation) is verified against the list of these companies also published on the FAGG/AFMPS website:

https://www.fagg.be/nl/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/vergunningen/bereidingsvergunning  https://www.afmps.be/fr/humain/medicaments/medicaments/autorisations/autorisation_de_preparation

It is clear that if a company in this list is considering that his activity or the products they are preparing are not in scope for FMD, they do not need to request access.

Public Pharmacies Luxembourg

The Luxembourg pharmacies that will receive access to the Verification System are the pharmacies that are present in the list of public pharmacies in Luxembourg which is provided by the Luxembourg Ministry of Health.

Hospital Pharmacies Belgium

The verification of the legitimacy for a Hospital pharmacy to access the Verification System will be done based on the list of hospitals with a hospital pharmacy which is published on the website of FOD Volksgezondheid / SPF Santé Publique:

https://www.belgium.be/nl/gezondheid/gezondheidszorg/medische_diensten/ziekenhuizen
https://www.belgium.be/fr/sante/soins_de_sante/services_medicaux/hopitaux

The pharmacies of the hospitals where this file indicates the presence of a hospital pharmacy can receive access.

Hospital Pharmacies Luxembourg

The verification of the legitimacy for a Hospital pharmacy in Luxembourg is based on the list of hospital pharmacies which is provided by the Ministry of Health in Luxembourg.

Wholesalers Belgium

The legitimacy check for this group of wholesalers will be done based on the list of ‘groothandel-verdelers / grossistes répartiteurs’ which is published on the website of FAGG/AFMPS (supplemented with their presence in the WDA list of EUDRA-GMDP – see hereafter):

https://www.fagg-afmps.be/nl/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/distributie_aflevering/groothandels-verdelers
https://www.afmps.be/fr/humain/medicaments/medicaments/distribution/grossistes-repartiteurs

Only the wholesaling companies which are marked for Human products can receive access to the Verification System.

Wholesalers Luxembourg

The legitimacy check for this group of wholesalers will be done based on the list provided by the Ministry of Health of Luxembourg and that are marked as full line wholesalers for Human products.

Other Wholesalers Belgium

To receive a wholesaler-type access to the Verification System within this category, the concerned company must be listed with a wholesaling license in the WDA list of the EUDRA-GMDP list for country Belgium.

http://eudragmdp.ema.europa.eu/inspections/view/wda/searchWDA.xhtml

It is important for any company in this category that requires access to verify if the information in the WDA list is correct.

Other Wholesalers Luxembourg

The legitimacy check for this group of wholesalers will be done based on the list provided by the Ministry of Health of Luxembourg and that are not marked as full line wholesalers, but with a license for Human products.

APPROVAL

If and only if:

  1. The legitimacy of the request for access receives a positive evaluation from BeMVO based on the rules above
  2. The NMVS Access Policy was accepted on line or a signed scan was received

then BeMVO will approve the access request and inform the End User, i.e. the legally responsible person, of the approval. In case of an external software provider, this provider will also be informed about the End User’s access request.

In the other case, the End User will be informed about the refusal.
In specific cases, BeMVO might request additional information from the End User before taking a decision and/or consult other public information sources.