Other government information and services

DIRECTORATE GENERAL

INSPECTION

competent for all inspection and control activities

Divisions

INDUSTRIE DIVISION

Inspections

0
GMP inspections
0
GCP inspections of medicines
0
HBT inspections
0
blood establishments

Investigations

0
investigation into industrial medicines

Advisory Commission

0
advisories from the Advisory Commission

Rapid alert system

0
rapid alerts on the quality of medicines

Analyses of products on the market

0
medicines
0
preparations
0
raw materials
0
products seized

New

Mutual recognition agreement

Since 11 July 2019, the US and the EU have been implementing the mutual recognition agreement (MRA) for inspections of production sites for certain medicines for human use on their respective territories. Since the FDA recognised the GMP inspection system as suitable (equivalent) in 2018, the services at the DG Inspection responsible for medicine manufacturers have been putting the various points in the MRA between the US and the EU into practice. Those involved are currently working to exchange information on the GMP reports and the certifications of production locations for medicines of chemical or similar origin falling under the scope of the agreement, in both American and Belgian territory. Since the customs and views on both sides of the Atlantic Ocean differ, it will take some time before the practical implications become clearly visible to our companies, but the teams remain enthusiastic and are continuing to build trust between the competent authorities concerned.

Collaboration with the French ASNM

In 2019, an informal but highly practical collaboration between the FAMHP and the French ANSM was assured, for the inspection services specifically between the GMP inspectors for vaccines. This collaboration consists of the exchange of experiences in the field during cross-observation of inspections, and during discussions on the organisation of pre and post-inspection procedures.

Distribution Division

Inspections

0
inspections of advertising for medicines
0
GDP inspections (routine)
0
GDP inspections of medicines for obtaining or amending a WDA
0
pharmacovigilance inspections

Investigations

0
investigations relating to the distribution of medicines
0
pharmacovigilance investigations

Notifications

0
notifications from the local pharmacovigilance officer

Checks on advertising and other promotional activities for medicines and health products

0
investigations of medicines

Accreditation number for responsible qualified persons

0
accreditation numbers awarded to persons responsible for information
0
changes to the management of persons responsible for information

New

The Industry and Distribution Divisions are implementing the collaboration with the Grand Duchy of Luxembourg

The financial agreement between the Grand Duchy of Luxembourg’s Ministry of Public Health (Pharmacy and Medicines Division) and the FAMHP on the inspections of manufacturers and distributors of medicines and medicine brokers was concluded in 2019. The collaboration between Belgium and the Grand Duchy of Luxembourg’s inspection services, which has been running for several years, was substantiated in 2019 with two inspections of distributors and two of manufacturers in the Grand Duchy of Luxembourg.

Dispensing Division

Inspections

0
retail pharmacies
0
hospital pharmacies for medicines
0
medicinal stocks at veterinarians

Investigations

0
investigations into the dispensing of medicines

Authorisations Division

Hormones and antibiotics

0
new authorisations
0
renewals
0
letters of no objection (import certificates)
0
extensions and amendments of authorisations

Narcotics and psychotropic substances

Activity licences

0
new annual activity authorisations
0
amendments to annual authorisations

Narcotics order forms

0
narcotics order forms (per 100 forms)
0
letters of no objection

Licences for import and export

0
authorisations for import and export
0
inspections of authorisations for import and export
0
inspections of activity authorisations

Precursors

0
authorisations for precursors
0
suspicious orders and transactions
0
inspections of precursors

Manufacturing and distribution authorisations

0
authorisations for manufacturing/distribution of medicines
0
authorisations for manufacturing/distribution of API's
0
copies of authorisations for manufacturing/distribution of API's
0
certificates for GDP/GDP
0
copies of certificates for GMP/GDP
0
CPP
0
legalisations of documents

(except CPP)

Human bodily tissue and blood establishments

0
preliminary accreditations of HBT institutions
0
accreditations of HBT institutions

Pharmacies

0
new applications for the Commission for the Establishment of Pharmacies
0
registration forms for the registry of pharmacies
0
recognitions of pharmacists/clinical biologists  

Medical Devices Division

Inspections

0
inspections of medical devices of which

20

were GCP inspections of medical devices

57

inspections of MD/IVD manufacturers

6

6 inspections of registered bodies

148

inspections of medical device distributors

1

inspection of healthcare providers

4

inspections of medical device advertising

27

inspections of medical devices in hospitals

New

The Medical Devices Division was established in September 2018. The division’s inspectors and controllers carry out inspections of all actors in the medical device sector. There are six types of inspections.

GCP – Inspection of good clinical practices
In order for a MD to be placed on the market and remain on it, its manufacturer must demonstrate that it meets the essential performance and safety requirements set out in legislation, which in some cases requires the manufacturer to conduct a clinical study consistent with good clinical practices. The MD GCP inspectors monitor the implementation of good clinical practices and the follow-up of the submitted study protocol.

NB – Inspection of notified bodies
Notified bodies play an important role in the certification of MD’s placed on the European market by manufacturers. They are designated by the competent national authorities in collaboration with and under the supervision of the European Commission. The FAMHP is the national authority responsible for designation in Belgium and also takes part in joint European audits of notified bodies.

Inspection of manufacturers and representatives
The FAMHP can carry out inspections of medical devices manufacturers and their representatives who are established in Belgium. This applies both to traditional manufacturers and to manufacturers of custom-made medical devices and procedure packs, for all classes of MD’s and IVD’s. 

Inspection of distributors
Distributors of MD’s established in Belgium shall register with the FAMHP, which can then inspect them. Inspections and controls of MD distributors are planned on the basis of a risk analysis relying on data from the FAMHP web portal.

Inspection of hospitals
Within hospitals, managing medical devices is the responsibility of the hospital pharmacist and the “purchasing – economat – warehouse” services. Inspections are intended to control quality and raise awareness on the role hospitals play in market surveillance.

Bonuses and benefits – Advertising rules
In order to best protect consumers, advertising for medicinal products and MD’s for human use is subject not only to general regulations on advertising, but also to specific legislation with the aim of promoting rational use of medicinal products and MD’s, in full objectivity and on the basis of correct and complete information.

The majority of advertising controls are carried out in response to complaints.

New

In 2019, the Medical Devices Division conducted 38 inspections of MD distributors as part of autocontrol. The inspected companies had reported on the FAMHP web portal that they were following the guide on good distribution practices for MD distributors.

It was chosen to inspect distributors of class III medical devices, such as breast, hip, knee and shoulder prostheses and invasive MD’s in direct contact with the heart, the central circulatory system or the central nervous system.

During the controls, a total of 115 deficiencies of different types and degrees of severity were identified. These can be divided into six categories: data reported on the FAMHP web portal, quality system, materiovigilance, MD conformity (only administrative), control of storage conditions and outsourced activities.

The inspected distributors have agreed to take the necessary measures to comply with the legislation in force.

Special Investigation Unit

Investigations

0
investigations of illegal medicines or illegal circulation
0
post packages were confiscated after inspection
0
administrative and judicial investigations of which

58%

were assistance to police and public prosecutors

5,5%

were assistance to external partners (FASFC, customs, FPS Public Health, etc.)

0
official investigation files followed-up by

13%

an official report with amicable settlement

22%

an official report leading to prosecution

Trend

De SIU collaborates with a range of external partners. In order to offer professional advice and support on the ground, the unit is in constant contact with police and customs services active at the strategic points where transit, import and export of goods takes place. The unit provides professional, scientifically underpinned advice based on years of experience.

2019 saw a slight drop (5,451) in confiscated shipments of illegal medicines and/or medical devices confiscated by the SIU.

The number of confiscated shipments of illegal medicines does remain high. For each seizure, the FAMHP notifies the citizen of the risks they are taking with their health and of the applicable administrative and legal procedures.

The vast majority of the confiscated shipments continue to be erection-stimulating medicines such as sildenafil and tadalafil.

Compared to 2018, we see

  • an increase (x4) in confiscations of shipments of products based on DHEA (prasteron) and pregnenolon (hormonal lifestyle medicines that are mainly promoted as an anti-aging therapy);
  • an increase (x7) in confiscations of shipments of hair-restoring agents based on the substance minoxidil. These products are medicines and should not be considered innocent cosmetic products;
  • an increase of postal shipments of anabolic steroids, including the newer SARMs and soporifics based on melatonin.

In order to tackle this issue, it remains essential for the SIU to maintain and enhance the international contact with the European medicinal authorities and with the WHO working groups that has been developed.

New

Cannabidiol

A controversial phenomenon continued to develop in 2019: the sale of CBD, in the form of cannabis flowers, oils and other variants. These products contain insufficient THC to produce intoxication. They are recommended for a wide range of health conditions, but scientific research has only been able to convincingly demonstrate their usefulness for a very limited number of indications up to now.

 

In order to inform the public correctly and familiarise them with the range of legal products, the FAMHP took several initiatives. The FAMHP actively collaborated with FPS Justice, FASFC, FPS Public Health and customs, among others, to arrive at a considered and well-founded approach.

The agency also took part in 46 campaigns on the ground with the various partners and CBD has been included in inspections of postal shipments of illegal medicines. The question-and-answer section on cannabis has been amended to provide an answer for the populace to the frequently asked questions about CBD.

 

The FAMHP drew up a circular that creates a clear framework for the delivery of medicinal CBD. The number of proven indications is very low, but this makes sure that patients whose attending physician is recommending CBD are not left out in the cold and having to resort to products that lack the high quality of a medicine.

 

All these initiatives, along with the initiatives from the FAMHP partners, have clarified the framework significantly. This will undoubtedly be pursued further in 2020.

The DG Inspection and the entry into force of the Falsified Medicines Directive

2019 was the year in which the FMD entered into force. The months prior to the “go-live” saw intense consultation with the partners.

The new system officially became operational on 10 February 2019. In order to resolve teething problems, such as people involved who were not yet connected, false alarms and non-compliant barcodes, a stabilisation period was introduced. The situation was closely monitored, along with BeMVO. Various actors on the ground were also approached to tackle the problems step by step. This approach led to a rise in the number of connected pharmacies, wholesalers, manufacturers, etc., and a drop in the number of false alarms. In late August 2019, the stabilisation period expired and the final months of 2019 were used to gradually apply full pressure for FMD conformity as a standard component of the activities to be inspected.

Thanks to the system, some falsified medicines were found in a different European Member State in 2019. 2020 will see further work to maximise performance in tracking down falsified medicines. This is mainly to offer patients additional protection.

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