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DIRECTORATE-GENERAL

INSPECTION
competent for all inspection and control activities

INDUSTRY DIVISION

INSPECTIONS

GMPGood Manufacturing Practices inspections

 

GCPGood Clinical Practices inspections

 

pharmacovigilance inspections

GCPGood Clinical Practices inspections medical devices

 

not GCPGood Clinical Practices inspections medical devices

inspections human tissue material

ADVISORY COMMISSION

applications for variations submitted to the Advisory Commission

 

CERTIFICATE OF RESPONSIBLE QUALIFIED PERSONS

certificates

 

RAPID ALERT SYSTEM

rapid alerts of quality of which

class 1

class 2

class 3

fraud/counterfeit

concerning medicines for human use

concerning medicines for veterinary use

concerning raw materials

concerning IMPsInvestigational Medicinal Product - a medicinal product for research

ANALYSIS OF PRODUCTS ON THE MARKET

medicines

preparations

raw materials

products seized

DISTRIBUTION DIVISION

INSPECTIONS

inspections on advertising for medicines

inspection on advertising for medical devices

GDPGood Distribution Practices inspections of medicines

 

GDPGood Distribution Practices inspections of medicines for obtaining or amending a WDAWholesaler’s Distribution Authorisation

inspections of the distribution of medical devices, of which

thematic inspections

CHECKS ON ADVERTISING AND OTHER PROMOTIONAL ACTIVITIES FOR MEDICINES AND HEALTH PRODUCTS

investigations

QUESTIONS ABOUT MEDICINES AND HEALTH PRODUCTS

about medicines

about medical devices

ACCREDITATION NUMBER FOR RESPONSIBLE QUALIFIED PERSONS

accreditation numbers awarded to persons responsible for information

changes relating to persons responsible for information

TrendTrend

In 2017, a large number of investigations on advertising violations and good distribution practices of medicines and medical devices took place.
Result: numerous warnings, various official reports with an administrative fine and in exceptional but serious cases the official report was forwarded to the prosecutor.

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The Distribution division contacted the pharmaceutical companies several times to obtain the updated contact details of the person responsible for the information or contact persons. These contacts are used, among other things, in warnings of manufacturing errors and falsified or stolen medicines.

DISPENSING DIVISION

INSPECTIONS

retail pharmacies

TrendTrend

In 2017, the number of inspections of retail pharmacies decreased. Because of their competencies, the inspectors for pharmacies were involved in the projects concerning the implementation of the multiannual plan for patients with the officinal pharmacists.

hospital pharmacies, of which

for medicines

for medical devices

medicinal stocks at veterinarians

TrendTrend

After the publication of the Royal Decree of 21 July 2016, a thematic action was realised for the inspections of medicinal stocks at veterinarians on the use of so-called critical antibiotics and the encoding in SANITEL-MED (FRNL).

SANITEL-MED
0
controls performed at veterinarians
5.0 %
non-conformities, followed by a reminder of the legal obligation of encoding in SANITEL-MED
Critical antibiotics and practices related to food producers

controlled depots of which
 

depots no longer used critical antibiotics

depots used critical antibiotics in line with the legislation (samples, antibiogram)

medicinal stocks at healthcare professionals

AUTHORISATIONS DIVISION

HORMONES AND ANTIBIOTICS

new licences

renewals

import certificates

extensions of licences, import certificates and duplicates

NARCOTICS AND PSYCHOTROPIC SUBSTANCES

Activity licences

0
new annual activity licences
0
amendments of annual licences
0
renewals of annual licences

Licences for import and export

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

Narcotics order forms

0
narcotics order forms (per 100 forms)
0
letters of no objection
0
authorisations for small quantities

TrendTrend

There is a strong increase in the number of applications for Schengen declarations. It is clear that this document is more and more known by citizens who wants to travel with medicines for personal use and wants to avoid customs problems.

PRECURSORS

0
new activity licences
0
import licences
0
export licences
0
suspicious orders and transactions

MANUFACTURING AND DISTRIBUTION AUTHORISATIONS

0
fabrication licences
0
copies of fabrication licences
0
distribution licences
0
copies of distribution licences
0
registrations APIActive Pharmaceutical Ingredient – active substance or ingredient in medicines
0
certificates of GMPGood Manufacturing Practices
0
copies of GMPGood Manufacturing Practices-certificates
0
certificates GDPGood Distribution Practices
0
copy of GDPGood Distribution Practices-certificate
0
export declarations
0
declarations of toll manufacturing activity
0
registrations broker
0
quarterly declarations fabrication/distribution IMPInvestigational Medicinal Product - a medicinal product for research
0
legalise of documents for industry (except CPPCertificate of Pharmaceutical Product – Product-specific certificates)

HUMAN TISSUE MATERIAL AND BLOOD INSTITUTIONS

0
preliminary accreditations MLM-MCHHuman tissue material organisations
0
accreditations for MLM-MCHHuman tissue material organisations
0
renewals accreditation for a blood institution

PHARMACIES

0
new applications for the Commission for establishment of retail pharmacies
0
registration forms registry of pharmacies
0
recognitions of pharmacists-clinical biologists

SPECIAL INVESTIGATION UNIT

0
administrative and judicial investigations closed of which
0 %
assistance to public prosecutors
0
investigations into non-compliant medical devices closed
0
investigations into abortive drugs

Number of postal packages inspected

TrendTrend

The FAMHPFederal Agency for Medicines and Health Products confiscates more and more SARMsSelective androgen receptor modulator. SARMsSelective androgen receptor modulator are often abused by athletes to improve their performance. More and more SARMsSelective androgen receptor modulator can also be found in nutritional supplements for athletes and in aromatic oils. These products are not only difficult to identify for the users but also for the inspection services.

SARMsSelective androgen receptor modulator were included in the WADAWorld Anti-Doping Agency doping list as androgenic anabolic steroids, classified as substances and methods that are prohibited at all times (both within competition and outside competition).

The interception of anabolic products in large quantities is worrying and may indicate illegal production.

The illegally produced anabolic products are offered much cheaper than the legally produced products, but they cause a great risk to the user: lack of sterility, dangerous overdoses, other potentially toxic ingredients.

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