INDUSTRY DIVISION
INSPECTIONS
GMPGood Manufacturing Practices inspections
GCPGood Clinical Practices inspections
of which
GCPGood Clinical Practices inspections medicines
inspections of manufacturers of medical devices
ADVISORY COMMISSION
RAPID ALERT SYSTEM
ANALYSIS OF PRODUCTS ON THE MARKET
DISTRIBUTION DIVISION
INSPECTIONS
CHECKS ON ADVERTISING AND OTHER PROMOTIONAL ACTIVITIES FOR MEDICINES AND HEALTH PRODUCTS
investigations on medicines
investigations on advertising for medical devices
investigations on the distribution of medical devices
QUESTIONS ABOUT MEDICINES AND HEALTH PRODUCTS
questions about medicines
questions about medical devices
questions about advertising for medical devices
ACCREDITATION NUMBER FOR RESPONSIBLE QUALIFIED PERSONS
Trend
In 2018 there was a strong increase in the number of requests via the e-mailbox of the distribution department, including, among others, requests about the implementation of the Falsified Medicines Directive and Brexit.
New
In 2018, the distribution department started to report systematically to the pharmaceutical industry regarding warnings of falsified medicines that are discovered in the European Union or elsewhere in the world. The sector has also been updated regarding stolen medicines to increase vigilance and to reduce the risk of stolen medicines being re-introduced into the local circuit. By sending documents such as inspection reports via an electronic path, the use of paper is reduced, as is transmission time of documents. The archiving of all documents related to inspections and approvals of RIPsResponsible for information and publicity is done electronically. Thematic actions performed in 2018 such as temperature control of approved rooms for the storage of medicines and for the storage of medicines in transit zones. Inspections of the transfer of medical samples were increased and reinforced the presence of the FAMHPFederal Agency for Medicines and Health Products in the field.
DISPENSING DIVISION
INSPECTIONS
Trend
In 2018, there was an increase in the number of inspections of pharmacies open to the general public.
hospital pharmacies
including
Trend
In 2018, there was a reduction in the number of inspections of medicinal stocks at veterinarians.
HORMONES AND ANTIBIOTICS
letters of no objection (import certificates)
extensions/amendments of authorisations
NARCOTICS AND PSYCHOTROPIC SUBSTANCES
Activity licences
Licences for import and export
Narcotics order forms
letters of no objection (import certificates)
authorisations end user (before “small quantities”)
PRECURSORS
MANUFACTURING AND DISTRIBUTION AUTHORISATIONS
HUMAN TISSUE MATERIAL AND BLOOD INSTITUTIONS
PHARMACIES
MEDICAL DEVICES DIVISION
new
In September 2018, the Medical Devices department was established. The numbers for 2018 were still being included in the numbers of the other departments of DG Inspection. From 2019 on, the Department of Medical Devices will maintain separate reporting.
SPECIAL INVESTIGATION UNIT
Number of postal packages inspected
Trend
There is still an increase in the number of seized packages with illegal medicines. For each seizure, the FAMHPFederal Agency for Medicines and Health Products notifies the citizen of the risks they are taking for their health and of the applicable administrative and legal procedures.
The FAMHPFederal Agency for Medicines and Health Products works together closely with the justice department, the police and other federal agencies in the very high number of controls of cannabis shops.
The number of examinations of abortion drugs has increased. Irrespective of the action of SIUSpecial Investigation Unit for the investigation itself, the affected parties are always referred to the healthcare professionals to ensure adequate medical and psychological follow-up.
On an international level, the unit is very active in various WHO working groups to combat drugs criminality, including:
- the task force combating internet criminality,
- the task force charged with developing and promoting materials and supporting documents to increase the capacity of the agencies involved and thus detect unreliable, illegal and falsified medicines and prevent them,
- the task force developing effective communication media and prevention campaigns for those medicines that do not fulfil the standards and are falsified.
The SIUSpecial Investigation Unit supported various university projects, including studying the internet criminality problem and developing a technique to quickly identify illegal products.
FAMHP Annual report 2018 - powered by THE CREW COMMUNICATION