Events
Narcotics training

About the session

This practical training provides a comprehensive overview of the Belgian legal requirements
governing narcotic and psychotropic substances used in medicinal products.

The course will focus on the requirements of the Royal Decree of 6 September 2017 regulating
narcotics and psychotropic substances, as well as the practical expectations of the Federal
Agency for Medicines and Health Products (FAMHP).

The training will explain how the legislation applies to pharmaceutical companies, wholesalers,
distributors and other operators involved in the procurement, possession, storage, transport,
delivery, import or export of narcotic and psychotropic substances.
Particular attention will be given to the interaction between narcotics legislation and Good
Distribution Practices (GDP), including supplier and customer qualification, traceability,
documentation, stock control, discrepancies, returns, destruction and the responsibilities of
personnel involved in these activities.

The course is intended for Quality Assurance profiles, Responsible Persons, regulatory
professionals, warehouse and distribution personnel, and other employees involved in the
handling or oversight of narcotic and psychotropic medicinal products.

This interactive training will be held in English. The presentation slides will be provided. Upon
passing the test, a certificate will be provided.

Speaker :

Laïs Gryffroy – RP & QP expert

Topics covered by the training:

1. Introduction to narcotic and psychotropic substances

• What are narcotic and psychotropic substances?
• Scope of the Belgian legislation

2. Belgian legal framework

• Royal Decree of 6 September 2017
• Role and responsibilities of the RP for Narcotics

3. Licensing requirements

• Activity license
• Scope of activities requiring a license

4. Procurement, receipt and delivery

• Legal requirements for purchasing and receiving narcotics
• Verification of suppliers and customers
• Use of Narcoreg

5. Narcoreg and record keeping

• Registration of deliveries and receipts
• Applicable deadlines
• Corrections and discrepancies

6. Storage and security

• Requirements for storage of narcotics and psychotropic substances
• Access control
• Handling of discrepancies, loss and theft

7. Transportation and distribution

• Requirements for transport
• Security during transportation
• Qualification and oversight of transporters
• Traceability throughout the supply chain

8. Import and export

• When an import/export authorisation is required
• Belgian and foreign authority requirements
• Import authorisations and export authorisations
• Letter of No Objection (LONO)
• Export to countries with different controlled-substance classifications

9. Returns, recalls and destruction

• Handling of returned narcotic products
• Recall management
• Destruction requirements
• Documentation and destruction certificates

10. Practical tips & tricks

• How to build a compliant and pragmatic narcotics QMS
• What should be covered in your SOPs?

Price :

457.35 euros excl VAT

Location :

Online – Teams