Workshop: “Regulatory framework in medicinal products distribution”
The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb, a one day workshop "Regulatory framework in medicinal products distribution” intended to wholesales authorisation holders. Workshops will be held at HALMED’s premises, Ksaverska cesta 4. The exact date of the first workshop will be announced later, depending on the number of registered participants.
Topics
- Introduction - Overview of legislation amendments after the Croatia’s accession to the EU
- Good Distribution Practice rules
- Granting wholesales authorisation, brokerage authorisation and GDP certificate; notification of natural and legal entities with the seat outside of the Republic of Croatia in another EU Member State carrying out wholesale or brokerage of medicinal products on the Croatian territory
- Ensuring the supply chain in Croatia - regulatory tools
- Parallel import and parallel distribution
- "GMP meets GDP” - Challenges of harmonisation with the new requirements medicines wholesale and comparison with Good Manufacturing Practice
- Counterfeit medicines
Registration
We would kindly ask you to submit the fulfilled registration form to Ms Ana Marija Jakelić by e-mail: anamarija.jakelic@halmed.hr or fax on +385 1 4884 110, with the attention to Ms Jakelić.
Registration form
The registration form is accessible here: .doc; .pdf
The number of participants is limited (15), therefore, we suggest an early registration
Workshop fee
The workshop fee for participation is 1000,00 kn + VAT = 1250,00 kn, including written material, coffee break and certificate of attendance.
Fee payment
After registration, the fee will be paid exclusively via pro-forma invoice that will be sent to the participant by mail/fax to the contacts indicated in the registration form
The copy of money order should be forwarded to Ms Ana Marija Jakelić by e-mail to: anamarija.jakelic@halmed.hr or fax on +385 1 4884 110, with the attention to Ms Jakelić.
Cancellation
In case of inability to attend, the registered participant should inform Ms Ana Marija Jakelić on +385 1 4884 107. In case the registered participant is not in possibility to attend, a replacement from the same company is possible, which should be promptly notified to Ms Ana Marija Jakelić.
