Tuesday, October 24, 2017, 14.00 – 17.00 hrs. at Lersø Parkallé 101, 2100 Copenhagen Ø
Dear marketing authorisation holders, manufacturers and parallel importers,
As follow-up on the previously forwarded letter regarding the new directive to prevent falsified medicines that will become effective from February 9, 2019, DMVO invites to an information meeting on October 24, 2017 for marketing authorisation holders, manufacturers and parallel importers in Denmark.
The purpose of the information meeting is to ensure that you as marketing authorisation holder, manufacturer and parallel importer are aware of the directive and the authorities’ expectations, DMVO, including role and tasks, onboarding process to the European hub and contract formation with DMVO.
The meeting takes place on Tuesday, October 24, 2017, 14.00 – 17.00 hrs. at Lersø Parkallé 101, 2100 Copenhagen Ø.
Issues to be dealt with at the meeting:
- Background and introduction to DMVO – Danish Medicine Verification Organisation
- Patient safety, including the authorities’ expectations to marketing authorisation holders and DMVO in connection with the Falsified Medicines
- Directive and the new rules of safety features on the packaging of medicinal products.
- EMVO and onboarding of the European database: EMVS (”the hub”)
- Brief status on establishment of the Danish Verification System - DMVS
- The Danish marketing authorisation holder contract and payment model and legal content
- Summarising and closing of the meeting.
Representatives from the Danish Medicines Agency, EMVO and DMVO and the Board will speak at the meeting.
The language at the meeting will be Danish, but the item regarding EMVO will be in English.
The above-mentioned programme will include a short break during the afternoon when light refreshments will be served.
Number of seats will be limited, therefore we recommend you to let us know about your attendance as soon as possible. If you would be unable to participate even though you have registered previously, please let us know, so we can give your seat to another person on the waiting list. We would like to thank you for your kindness in this matter.
Please inform Linda Hvidberg Jensen about your participation in the meeting on e-mail: firstname.lastname@example.org indicating your full name, title and organisation/company and whether you are marketing authorisation holder, manufacturer or parallel importer.
Your participation requires your attendance on location. No online participation.
Please note that closing date for registration is Thursday, October 19, 2017.
We look forward to seeing you.