Availability of veterinary medicines in the Nordic region - from a regulatory perspective

Swedish Academy of Pharmaceutical Science in cooperation with LIF (the trade association for the research- based pharmaceutical industry in Sweden).

The education has been designed in consultation with the Medical Products Agency.

The availability of veterinary medicines in smaller markets depends to a large extent on the possibility to distribute the same multilingual pack in more than one country.
In the Nordic countries, with five independent health authorities and five official languages, this has been a constant challenge for both regulators and industry over the years.
The meeting aims at bringing together regulators and industry representatives to share experience on real cases and to discuss ongoing and planned regulatory initiatives to increase availability of veterinary medicines in the Nordic region.

Participating authorities include:

Download information leaflet as pdf.

Courses

Date

Location

Course fee (SEK excl. VAT, early/late)

Who should attend?

Representatives from Health Authorities, Industry and Veterinary Organizations with an interest in the regulation, distribution and availability of veterinary medicines.

What will you learn?

Good working examples from both regulators and industry on how to facilitate smooth implementation and maintenance of multilingual veterinary medicine packs will be shared. The symposium will also give a look into a promising future of simplified and pragmatic regulatory approaches to increase availability of veterinary medicines in smaller markets. In addition, time will be devoted for discussions with peers and counterparts on the topics.

Program

09.00	Registration and coffee
09.30	Welcome and Introduction, Rikard Pellas, LIF
	- The Nordic VMP market in perspective
	- Purpose of the day
09.35	Initiatives to increase availability
	- Short introduction to European harmonization of nationally SPCs, Alenoosh Abedi, LV
	- Authority Initiative II: Work Sharing - Periodic Safety Update Reports and Variations, Alenoosh Abedi and Peter Ekström, LV
	- Authority Initiative III: Minor Use Minor Species/Limited Markets. Relevance for the Nordic market, Tita-Maria Muhonen, FIMEA
	- Industry Initiative: The 1-1-1 Concept, Rick Clayton, IFAH-Europe
	- Temporary authorization and special license Norway, Tonje Höy, NoMA
12.00	Lunch
13.00	Implementation of updated packaging material - what does it take?, Christer Olsson, Merial
13.30	Multi-lingual packs increase availability
	- Trade names: Regulations, procedures and experiences, Ylva Satrell, LV
	- How to achieve a common trade name, Christer Olsson, Merial
14.30	Coffe
14.50	- Nordic Labeling: Industry Perspective and Experiences, Britta Rosenqvist, Boehringer Ingelheim
	- Nordic Labeling: Regulatory Advice and Experience, Heidi Mustalammi, FIMEA
	- Joint labeling assessment: Example from the Baltic states, Marina Stenlander, BMS
16.00	Plenary discussions: Regulatory solutions to ensure/increase availability of VMPs in the Nordic Market? Moderator: Jan Ström, LIF
16.45	End

Läkemedelsakademin. Besöksadress: Wallingatan 26 A. Postadress: Box 1136, 111 81 Stockholm.
Tel: 08-723 50 00. Fax: 08-20 55 11. E-post: info@lakemedelsakademin.se