Transcript Pharmakovigilanz

CPNP:
COSMETIC PRODUCTS
CATEGORIES
2ND MEETING OF THE
EAPCCT WORKING GROUP ON
POISONS CENTRES ACTIVITIES /
EUROPEAN REGULATORY ISSUES
24TH MAY 2011 - DUBROVNIK
ANDREAS STÜRER, MD
SWISS TOXIKOLOGICAL INFORMATION CENTRE
AGENDA
[CPNP/CAT]
1. Process of Harmonisation
2. Current Version 0-7-3
3. Future Steps
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
PROCESS OF HARMONISATION
[CPNP/CAT]
 29 June 2009 first meeting of the
CPNP working group in Brussels:
3 Ad-hoc groups were launched
 19 Sept. 2009 second meeting of the
CPNP working group in Brussels:
Presentation of the TDI Categories
 28 Oct. 2009 informal Meeting of COLIPA
and KliniTox representatives in Zurich:
Start of a Joint Venture on
Cosmetics Products Categories
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
PROCESS OF HARMONISATION
[CPNP/CAT]
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
Start with ~200 TDI Categories*
- 5 level hierarchical system
- Comprises all 110 Frame Formulae 2000
- 10 year experience of 11 Poisons Centres
- Experience of the Federal Office of
Consumer Protection and Food Safety
(BVL), Berlin
Taking into consideration:
- Categories mentioned in Cosmetics-Reg.
- Experience of COLIPA / industries
- Experience of the CPNP working group
*Frame Formulae – TDI-Cos.Cat.
www.klinitox.de -> Arbeitsgruppe V -> TDI
=> ALLOCATION TABLE [DE] xls-file [DE/EN]
PROCESS OF HARMONISATION
[CPNP/CAT]
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
 Nov. 2009 – May 2011:
several meetings / conference calls
21 temporary versions
 19 May 2011:
version 0.7.3 ready for beta-test
VERSION 0-7-3
[CPNP/CAT]
STRUCTURE:
 1 Table
 4 Levels
 1.
 2.
 3.
 4.
Level:
Level:
Level:
Level:
Organ [n=4]
Product Purpose Group [n=22]
Product Purpose Type [n=82]
Frame Formulae [n=213; (137 diff.)]
“Others … products” (no FF) [n=82]
 Unique ID (Versioning)
> Link to CPNP Cosmetics Categories
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
FUTURE
[CPNP/CAT]
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
 Beta-test starts June 2011
 Poisons Centres (PCs) could test
cosmetics categories within the CPNP
 CPNP ad hoc working group CATEGORIES
is ready to receive feedback from PCs
 Missing categories (product types)
could be integrated
 12 Jan. 2012 CPNP will start with a final
version 1.x.y of cosmetics categories
 Thereafter all EU cosmetics products will
be categorised uniform for all EU PCs
QUESTIONS ?
with
best
wishes
and
success
for the
congress
from
Zurich
A. STÜRER ▪ DUBROVNIC
24 MAY 2011
> [email protected]