This is an HTML version of an attachment to the Freedom of Information request 'TTIP lobbying'.



Ref. Ares(2015)5008790 - 11/11/2015
Ref. Ares(2016)6036878 - 20/10/2016
To: 
 (TRADE); 
 (SANTE); 
(SANTE); 
 (SANTE); 
 (SANTE); 
 (TRADE); 
 (TRADE); 
(TRADE); 
 (TRADE); 
 (TRADE); 
 (TRADE) 
Cc: 
TRADE TTIP TRANSPARENCY 
Subject: 
TTIP Meeting with IFHA International Federation for Animal Health Europe  on 
10/11/2015 
DG TRADE and DG SANTE officials meet on 10/11/2015 with the International Federation 
for Animal Health Europe (IFHA) 
IFAH-Europe is the federation representing manufacturers of veterinary medicines, 
vaccines and other animal health products in Europe. It represents both corporate 
members and national animal health associations in Europe. These associations 
comprise both local medium-size enterprises (SMEs) and international companies. IFAH-
Europe's membership covers 90% of the European market for veterinary products. 
• IFHA enquired about progress in the TTIP pharmaceuticals regulatory discussions
and whether there are still opportunities for specific provisions on veterinary
medicines
• IFHA referred to VICH which is a trilateral (EU-Japan-USA) programme. The role of
VICH is to harmonise technical requirements for data necessary for the marketing
authorisation of a veterinary medicinal product.  This is achieved by developing
harmonised guidelines on the studies to be submitted in a marketing
authorisation application. VICH exists since 1996. IFHA enquired whether TTIP
might replace some vICH activities.
• IFHA inquired whether the EU-US recognition of GMP inspections for human
medicines could be expanded to veterinary medicines
• IFHA showed interest in the EU proposal to include an Article on Anti-Microbial
Resistance (AMR) in the SPS Chapter of TTIP (IFHA will take contact with the SPS
unit)
• COM noted that a detailed report of Round 11 is available online. It includes
details on pharmaceuticals regulatory discussions as well as on SPS discussions.
• As regards GMP, the modalities and scope (type of products to be covered) of the
GMP provisions has not yet been discussed. The focus of the works has been so
far on human medicines but other products are not excluded (EU-US 1998  MRA
covered veterinary medicines)
• COM supports (including through TTIP) the works of International fora such as
vICH and ICH. Wherever possible, harmonisation activities on technical
requirements for authorisation of medicinal and veterinary products will continue
to be deferred to these fora that are working well.

•  IFHA would need to specify its position (e.g. are there any other matters not 
covered in VICH that would require specific attention/action)  
•  IFHA will consult members and decide whether a joint EU-US position will be put 
forward  
 
 
Participants: 
 (TRADE)  



 

 (IFHA) 
 
 
 
European Commission 
Directorate General for Trade