Activities

Regulatory Affairs: Activities

EXECUTING 3 YEAR PLAN - 2016/2019

Further interaction with the CMDh and EMA-
• LEU Nuclide conversion-support for further applications (work-sharing benefits)
• Explore other regulations and requirements - possible future interactions, including invitation to proposed 2017 Symposium

Involvement with EDQM an expert group reviewing proposed new, or changes to existing, pharmacopeia monographs
• Representation from the RA&Q working group now established

Review regulatory guidance and directives to ensure members are informed of changes and submit comments on behalf of members, in order to influence regulatory authorities during consultation procedures
• Regulatory update table (quarterly update) - What’s new
• Conferences/seminars - proposal to hold seminar on regulatory developments with expert speakers : London Q4 2017

Expand use of the AIPES website to provide access to information for members, to more effectively utilise tools and information - Expert resumes for members seeking advice.

parag
ACTIVITIES OF THE GROUP PRESENTED AT THE ANNUAL GENERAL ASSEMBLY OF AIPES
On 10 May 2017 in Brussels
Click here to download the Working Group Presentation (PDF)

RA Q WORKING GROUP

Italy: Bollino
On 8 November 2012, the Italian authorities adopted a law which exempts radiopharmaceuticals from the obligation to be affixed a sticker (bollino).
The law was published in the Italian gazzetta ufficiale of 10 November - here below the link to the law, see article 10 : http://www.gazzettaufficiale.it/guridb//dispatcher?task=attoCompleto&service=10&datagu=2012-11-10&redaz=12A11988&connote=false
This outcome is very positive for AIPES and its members who had been asking for this exemption for many years.