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Background documents to 10th July Skype Policy call

 

AGENDA

1. Medicines shortages
a. Update on meeting with Commission
b. Update on meeting with PGEU, EGA and EFPIA (NOT for wider circulation)
c. Potential next steps on lobbying – information on new European Parliament health committee here.
d. Shortages survey report and use of the information.

2. Clinical trials
a. Update on recent EMA meeting on new CT database
b. Other trials news including TTIP and recent EMA Board discussions

3. Specialisation
a. Deciding date and agenda of October meeting, as well as meeting chair.
b. Report from CPD tender workshop in Brussels. (background doc)

4. Bar coding
a. Draft letter to EFPIA
b. Falsified Medicines Directive update

Draft Delegated Act (not for circulation – shared in confidence)

see section 6 on p9 in particular: "6. Modalities of verification of the safety features by pharmacies and persons authorised or entitled to supply medicinal products to the public"

– Past presentations from EDQM and ESM to the EAHP Board on the application of the FMD to pharmacy

– Useful recent summarising article here.

5. Biosimilar substitution regulations
a. Potential member survey
b. Potential letter to the EMA

Background:

  • recent Wall Street Journal article on biosimilar naming here
  • Article on France substitution regulations here

6. Austerity
a. Potential member survey

7. AOB

including: 

 

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