Dear
On behalf of Vaccines Europe (VE) members I would like to share with you the VE position
paper on a proposal for a revision of the Annex to the European Commission guideline on
"Excipients in the labelling and package leaflet of medicinal products for human use"
(SANTE-2017-11668), which cover the following section:
1. Background and objective
2. Vaccine Europe assessment
2.1 Para-aminobenzoic Acid (PABA)
2.2 Phenylalanine
2.3 Sodium and potassium
2.4 Ethanol
3. Discussion and recommendation
4. Literature references
We would like to propose to set up a virtual meeting (TC) to explain the issue described in the
VE position paper and to discuss the possible solution. I would like to inform you that the
attached documents (word, pdf) have also been submitted to EMA.
Looking forward to hearing from you,
kind regards
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Vaccines Europe
Leopold Plaza Building
Rue du Trône 108
B-1050 Brussels (Belgium)
@vaccineseurope.eu
www.vaccineseurope.eu