Brussels, 18 February 2019
Interinstitutional files:
2018/0161(COD)
WK 2211/2019 COR 1
LIMITE
PI
CODEC
COMPET
PHARM
IA
WORKING PAPER
This is a paper intended for a specific community of recipients. Handling and
further distribution are under the sole responsibility of community members.
NOTE
From:
General Secretariat of the Council
To:
Delegations
N° prev. doc.:
5411/19, WK 1583/2019 REV 1
N° Cion doc.:
9485/18 + ADD1 to ADD4
Subject:
Proposal for a Regulation of the European Parliament and of the Council amending
Regulation (EC) No 469/2009 concerning the supplementary protection certificate
for medicinal products (SPC)
Corrigendum: The second sentence of the review clause in Article 21a in row 85, 4th column of the 4-
column table attached to WK 2211/2019 should read:
' In addition to evaluating the impact of the exception of making for the purpose of export, special account
shall be taken of the effects of making for the purpose of storing with a view to ensuring EU Day-one
entry, on access to medicines and on public health expenditure, and on whether
the waiver and in
particular the period foreseen in point (a)(iii) of Article 5(2) is sufficient to achieve the objectives
mentioned in Article 5 including public health.
'
WK 2211/2019 COR 1
LIMITE
EN
Document Outline
