G/MA/QR/N/EU/5/Add.5  
 
9 July 2021 
(21-5443) Page: 1/10 
Committee on Market Access  Original: English  
 
  
NOTIFICATION PURSUANT TO THE DECISION ON NOTIFICATION  PROCEDURE S 
FOR QUANTITATIVE RESTRICTIONS (G/L/59/REV.1)  
EUROPEAN UNION 
Addendum  
The following communication, dated 8 July  2021, is being circulated at the request of the delegation 
of the European Union . 
 
A. Notifying Member : European Union  
B. Date of notification : 8 July 2021  
C. First time notification:  
 Yes 
 No, last notification was made in (doc. symbol ): G/MA/QR/N/EU/5, 
G/MA/QR/N/EU/5/Add.1 , G/MA/QR/N/EU/5/Add.2 , G/MA/QR/N/EU/5/Add.3 ,  and 
G/MA/QR/N/EU/5/Add.4  
D. Type of notification:  
 1. Complete (i.e. notification of all quantitative restrictions in force ) 
 2. Changes to a notification previously made in G/MA/QR/N/EU/ 4/Add. 3 which are of the 
following nature : 
  2.1 Introduction of new restrictions, as listed in Section 1. 
  2.2 Elimination of restrictions, as described in G below . 
  2.3 Modification of a previously notified restriction, as described in Section 1. 
 3. Reverse notification of restrictions maintained by (Member ):  
E. The notification provides information for the follo wing biennial period 
(e.g.  2012 -2014): 2020-2022 and relates to restrictions in force as of 05.05. 2021 
F. This notification contains information* relating to:  
 Section  1: List of quantitative restrictions that are currently in force . 
 Section  2: Cross -reference to other WT O notifications with information on quantitative 
restrictions that are currently in force and additional information . 
 
* In English  only. G/MA/QR/N/EU/5/Add.5  
 
- 2 - 
 
  G. Comments of a general nature, including a description of the elimination of 
restrictions notified under D.2.2 and the date they ceased to be in force.   
 1. The following temporary measures taken by some EU Member States (notified in 
G/MA/QR/N/EU/4/Add.3) are no longer in force:  
 
 - Cyprus (G/MA/QR/N/EU/4/Add.3  QR no. 1): terminated on 26 May 2020  
 - France (G/MA/QR/N/EU/4/Add.3  QR no. 3): terminated on 11 May 2020  
 - Slovak Republic ( G/MA/QR/N/EU/4/Add.3  QR no.6): terminated on 7 April 2020  
 
  2. In section 1, the EU notifies : 
 
 2.1  M easures previously no tified in G/MA/QR/N/EU/4/Add.3, which remain in force : 
 - Estonia (Q R no. 1) 
 - Greece (Q R no. 2) 
 
      2.2  New temporary measures adopted by : 
 - Hungary (Q R no. 3) 
 - Romania (Q R no. 4) 
 
 
 
 
 
 
 
 
 
  
  G/MA/QR/N/EU/5/Add.5  
 
- 3 - Section  1: List of quantitative restrictions that are currently in force  
 
EU Member States  
 
Estonia  
 
 
QR 
No.  General 
description 
of the 
restriction  Type of 
restriction  Tariff line 
code  (s) 
affected, based 
on HS (2017)  Detailed Product 
Description  WTO Justification  
and Ground for 
Restriction, e.g. Other 
International 
Commitments  National legal basis and 
entry into force  Administration, 
modification of 
previously notified 
measures, and other 
comments  
1 2 3 4 5 6 7 
1 Export 
restriction of 
medicinal 
products  P-X  1. Diovan 80 mg film -
coated tablets N28 (SIA 
"Novartis Baltics")  
2. Diovan 160 mg film -
coated tablets N28 (SIA 
"Novartis Baltics")  
3. Valsacor 80 mg film -
coated tablets N28 
(KRKA d.d., Novo 
mesto)  
4. Valsacor  160 mg film -
coated tablets N28 ja 
N56 (KRKA d.d., Novo 
mesto)  
5. Valsacor 320 mg film -
coated tablets N28 
(KRKA d.d., Novo 
mesto)  
6. Co-Diovan 80 mg + 
12,5 mg film -coated 
tablets N28 (SIA 
"Novartis Baltics")  
7. Co-Diovan 80 mg film -
coated tablets N28 (SIA 
"Novartis  Baltics")  Protection of human life or 
health, inter alia  
 Decision by the State 
Agency of Medicines  
 
Basis:  § 20(6) of the 
Medicinal Products Act  
https://www.ravimiamet.ee
/en/import -and-export -
goods -require -special -
authorisation -including -
medicinal -products   
 Estonian  State Agency of 
Medicines  
 
The measure is temporary  
    8. Valsacombi  80 mg + 
12,5 mg film -coated 
tablets N28 (KRKA d.d., 
Novo mesto)      
  G/MA/QR/N/EU/5/Add.5  
 
- 4 - QR 
No.  General 
description 
of the 
restriction  Type of 
restriction  Tariff line 
code  (s) 
affected, based 
on HS (2017)  Detailed Product 
Description  WTO Justification  
and Ground for 
Restriction, e.g. Other 
International 
Commitments  National legal basis and 
entry into force  Administration, 
modification of 
previously notified 
measures, and other 
comments  
1 2 3 4 5 6 7 
9. Valsacombi 160 mg + 
12,5 mg film -coated 
tablets N28 (KRKA d.d., 
Novo mesto)  
10. Valsacombi 160 mg + 
25 mg film -coated 
tablets N28 (KRKA d.d., 
Novo mesto)  
11. Valsacombi 320 mg + 
12,5 mg film -coated 
tablets N28 (KRKA d.d., 
Novo mesto)  
12. Orgalutran 0,25 mg/0,5 
ml solution for injection 
0,5 ml N1 (Merck Sharp 
& Dohme B.V.)  
13. Moduretic 50 mg + 5 
mg tablets N30 (Merck 
Sharp & Dohme OÜ)  
14. M-M-Rvaxpro powder 
and solvent for 
suspension for injection 
N1 (MSD VACCINS ) 
15. Xarelto 15 mg film -
coated tablets N28 
(Bayer AG)  
16. Xarelto 20 mg film -
coated tablets N28 
(Bayer AG)  
17. Lantus Solostar 100 
IU/ml solution for 
injection in pre -filled 
pen 3 ml N5  (Sanofi -
Aventis Deutschland 
GmbH)  
 
  
  G/MA/QR/N/EU/5/Add.5  
 
- 5 - QR 
No.  General 
description 
of the 
restriction  Type of 
restriction  Tariff line 
code  (s) 
affected, based 
on HS (2017)  Detailed Product 
Description  WTO Justification  
and Ground for 
Restriction, e.g. Other 
International 
Commitments  National legal basis and 
entry into force  Administration, 
modification of 
previously notified 
measures, and other 
comments  
1 2 3 4 5 6 7 
    18. Roactemra  162 
mg/0,9ml solution for 
injection in pre -filled 
pen 0,9 ml N4  (Roche 
Registration GmbH)     
    19. Roactemra 162 
mg/0,9ml solution for 
injection 0,9ml 
N4 (Roche Registration 
GmbH)  
20. Roactemra  20mg/ml 
concentrate for solution 
for infusion  (Roche 
Registration GmbH)  
21. Brilique 90 mg film -
coated tablets 
N56 (AstraZeneca AB)  
22. Forxiga 5 mg film -
coated tablets 
N30 (AstraZeneca AB)  
23. Forxiga 10 mg film -
coated tablets 
N30 (AstraZeneca AB)  
24. Pulmicort Turbuhal er 
0,2mg/dose inhalation 
powder 100 doses 
N1 (AstraZeneca AB)  
25. Symbicort Turbuhaler 
4,5 mcg + 160 
mcg/dose inhalation 
powder 120 doses 
N1 (AstraZeneca AB)  
26. Symbicort Turbuhaler 9 
mcg + 320 mcg/dose 
inhalation powder 60 
doses N1  (AstraZeneca 
AB) 
     
  G/MA/QR/N/EU/5/Add.5  
 
- 6 - QR 
No.  General 
description 
of the 
restriction  Type of 
restriction  Tariff line 
code  (s) 
affected, based 
on HS (2017)  Detailed Product 
Description  WTO Justification  
and Ground for 
Restriction, e.g. Other 
International 
Commitments  National legal basis and 
entry into force  Administration, 
modification of 
previously notified 
measures, and other 
comments  
1 2 3 4 5 6 7 
    27. Xigduo 850 mg + 5 mg 
film-coated tablets 
N56 (AstraZeneca AB)  
28. Xigduo 1000mg + 5mg 
film-coated tablets 
N56 (AstraZeneca AB)     
    29. Betaferon  250 mcg/ml 
powder and solvent for 
solution for injection 
(Bayer AG)  
30. Paracetamol (ATC code 
N02BE01) all dosage 
forms  
    
 
   
  G/MA/QR/N/EU/5/Add.5  
 
- 7 - Greece  
 
QR 
No.  General 
description 
of the 
restriction  Type of 
restriction  Tariff line 
code  (s) 
affected, based 
on HS (2017)  Detailed Product 
Description  WTO Justification  
and Ground for 
Restriction, e.g. Other 
International 
Commitments  National legal basis and 
entry into force  Administration, 
modification of 
previously notified 
measures, and other 
comments  
1 2 3 4 5 6 7 
2 Export 
prohibition of 
medicinal 
products  P-X  Vaccines and medicines 
that are or might be in 
shortage due to the Covid -
19 pandemic  
 
For details, please see the 
links in column 6  
 
 
 Protection of human life or 
health, inter alia  
 
 Decisions from the Ministry 
of Health,  all adopted on 
13 April 2020:  
 
No 43196 (concerning 
vaccines)  
https://www.eof.gr/c/docu
ment_libra ry/get_file?uuid
=e9749853 -3c85-4a85-
a380-
9ebe174e1c35&groupId=1
2225 
 
No 43197 (concerning 
pharmaceutical products 
potentially in shortage due 
to Covid -19) 
https://www.eof.gr/c/docu
ment_library/get_file?uuid
=b4f8f46f -9168-48c8-
a3e6-
c6d01cd5c360&groupId=1
2225 
List of products:  
https://www.eof.gr/c/docu
ment_library/get_file?uuid
=c90c8cfe -d2c8-497b-
9f81-
2b6f84da6096&groupId=1
2225 Republic of Greece, 
Ministry of Health  
 
The measures  are 
temporary   
  G/MA/QR/N/EU/5/Add.5  
 
- 8 - QR 
No.  General 
description 
of the 
restriction  Type of 
restriction  Tariff line 
code  (s) 
affected, based 
on HS (2017)  Detailed Product 
Description  WTO Justification  
and Ground for 
Restriction, e.g. Other 
International 
Commitments  National legal basis and 
entry into force  Administration, 
modification of 
previously notified 
measures, and other 
comments  
1 2 3 4 5 6 7 
      No 43198 (concerning 
pharmaceutical products in 
shortage)  
https://www.eof.gr/c/docu
ment_library/get_file?uuid
=96aca85a -4551-4d66-
8063-
540e4ad09517&groupId=1
2225 
List of products:  
https://www.eof.gr/c/docu
ment_library/get_file?uuid
=426a5298 -e17f-4fba-
a951-
b282414b5736&groupId=
12225  
  
 
 
 
   
  G/MA/QR/N/EU/5/Add.5  
 
- 9 - Hungary  
 
 
  QR 
No. General 
description of 
the restriction  Type of 
restriction  
 Tariff line 
code(s) 
affected, based 
on HS(2017)  Detailed Product 
Description  WTO Justification and 
Grounds for Restriction, 
e.g., Other International 
Commitments  National legal basis 
and entry into 
force  
 Administration, 
modification of 
previously notified 
measures, and 
other comments  
1 2 3 4 5 6 7 
3 Export prohibition 
of medicinal 
products  P-X  Gelofusine solution for 
infusion and Gelaspan 4 
% solution for infusion  Protection of human life or 
health, inter alia  
 
 Decision 
OGYÉI/71261 -
1/2020, adopted 
11/12/2020.  
  
https://ogyei.gov.hu/
elofusine_oldatos_inf
uzio_es_a_gelaspan_
4_oldatos_infuzio_tila
lom/ 
 
Entry into force: 11 
December 2020  Hungary, National 
Institute of 
Pharmacy and 
Nutrition  (OGYÉI)  
 
The measure is 
temporary   
  G/MA/QR/N/EU/5/Add.5  
 
- 10 - Romania  
 
 
__________  QR 
No. General description 
of the restriction  Type of 
restriction  
 Tariff line 
code(s) 
affected, based 
on HS(2017)  Detailed Product 
Description  WTO Justification 
and Grounds for 
Restriction, e.g., 
Other International 
Commitments  National legal basis 
and entry into force   
 Administration, 
modification of 
previously notified 
measures, and 
other comments  
1 2 3 4 5 6 7 
4 Export prohibition of 
medical devices and 
medicinal products  CP-X  Certain medical devices and 
medication necessary for the 
prevention and treatment of 
SARS -CoV-2  
 
For details, please see the 
annex to Order 672/2020  Protection of human life 
or health, inter alia  
 
 Order 672/2020 of 
the Ministry of 
Health; extended by 
Order No. 1801/2020 
(21 October 2020)  
 
http://www.monitorul
oficial.ro/emonitorne
w/emonviewmof .php?
fid=MS44MDU1MTU3
MTkwNjYzRSszMA   
 
Entry into force: 23 
April 2020  Romania, Ministry of 
Health  
 
The measure is 
temporary