G/MA/QR/N/EU/4/Add.3  
 
16 June 2020 
(20-4232) Page: 1/11 
Committee on Market Access  Original: English  
 
  
NOTIFICATION PURSUAN T TO THE DECISION ON  NOTIFICATION  PROCEDURE S 
FOR QUANTITATIVE RES TRICTIONS (G/L/59/REV.1)  
 EUROPEAN UNION 
Addendum   
The following communication, dated 12 June  2020, is being circulated at the request of the 
delegation of the European Union . 
 
A. Notifying Member :  European Union  
B. Date of notification :  10 June 2020  
C. First time notification:  
 Yes 
 No, last notification was made in (doc. symbol ): G/MA/QR/N/EU/ 4, G/MA/QR/N/EU/4/Add.1  
and G/MA/QR/N/EU/4/Add.2  
D. Type of notification:  
 1. Complete (i.e. notification of all quantitative restrictions in force ) 
 2. Changes to a notification previously made in (doc symbol)  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): 2018-2020 and relates to restrictions in force as of 4 June 2020  
F. This notification contains information* relating to:  
 Section  1: List of quantitative restrictions that are currently in force . 
 Section  2: Cross -reference to other WTO notifications with information on quantitative 
restrictions that are currently in force and additional information . 
 
* In English  only. G/MA/QR/N/EU/4/Add.3  
 
- 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.   
 The temporary measure in relation to the COVID -19 pandemic  contained in notification 
G/MA/QR/N/EU/ 4/Add.2 of 5 May 2020 ( Commission Implementing Regulation (EU) 
2020/568 of 23 April 2020 making the exp ortation of personal protection equipment (PPE) 
subject to an export authorisation) expired on 25 May 2020 and will not be extended or 
replaced . 
 The EU is notifying temporary measures taken by some EU Member States (Cyprus, Estonia, 
France, Greece, Romani a, Slovak Republic) and the United Kingdom1 in order to protect 
human health, including in relation to the Covid -19 pandemic.    
 
 
 
 
 
 
 
 
 
 
1 The United Kingdom withdrew from the European Union as of 1 February 2020. During the transition 
period, which ends on 31 December 2020, Union law, with a few limited exceptions, continues to be applicable 
to and in the United Kingdom.   
  G/MA/QR/N/EU/4/Add.3  
 
- 3 - Section  1: List of quantitative restrictions that are currently in force  
 
1) EU Member States  
 
Cyprus  
 
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 
prohibition of 
medicinal 
products  CP-X  Exports of all 
pharmaceutical products for 
human use are prohibited, 
unless the Minister of 
Health authorizes such 
exports in writing  Protection of human life or 
health, inter alia  
 
 Ministerial Decree No 
11/2020  Republic of Cyprus, 
Ministry of Health  
 
The measure is 
temporary  
 
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 
2 
 Export 
prohibition  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)  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   
  G/MA/QR/N/EU/4/Add.3  
 
- 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 
    6. Co-Diovan 80 mg + 12,5 
mg film -coated tablets 
N28 (SIA "Novartis 
Baltics")  
7. Co-Diovan 160 mg + 
12,5 mg film -coated 
tablets N28 (SIA 
"Novartis Baltics")  
8. Valsacombi 80 mg + 12,5 
mg film-coated tablets 
N28 (KRKA d.d., Novo 
mesto)  
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)  
     
  G/MA/QR/N/EU/4/Add.3  
 
- 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 
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)  
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 Turbuhaler 
0,2mg/dose inhalation 
powder 100 doses 
N1 (AstraZeneca AB)  
  
  G/MA/QR/N/EU/4/Add.3  
 
- 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 
    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) 
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/4/Add.3  
 
- 7 - France  
 
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 
3 Export 
prohibition of 
medicinal 
products  P-X  Medicinal products 
containing  
hydroxychloroquine or the 
combination  
lopinavir/ritonavir  Protection of human life or 
health, inter alia  
 
 Decree No 2020-545 of 11 
May 2020 laying down the 
general measures 
necessary to deal with the 
Covid -19 outbreak in the 
context of a state of 
emergency  
 
https://www.legifrance.gou
v.fr/affichTexte.do;jsessioni
d=1FD638F68E134562869
5FA7093839ED2.t plgfr24s_
2?cidTexte=JORFTEXT0000
41858681&dateTexte=202
00511  
 The measure is 
temporary  
 
   
  G/MA/QR/N/EU/4/Add.3  
 
- 8 - 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 
4 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_library/get_file?uuid
=e9749853 -3c85-4a85-
a380-
9ebe174e1c35&groupId=1
2225  
 Republic of Greece, 
Ministry of Health 
 
The measures are 
temporary  
      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 
   
  G/MA/QR/N/EU/4/Add.3  
 
- 9 - 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/4/Add.3  
 
- 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 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 
5 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  
 
http://www.monitoruloficial
.ro/emonitornew/emonview
mof.php?fid=MS44MDU1M
TU3MTkwNjYzRSszMA   
 
Entry into force: 23 April 
2020 Romani a, Ministry of 
Health  
 
The measure is 
temporary  
 
Slovak Republic  
 
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 
6 Restriction of 
parallel 
exports of 
medicinal 
products  CP-X  Registered medicinal 
products for human use and 
in vitro diagnostic medical 
devices intended for the 
market of the Slovak 
Republic  Protection of human life or 
health, inter alia  
 
 The Measure is issued in 
accordance with § 5(1)(e) 
of Act No 387/2002 on 
state governance during 
crisis situations outside of 
wartime conditions and 
during wartime conditions, 
as amended  
 
Entry into force: 16 March 
2020 Slovak Republic, Ministry 
of Health  
 
The measure is 
temporary. Application 
only during a state of 
emergency which has 
been declared by the 
Government of the 
Slovak Republic   
  G/MA/QR/N/EU/4/Add.3  
 
- 11 - United Kingdom2 
 
 
 
__________  
 
2 The United Kingdom withdrew from the European Union as of 1 February 2020. During the transition period, which ends  on 31 December 2020, Union law, 
with a few limited exceptions, continues to be applicable to and in the United Kingdom.  QR 
No. General 
description of 
the restriction  Type of 
restriction  
(Symbol in 
Annex 2 of 
the 
Decision)  Tariff line 
code(s) 
affected, based 
on HS(2017)  Detailed Product Description  WTO Justification 
(e.g. Article  XX(g) of 
the GATT, etc.) and 
Grounds for 
Restriction, e.g., 
Other International 
Commitment s (e.g. 
Montreal Protocol, 
CITES, etc.)  National legal basis 
and entry into force   
(i.e. Law, regulation 
or administrative 
decision)  Administration, 
modification of 
previously 
notified 
measures, and 
other comments  
1 2 3 4 5 6 7 
1  Measures to 
regulate exports 
of certain 
medicaments  CP-X Certain 
medicaments of 
HS chapters 
2501, 2530, 
2827, 2835, 
2907, 2922, 
2923, 2924, 
2933, 2934, 
2935, 2936, 
2937, 2939, 
2941, 2942, 
3001, 3002, 
3003, 3004, and 
3104 Certain medicaments needed to 
protect human health, including 
to treat Covid -19, inter alia . 
The restrictions only apply to 
medicines placed on the market 
in the UK for UK patients.  
 
Full list available at 
https://assets.publishing.servic
e.gov.uk/government/uploads/
system/uploads/attachment_da
ta/file/876961/Medicines_that_
cannot_be_parallel_exported_fr
om_the_UK_MASTER__4_.csv/
preview . 
 
Further information on the 
scope of the measures available 
at 
https://www.gov.uk/guidance/
parallel -export -and-hoarding -
of-restricted -medicines   Protection of human life 
or health, inter alia  
 
 Regulations 43(2) and 
78 of the Human 
Medicines Regulations 
2012 requiring 
wholesale dealers and 
marketing 
authorisation holders 
to ensure continued 
supply for UK patients.  
 
Effective dates vary,  
according to the list, 
and corresponding 
date of entry into 
force, available under 
Column 4.  
 UK Government, 
Department of 
Health and Social 
Care  
 
These are 
temporary 
measures, in place 
to relieve critical 
shortages of 
medicines 
necessary for the 
protect ion of 
human health.