G/MA/QR/N/EU/4/Add.3  
16 de junio de 2020 
(20-4232) Página: 1/11 
Comité de Acceso a los Mercados  Original:  inglés  
 
  
NOTIFICACIÓN DE CONFORMIDAD CON LA DECISIÓN SOBRE EL  
PROCEDIMIENTO DE NOTIFICACIÓN DE RESTRICCIONES  
CUANTITATIVAS (G/L/59/REV.1)  
UNIÓN EUROPEA  
Addendum  
La siguiente comunicación, de fecha 12 de junio de 2020 , se distribuye a apetición de la delegación 
de la Unión Europea . 
 
A. Miembro notificante : Unión Europea  
B. Fecha de la notificación : 10 de junio de 2020  
C. Primera notificación : 
 Sí 
 No, la última notificación se presentó con la signatura  (signatura del documento ): 
G/MA/QR/N/EU/ 4, G/MA/QR/N/EU/4/Add.1  y G/MA/QR/N/EU/4/Add.2  
D. Tipo de notificación : 
 1. Completa (es decir, notificación de todas las restricciones cuantitativas en vigor)  
 2. Cambios de una notificación presentada anteriormente con la signatura (signatura del 
documento) consistentes en lo siguiente : 
  2.1 Establecimiento de nuevas restricciones, enumeradas en la sección 1 . 
  2.2 Eliminación de restricciones, como se describe en la  casilla G infra. 
  2.3 Modificación de una restricción notificada anteriormente, como se indica en la 
sección 1 . 
 3. Notificación inversa de restricciones mantenidas por (Miembro) : 
E. La notificación proporciona información sobre el siguiente período bienal  
(por ejemplo, 2012 -2014) : 2018-2020 y se refiere a restri cciones en vigor al  4 de 
junio de 2020  
F. La presente notificación contiene información* relati va a: 
 Sección 1: Lista de restricciones cuantitativas actualmente en vigor.  
 Sección 2: Referencia a otras notificaciones presentadas a l a OMC que contengan 
información sobre restricciones cuantitativas actualmente en vigor e 
información adicional . 
 
* En inglés solamente.  G/MA/QR/N/EU/4/Add.3  
- 2 - 
  G. Observaciones de carácter general, con inclusión de una descripción de la 
eliminación de restricciones notificada en el apartado 2.2 de la casilla D y la fecha en 
que esas restricciones dejaron de estar en vigor . 
La medida temporal adoptada en relación con la pandemia de COVID -19 notificada en el 
documento  G/MA/ QR/N/EU/4/Add.2 de 5 de mayo de 2020  (Reglamento de Ejecución (UE) 
2020/568 de la Comisión de 23 de abril de 2020  por el que se supedita la exportación de 
equipos de protección individual (EPI)  a la presentación de una licencia de exportación ) 
expiró el 25 de mayo de 2020  y no se prorrogará ni sustituirá . 
La UE notifica las me didas temporales adoptadas por algunos Estados miembros de la UE 
(Chipre, Estonia, Francia, Grecia, República Eslovaca, Rumania ) y el Reino Unido1 a fin de 
proteger la salud humana, en especial en relación con la pandemia de COVID -19. 
 
 
 
 
 
 
 
 
 
 
1 El Reino Unido abandonó la Unión Europea el 1º de febrero de 2020. Durante el período de transición, 
que finaliza el 31 de diciembre de  2020, la legislación de la Unión Europea, con algunas excepciones, sigue 
siendo aplicable al Reino Unido y en el Reino Unido.    
  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 l egal 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 l ife or 
health, inter alia  
 
 Decision by the State  
Agency of Medicines  
 
Basis:  § 20(6) of the 
Medicinal Products Act  
 
https://www.ravimiamet.e
e/en/import -and-export -
goods -require -special -
authorisation -including -
medicinal -products   Estonian State Ag ency 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 ) 
15. Xarelto 15 mg film -
coated tablets N28 
(Bayer AG)       
  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 
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 i n 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.go
uv.fr/affichTexte.do;jsessi
onid=1FD638F68E134562
8695FA7093839ED2.tplgfr
24s_2?cidTexte=JORFTEXT
000041858681&dateTexte
=20200511  
 The measure is 
tempo rary 
 
    
  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.monitoruloficia
l.ro/emonitornew/emonvie
wmof.php?fid=MS44MDU1
MTU3MTkwNjYzRSszMA   
 
Entry into force: 23 April 
2020 Romania, 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 
 
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 
Commitments (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 co mments  
 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/s
ystem/uploads/attachment_dat
a/file/876961/Medicines_that_c
annot_be_parallel_exported_fro
m_the_UK_MASTER__4_.csv/pr
eview  
 
Further information on the scope 
of the measures available at  
https://www.gov.uk/guidance/p
arallel -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 
protection  of 
human health.  
 
 
 
__________  
 
2 The United Kingdom withdrew from the European Union as of 1 February 2020. During the transition period, which ends on 31 Dec ember 2020, Union law, with a few 
limited exceptions, continues to be applicable to and in the United Kingdom.