G/MA/QR/N/GBR/2/Add.1  
 
9 January 2023  
(23-0242) Page: 1/5 
Committee on Market Access  Original: English  
 
 
NOTIFICATION PURSUANT TO THE DECISION ON NOTIFICATION PROCEDURES  
FOR QUANTITATIVE RESTRICTIONS (G/L/59/REV.1)  
UNITED KINGDOM  
Addendum  
The following communication, dated 3 January 2023, is being circulated at the request of the 
delegation of the United Kingdom.  
 
A. Notifying Member: United Kingdom  
B. Date of notification: 3 January 2023 
C. First time notification:  
 Yes 
 No, last notification was made in (doc. symbol ): G/MA/QR/N/GBR/2  
D. Type of notification:  
 1. Complete (i.e. notification of all quantitative restrictions in force ) 
 2. Changes to a notification previously made in G/L/59/REV.1 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 restri ction, as described in Section 1. 
 3. Reverse notification of restrictions maintained by (Member ):  
E. The notification provides information for the following biennial period 
(e.g.  2012 -2014): 2022-2024 and relates to restrictions in fo rce as of 
20 December  2022  
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 wi th information on quantitative 
restrictions that are currently in force and additional information . 
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. This addendum modifies and replaces QR No.  21 of G/MA/QR/N/GBR/2. This notification 
updates the list of commodity codes applicable to the medicines in scope and provides 
appropriate information on the product descriptions.  
 
* In English  only. G/MA/QR/N/GBR/2/Add.1  
 
- 2 - 
 
  2. The UK is notifying the reduction of 10 medicines from the list of medicines, placed on 
the UK market, which are subject to limited export restrictions. These medicines no 
longer meet the tests set to maintain measures. These are: Anakinra, Budesonide, 
Calcium Chloride, Colestyramine, Dexmedetomidine, Epoprostenol, Milrinone, 
Rifampicin, Rivaroxaban and Salbutamol . Insulin human  has also been removed 
as this is the same product as insulin soluble human.  
3. The UK is also notifying the addition of 10 medicine s to the list in critical short supply, in 
lieu of other shortage mitigations taking effect.  
4. Amoxicillin, Phenoxymethylpenicillin (Penicillin V), Flucloxacillin  (3004.10.00); 
Cefalexin and Azithromycin  (3004.20.00) are antibiotics used in the treatment of  
Streptococcal A infections. Measures are in place while the Department of Health and 
Social Care (DHSC) work across the supply chain to bring forward stock and expedite 
deliveries, ensure antibiotic orders are proportionate, and issue directions to utilis e 
alternative medicines where appropriate.  
5. Alteplase  and Tenecteplase  (3004.90.00) are used for a number of critical indications 
including ischaemic stroke, myocardial infarction and pulmonary embolism for which 
there is no alternative treatment. Oseltamiv ir and Zanamivir (3004.90.00)  are 
antiviral medicines used to treat and prevent influenza. Semaglutide  (3004.90.00) is a 
critical drug used to treat patients with Type 2 diabetes. Measures are in place  while 
DHSC works with healthcare bodies to ensure cont inued access to treatment, and while 
Serious Shortage Protocols (SSPs) take effect, enabling Pharmacists to issue alternative 
medicines where available to manage shortages.  
6. These are temporary measures, in place to relieve critical shortages of medicines 
necessary for the protection of human health. Measures are reviewed regularly and only 
applied where the critical need cannot be met by alternative measures. On 
15 December  2021, 47 medicines were removed from the list. On 24 June 2022, a 
further 30 (net) medicines were removed from the list.  
7. The UK 's notification G/MA/QR/N/GBR/2  included details relating to Northern Ireland. 
This notification does not amend those details which continue to apply  
 
 
 
 
  
  G/MA/QR/N/GBR/2/Add.1  
 
- 3 - Section 1: List of quantitative restrictions that are currently in force  
 
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 
1 Measures to 
regulate 
exports of 
certain 
medicaments.  CP-X Medicines fall 
under the following 
commodity codes:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3002.41.90  1. Heading 3002 - 
Classification  
Human blood; animal 
blood prepared for 
therapeutic, prophylactic 
or diagnostic uses; 
antisera, other bl ood 
fractions and 
immunological products, 
whether or not modified 
or obtained by means of 
biotechnological 
processes; vaccines, 
toxins, cultures of micro -
organisms (excluding 
yeasts) and similar 
products; cell cultures, 
whether or not modified  
 
Product Des cription per 
Commodity Code under 
Heading 3002  
 
Vaccines, toxins, cultures 
of micro -organisms 
(excluding yeasts) and 
similar products, Other  Article XX(b) GATT  
Protection of human, 
animal or plant life or 
health.  
 Regulation 43(2) of 
the Human 
Medicines 
Regulations 2012 
requiring wholesale 
dealers to ensure 
continued supply of 
medicinal products 
so that the needs of 
patients in the UK 
are met. Further 
details can be found 
through: 
https://www.legislati
on.gov.uk/uksi/2012
/1916/contents/mad
e 
 
The date restrictions 
came into effect 
varies by medicine; 
this is specified for 
each medicine on 
the list, last updated 
on 20  December 
2022 and availa ble 
on gov.uk at : 
https://assets.publis
hing.service.gov.uk/
government/uploads
/system/uploads/att
achment_data/file/1
125639/restricted_m
edicines_list_19_dec
ember_2022_v.1.csv  
 The list of medicines is 
maintained by the 
Department of Health and 
Social Care.  
 
These measures are reviewed 
regularly.  
A full change log of previous 
measures, from October 
2019, can be found here:  
https://www.go v.uk/governm
ent/publications/medicines -
that-cannot -be-parallel -
exported -from-the-uk  
 
Medicines included on this list 
meet the following conditions:  
• The medicine is required 
to meet the needs of UK 
patients  
• The medicine is currently 
in shortage or risk of 
being in shortage  
• The export of the 
medicine would 
contribute to or 
exacerbate a shortage, or 
risk of shortage, of that 
medicine in the UK   
  G/MA/QR/N/GBR/2/Add.1  
 
- 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 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 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3004.10.00  
 
 
 
 
 
 
3004.20.00  
 
 
3004.31.00  2. Heading 3004 - 
Classification  
Medicaments consisting of 
mixed or unmixed 
products for therapeutic or 
prophylactic uses, put up 
in measured doses 
(including those in the 
form of transdermal 
administration systems) 
or in forms or packings for 
retail sale  
 
Product Description per 
Commodity Code under  
Heading 3004  
 
Containing penicillins or 
derivatives thereof, with a 
penicillanic acid  
structure, or 
streptomycins or their 
derivatives  
 
Other, containing 
antibiotics  
 
Other, containing 
hormones or other 
products of heading 2937, 
Containing insulin  
   Medicines on this list which 
have been produced to fulfil 
contracts overseas are not 
subject to restriction. As such, 
restrictions only apply to 
wholesaler dealer licen ce 
holders that are not the 
market authori zation holder 
for a medicine intended for 
export. The measures are 
designed to ensure 
wholesalers fulfil their legal 
obligations to maintain supply 
to UK patients.  
 
These restrictions are only 
applied and maintained where 
alternative measures are not 
considered sufficient on their 
own to ensure that U K supply 
meets demand.  
 
A number of exemptions 
apply to medicines in scope of 
these restrictions. For 
example, exports destined for 
international humanitarian 
organizations such as COVAX 
are not covered. A full list of 
exemptions can be found at: 
https://www.gov.uk/guidance
/parallel -export -and-
hoarding -of-restricted -
medicines  
  
  G/MA/QR/N/GBR/2/Add.1  
 
- 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 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 
   3004.32.00  
 
 
 
 
3004.39.00  
 
 
 
 
3004.49.00  
 
 
 
3004.90.00  Containing corticosteroid 
hormones, their 
derivatives or structural 
analogues  
 
Other, containing 
hormones or other 
products of heading 2937, 
Other  
 
Other, containing alkaloids 
or derivatives thereof, 
Other  
 
Other    Requests for exemptions are 
considered on a case-by-case 
basis. These can be submitted 
by a foreign government  or 
government agency, or a 
wholesaler on their behalf at: 
restrictedmedicines@dhsc.gov
.uk 
 
Further information on these 
measures is available here:  
https://www.gov.uk/guidance
/parallel -export -and-
hoarding -of-restricted -
medicines  
 
    Further detail of these 
medicines can be found 
at:  
https://www.gov.uk/gover
nment/publications/medici
nes-that-cannot -be-
parallel -exported -from-
the-uk 
 
These restrictions apply in 
certain circumstances to 
exports of specified 
medicines which are 
placed on the UK market 
for UK patients and 
needed to protect human 
health, including to treat 
COVID -19, inter  alia.   It is the responsibility of the 
wholesaler to ensure any 
exports are made or withheld 
in compliance with these 
restrictions. Failure to comply 
with these restrictions may 
lead to regulatory action by 
the Medicines and Healthcare 
products Regulatory Authority 
(MHRA) against the wholesale 
dealer's licence.  
 
There are no additional steps 
or declarations required from 
a customs perspective.  
__________