G/MA/QR/N/GBR/2/Add.3  
 
18 December  2023 
(23-8653) 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 15 November  2023, is being circulated at the request of the 
delegation of the United Kingdom.  
 
A. Notifying Member: United Kingdom  
B. Date of notification: 15 November  2023 
C. First time notification:  
 Yes 
 No, last notification was made in (doc. symbol ): G/MA/QR/N/GBR/2 /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 G/MA/QR/N/GBR/2  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 following biennial period 
(e.g.  2012 -2014): 2022-2024 and relates to restrictions in force as of 9 October  2023 
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 . 
 
* In English  only. G/MA/QR/N/GBR/2/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.  
1. The UK is notifying the addition of 20 medicines to the list in critical short supply, in lieu 
of other shortage mitigations taking effect.  
2. Molnupiravir and Nirmatrelvir  (3004.90.00) are antivirals used to treat patients who 
remain at risk of Covid following the vaccination programme. The UK is further protecting 
existing supply by placing limits on the amount of each drug that can be ordered from any 
community pharmacy.  
3. Semaglutide, Dulaglutide, Exenatide, Liraglutide and Insulin/GLP -1 combination 
(3004.39.00) are critical medicines used in the treatment of Type 2 diabetes. A global 
supply problem with these medicines is expected until mid -2024. There are alternative 
classes of medicines available to treat Type 2 diabetes; however, switching to an 
alternative medicine can cause complications for patients.  
4. Glucagon  powder for injection and pre -filled syringe (3004.39.00) is a critical 
medicine used in the treatment of severe hypoglycaemia and beta blocker overdose. 
There is an intermittent supply probl em and licensed alternatives are also in short supply; 
however, the UK is regularly engaging with the manufacturers to monitor stock levels.  
5. Progesterone 100mg capsules (3004.39.00) is used in hormone replacement therapy 
for post -menopausal women. There is  no licensed alternative available, however the UK 
has issued a Serious Shortage Protocol (SSP) to limit the amount that a pharmacist can 
dispense to a maximum of two months ' supply.  
6. Permethrin 5% Cream (3004.90.00) is a medicine used to treat scabies. The disruption 
has been caused by an uptick in demand. There is no direct alternative medicine 
available, but the UK has engaged manufacturers to take steps to increase supply . 
7. Ketamine (3004.90.00) is an a naesthetic used in short procedures not involving intense 
pain. Although a limited supply of an alternative has been diverted to the UK by the 
supplier, this is not sufficient to meet demand.  
8. Bupivacaine with Fentanyl and Levobupivacaine (3004.90.00) are used for pain 
management and the induction of anaesthesia, particularly for epidural procedures. 
Supply has been restricted for use in epidural procedures as no other alternative 
medicines are available.  
9. Human  corticotrophin releasing hormone (3004.32.00)  is used to diagnose Cushing 's 
syndrome, a hormonal disorder. There is no direct alternative available and the UK has 
prioritised the use of existing supply for specific specialist centres.  
10. Hyoscine hydrobromide (3004.90.00) is used to treat travel sickne ss symptoms. 
Supply has decreased due to the closure of the manufacturing site, however transfer to a 
new manufacturing site has been scheduled.  
11. Bumetanide (3004.90.00) is a critical medicine used to treat oedema. The disruption has 
been caused by issues with the supply of the active pharmaceutical ingredient used to 
produce the medicine. Although there are alternative medicines available, some patients 
may be intolerant to these.  
12. Methylphenidate hydrochloride, Atomoxetine, Dexamfetamine sulfate and 
Guanfacine (3004.90.00) are critical medicines used to Attention Deficit Hyperactivity 
Disorder (ADHD). Advice has been given to healthcare professionals to manage existing 
supply as global demand for ADHD products increases.  
13. The UK is also notifying minor technical changes to existing medicines on the restricted 
list. 
14. Two duplicated listings of steroids used to treat a wide range of health conditions, 
Dexamethasone (tablets and capsules) and Dexamethasone (oral solution) (3004.32. 00), 
are being combined into one listing, Dexamethasone (All) (3004.32.00).  G/MA/QR/N/GBR/2/Add.3  
 
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  15. The pharmaceutical form for Diamorphine (tablets) (3004.49.00) is being amended to 
Diamorphine (solution for injection).  
16. 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 24 June 2022, 
30 (net) medicines were removed from the list. On 3 Janua ry 2023 1 (net) medicine was 
removed from the list. We expect the next review to take place in five months ' time (April 
2024).  
The UK 's notification G/MA/QR/N/GBR/2  included details relating to the Windsor 
Framework (previously the Northern Ireland Protocol). This notification does not amend 
those details which continue to apply.  
  
  G/MA/QR/N/GBR/2/Add.3  
 
- 4 - 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:  1. 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.  Article XX(b) GAT T 
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.legislation.go
v.uk/uksi/2012/1916/cont
ents/made . 
The date restrictions came 
into effect varies by 
medicine; this i s specified 
for each medicine on the 
list, updated on 9 October 
2023 and available on  
gov.uk  at:  
https://www.gov.uk/gover
nment/publications/medici
nes-that-cannot -be-
parallel -exported -from-
the-uk. 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.gov.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.  
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 license 
holders that are not the market 
authorisation h older for a 
medicine intended for export. 
The measures are designed to 3004.10.00  Containing penicillins or 
derivatives thereof, with a 
penicillanic acid structure, 
or streptomycins or their 
derivatives.  
3004.20.00  Other, containing 
antibiotics.  
3004.32.00  Containing corticosteroid 
hormones, their 
derivatives or structural 
analogues.  
3004.39.00  Other, containing 
hormones or other 
products of heading 2937 
> Other.  
3004.49.00  Other, containing 
alkaloids or derivatives 
thereof > Other.  
3004.90.00  Medicaments (excluding 
goods of heading 3002, 
3005 or 3006) consisting 
of mixed or unmixed 
products for therapeutic or 
prophylactic uses, put up  
  G/MA/QR/N/GBR/2/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 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 
in measured doses 
(including those in the 
form of transdermal 
administration systems) or 
in forms or packings f or 
retail sale > Other.  
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 . 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 suf ficient on their 
own to ensure that  UK supply 
meets demand.  
A number of exemptions apply 
to medicines in scope of these 
restrictions. For example, 
exports destined for 
international humanitarian 
organisations are not covered. 
A full list of exemptions can be 
found at : 
https://www.gov.uk/governm
ent/publications/medicines -
that-cannot -be-parallel -
exported -from-the-uk. 
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-restric ted-medicines . 
 
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