Notification System for exempt medicinal products

Information on exempt medicinal products and the Notification System for exempt medicinal products

Exempt Medicinal Products  

Medicines placed on the Irish market must be authorised by the HPRA or, in the case of centrally authorised products, by the European Commission. However, European regulations do provide for an exemption to this rule – this is via Article 5 of Directive 2001/83/EC. In this case, unauthorised medicines may be supplied where a registered doctor or dentist has prescribed the product for an individual patient under his or her direct responsibility.  This is in order to fulfil the special needs of those patients. Such products are defined as ‘exempt medicinal products’.

For further information on access to medicines prior to their authorisation, please see the following link

Our Role

In accordance with the Medicinal Products Regulations 2007-2010, wholesalers and manufacturers of medicinal products are obliged to provide certain information to the HPRA in relation to any exempt products that they source. The Notification System for exempt products was set up to meet this requirement. The main purpose of our receiving such information is to facilitate, when needed, the effective recall of any defective exempt medicine from the Irish market.

Additional Information

For further information on HPRA’s Notification System and on the circumstances under which exempt medicinal products may be used, please refer to our Guide Note.

The regulations for exempt medicinal products require the manufacturer/wholesaler to complete and upload a specific Exempt products excel spreadsheet to the Notification System within 2 working days of their receipt of exempt medicinal products. Please address any queries relating to the Guidance document or to the spreadsheet to the following email address: ep@hpra.ie

 

Top 50 notified exempt medicines 2020

Rank

Exempt Medicinal Product Name

Active Ingredient

Common Forms and Strengths (Not Exhaustive)

Approximate Number of Packs Notified

Additional Notes

 
1

Amitriptyline
Amitriptyline
Tablets (10mg, 25mg)

291116

Two authorised forms of Amitriptyline tablets came to market in 2020
 2 Fluoxetine
Fluoxetine
Capsules (20mg)

162930


 3
Propranolol


Propranolol


Tablets (10mg, 40mg)


122092 


 4 Chloramphenicol   
      Chloramphenicol

 
Ointment (1.0%)

74833 

 
 5 Scopoderm


Scopolamine
 



Patches (1.5mg)
 



63685
 

 
 6

 Kidnaps (Melatonin)
 

 
Melatonin
 
Oral Solution (1mg/1ml, 5mg/1ml)

Capsules (3mg, 5mg)
63591

 7
Serenace / Haldol
 
 
Haloperidol


Tablets (5mg, 10mg)

Intramuscular injection (5mg/ml)

Oral Liquid (2mg/ml)



41026
 


 8 Cyclogest
 
Progesterone

Pessary (200mg, 400mg) 39098
 
 9
Trandate (Labetol)

 Labetalol Tablets (50mg, 100mg, 200mg) 34641  
 10
Eumovate
 
Clobetasone butyrate Ointment (0.05% w/w) 34478  
 11

Bumetanide
 



Bumetanide
 


Tablets (1mg)

Oral Suspension (Various)

Injection (Various)
 


33864
 

 
 12  
Antepsin
 


   
Sucralfate

 

Tablet (1000mg)

Oral Suspension (20%)


32124
 

 
 13
Utrogestan
 

Progesterone
 

Oral Capsules (100mg, 200mg)

Vaginal Capsules (100mg, 200mg) 


 28762

 
 14
Kabi Parenteral Nutrition Products


Various
 

Various

28348
 15  
Atracurium
 
Atracurium Besilate
Solution for Injection (10mg/ml)



26576
 
 
 
 16 Cariban
Doxylamine Succinate/ Pydridine Hydrochloride


 Capsules (10mg/10mg)
 
26015  
 17
Hydrocortisone Ointment 1% 

Hydrocortisone
Ointment 1% 
 

24921
 
 
 18 Anafranil (Clomipramine)
Clomipramine hydrochloride
 

Tablets (10mg, 25mg)
 

21203
 
 
 19 Dormicum (Midazolam)
Midazolam
 

Solution for injection/infusion (1mg/ml, 5mg/ml)

Buccal Liquid (10mg/ml)

 


21098

 

 
 20  
Betadine
 

Povidone-iodine
 

Opthalmic Solution (5%)

Gel (10%)

Dry Powder Spray (25mg/g)

 20478

 
 
 21
Cefazoline
 

Cefazoline
 

Powder for solution for injection (1mg, 2mg)
 

20000
 
 
 22  
Trental
 

Pentoxifylline
 

Solution for injection (100mg/5ml)

Tablets (400mg)


19813
 
 
 23
Clonidine HCl
 

Clonidine Hydrochloride
 

Tablets (0.025mg)

Oral suspension (100mg/5ml, 200mg/5ml)

Injection (5000mcg/10ml)

Transdermal Patch (Various)




19800
 


 
 24
Fres Kabi Homecare

Various
IV Infusion (Various)

19000  
25 
Heparin Sodium Flushing Solution


Heparin Sodium
 
Flushing solution (500 I.U./ml, 1000I.U/ml, 5000 I.U/ml)
18150
 
 
26
 Hydrex Pink
 

Chlorhexidine Gluconate
 

Topical Solution (200mg/ml)



17376
 

 
 27  
Digoxin
 

Digoxin
 


Tablets (62.5mcg, 125mcg, 250 mcg)
 
 


16552
 

 
 28  
Fluorouracil
 


Fluorouracil
 



Solution for infusion (Various strengths)
 


16390
 

 
 29
Codeine Phosphate
 

Codeine Phosphate
 

Tablets (15mg, 30mg)

Oral Syrup (25mg/5ml)

Suppositories (15mg)

Injection (60mg/ml)



15534
 

 
 30
Fentanyl 
 

Fentanyl 
 

Injection (2mcg/ml, 50mcg/ml)

 
15206
 
 
 31
Sodium Bicarbonate
 

Sodium Bicarbonate
 

Tablets (300mg, 500mg, 600mg)
 
15011  
 32
Slow Sodium
 

Sodium Chloride
 

Tablets (600mg)

 
13844

 
 
 33  
Ovestin
 

Oestriol
 

Cream (1mg/g)
 
12835  
 34
 Allegron
 

Nortriptyline
 


Tablets (25mg)
 


12694
 
 
 35  
Gonasi HP
 

Chorionic Gonadotrophin
 

Ampules for injection (5000 I.U./ml)
 


12633
 

 
 36
Quinine Sulphate 
 

Quinine Sulphate 
 


Tablets (200m, 300mg)
 

 
12343
 
 
 37  
Prolutex
 

Progesterone
 

Solution for injection (25mg/ml)
 

10802
 
 
 38  
Normix
 

Rifaximin



Capsules (200mg)
 

 
10480

 
 
 39  
Dioctyl
 

Docusate Sodium
 


Capsules (100mg)
 



10169
 

 
 40
Dentinox Infant Colic Drops
 

Activate Dimeticone
 

Colic Drops (25mg/2.1ml)

 
10038

 
 
 41
Propofol
 

Fresofol
 

Ampule for Injection (10mg/ml)
 

10000
 
 
 42  
Primolut N
 

Norethisterone
 

Tablets (5mg)
 
 
9800
 
 
 43
Oestrogel
 

Estradiol
 

Gel (Various)
 

9205
 
 
 44
Ilomedin
 

Iloprost Trometamol
 

Solution for infusion (0.1mg/ml)

 
9200
 
 
 45  
KCL-Retard
 

Potassium Chloride
 


Tablets (600mg)
 



8691
 

 
 46
Calcium Gluconate
 

Calcium Gluconate
 

Solution for Injection (10% w/v)

 
8090

 
 
 47  
Proctosedyl 
 

Various
 

Suppositories (10mg)

Ointment


7613

 
 
 48
Maxitrol
 

Dexamethasone, Neomycin Sulphate, Polymyxin B Sulphate 
 



Ointment (0.1%/ 3500IU/g/6000IU/g)
 


 
7266

 
 
 49
Atropine Sulphate
 

Atropine Sulphate
 


 Injection (600mcg/ml)
 


7090

 
 50  
Metanium
 

Titanium Dioxide, Titanium Salicylate, Titanium Peroxide



Ointment (20%/ 50%/ 3%)
 

7051