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 30 notified exempt medicines 2019

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) 

Oral Solution (25mg/5ml, 50mg/5ml) 
255,000 - 260,000 An authorised version has been released to the Irish market as of 2020
 2  Bendroflumethiazide  Bendroflumethiazide Tablets (2.5mg, 5mg)

Oral Suspension (2.5mg/5ml, 5mg/5ml)
120,000 - 125,000 An authorised version has been released to the Irish market as of 2020
 3  Propranolol  Propranolol Tablets (10mg, 40mg, 80mg)

Oral Solution (10mg/5ml, 50mg/5ml)

Solution for Injection (1mg/ml)

100,000 - 105,000  
 4  Scopoderm  Scopolamine (Hyoscine) Transdermal Patches (1.0mg, 1.5mg)

75,000 - 76,000  
 5  Chloramphenicol  Chloramphenicol Ointment (1.0% w/w) 

Powder for Solution for Injection (1g)

75,000 - 78,000  
 6  Levothyroxine   Levothyroxine Tablets (15mg, 30mg, 60mg, 90mg, 120mg)

Oral Solution (50mcg/ml, 125mcg/ml)

55,000 - 56,500 43000 packs were not released to the Irish Market
 7  Hydrocortisone  Hydrocortisone Tablets (2.5mg, 5mg, 10mg)

Ointment (1%, 2.5%)

Cream (0.5%, 1%, 2%)

Suppositories (50mg, 100mg, 200mg)

Oral Suspension (5mg/5ml)
Solution for Injection (100mg/ml)

40,000 - 41,000  
 8  Serenace  Haloperidol Tablets (0.5mg, 5mg)

Solution for Injection (5mg/ml)

40,000 - 41,000  
 9  Quinine Sulphate   Quinine Sulphate  Tablets (200mg, 300mg)

Oral Suspension (300mg/5ml)

26,000 - 29,000
 
 10  Kidnaps  Melatonin  Oral Solution (1mg/ml) 26,000 - 28,000  
 11  MisoOne  Misoprostol  Tablets (100mcg, 200mcg, 400mcg)

25,000 - 27,000  
 12  Colgout  Colchicine  Tablets (500mcg) 25,000 - 26,000  
 13 Heparin Sodium Flushing Solution Heparin Sodium
 Solution (100 I.U./ml) 23,000 - 24,000  
 14  Paracetamol  Paracetamol Effervescent Tablets (500mg)

Suppositories (30mg)

Caplets (500mg) 

23,000 - 23,500 Majority of packs were 1x100 caplets size as a result of a shortage
 15  Betadine 5%  Povidone-Iodine Ophthalmic Solution (5% w/w, 10% w/w)

20,000 - 21,000  
 16  Cyclogest  Progesterone  Pessaries (200mg, 400mg) 20,000 - 21,000  
 17  Antepsin  Sucralfate  Tablets (1g) 20,000 - 21,000  
 18  Trental  Pentoxifylline  Tablets (400mg) 18,000 - 19,000  
 19  Hydrex Pink  Chlorhexidine Gluconate (CHG)  Topical Solution (20% v/v) 16,500 - 17,500  
 20  Gonasi HP Human Chorionic Gonadotrophin Powder and solvent for solution for injection (5000 I.U./ 1ml)

16,000 - 16,500  
 21 Kabi Parenteral Nutrition (Various) Various Nutritional Supplements  IV Infusion (Various) 15,000 - 16,000  
 22  Verorab Inactivated Rabies Vaccine Powder and solvent for solution for injection (2.5 I.U/0.5ml)

14,500 - 15,000  
 23  Bumetanide Bumetanide  Tablets (1g) 12,500 - 13,500  
 24  Sotalol  Sotalol Tablets (40mg, 80mg)

Solution for Injection (25mg/5ml)

11,000 - 12,000  
25   Slow Sodium  Sodium Chloride  Tablets (600mg) 11,000 - 12,000  
 26  Septanest Adrenaline/ Articane Hydrochloride Solution for Injection (1:100000/2.2ml, 1:200000/2.2ml, 88mg/2.2ml)

11,000 - 11,500  
 27  Cariban Doxylamine Succinate/ Pyridoxine Hydrochloride  Capsules (10mg) 10,000 - 11,000  
 28  Anafranil Clomipramine  Tablets (10mg, 25mg) 10,000 - 11,000  
 29  Galfer Ferrous Fumarate  Capsules (305mg) 10,000 - 11,000  
 30  Cefazoline Cefazoline
Powder and solution for injection (1g, 2g)

 9,500 - 10,000