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 20 notified exempt medicines 2018

Product

Number of units notified

(approximate band)

1

Amitriptyline 10mg tablets

300,000-310,000

2

Bendroflumethiazide 2.5mg tablets

160,000-170,000

3

Hyoscine 1.5mg patches

110,000-115,000

4

Propranolol 10mg tablets

110,000-115,000

5

Chloramphenicol 1% eye ointment

50,000-60,000

6

Bendroflumethiazide 5mg tablets

25,001-35,000

7

Propranolol 40mg tablets

25,001-35,000

8

Hydrocortisone 1% ointment

25,001-35,000

9

Clomipramine 25mg tablets and capsules

25,001-35,000

10

Melatonin 1mg/ml liquid

20,001-25,000

11

Colchicine 500mcg tablets

20,001-25,000

12

Cefazolin 1g injection (individual vials)

20,001-25,000

13

Pentoxifylline 400mg tablets

20,001-25,000

14

Haloperidol 500mcg capsules & tablets

20,001-25,000

15

Hydrocortisone 10mg tablets

20,001-25,000

16

Progesterone 400mg pessaries

20,001-25,000

17

Co-Careldopa 25mg/100mg tablets

15,000-20,000

18

Doxylamine/Pyridoxine 10 mg/10 mg capsules

15,000-20,000

19

Sucralfate 1g tablets

15,000-20,000

20

Codeine 15mg tablets

15,000-20,000