asked the Minister for Health the steps, if any, he proposes to take to ensure that drugs without a product authorisation number are removed from the Irish market.
Written Answers. - Product Authorisation Number.
182.
1. The regulations governing product authorisations are contained in the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984.
2. Under these regulations all proprietary medical preparations and only non-proprietary medical preparations placed on the market after 1 October 1984 require product authorisations issued by me as Minister for Health from 1 October 1984.
3. In the case of non-proprietary medical preparations which were on the market prior to 1 October 1984, some for many years, it was decided that these should be reviewed by the National Drugs Advisory Board within a timetable which extends from October 1984 to April 1989 as set out in the second schedule to the regulations. Under these regulations applications for product authorisations are required 12 months before the commencement dates as follows:
Non-Proprietary Medicinal Preparations
|
Category of preparations |
Date by which Application for P.A. should be received |
Commencement date for Product Authorisation |
|
(a)Anti-Infectives |
1 December 1984 |
1 December 1985 |
|
(b)Hypnotics, sedatives, tranquilisers and anti-depressants |
1 April 1985 |
1 April 1986 |
|
(c)Corticosteriods, hormones diuretics and drugs affecting the cardiovascular system |
1 April 1986 |
1 April 1987 |
|
(d)Analgesics, miscellaneous central and autonomic nervous system drugs (including anaesthetics) |
1 April 1987 |
1 April 1988 |
|
(e)Metabiolic and haematinic drugs, products locally acting on skin or mucosa |
1 September 1987 |
1 September 1988 |
|
(f)Miscellaneous including products locally acting on gastrointestinal or respiratory tract |
1 April 1988 |
1 April 1989 |
4. My Department have written to all the companies known to be marketing medical preparations in categories (a) (b) and (c) requesting that they withdraw all products from the market which do not have product authorisations, are not the subject of application for product authorisations or the subject of application for review or renewal of product authorisations.
5. My Department have also written to companies known to be marketing medical preparations in categories (d) and (e) requesting that they make arrangements to withdraw their products from the market by the commencement dates if they have not submitted applications for product authorisations.
6. I am also placing a notice in the relevant journals indicating that all medical preparations excepting those in categories (d) (e) and (f) must now hold a product authorisation and carry this product authorisation number on the label. Authorised officers will also continue to carry out inspections in accordance with these regulations in particular to ensure that each product carries a product authorisation.
7. In addition, as part of this process I personally have had discussions with the Chairman and Medical Director of the National Drugs Advisory Board to ensure a speedy conclusion to the matter.