asked the Minister for Health whether all untested drugs have been withdrawn from the market.
Written Answers. - Untested Drugs.
128.
I am assuming that the reference to untested drugs refers to drugs placed on the market in Ireland without the Irish PA number (Product Authorisation Number). Drugs could for example, carry a PL number (British Product Licence Number) or the licence reference of some other country of the European Community. Such references indicate that the drugs have been tested in the countries on whose markets they are placed but they may be illegal on the Irish market unless they carry the product authorisation number granted by me, following examination of the medical preparation by the National Drugs Advisory Board.
The regulations governing product authorisations are contained in the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. The legality or otherwise of a product which is on the market is determined by these regulations. Under the 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.
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 PA should be received |
Commencement date for product authorisation |
|
(a) Anti-Infectives |
1 December 1984 |
1 December 1985 |
|
(b) Hypnotics, sedatives, tranquillisers 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 |
The Department of Health 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.
A joint committee of the Department and the General Medical Services (Payments) Board will report shortly on the status of each product. The 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.
A number of companies have indicated they will be removing their products from the market by the due date. In January and February of this year, the Department placed a notice in the daily newspapers and trade journals indicating that all medical preparations excepting those in categories (e) and (f) must now hold a product authorisation and carry this product authorisation on the label. Following the placing of the advertisement a number of parallel importers came to our notice. The Department are at present corresponding with these companies.
A number of inspections have also been carried out and there is one prosecution pending.
I have also arranged that only medical preparations which hold or which are the subject of an application for a product authorisation will appear in the General Medical Services (Payments) Board Code Book in future where such an authorisation is required under the regulations.