asked the Minister for Health if he will introduce legislation to prevent the export of pharmaceutical drugs and biotechnological products from this country whose sale and use in this country is not approved by his Department.
Written Answers. - Export of Pharmaceutical Products.
170.
Many pharmaceutical drugs currently being exported from this country are already authorised for sale and use on the Irish market. However, I not think it would be appropriate to introduce legislation to prevent the export from this country of those pharmaceutical products whose sale and use in this country is not approved by my Department. For example, may such products currently being exported would not be appropriate for sale or use in this country because of the specific conditions which they are designed to treat.
However, while our product authorisation scheme does not apply to products manufactured in Ireland for sale only in other countries, the manufacture of all such products, whether for sale in this country or for export, is subject to a statutory licensing scheme. All manufacturing plants are inspected at regular intervals in the course of which the requirements for good practices in the manufacture and quality control of drugs as recommended by WHO are applied as well as those of the Pharmaceutical Inspection Convention (EFTA).
This country also fully participates in the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. This certification scheme was designed primarily to safeguard the interests of developing countries which lack adequate laboratory facilities for drug analysis.