Does the Irish Department of Health allow for reimbursement of unlicensed or exempt medicines?
1. The medicinal product concerned should be an allopathic medicinal product which has been industrially produced and which is appropriate for use in the community.
2. The medicinal product concerned should be such that no authorised medicinal product of essential similarity is available for prescription and supply under the Community Drug Scheme concerned.
3. The prescription concerned should be written or initiated by a medical consultant who is aware of the unauthorised status of the medicinal product concerned and who has informed the patient of the situation.
4. The dispensing pharmacist has also informed the patient of the unauthorised status of the medicinal product prescribed and that its quality, safety and efficacy has not been established in this country.
5. The medicinal product concerned is not being advertised or promoted in the State either as such or in any trade catalogue or price list in circulation in the State.
6. The application made for re-imbursement is accompanied by a copy of the invoice relating to the supply of the medicinal product to the pharmacist concerned and, if necessary, is supported by an explanation of the special circumstances which required the supply of the unauthorised medicinal product.
8. The cost of the medicinal product concerned should be reasonable in the context of medicinal products ordinarily supplied and used in the community and be of a category which, if it were authorised, would be eligible for reimbursement in the Community Drug Scheme concerned.
9. The original prescription or a copy thereof, together with appropriate records of supply, is retained in the pharmacy and kept available for inspection as required.