Why is it necessary to explain the reasons for which a product with marketing authorisation cannot be used?
The Finnish Medicines Agency (Fimea) may grant a special permit for the use of a medicinal product for special reasons, if authorised products will not yield the desired result. The person prescribing the medicine is required to explain the special medical reasons for which the medicinal product is needed. Fimea makes its decisions in accordance with the Medicines Act 395/1987 (Section 21 f) and the Medicines Decree 693/1987 (Section 10 b and c). The so-called cascade rule on the use of medicines reflects the same principle.