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Subject: restricted medical prescription clin.trial. Пожалуйста, помогите перевести.Выражение встречается в следующем контексте:
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). Поиск в сети дал, в частности, следующее описание:
• Medicinal product subject to restricted medical prescription, where the medicinal product:
- is reserved for treatments which can only be followed in a hospital environment, because of its pharmaceutical characteristics or novelty or in the interests of public health,
- is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or
- is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. Также вот эта, информация, возможно, будет полезна:
Legal classification
”R” means prescription only medicine (in need of a medical prescription)
“N” means subjected to special (restricted) medical prescription (narcotics and similar)
“K” means over the counter (OTC) product. Правильно ли будет перевести данную фразу как "отпуск по рецепту с ограниченным применением", или, возможно, как-то иначе? Заранее спасибо.
С уважением, Юрий
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