Any pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions.
A Medicinal Product may contain in the packaging one or more manufactured items and one or more pharmaceutical products. In certain regions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.
This applies to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorized by a Medicines Regulatory Agency. However, the provisions do not apply to:
(i) medicinal products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient)
(ii) medicinal products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy)
(iii) medicinal products intended for research and development trials intermediate products intended for subsequent processing by an authorized manufacturer.