Furthermore, by the end of 2011, 72 new paediatric indications had been approved for medicines already authorised, including 30 indications (18 centralised) arising from the obligation in Article Moreover, 26 new pharmaceutical forms were authorised for paediatric use, including 18 adapted forms for centrally authorised medicines.

4)‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.

As representatives from the FDA noted in a publication I believe it was The New England Journal of Medicine the immense biological subtlety of human pharmaceuticals often cannot practically or adequately be detected in formal clinical studies.

Where a medicinal product is intended for a different therapeutic use or presented in a different pharmaceutical form or to be administered by different routes or in different doses or with a different posology, the results of appropriate toxicological and pharmacological tests and/or of clinical trials shall be provided.

Vitamins for pharmaceutical purposes are marketed to the public as diet supplements in tablet or capsule form.

- Since the notifying parties have overlapping activities of limited importance in the oral care and pharmaceutical businesses, they undertake that none of their activities pursuant to the agreements, including the exchange of information or any other form of cooperation, will involve products other than SPP.